Report Sections

See All Reports

Coronavirus Infections (722) Severe Acute Respiratory Syndrome (493) Infection (402) Pneumonia (331) Communicable Diseases (176) Respiratory Distress Syndrome, Adult (161) Acute Lung Injury (126) Respiratory Distress Syndrome, Newborn (126) (114) Syndrome (106) Virus Diseases (85) Pneumonia, Viral (73) Critical Illness (63) Depression (62) Anxiety Disorders (44) Disease (39) Stress Disorders, Post-Traumatic (34) Emergencies (31) Respiratory Tract Infections (31) Inflammation (30) Neoplasms (30) Cardiovascular Diseases (29) Stress Disorders, Traumatic (29) Wounds and Injuries (29) Lung Injury (27) Stress, Psychological (27) Mental Disorders (26) Diabetes Mellitus (25) Hypoxia (25) Depressive Disorder (24) Thrombosis (23) Hypertension (22) Respiratory Tract Diseases (22) Acute Kidney Injury (21) Lung Diseases (21) Disease Progression (18) Olfaction Disorders (18) Embolism (16) Influenza, Human (16) Stroke (16) Arthritis (15) Pulmonary Embolism (15) Respiration Disorders (15) Blood Coagulation Disorders (14) HIV Infections (14) Hemostatic Disorders (14) Thromboembolism (14) Burnout, Psychological (13) Chronic Disease (13) Fibrosis (13) Lung Diseases, Obstructive (13) Multiple Sclerosis (13) Sclerosis (13) Cognitive Dysfunction (12) Diabetes Mellitus, Type 2 (12) Lung Diseases, Interstitial (12) Myocardial Infarction (12) Pulmonary Disease, Chronic Obstructive (12) Pulmonary Fibrosis (12) Respiratory Aspiration (12) Arthritis, Rheumatoid (11) Autism Spectrum Disorder (11) Brain Injuries (11) Chronic Pain (11) Heart Diseases (11) Kidney Diseases (11) Substance-Related Disorders (11) Venous Thrombosis (11) Crohn Disease (10) Diabetes Mellitus, Type 1 (10) Heart Failure (10) Infarction (10) Lung Neoplasms (10) Autistic Disorder (9) Dyspnea (9) Myocarditis (9) Obesity (9) Pneumonia, Ventilator-Associated (9) Pregnancy Complications (9) Brain Injuries, Traumatic (8) Carcinoma (8) Colitis (8) Colitis, Ulcerative (8) Depression, Postpartum (8) Liver Diseases (8) Renal Insufficiency, Chronic (8) Respiratory Syncytial Virus Infections (8) Rheumatic Diseases (8) Ulcer (8) Vitamin D Deficiency (8) Coronary Artery Disease (7) Coronary Disease (7) Dementia (7) Feeding and Eating Disorders (7) Hematologic Neoplasms (7) Infertility (7) Inflammatory Bowel Diseases (7) Kidney Failure, Chronic (7) Parkinson Disease (7) Problem Behavior (7) Pulmonary Valve Insufficiency (7) Venous Thromboembolism (7) Burnout, Professional (6) Collagen Diseases (6) Frailty (6) Immune System Diseases (6) Immunologic Deficiency Syndromes (6) Ischemia (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Musculoskeletal Pain (6) Overweight (6) Parasomnias (6) Pediatric Obesity (6) Psychotic Disorders (6) RNA Virus Infections (6) Sepsis (6) Shock (6) Spinal Cord Injuries (6) Acute Coronary Syndrome (5) Alcohol Drinking (5) Alcoholism (5) Autoimmune Diseases (5) Breast Neoplasms (5) Carcinoma, Non-Small-Cell Lung (5) Child Development Disorders, Pervasive (5) Convalescence (5) Coronaviridae Infections (5) Cystic Fibrosis (5) Delirium (5) Depressive Disorder, Major (5) Disease Susceptibility (5) Dyssomnias (5) Gastroparesis (5) Hypersensitivity (5) Leukemia (5) Lymphopenia (5) Multiple Organ Failure (5) Myocardial Ischemia (5) Neurologic Manifestations (5) Osteoarthritis (5) Prostatic Neoplasms (5) Renal Insufficiency (5) Alzheimer Disease (4) Asthma (4) Attention Deficit Disorder with Hyperactivity (4) Behavior, Addictive (4) Body Weight (4) Brain Diseases (4) Coinfection (4) Colonic Neoplasms (4) Death (4) Deglutition Disorders (4) Disseminated Intravascular Coagulation (4) Embolism and Thrombosis (4) Fibromyalgia (4) Head and Neck Neoplasms (4) Heart Arrest (4) Hemorrhage (4) Hypertension, Pulmonary (4) Liver Cirrhosis (4) Metabolic Syndrome (4) Migraine Disorders (4) Mycobacterium Infections (4) Neoplasm Metastasis (4) (4) Pancreatic Neoplasms (4) Postoperative Complications (4) Prediabetic State (4) Signs and Symptoms, Respiratory (4) Sjogren's Syndrome (4) Sleep Apnea Syndromes (4) Sleep Initiation and Maintenance Disorders (4) Thrombophilia (4) Vascular Diseases (4) Weight Loss (4) Acquired Immunodeficiency Syndrome (3) Adenoviridae Infections (3) Appendicitis (3) Arrhythmias, Cardiac (3) Arthritis, Psoriatic (3) Asymptomatic Diseases (3) Bronchiectasis (3) Carcinoma, Renal Cell (3) Cardiomyopathies (3) Chilblains (3) Common Cold (3) Cross Infection (3) Dermatitis (3) Developmental Disabilities (3) Digestive System Diseases (3) Dysgeusia (3) Endometriosis (3) Fatigue (3) Fever (3) Gastrointestinal Diseases (3) Giant Cell Arteritis (3) Glucose Intolerance (3) Glucose Metabolism Disorders (3) Hemophilia A (3) Leukemia, Lymphoid (3) Macular Edema (3) Malnutrition (3) Measles (3) Melanoma (3) Metabolic Diseases (3) Mucocutaneous Lymph Node Syndrome (3) (3) Nervous System Diseases (3) Neuroendocrine Tumors (3) Occupational Stress (3) Osteoarthritis, Knee (3) Ovarian Neoplasms (3) Panic Disorder (3) Paramyxoviridae Infections (3) Peripheral Arterial Disease (3) Polymyalgia Rheumatica (3) Precursor Cell Lymphoblastic Leukemia-Lymphoma (3) Pregnancy Complications, Infectious (3) Premature Birth (3) Psychological Trauma (3) Pulmonary Edema (3) Rheumatic Fever (3) ST Elevation Myocardial Infarction (3) Schizophrenia (3) Seizures (3) Sleep Apnea, Obstructive (3) Sleep Wake Disorders (3) Systemic Inflammatory Response Syndrome (3) Taste Disorders (3) Tobacco Use Disorder (3) Triple Negative Breast Neoplasms (3) Ventricular Dysfunction (3) Ventricular Dysfunction, Left (3) Acute Disease (2) Ageusia (2) Agoraphobia (2) Alopecia (2) Alpha 1-Antitrypsin Deficiency (2) Amyotrophic Lateral Sclerosis (2) Anemia, Sickle Cell (2) Angina Pectoris (2) Angioedema (2) Angioedemas, Hereditary (2) Anxiety, Separation (2) Arteritis (2) Asymptomatic Infections (2) Atherosclerosis (2) Atrial Fibrillation (2) Bacterial Infections (2) Behcet Syndrome (2) Bipolar Disorder (2) Caliciviridae Infections (2) Clinical Deterioration (2) Cognition Disorders (2) Colorectal Neoplasms (2) Communicable Diseases, Emerging (2) Compassion Fatigue (2) Compulsive Personality Disorder (2) Congenital Abnormalities (2) Conjunctivitis (2) Dermatitis, Atopic (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Eczema (2) Emphysema (2) Endocrine System Diseases (2) Fatigue Syndrome, Chronic (2) Ganglion Cysts (2) Gastroenteritis (2) Gastroesophageal Reflux (2) Gaucher Disease (2) Glioblastoma (2) Headache (2) Healthcare-Associated Pneumonia (2) Heart Defects, Congenital (2) Heart Failure, Systolic (2) Hematologic Diseases (2) Huntington Disease (2) Hyperglycemia (2) Hyperkinesis (2) Hyperphagia (2) Hypothermia (2) Hypoventilation (2) Idiopathic Pulmonary Fibrosis (2) Intervertebral Disc Degeneration (2) Intestinal Diseases (2) Ischemic Attack, Transient (2) Jaundice (2) Leukemia, Myeloid, Acute (2) Lymphoproliferative Disorders (2) Macular Degeneration (2) Mobility Limitation (2) Mood Disorders (2) Motor Neuron Disease (2) Multiple Myeloma (2) Multiple Sclerosis, Relapsing-Remitting (2) Muscular Dystrophies (2) Mutism (2) Mycoses (2) Myelodysplastic Syndromes (2) Myeloproliferative Disorders (2) Myositis (2) Necrosis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neurodevelopmental Disorders (2) Nidovirales Infections (2) Noncommunicable Diseases (2) Nutrition Disorders (2) Obesity, Morbid (2) Obsessive-Compulsive Disorder (2) Oral Manifestations (2) Pain, Postoperative (2) Peripheral Vascular Diseases (2) Phobia, Social (2) Phobic Disorders (2) Pneumonia, Pneumocystis (2) Psoriasis (2) Purpura, Thrombocytopenic, Idiopathic (2) Rare Diseases (2) Recurrence (2) Respiratory Sounds (2) Sarcoidosis (2) Shock, Septic (2) Small Cell Lung Carcinoma (2) Spinal Diseases (2) Sprains and Strains (2) Suicidal Ideation (2) Suicide (2) Tachycardia (2) Thoracic Diseases (2) Thrombocytopenia (2) Toxemia (2) Trauma and Stressor Related Disorders (2) Tuberculosis (2) Urinary Bladder, Overactive (2) Urinary Tract Infections (2) Uterine Cervical Neoplasms (2) Uveitis (2) Vision Disorders (2) Vision, Low (2) Yellow Fever (2) Abruptio Placentae (1) Acalculous Cholecystitis (1) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Alcohol Drinking in College (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Alveolitis, Extrinsic Allergic (1) Amblyopia (1) Anemia, Aplastic (1) Angina, Stable (1) Anorexia (1) Anorexia Nervosa (1) Aortic Valve Stenosis (1) Apnea (1) Arthritis, Juvenile (1) Aspergillosis (1) Aspergillosis, Allergic Bronchopulmonary (1) Asphyxia Neonatorum (1) Asthenopia (1) Atrioventricular Block (1) Atrophy (1) Autonomic Nervous System Diseases (1) Back Pain (1) Bacteremia (1) Barotrauma (1) Birth Weight (1) Blister (1) Body Weight Changes (1) Bone Diseases, Metabolic (1) Bradycardia (1) Brain Concussion (1) Breast Cancer Lymphedema (1) Bronchial Diseases (1) Bronchiolitis (1) Bronchitis (1) Bronchitis, Chronic (1) Bronchopulmonary Dysplasia (1) Brucellosis (1) Bulimia (1) Calculi (1) Carcinoma, Hepatocellular (1) Carcinoma, Ovarian Epithelial (1) Carcinoma, Small Cell (1) Carcinoma, Squamous Cell (1) Cardiovascular Abnormalities (1) Cataract (1) Celiac Disease (1) Cellulitis (1) Cerebral Hemorrhage (1) Cerebral Palsy (1) Cerebrovascular Disorders (1) Chest Pain (1) Chlamydia Infections (1) Cholangiocarcinoma (1) Cholangitis (1) Cholecystitis (1) Cholecystitis, Acute (1) Chronic Traumatic Encephalopathy (1) Clostridium Infections (1) (1) Colonic Diseases (1) Communication Disorders (1) Compulsive Behavior (1) Consciousness Disorders (1) Constipation (1) Constriction, Pathologic (1) Conversion Disorder (1) (1) (1) Coronary Artery (1) Coronary Stenosis (1) (1) Cough (1) Coxsackievirus Infections (1) Cryopyrin-Associated Periodic Syndromes (1) Deafness (1) Death, Sudden, Cardiac (1) Dental Calculus (1) Dental Plaque (1) Depressi (1) Depressive Disorder, Treatment-Resistant (1) DiGeorge Syndrome (1) Diabetic Nephropathies (1) Diabetic Neuropathies (1) Diphtheria (1) (1) Down Syndrome (1) Dyspareunia (1) Emergence Delirium (1) Encephalitis (1) Endocarditis (1) Endophthalmitis (1) Endotoxemia (1) Enuresis (1) Epilepsy (1) Esophageal and Gastric Varices (1) Esophagitis, Peptic (1) Eye Diseases (1) Eye Infections (1) Fabry Disease (1) Facial Pain (1) Familial Mediterranean Fever (1) Fatty Liver (1) (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fever of Unknown Origin (1) Fistula (1) Food Hypersensitivity (1) Fractures, Closed (1) Fractures, Stress (1) Gait Disorders, Neurologic (1) Genetic Diseases, Inborn (1) Genetic Predisposition to Disease (1) Gestational Weight Gain (1) Gingivitis, Necrotizing Ulcerative (1) Gout (1) (1) Headache Disorders, Secondary (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Failure, Diastolic (1) Heart Murmurs (1) Helminthiasis (1) Hematoma (1) Hematoma, Subdural (1) Hematoma, Subdural, Chronic (1) Hemoglobinopathies (1) Hepatitis (1) Hepatitis A (1) Hepatitis C (1) Hepatitis, Alcoholic (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hodgkin Disease (1) Hyaline Membrane Disease (1) Hyperaldosteronism (1) Hypercapnia (1) Hyperphosphatemia (1) Hyperplasia (1) Hypersensitivity, Immediate (1) Hypertension, Pregnancy-Induced (1) Hypokalemia (1) Hyponatremia (1) Hypoparathyroidism (1) Hypotension (1) Iatrogenic Disease (1) Infant, Newborn, Diseases (1) Infec (1) Infecti (1) Infertility, Female (1) Infertility, Male (1) Intellectual Disability (1) Intestinal Atresia (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Joint Diseases (1) Keratoconjunctivitis (1) Keratosis (1) Keratosis, Actinic (1) Leishmaniasis (1) Leukemia, Lymphocytic, Chronic, B-Cell (1) Leukemia, Myeloid (1) Leukemia, Myelomonocytic, Acute (1) Leukemia, Myelomonocytic, Chronic (1) Liver Cirrhosis, Biliary (1) Liver Failure (1) Low Back Pain (1) Lung (1) Lyme Disease (1) Lymphedema (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Mantle-Cell (1) Macrophage Activation Syndrome (1) Malaria (1) Maternal Death (1) Maxillofacial Injuries (1) Memory Disorders (1) Meningitis (1) Meningitis, Meningococcal (1) Menorrhagia (1) Menstruation Disturbances (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Molluscum Contagiosum (1) Monoclonal Gammopathy of Undetermined Significance (1) Mouth Diseases (1) Mouth, Edentulous (1) Movement Disorders (1) Mucositis (1) Multiple Chronic Conditions (1) Muscle Spasticity (1) Muscular Atrophy (1) Muscular Dystrophy, Duchenne (1) Myalgia (1) Myocardial Reperfusion Injury (1) Myofascial Pain Syndromes (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Neurobehavioral Manifestations (1) Neurocognitive Disorders (1) Neuromyelitis Optica (1) Non-alcoholic Fatty Liver Disease (1) Obsessive Behavior (1) Olfactory Nerve Injuries (1) Orbital Cellulitis (1) Osteoarthritis, Hip (1) Osteochondritis (1) Osteomyelitis (1) Otitis Media with Effusion (1) Overweig (1) Pain (1) Pain, Procedural (1) Pancreatitis (1) Paraproteinemias (1) Paresis (1) Peanut Hypersensitivity (1) Perinatal Death (1) Periodontal Diseases (1) Peripheral Nervous System Diseases (1) Peritoneal Neoplasms (1) Pharyngeal Diseases (1) Pleuropneumonia (1) (1) (1) Pneumonia, Bacterial (1) Pneumonia, V (1) Pre-Eclampsia (1) Pregnancy in Diabetics (1) Preleukemia (1) Primary Dysautonomias (1) Prostatic Hyperplasia (1) Protein-Energy Malnutrition (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Aspergillosis (1) Pulmonary Atelectasis (1) Pulmonary Eosinophilia (1) Radiculopathy (1) Rectal Neoplasms (1) Reperfusion Injury (1) (1) (1) Respiratory Distress Sy (1) Respiratory Hypersensitivity (1) Retinal Vein Occlusion (1) Rupture (1) Sarcoidosis, Pulmonary (1) Sarcopenia (1) Schizophrenia Spectrum and Other Psychotic Disorders (1) (1) Scleroderma, Localized (1) Scleroderma, Systemic (1) Self-Injurious Behavior (1) Severe Acute Respiratory Syn (1) Sexually Transmitted Diseases (1) Sexually Transmitted Diseases, Bacterial (1) Shock, Cardiogenic (1) Short Bowel Syndrome (1) Signs and Symptoms, Digestive (1) Skin Abnormalities (1) Skin Diseases (1) Skin Manifestations (1) Skin Neoplasms (1) Skull Fractures (1) Sleep Apnea, Central (1) Soft Tissue Neoplasms (1) Somatoform Disorders (1) Spinal Stenosis (1) Spondylarthritis (1) Spondylolisthesis (1) Status Epilepticus (1) Stillbirth (1) Stomatitis (1) Str (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Superinfection (1) Syncope (1) Syncope, Vasovagal (1) Tachycardia, Sinus (1) Tachycardia, Ventricular (1) Temporomandibular Joint Disorders (1) Temporomandibular Joint Dy (1) Temporomandibular Joint Dysfunction Syndrome (1) Thalassemia (1) Thrombophlebitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Trauma, Nervous System (1) Trichuriasis (1) Tuberculosis, Pulmonary (1) Ulce (1) Urinary Bladder, Underactive (1) Urinary Incontinence (1) Urinary Retention (1) Urologic Diseases (1) Urticaria (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Ventricular Dysfunction, Right (1) Virus Dis (1) Von Willebrand Diseases (1) Vulvar Neoplasms (1) Weight Gain (1) Xerostomia (1) beta-Thalassemia (1)

D004194: Disease

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (75)


Name (Synonyms) Correlation
drug557 Brief cognitive intervention Wiki 0.23
drug491 Biological: mRNA-1273: 100 mcg Wiki 0.16
drug635 COVID-19 FACILITY Wiki 0.16
Name (Synonyms) Correlation
drug637 COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) Wiki 0.16
drug1268 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.16
drug1695 Interleukin assessment in semen Wiki 0.16
drug2527 Placebo Infusion Wiki 0.16
drug2398 PLACEBO GROUP Wiki 0.16
drug2777 RO6953958 Wiki 0.16
drug1309 Feeling Good Digital App Wiki 0.16
drug929 Counter Attitudinal Therapy Wiki 0.16
drug2661 Prolonged Exposure (PE) Wiki 0.16
drug2869 Reporting of anosmia, ageusia and other clinical symptoms Wiki 0.16
drug4176 zinc Wiki 0.16
drug2836 Reconsolidation of Traumatic Memories (RTM) Wiki 0.16
drug1559 Hydroxychloroquine plus standard preventive measures Wiki 0.16
drug1590 IIEF-5 questionnaire Wiki 0.16
drug510 Blood collection on their first consultation and 10 to 14 days later Wiki 0.16
drug1677 Injection into olfactory cleft Wiki 0.16
drug3079 Semen Qualitative Analysis Wiki 0.16
drug3949 lung ultrasound Wiki 0.16
drug2853 Relaxation Therapy Wiki 0.16
drug3511 Training video on anxiety, fear and loneliness in the COVID-19 environment. Wiki 0.16
drug490 Biological: COVID-19 convalescent plasma Wiki 0.16
drug492 Biological: mRNA-1273: 50 mcg Wiki 0.16
drug3384 Tele-delivered psychological intervention Wiki 0.16
drug514 Blood for pharmacokinetic samples Wiki 0.16
drug2049 Mindful Self-Compassion Wiki 0.16
drug1961 Male Sexual Health Questionnaire (MSHQ) Wiki 0.16
drug1602 IPSS questionnaire Wiki 0.16
drug2990 SECRET questionnaire Wiki 0.16
drug3510 Training session adressing information and health literacy Wiki 0.16
drug2943 SARS-CoV 2 RNA PCR Urine Wiki 0.16
drug3438 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.16
drug388 BCG GROUP Wiki 0.16
drug641 COVID-19 PCR and serology testing Wiki 0.16
drug446 Barrier box Wiki 0.16
drug874 Connor-Davidson Resilience Scale 10 items (CD-RISC 10) Wiki 0.16
drug919 Cord Tissue Mesenchymal Stromal Cells Wiki 0.16
drug513 Blood for anti-drug antibody (ADA) Wiki 0.16
drug1708 Intervention App Wiki 0.16
drug3726 Woebot Substance Use Disorder Wiki 0.16
drug2150 Narrative Exposure Therapy Wiki 0.16
drug3197 Standard Dissemination Practice Wiki 0.16
drug2164 Nasopharyngeal, oropharyngeal, or saliva swab Wiki 0.16
drug2425 Parents and Infants Engaged Wiki 0.16
drug726 Cannabis, Medical Wiki 0.16
drug1258 Exposure to the SARS-CoV-2 and its consequences Wiki 0.16
drug1234 Exercise Intervention Wiki 0.16
drug2065 MinnRAP Peer Support Program Wiki 0.16
drug1642 Implementation Facilitation (IF) Wiki 0.16
drug1707 Interpersonal Therapy Wiki 0.16
drug2559 Placebo plus standard preventive measures Wiki 0.16
drug2476 Personal protective equipment from biological hazard Wiki 0.16
drug1714 Interview by psychologists Wiki 0.16
drug2370 PACE-Life Wiki 0.16
drug1255 Exposure Therapy Wiki 0.16
drug554 Brief Psychiatric Rating Scale Wiki 0.16
drug509 Blood collection on admission and longitudinally Wiki 0.16
drug1022 Depression, Anxiety and Stress Scale Wiki 0.16
drug2142 NT-I7 Wiki 0.16
drug374 Açaí palm berry extract - natural product Wiki 0.16
drug515 Blood for research purposes Wiki 0.16
drug1641 Impact of Event Scale-Revised Wiki 0.16
drug2942 SARS-CoV 2 RNA PCR Semen Wiki 0.16
drug399 BI 474121 Wiki 0.11
drug821 Cognitive Behavioral Therapy Wiki 0.11
drug648 COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki 0.11
drug2484 Phone call Wiki 0.11
drug422 BNT162b2 Wiki 0.11
drug644 COVID-19 RT-PCR Wiki 0.09
drug421 BNT162b1 Wiki 0.09
drug389 BCG Vaccine Wiki 0.08
drug776 Chloroquine Wiki 0.06
drug2505 Placebo Wiki 0.05

Correlated MeSH Terms (84)


Name (Synonyms) Correlation
D013313 Stress Disorders, Post-Traumatic NIH 0.33
D001523 Mental Disorders NIH 0.31
D040921 Stress Disorders, Traumatic NIH 0.30
Name (Synonyms) Correlation
D000067877 Autism Spectrum Disorder NIH 0.24
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.24
D019964 Mood Disorders NIH 0.23
D001010 Anxiety, Separation NIH 0.23
D065886 Neurodevelopmental Disorders NIH 0.23
D000072861 Phobia, Social NIH 0.23
D000068099 Trauma and Stressor Related Disorders NIH 0.23
D000379 Agoraphobia NIH 0.23
D002659 Child Development Disorders, Pervasive NIH 0.21
D016584 Panic Disorder NIH 0.18
D000067073 Psychological Trauma NIH 0.18
D000066553 Problem Behavior NIH 0.18
D001008 Anxiety Disorders NIH 0.17
D019967 Schizophrenia Spectrum and Other Psychotic Disorders NIH 0.16
D013001 Somatoform Disorders NIH 0.16
D000070627 Chronic Traumatic Encephalopathy NIH 0.16
D015775 Fractures, Stress NIH 0.16
D009069 Movement Disorders NIH 0.16
D001997 Bronchopulmonary Dysplasia NIH 0.16
D008595 Menorrhagia NIH 0.16
D006929 Hyperaldosteronism NIH 0.16
D054559 Hyperphosphatemia NIH 0.16
D004314 Down Syndrome NIH 0.16
D001321 Autistic Disorder NIH 0.16
D011602 Psychophysiologic Disorders NIH 0.16
D003291 Conversion Disorder NIH 0.16
D005879 Tourette Syndrome NIH 0.16
D061219 Olfactory Nerve Injuries NIH 0.16
D000309 Adrenal Insufficiency NIH 0.16
D007008 Hypokalemia NIH 0.16
D019966 Substance-Related Disorders NIH 0.14
D010300 Parkinsonian NIH 0.12
D000857 Olfaction Disorders NIH 0.11
D009771 Obsessive-Compulsive Disorder NIH 0.11
D000070642 Brain Injuries, Traumatic NIH 0.11
D000690 Amyotrophic Lateral Sclerosis NIH 0.11
D006948 Hyperkinesis NIH 0.11
D014552 Urinary Tract Infections NIH 0.11
D009155 Mutism NIH 0.11
D000755 Anemia, Sickle Cell NIH 0.11
D003193 Compulsive Personality Disorder NIH 0.11
D016472 Motor Neuron Disease NIH 0.11
D000068376 Compassion Fatigue NIH 0.11
D010698 Phobic Disorders NIH 0.11
D001714 Bipolar Disorder NIH 0.11
D001930 Brain Injuries, NIH 0.10
D012559 Schizophrenia NIH 0.09
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.09
D012640 Seizures NIH 0.09
D002658 Developmental Disabilities NIH 0.09
D009422 Nervous System Diseases NIH 0.09
D013651 Taste Disorders NIH 0.09
D014947 Wounds and Injuries NIH 0.09
D005356 Fibromyalgia NIH 0.08
D001927 Brain Diseases NIH 0.08
D006470 Hemorrhage NIH 0.08
D009461 Neurologic Manifestations NIH 0.07
D000437 Alcoholism NIH 0.07
D007153 Immunologic Deficiency Syndromes NIH 0.07
D011618 Psychotic Disorders NIH 0.07
D013315 Stress, Psychological NIH 0.06
D001068 Feeding and Eating Disorders NIH 0.06
D015212 Inflammatory Bowel Diseases NIH 0.06
D007238 Infarction NIH 0.05
D003424 Crohn Disease NIH 0.05
D059350 Chronic Pain NIH 0.05
D012598 Scoliosi NIH 0.04
D009103 Multiple Sclerosis NIH 0.04
D020141 Hemostatic Disorders NIH 0.04
D001778 Blood Coagulation Disorders NIH 0.04
D020521 Stroke NIH 0.04
D009203 Myocardial Ischemia NIH 0.04
D006973 Hypertension NIH 0.03
D003866 Depressive Disorder NIH 0.03
D013577 Syndrome NIH 0.03
D004630 Emergencies NIH 0.03
D003141 Communicable Diseases NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D016638 Critical Illness NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D007239 Infection NIH 0.02

Correlated HPO Terms (28)


Name (Synonyms) Correlation
HP:0000729 Autistic behavior HPO 0.24
HP:0007018 Attention deficit hyperactivity disorder HPO 0.24
HP:0000756 Agoraphobia HPO 0.23
Name (Synonyms) Correlation
HP:0000708 Behavioral abnormality HPO 0.18
HP:0002905 Hyperphosphatemia HPO 0.16
HP:0006802 Abnormal anterior horn cell morphology HPO 0.16
HP:0002900 Hypokalemia HPO 0.16
HP:0000846 Adrenal insufficiency HPO 0.16
HP:0000717 Autism HPO 0.16
HP:0000132 Menorrhagia HPO 0.16
HP:0007354 Amyotrophic lateral sclerosis HPO 0.16
HP:0000859 Hyperaldosteronism HPO 0.16
HP:0002487 Hyperkinetic movements HPO 0.11
HP:0100754 Mania HPO 0.11
HP:0002300 Mutism HPO 0.11
HP:0000722 Obsessive-compulsive behavior HPO 0.09
HP:0001250 Seizure HPO 0.09
HP:0100753 Schizophrenia HPO 0.09
HP:0000458 Anosmia HPO 0.09
HP:0001298 Encephalopathy HPO 0.08
HP:0002721 Immunodeficiency HPO 0.07
HP:0000709 Psychosis HPO 0.07
HP:0002037 Inflammation of the large intestine HPO 0.06
HP:0012532 Chronic pain HPO 0.05
HP:0100280 Crohn's disease HPO 0.05
HP:0001928 Abnormality of coagulation HPO 0.04
HP:0000822 Hypertension HPO 0.04
HP:0000716 Depressivity HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 39 clinical trials


1 Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth

This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder....

NCT00025935
Conditions
  1. Mood Disorder
MeSH:Disease Mood Disorders

Primary Outcomes

Description: This study will examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variablesin individuals with SMD or DMDD and/or MDD, BD (BD, see protocol 00-M-0198) or those with anxiety (01-M-0192) (Leibenluf

Measure: This study will examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables

Time: ongoing
2 Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety

Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life anxiety, but as many as 40% of young patients who receive CBT fail to get better. The proposed study will examine brain changes marking positive response to CBT for anxiety and how these changes may differ in children compared adolescents. By helping us to understand how CBT works, this study will pave the way for new treatments to stop anxiety early.

NCT02810171
Conditions
  1. Anxiety Disorders
  2. Social Anxiety Disorder
  3. Social Phobia
  4. Generalized Anxiety Disorder
  5. Separation Anxiety Disorder
  6. Specific Phobia
  7. Phobia
  8. Agoraphobia
  9. Panic Disorder
  10. Panic Attack
  11. Anxiety
Interventions
  1. Behavioral: Cognitive Behavioral Therapy
  2. Behavioral: Relaxation Therapy
MeSH:Disease Anxiety Disorders Phobic Disorders Panic Disorder Phobia, Social Agoraphobia Anxiety, Separation
HPO:Agoraphobia

Primary Outcomes

Description: Pre- to post-CBT changes in functional, connectivity and structural MRI measures of brain networks relevant for anxiety. Brain regions include the amygdala, anterior insula, dorsal anterior cingulate cortex (dACC) and ventrolateral prefrontal cortex (vlPFC). Functional activation and connectivity of these brain regions are assessed using simple computer tasks performed during MRI scanning. Tasks engage threat reactivity, self-regulatory control and the interaction of these processes. Structural connections between regions will be measured using a MRI technique that measures water diffusion in the brain.

Measure: Brain function/structure as assessed by Magnetic Resonance Imaging scans

Time: Baseline and 12-weeks

Secondary Outcomes

Description: The Pediatric Anxiety Rating Scale (PARS) is a clinician-administered assessment to rate the severity of anxiety symptoms associated with common DSM-V anxiety disorders (social phobia, separation anxiety disorder, and generalized anxiety disorder) in children. The investigators are looking for decreases in anxiety severity ratings from pre- to post-treatment.

Measure: Pediatric Anxiety Rating Scale

Time: weeks 0, 3, 6, 9, 12
3 Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069

The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.

NCT03023930
Conditions
  1. Opioid Use Disorder
Interventions
  1. Other: Standard Dissemination Practice
  2. Other: Implementation Facilitation (IF)
MeSH:Disease Emergencies Substance-Related Disorders

Primary Outcomes

Description: The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT over the 12 month period.

Measure: Implementation (Considered the Primary Outcome)

Time: 12 months

Description: The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.

Measure: Effectiveness

Time: 30 Days Post Enrollment

Secondary Outcomes

Description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.

Measure: Implementation: Fidelity

Time: Baseline Period (Baseline)

Description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.

Measure: Implementation: Fidelity

Time: IF Evaluation Period (18 months)

Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Measure: Implementation: ED provider Readiness and Preparedness Ruler Score

Time: Pre IF (Baseline)

Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Measure: Implementation: ED provider Readiness and Preparedness Ruler Score

Time: Post IF (6 months)

Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Measure: Implementation: ED provider Readiness and Preparedness Ruler Score

Time: post IF Evaluation Period (12 months)

Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score

Time: Pre IF (Baseline)

Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score

Time: Post IF (6 months)

Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score

Time: Post IF Evaluation Period (12 months)

Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community Readiness and Preparedness Ruler Score

Time: Pre IF (Baseline)

Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community Readiness and Preparedness Ruler Score

Time: Post IF (6 months)

Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community Readiness and Preparedness Ruler Score

Time: post IF Evaluation Period (12 months)

Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community ORCA Score

Time: Pre IF (Baseline)

Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community ORCA Score

Time: Post IF (6 months)

Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Measure: Implementation: Community ORCA Score

Time: post IF Evaluation Period (12 months)

Description: Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days

Measure: Effectiveness: Opioid Use

Time: 30 days post enrollment

Description: Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records

Measure: Effectiveness: Overdose Event

Time: 30 days post enrollment

Description: HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale

Measure: Effectiveness: HIV Risk

Time: 30 days post enrollment

Description: All Healthcare Service Utilization Inpatient and Outpatient

Measure: Effectiveness: Healthcare Service Utilization

Time: 30 days post enrollment

Description: Rates of illicit opioid negative urines

Measure: Effectiveness: Illicit Opioid Urine Toxicology

Time: 30 days post enrollment
4 Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders

Most people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews. In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.

NCT03261050
Conditions
  1. Eating Disorder
Interventions
  1. Behavioral: Counter Attitudinal Therapy
  2. Behavioral: Interpersonal Therapy
MeSH:Disease Feeding and Eating Disorders

Primary Outcomes

Description: Interviewer assesses frequency in binge eating episodes

Measure: Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview

Time: Week 8; R33 also reviews at 6-month follow-up

Description: Interviewer assesses frequency of compensatory weight control behaviors

Measure: Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview

Time: Week 8; R33 also reviews at 6-month follow-up

Description: Interviewer assesses change in psychosocial impairment

Measure: Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire

Time: Week 8; R33 also reviews at 6-month follow-up

Secondary Outcomes

Description: Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)

Measure: Change in reward region of the brain using fMRI

Time: Week 1 and Week 8

Description: Assess if there are any changes in suicide ideation/attempts

Measure: Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)

Time: Weeks 2, 4 and 6

Description: Assess if there are any changes in negative affect

Measure: Change in negative affect using the Positive Affect and Negative Affect Scale-Revised

Time: Weeks 2, 4, and 6

Description: Assess if there are any changes in body dissatisfaction

Measure: Change in body dissatisfaction using the Body Dissatisfaction Scale

Time: Weeks 2, 4 and 6

Description: Assess if there are any changes in food addiction (Only collected during R61 phase)

Measure: Change in food addiction using the Yale Food Addiction Scale version 2.0

Time: Weeks 2, 4, and 6

Description: Assess if there are any changes in valuation of the thin beauty ideal

Measure: Change in valuation of thin ideal using the Thin Ideal Valuation Scale

Time: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up

Description: Assess if there are any changes in dietary restraint

Measure: Change in dietary restraint using the 10-item Dutch Restrained Eating Scale

Time: Week 8; R33 also reviews at 6-month follow-up

Description: Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)

Measure: Change in implicit associations of binge foods, thin models, and eating disorder behavior words

Time: Week 8; R33 also reviews at 6-month follow-up
5 Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders

This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.

NCT03388294
Conditions
  1. Autism Spectrum Disorder
  2. Neurodevelopmental Disorders
Interventions
  1. Behavioral: Parents and Infants Engaged
MeSH:Disease Autism Spectrum Disorder Neurodevelopmental Disorders
HPO:Autistic behavior

Primary Outcomes

Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.

Measure: Change in Parent Child Engagement Coding from pretest to posttest 1

Time: Baseline, posttest 1 (6-8 weeks after pretest)

Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.

Measure: Change in Parent Child Engagement Coding from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Secondary Outcomes

Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.

Measure: Change in Mullen Scales of Early Learning Receptive Language T-Scores from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.

Measure: Change in Mullen Scales of Early Learning Expressive Language T-scores from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5), Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).

Measure: Change in Sensory Processing Assessment for Young Children from Pretest to Posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: A treatment response measure of social communication behaviors and other behaviors associated with autism spectrum disorder (ASD). Administration of the BOSCC involves a 12-minute video recorded interaction between an examiner and a young child using two standard sets of toys and play with bubbles. Behaviors are coded from video. Total score range is 16-80. Higher scores indicate more typical social communication skills, lower scores indicate poorer skills.

Measure: Change in The Behavioral Observation of Social Communication Change (BOSCC) from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: Designed to measure the extent to which children will follow attentional cues of the examiner. Six prompts for attention following are embedded into the larger study protocol. Items are scored dichotomously as yes "1" or no "0".Total score range is 0-6. Higher scores indicate more typical responses to bids for joint attention.

Measure: Change in The Attention Following Protocol (AF Protocol) from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: A parent report measure of children's expressive communication skills, such as vocabulary and pre-grammar abilities. The Words and Gestures (toddler) form will be used. Total words and gestures endorsed by parents will be reported. Greater words and gestures reported indicates larger expressive vocabulary.

Measure: Baseline expressive communication level: The MacArthur-Bates Communicative Development Inventory

Time: Baseline

Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.

Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 1

Time: Baseline, posttest 1 (6-8 weeks after pretest)

Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.

Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: The Parental Stress Scale is a brief, 18-item scale designed to assess parent stress in nonclinical or clinical populations. It has acceptable levels of internal consistency (coefficient α = .83) and test-retest reliability (r = .81 over 6 weeks). It has good concurrent validity with the widely used Parent StressIndex (r =.75), which is a longer, more intrusive measure. A total score will be reported (range = 18-90).

Measure: Baseline level of parent stress: Parental Stress Scale

Time: Baseline

Description: RSA levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.

Measure: Change in Respiratory sinus arrhythmia from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: Skin conductance levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.

Measure: Change in skin conductance levels from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.

Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 1

Time: Baseline, posttest 1 (6-8 weeks after pretest)

Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.

Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)

Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.

Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 1

Time: Baseline, posttest 1 (6-8 weeks after pretest)

Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.

Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 2

Time: Baseline, posttest 2 (13-16 weeks after pretest)
6 Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth, home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

NCT03528109
Conditions
  1. Obsessive-Compulsive Disorder
  2. Anxiety Disorders
  3. Pediatric Disorde
  4. Pediatric Disorder
  5. Anxiety
  6. OCD
  7. Phobia
  8. Agoraphobia
  9. Generalized Anxiety
  10. Generalized Anxiety Disorder
  11. Selective Mutism
  12. Separation Anxiety
  13. Social Anxiety
  14. Social Anxiety Disorder
  15. Panic Disorder
Interventions
  1. Behavioral: Exposure Therapy
MeSH:Mutism Disease Anxiety Disorders Compulsive Personality Disorder Obsessive-Compulsive Disorder Panic Disorder Phobia, Social Agoraphobia Anxiety, Separation
HPO:Agoraphobia Mutism Obsessive-compulsive behavior

Primary Outcomes

Description: The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.

Measure: Children's Yale-Brown Obsessive-Compulsive Scale

Time: In-treatment and follow-up (6-12 months)

Description: The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.

Measure: Pediatric Anxiety Rating Scale

Time: In-treatment and follow-up (6-12 months)

Secondary Outcomes

Description: The CSQ-8 measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.

Measure: Client Satisfaction Questionnaire-8

Time: In-treatment and follow-up (6-12 months)

Description: The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.

Measure: Clinical Global Impression Scales

Time: In-treatment and follow-up (6-12 months)

Description: The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.

Measure: Child Sheehan Disability Scale

Time: In-treatment and follow-up (6-12 months)

Description: The measure tracks both the quality and quantity of homework completed between treatment sessions. This form has been used previously by our research group in large-scale treatment trials, and has been helpful in determining barriers to homework completion.

Measure: Homework Compliance Form

Time: Up to 6 months

Description: The Exposure Guide is a exposure therapy fidelity/quality tool completed by study therapists. This tool collects information regarding the use of specific therapeutic tools during exposures.

Measure: Exposure Guide

Time: Up to 6 months

Description: The TASCP is a 12-item measure of therapeutic alliance between a caregiver and his/her child's therapist. This measure assesses the bond and collaboration between caregiver and therapist. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Caregivers and Parents (TASCP)

Time: Up to 6 months

Description: 75 The TASC-r is a 12-item measure of therapeutic alliance between a child and his/her therapist. This measure assesses the degree of affective bond between child and therapist, as well as amount of therapeutic task collaboration. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Children-Revised (TASC-r)

Time: Up to 6 months

Description: The PQ-LES-Q is a 13-item measure of child functioning in life that uses a 5-point ratings scale, with higher scores indicating better quality of life. This measure has both parent and child versions, assessing the same items from both child and parent perspectives. The measure assesses quality of the child's life in a variety of domains.

Measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

Time: In-treatment and follow-up (6-12 months)

Description: The TPA is designed to independently solicit from youth and parent the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).

Measure: Top Problems Assessment (TPA)

Time: In-treatment and follow-up (6-12 months)

Description: The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.

Measure: Caregiver Strain Questionnaire (CSQ)

Time: In-treatment and follow-up (6-12 months)

Description: The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.

Measure: Barriers to Treatment Questionnaire - Parent Version (BTQ-P)

Time: In-treatment and follow-up (6-12 months)

Description: The PAS-PR is a 5-item questionnaire assessing the frequency and interference associated with accommodating the child's anxiety. Each item is followed by a series of common examples to illustrate the principle of accommodation for parents. Responses for frequency include 0 (never), 1 (rarely), 2 (occasionally), 3 (often), and 4 (always). Response options for interference due to accommodation include 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extreme).

Measure: Pediatric Accommodation Scale-Parent Report (PAS-PR)

Time: In-treatment and follow-up (6-12 months)

Description: We will record reactions from caregivers and child to treatment assignment using this clinician-rated measure. It includes capturing both verbatim responses from caregivers and child, as well as asking for interviewer impressions reactions from caregivers and child to treatment group assignment following randomization. The clinician also records the likelihood that the family will remain in the study and adhere to study protocols.

Measure: Randomization Debrief

Time: Administered at baseline

Description: This measure is a 3-item self-report questionnaire that captures parental beliefs about the efficacy about each treatment condition (office-based or home/community-based) using a scale from 1:"I expect my child will be very much improved," to 7: "I expect my child will be very much worse." The parent is also asked to select which treatment option would be best for their family. There is also a patient version of this measure used to capture patient beliefs about the efficacy about each treatment condition (office-based or home/community-based) using the same scale. The patient is asked to select which treatment option they believe would be best for them and their family. The patient version of this measure will be completed by youth 12+.

Measure: Treatment Expectancy

Time: Administered at baseline

Description: The SRS-2 is a 65-item self-report measure administered to caregivers or teachers to assess their perception of the presence of a child's social impairment. This measure is used to evaluate children aged 4-18 years old. Items are rated on a scale from 1 ("not true") to 4 ("almost always true").

Measure: The Social Responsiveness Scale, Second Edition (SRS-2)

Time: Administered at baseline and at discharge (up to 6-months)

Description: The ARI-P is a 7-item parent report questionnaire assessing child's irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Parent Version (ARI-P)

Time: In-treatment and follow-up (6-12 months)

Description: The ARI-S is a 7-item self-report report questionnaire assessing irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Self Report (ARI-S)

Time: In-treatment and follow-up (6-12 months)

Description: The Distress Intolerance Index is a 10-item self-report report questionnaire assessing the inability to tolerate negative somatic and emotional states. Items are rated on a 5-point scale from "very little" (0) to "very much".

Measure: Distress Intolerance Index

Time: In-treatment and follow-up (6-12 months)

Description: The PAS is a 12-item questionnaire assessing the frequency of and beliefs about parental accommodation. The frequency of parental accommodation is measured on a scale from "Never/Almost Never" (0), to "Always/Almost Always" (3). The beliefs about parental accommodation are measured on a scale from "Strongly Disagree" (0), to "Strongly Agree" (3).

Measure: Parent Accommodation Scale (PAS)

Time: In-treatment and follow-up (6-12 months)

Description: The feedback form is a 3-item self-report questionnaire that asks caregivers or child which treatment group their family was in and for open-ended feedback about their experience in the study (i.e. what did they really like, what would they change, general suggestions/ comments). All responses on this survey are received anonymously. Caregivers and children complete separate feedback forms. Children 8+ will complete the child version of this measure.

Measure: Feedback Forms - Caregiver and Child Versions

Time: Administered only at discharge, up to 6-months into study

Description: This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.

Measure: End of Treatment Form

Time: Administered only at discharge, up to 6-months into study

Description: This 7-item measure asks for participants' caregivers to discuss to whom they would like the findings of the study to be disseminated (i.e., local policy makers, educators, etc.). Additionally, it asks for information on how they would like findings to be shared (i.e., via social media, presentations, etc.) as well as caregivers to share highlights of their experience in the study.

Measure: Sharing Study Findings

Time: Administered only at discharge, up to 6-months into study

Description: We will record the rate of session reschedules, cancellations and no-shows, along with the overall number of sessions attended. We will also document the reason why a scheduled appointment does not occur using the Treatment Cancellation Form.

Measure: Treatment Attendance

Time: Up to 6 months

Description: This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.

Measure: Reasons for Treatment Discontinuation form

Time: Administered only at discharge, up to 6-months into study
7 Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD

Veterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.

NCT03681288
Conditions
  1. Substance Use Disorder
  2. Post-tra
  3. Post-traumatic Stress Disorder
  4. Moral Injury
Interventions
  1. Behavioral: Mindful Self-Compassion
MeSH:Disease Substance-Related Disorders Wounds and Injuries Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The SCS is a 26-item self-report questionnaire in which respondents describe how they relate to themselves during times of distress. The SCS includes the 5 item Self-Kindness subscale (ranging from 5-25; higher scores reflect more self-kindness), the 5-item Self-Judgment subscale (ranging from 5-25; higher scores reflect more self-judgment), the 4-item Common Humanity subscale (ranging from 4-20; higher scores reflect higher levels of common humanity), the 4-item Isolation subscale (ranging from 4-20; higher scores indicate higher levels of isolation), the 4-item Mindfulness subscale (ranging from 4-20; higher scores reflect higher levels of mindfulness) and the 4-item Over-Identification subscale (ranging from 4-20). Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." Mean scores on the six subscales are then averaged to create an overall self-compassion score ranging from 26 to 130. Higher scores correspond to higher levels of self-compassion.

Measure: Self-Compassion Scale (SCS); Change from baseline in Self-Compassion at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The TRGI is a 32-item validated self-report measure assessing traumatic guilt. The TRGI has three scales - Guilt Severity, Distress, and Guilt Cognitions. In all 32 items the answers are recorded on 5-point scale (ranging from 0 - not at all true to 4 - extremely true). Eight items are reverse-scored. We will use the TRGI as one of our eligibility criteria and to monitor changes in guilt and related cognitions over time.

Measure: Trauma-Related Guilt Inventory (TRGI); Change from baseline in trauma-related guilt at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The ISS is a 30-item self-report measure assessing shame proneness scored on a 5-point Likert scale ranging from 0 = "never" to 4 = "almost always". The ISS yields sum scores for two subscales, self-esteem (6 items; range = 0-24 with higher scores reflecting higher levels of self-esteem) and internalized shame (24 items; range = 0-96 with higher scores reflecting higher levels of shame) and has been well-validated with research and clinical populations. The self-esteem items are interspersed to counteract a negative response set.

Measure: Internalized Shame Scale (ISS); Change from baseline in shame at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Secondary Outcomes

Description: The CAPS is a semi-structured interview used to assess PTSD diagnostic criteria and severity. Respondents select up to three of the most traumatic events they have experienced, and those events are used as the basis for assessing PTSD symptoms. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-40). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).

Measure: Clinician Administered PTSD Scale for DSM-5; Change from baseline in PTSD symptoms at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The WHO-QOL BREF is a 26-item validated self-report measure that that assesses quality of life across four domains: physical (7 items, range 1-5), psychological (6 items, range 1-5), social relationships (3 items, range 1-5), and environment (8 items, range 1-5). The four domain scores denote an individual's perception of quality of life in each particular domain. The mean score of items within each domain is used to calculate the domain score. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life on a scale of 1 - "very poor" to 5 - "very good". Question 2 asks about an individual's overall perception of their health on a scale of 1 - "very dissatisfied" to 5 - "very satisfied". The WHO-QOL-BREF has excellent internal validity and test-retest reliability.

Measure: Quality Of Life Enjoyment & Satisfaction Questionnaire (WHO-QOL-BREF); Change from baseline in quality of life at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. The TLFB will be employed at all three assessment points to evaluate alcohol and other substance use during the 90 days preceding each interview. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB will be used at each follow-up to establish: percentage days heavy drinking, percent days abstinent, length of initial abstinence, length of use episodes, severity of relapse and current alcohol/drug use pattern. The Alcohol TLFB has been shown to have good psychometric characteristics with a variety of groups, and can generate variables that provide a wide range of information about an individual's use (e.g., pattern, variability, and magnitude of use).

Measure: Timeline Follow-back; Change from baseline in frequency of substance use at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Other Outcomes

Description: Beck Scale for Suicidal Ideation (BSSI): This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation (19). Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38 with higher score indicating more risk for suicide.

Measure: Beck Scale for Suicidal Ideation; Change from baseline in suicidal risk at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks
8 RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can now be conducted via video conferencing due to COVID-19.

NCT03827057
Conditions
  1. Posttraumatic Stress Disorder
  2. Traumatic Brain Injury
Interventions
  1. Behavioral: Reconsolidation of Traumatic Memories (RTM)
  2. Behavioral: Prolonged Exposure (PE)
MeSH:Brain Injuries Brain Injuries, Traumatic Dis Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity

Measure: Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Time: week 10

Secondary Outcomes

Description: well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity

Measure: Change in Patient Health Questionnaire (PHQ-9) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity

Measure: Change in PTSD Checklist for DSM5 (PCL5) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity

Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity

Measure: Change in Neurobehavioral Symptom Inventory (NSI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity

Measure: Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Other Outcomes

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the single molecule array (SIMOA) technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma tumor necrosis factor-alpha level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-6 level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-10 level

Time: week 10, compared to baseline

Description: Normalized Summary Score for a battery of 7 tests to measure various aspects of cognition including memory, executive function, attention span; normed for age, with a score of 50 being average, scores greater than 50 demonstrate greater than average cognitive function, and scores lower than 50 indicating lower than average cognitive function

Measure: Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Time: week 10, compared to baseline
9 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Moto Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
10 A Phase II Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Children With Autism Spectrum Disorder

The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).

NCT04089579
Conditions
  1. Autism
  2. Autism Spectrum Disorder
Interventions
  1. Biological: Cord Tissue Mesenchymal Stromal Cells
  2. Other: Placebo Infusion
MeSH:Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Autism Autistic behavior

Primary Outcomes

Description: The primary outcome measure is the mean of the change on the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3). The primary endpoint is the change on this outcome measure from baseline to six months.

Measure: Change on the Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales

Time: Baseline, 6 months

Secondary Outcomes

Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score

Measure: Change in VABS-3 Socialization Standard Score

Time: Baseline, 6 months

Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Communication Standard Score

Measure: Change in VABS-3 Communication Standard Score

Time: Baseline, 6 months

Description: Clinical Global Impression- Severity Scale

Measure: Change in CGI-Severity score

Time: Baseline, 6 months

Description: Clinical Global Impression- Impression

Measure: CGI-Intervention score

Time: Baseline, 6 months

Description: Pediatric Quality of Life Scale

Measure: Change in the Pediatric Quality of Life Scale

Time: Baseline, 6 months

Other Outcomes

Description: Assess for infusion reactions

Measure: Incidence and severity of infusion reactions

Time: Baseline, 6 months

Description: Assess for infections directly related to the study product infusions

Measure: Incidence and severity of product-related infections

Time: Baseline, 6 months

Description: Assess for anti-HLA antibodies

Measure: Evidence of formation of anti-HLA antibodies

Time: Baseline, 6 months, 12 months

Description: Assess for signs and symptoms of graft versus host disease

Measure: Incidence and severity of graft versus host disease

Time: 6 months, 12 months

Description: Assess for study related and unexpected adverse events

Measure: Incidence and severity of unexpected adverse events related to the study product

Time: Baseline, 6 months, 12 months
11 Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial

Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.

NCT04173572
Conditions
  1. Schizophrenia
  2. Schizoaffective Disorder
  3. Brief Psychotic Disorder
  4. Schizophreniform Disorders
  5. Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Interventions
  1. Behavioral: PACE-Life
  2. Behavioral: Exercise Intervention
MeSH:Disease Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders
HPO:Psychosis Schizophrenia

Primary Outcomes

Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Measure: Difference in Participant's Total Distance During 6-minute Walk

Time: Baseline and the last study visit (Up to 20 weeks)

Secondary Outcomes

Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.

Measure: Mean Difference in Minutes Spent Walking

Time: Baseline and the last study visit (up to 20 weeks)

Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.

Measure: Mean Difference in Daily Steps

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).

Measure: Mean Difference Overall UCLA Loneliness Scale Score

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).

Measure: Mean Difference Overall PANSS Score

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).

Measure: Mean Difference in Body Weight Change

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).

Measure: Mean difference in blood pressure change

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).

Measure: Mean Difference in Resting Heart Rate Change

Time: Baseline and the last study visit (Up to 20 weeks)

Other Outcomes

Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).

Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).

Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).

Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).

Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.

Measure: Mean Difference in Composite Score on the Autonomy Support Scale

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.

Measure: End of Study Survey

Time: Post treatment only (16 weeks)
12 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404
Conditions
  1. Coronavirus Infection (COVID-19)
  2. Pulmonary Arterial Hypertension
  3. Urinary Tract Infections in Children
  4. Hypertension
  5. Pain
  6. Hyperphosphatemia
  7. Primary Hyperaldosteronism
  8. Edema
  9. Hypokalemia
  10. Heart Failure
  11. Hemophilia
  12. Menorrhagia
  13. In
  14. Insomnia
  15. Pneumonia
  16. Skin Infection
  17. Arrythmia
  18. Asthma in Children
  19. Bronchopulmonary Dysplasia
  20. Adrenal Insufficiency
  21. Fibrinolysis; Hemorrhage
  22. Attention Deficit Hyperactivity Disorder
  23. Multisystem Inflammatory Syndrome in Children (MIS-C)
  24. Kawasaki Disease
  25. Coagulation Disorder
  26. Down Syndrome
Interventions
  1. Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
13 Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers

Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time. Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people. Eligibility: English-speaking adults ages 18 and older Design: This study will be conducted online. Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password. Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys. The surveys will ask about the following: Age, sex, race, and other sociodemographic data Mental and medical illness history and treatment Family medical history Mobility, self-care, and life activities Behaviors related to alcohol and substance use disorder Mental illness symptoms Psychological distress Stressors caused by the COVID-19 pandemic. Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support. Study website: nimhcovidstudy.ctss.nih.gov

NCT04339790
Conditions
  1. Healthy Volunteer
  2. Mood Disorder
  3. Anxiety Disorder
  4. Preexisting Medical Condition
MeSH:Disease Anxiety Disorders Mood Disorders

Primary Outcomes

Description: Thoughts and feelings about mental health impact of COVID-19

Measure: NIMH COVID Study survey - adult responses

Time: Biweekly online responses

Secondary Outcomes

Description: Ratings on measures of mental health symptoms and distress

Measure: DSM XC and KS survey

Time: Biweekly online self report
14 The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Accordingly, this prospective (0, 3, 6 and 12 months), multisite cohort study aims to describe, examine, and evaluate the impact of the Covid-19 pandemic on mental health and social factors among workers at health services from Latin America and the Caribbean, Europe and neighboring countries, the Middle East and North Africa, as well as Sub-Saharan Africa and Asia. Additionally, a team from the United States of America will also participate in this collaborative effort providing expertise on psychiatric epidemiology and supporting coordination across countries.

NCT04352634
Conditions
  1. Covid-19
  2. Mental Health Disorder
  3. Stress Disorder
  4. Anxiety
  5. Depression
  6. SARS-CoV-2
Interventions
  1. Other: Exposure to the SARS-CoV-2 and its consequences
MeSH:Disease Mental Disorders

Primary Outcomes

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 12 months

Secondary Outcomes

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: Baseline

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 3 months

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 6 months

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 12 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: Baseline

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 3 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 6 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 12 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: Baseline

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 3 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 6 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 12 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: Baseline

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 3 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 6 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 12 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: Baseline

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 3 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 6 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 12 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: Baseline

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 3 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 6 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 12 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: Baseline

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 3 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 6 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 12 months

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: Baseline

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 3 months

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 6 months
15 Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function

CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.

NCT04354818
Conditions
  1. HIV-1-infection
  2. Cancer
  3. Primary Immune Deficiency Disorder
  4. Immunosuppression Disorders
  5. COVID-19
MeSH:Immunologic Deficiency Syndromes Disease
HPO:Immunodeficiency

Primary Outcomes

Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

Time: Day 28

Secondary Outcomes

Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

Time: 3 months
16 PSYCHIatric Disorders and Covid-19 (PSYCHIC) : Observatory of the Psychiatric, Somatic and Pharmacological Impacts of the COVID-19 Pandemic on Patients Hospitalized for Psychiatric Disorders and Suspected to be Infected by COVID-19

Given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.

NCT04358042
Conditions
  1. Psychiatric Disorder
  2. Covid19
Interventions
  1. Other: Brief Psychiatric Rating Scale
  2. Other: Depression, Anxiety and Stress Scale
  3. Other: Impact of Event Scale-Revised
  4. Other: Connor-Davidson Resilience Scale 10 items (CD-RISC 10)
MeSH:Disease Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: total severity score from the Impact of Event Scale-Revised (IES-R)

Measure: impact of the COVID-19 pandemic on psychiatric symptomatology

Time: through study completion, an average of 2 year
17 Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders: An Observational Study of the Covid-19 Neurological and Psychiatric Manifestations

Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.

NCT04362930
Conditions
  1. Neurologic Manifestations
  2. Psychiatric Disorders
  3. COVID-19
MeSH:Neurologic Manifestations Disease Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19

Measure: Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19

Time: 12 months

Secondary Outcomes

Description: Impact on neurological or psychiatric disease trajectories assessed by severity scores or subjective progression (improved, stable, impaired) during and after COVID-19 pathology in patients with pre-existing neurological and psychiatric diseases

Measure: Progression of pre-existing neurological or psychiatric pathologies

Time: 12 months
18 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

NCT04393818
Conditions
  1. Mental Health Disorder
  2. Depression
  3. Posttraumatic Stress Disorder
  4. Burnout
  5. Anxiety Disorders
Interventions
  1. Behavioral: Intervention App
MeSH:Disease Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders

Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks
19 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Test of Replication to a New Population

This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394156
Conditions
  1. Post Traumatic Stress Disorder
  2. Stress Disorders, Post-Traumatic
  3. Stress Disorders, Traumatic
  4. Trauma, Psychological
  5. Trauma and Stressor Related Disorders
  6. Mental Disorder
Interventions
  1. Behavioral: Brief cognitive intervention
MeSH:Disease Wounds and Injuries Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Disorders Psychological Trauma Trauma and Stressor Related Disorders

Primary Outcomes

Description: Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.

Measure: Frequency of intrusive memories

Time: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.

Secondary Outcomes

Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.

Measure: Concentration

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.

Measure: Social and Occupational Activity Tally (SOAT)

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.

Measure: Dissociation

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.

Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Time: Baseline and 2-weeks post-intervention

Description: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.

Measure: Patient Health Questionnaire (PHQ-9)

Time: Baseline and 2-weeks post-intervention

Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.

Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version

Time: Baseline and 2-weeks post-intervention

Other Outcomes

Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.

Measure: Self-Guided Intervention Adherence Questionnaire

Time: Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.

Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.

Measure: Feedback Questionnaire

Time: 1-week post-intervention.
20 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study

This research study was designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention included a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study had a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants completed a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups were conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It was predicted that participants would report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394832
Conditions
  1. Stress Disorders, Post-Traumatic
  2. Stress Disorders, Traumatic
  3. Mental Disorder
  4. Trauma and Stressor Related Disorders
Interventions
  1. Behavioral: Brief cognitive intervention
MeSH:Disease Stress Disorders, Traumatic Mental Disorders Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders

Primary Outcomes

Description: Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.

Measure: Frequency of intrusive memories

Time: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.

Secondary Outcomes

Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.

Measure: Concentration

Time: Baseline and 2-weeks post-intervention

Description: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.

Measure: Social and Occupational Activity Tally (SOAT)

Time: Baseline and 2-weeks post-intervention

Description: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.

Measure: Dissociation

Time: Baseline and 2-weeks post-intervention

Description: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.

Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Time: Baseline and 2-weeks post-intervention

Description: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.

Measure: Patient Health Questionnaire (PHQ-9)

Time: Baseline and 2-weeks post-intervention

Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.

Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version

Time: Baseline and 2-weeks post-intervention

Other Outcomes

Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.

Measure: Self-Guided Intervention Adherence Questionnaire

Time: Intervention weeks 2-5, 1 week post-intervention and 2 weeks post-intervention

Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.

Measure: Feedback Questionnaire

Time: 1-week post-intervention.
21 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

NCT04396600
Conditions
  1. Stress
  2. Stress Disorder
  3. Stress, Psychological
  4. Trauma, Psychological
  5. Anxiety
  6. Anxiety State
  7. Post Traumatic Stress Disorder
  8. Secondary Traumatic Stress
  9. Professional Quality of Life
  10. Stress Related Disorder
  11. Stress Reaction
  12. Stress Risk
  13. Mental Resilience
  14. Emotional Resilience
Interventions
  1. Behavioral: MinnRAP Peer Support Program
MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)
22 Intranasal Injection of Platelet-rich Plasma Versus Saline for Treatment of Olfactory Dysfunction

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PrP) in the treatment of olfactory dysfunction. PrP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. We have completed a pilot study here evaluating it's use in olfactory loss which demonstrated safety and also suggested efficacy. Therefore, we aim to assess the ability of PrP to improve olfactory function in patients with decreased sense of smell.

NCT04406584
Conditions
  1. Olfactory Disorder
  2. Olfaction Disorders
  3. Olfactory Nerve Injuries
  4. Olfactory Nerve Disorder
  5. Olfactory Nerve Diseases
Interventions
  1. Procedure: Injection into olfactory cleft
MeSH:Nervous System Diseases Olfaction Disorders Olfactory Nerve Injuries Olfactory Nerve Diseases Disease
HPO:Anosmia

Primary Outcomes

Description: Using Sniffin' Sticks olfactory testing pens to test smell

Measure: Smelling ability

Time: 6 months
23 Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19

Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.

NCT04407494
Conditions
  1. COVID-19
Interventions
  1. Biological: Reporting of anosmia, ageusia and other clinical symptoms
MeSH:Disease

Primary Outcomes

Description: Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire

Measure: Diagnostic values of anosmia and ageusia for COVID-19

Time: at inclusion

Secondary Outcomes

Description: Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context

Measure: Diagnostic values of CODA

Time: at inclusion
24 COVID-19 Caregiver Emotional Support

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

NCT04409821
Conditions
  1. Posttraumatic Stress Disorder
  2. Prolonged Grief Disorder
  3. COVID
Interventions
  1. Behavioral: Tele-delivered psychological intervention
MeSH:Disease Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of consent among informed eligible participants

Measure: Recruitment rate

Time: At inclusion

Description: Rates of completion of intervention sessions among participants

Measure: Completion rate

Time: During and post-intervention (1 month)

Description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

Measure: Peri-traumatic distress inventory (negative emotions)

Time: Pre-post intervention (1 month after discharge/death)

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 1 month post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 6 months post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 12/13 months post intervention

Secondary Outcomes

Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

Measure: Prolonged Grief-13-scale

Time: 6 and 13 months

Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Depression (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Anxiety (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

Measure: Perceived Stress Scale (4 item)

Time: Baseline to 1, 6, and 12/13 months

Other Outcomes

Description: Worry, min. score 3, max score 15, higher score corresponds to greater worry

Measure: Short Penn State Worry Questionnaire (3 items)

Time: Baseline to 1, 6, and 12/13 months

Description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination

Measure: Brooding subscale of Ruminative Responses Scale

Time: Baseline to 1, 6, and 12/13 months

Description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance

Measure: Intolerance of uncertainty Scale (2 item)

Time: Baseline to 1, 6, and 12/13 months
25 Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).

NCT04416360
Conditions
  1. Autism Spectrum Disorder
  2. Attention-deficit Hyperactivity Disorder
Interventions
  1. Other: Interview by psychologists
MeSH:Hyperkinesis Disease Autistic Disorder Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Attention deficit hyperactivity disorder Autism Autistic behavior Hyperactivity Hyperkinetic movements

Primary Outcomes

Description: composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.

Measure: Interview of the parents : contextual data

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 1 month

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 3 months

Description: Data relating to disease and management of care. Experience of the referring caregiver.

Measure: Interview of the referring caregiver : data relating to disease and management of care

Time: 3 months
26 Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients

This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes. This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.

NCT04427267
Conditions
  1. Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Interventions
  1. Other: Personal protective equipment from biological hazard
MeSH:Disease

Primary Outcomes

Description: DS1923-F5 Thermochron iButtons

Measure: Skin thermometry

Time: 6 hours

Description: DS1923-F5 Thermochron iButtons

Measure: Hygrometry under costume

Time: 6 hours

Description: A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research

Measure: Heart rate

Time: 6 hours

Description: Meteoscop - M

Measure: Air thermometry

Time: 6 hours

Description: Meteoscop - M

Measure: Air hygrometry

Time: 6 hours
27 Brain Imaging and Infant Development

The aims of the BIBS Study The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development. The focus of the BIBS study MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need. Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.

NCT04443179
Conditions
  1. Autism Spectrum Disorder
  2. Attention Deficit Hyperactivity Disorder
  3. Neurodevelopmental Conditions
  4. COVID-19
MeSH:Disease Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder
HPO:Attention deficit hyperactivity disorder Autistic behavior

Primary Outcomes

Measure: Neurodevelopmental Outcomes

Time: 3-4 years of age
28 COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function

This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.

NCT04446169
Conditions
  1. SARS-CoV 2
  2. Sexual Function and Fertility Disorders
  3. Urinary Function Disorders
  4. Urine
  5. Semen
Interventions
  1. Diagnostic Test: SARS-CoV 2 RNA PCR Urine
  2. Diagnostic Test: SARS-CoV 2 RNA PCR Semen
  3. Diagnostic Test: Semen Qualitative Analysis
  4. Diagnostic Test: IIEF-5 questionnaire
  5. Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)
  6. Diagnostic Test: IPSS questionnaire
  7. Diagnostic Test: SECRET questionnaire
  8. Diagnostic Test: Interleukin assessment in semen
MeSH:Disease

Primary Outcomes

Description: SARS-CoV 2 RNA PCR in semen

Measure: SARS-CoV 2 presence in semen

Time: Enrollment

Description: SARS-CoV 2 RNA PCR in urine

Measure: SARS-CoV 2 presence in urine

Time: Enrollment

Description: Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present

Measure: Inflammation in Semen

Time: Enrollment

Description: Spermiogram done following WHO guidelines and criteria

Measure: Semen quantitative and qualitative analysis

Time: Enrollment

Secondary Outcomes

Description: International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function

Measure: Erectile Function

Time: Enrollment

Description: SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals

Measure: Sexual Habits

Time: Enrollment

Description: International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function

Measure: Urinary function

Time: Enrollment

Description: Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function

Measure: Sexual and Ejaculatory Function

Time: Enrollment
29 Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

NCT04449627
Conditions
  1. Anxiety Disorders
  2. Post Traumatic Stress Disorder
  3. Depressive Disorder
  4. Covid19
Interventions
  1. Other: Feeling Good Digital App
MeSH:Disease Depressive Disorder Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic
HPO:Depressivity

Primary Outcomes

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Day 14

Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.

Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)

Time: 14 days and week 12

Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.

Measure: Trauma as measured by Trauma screening questionnaire (TSQ)

Time: 12 weeks

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Week 12

Other Outcomes

Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.

Measure: Risk associated with distress

Time: Baseline analysis

Description: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Measure: Qualitative analysis

Time: Baseline
30 Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation/parkinson treatment possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care?

NCT04453475
Conditions
  1. Psychosomatic Disorder
  2. Parkinson
  3. Psychological Distress
  4. Psychological Stress
  5. Psychological Disease
  6. Psychological Disorder
  7. Psychological Impairment
  8. Psychological Disability
  9. Psychological Adjustment
  10. Psychological Adaptation
  11. Communication
  12. Health Care Seeking Behavior
  13. Anxiety
  14. Behavior, Health
  15. Health Risk Behaviors
  16. Healthy Lifestyle
Interventions
  1. Behavioral: Training session adressing information and health literacy
MeSH:Disease Psychophysiologic Disorders Stress, Psychological Mental Disorders Somatoform Disorders

Primary Outcomes

Description: Quantitative online questionnaire Survey using UniPark

Measure: Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Usability and effectiveness of digital interventions

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Stressors and barriers due to Covid-19

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
31 EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT04455360
Conditions
  1. Post Traumatic Stress Disorder
  2. Intensive Care Psychiatric Disorder
  3. Anxiety Disorders
  4. Depression
  5. Critical Care
  6. COVID
Interventions
  1. Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
MeSH:Disease Critical Illness Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge
32 Woebot for Substance Use Disorders During COVID-19

The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.

NCT04460027
Conditions
  1. Substance Use Disorders
  2. Alcohol Use Disorder
Interventions
  1. Other: Woebot Substance Use Disorder
MeSH:Disease Alcoholism Substance-Related Disorders

Primary Outcomes

Measure: Change of number of days drinking

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Change of number of days drug use

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Secondary Outcomes

Measure: Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5 (AUDADIS-V)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Short Inventory of Problems - Alcohol and Drugs (SIP-AD)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Drug Abuse Screening Test (DAST-10)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Brief Situational Confidence Questionnaire (BSCQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Craving rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 0-100 (no pain to worst pain imaginable)

Measure: Pain rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-27, higher scores indicate greater levels of depression

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-21, higher scores indicate greater levels of anxiety

Measure: General Anxiety Disorder-7 (GAD-7)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: CAIR Pandemic Impact Questionnaire (CAIR-PIQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 8 to 32, with higher values indicating higher satisfaction

Measure: Client Satisfaction Questionnaire (CSQ)

Time: Post-treatment (8 weeks from baseline)

Measure: Usage Rating Profile Intervention (URPI)

Time: Post-treatment (8 weeks from baseline)
33 Objective Assessment of Olfactory Dysfunction and Impact on Quality of Life in SARS CoV-2 (COVID-19)Infection Using the UPSIT, eQOD and SNOT-22 Questionnaires: A Prospective Observational Cohort Study

This study is designed to investigate the acuity of olfactory dysfunction in COVID-19 positive patients in the United Kingdom. In particular defining severity with objective testing and determining if this has any predictive value on the outcome of the SARS CoV-2 infection. In addition, this study will strive to determine duration / natural history of olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).

NCT04466982
Conditions
  1. Olfactory Disorder
  2. COVID19
  3. SARS-CoV-2
  4. Anosmia
  5. Microsomia
  6. Smell Disorder
  7. Quality of Life
MeSH:Olfaction Disorders Disease
HPO:Anosmia

Primary Outcomes

Description: I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients

Measure: UPSIT scores

Time: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study

Secondary Outcomes

Description: I. The changes in olfaction in patients with SARS CoV-2 infection over an initial 12 month period (at day 0, 1 month, 3 month, 6 month, 9 month and 12 month) using the UPSIT.

Measure: UPSIT scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Description: Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)

Measure: eQOD scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Description: Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)

Measure: SNOT 22 scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
34 Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.

The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.

NCT04470869
Conditions
  1. Post Traumatic Stress Disorder
Interventions
  1. Other: Phone call
MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.

Measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit

Time: Month 6

Secondary Outcomes

Description: The incidence of PTSD 6 months after patient's death in the intensive care unit

Measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit

Time: Month 6

Description: The incidence of PTSD 3 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 3

Time: Month 3

Description: The incidence of PTSD 12 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 12

Time: Month 12

Description: The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 3

Time: Month 3

Description: The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 6

Time: Month 6

Description: The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 12

Time: Month 12

Description: The incidence of persistent complicated grief 3 months after death in intensive care

Measure: incidence of persistent complicated grief at month 3

Time: Month 3

Description: The incidence of persistent complicated grief 6 months after death in intensive care

Measure: incidence of persistent complicated grief at month 6

Time: Month 6

Description: The incidence of persistent complicated grief 12 months after death in intensive care

Measure: incidence of persistent complicated grief at month 12

Time: Month 12
35 A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 Following Oral Administration in Healthy Male Participants

This study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.

NCT04475848
Conditions
  1. Autistic Disorder
  2. Autism Spectrum Disorder
  3. Child Development Disorders, Pervasive
  4. Mental Disorders
  5. Neurodevelopmental Disorders
Interventions
  1. Drug: RO6953958
  2. Drug: Placebo
MeSH:Disease Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Neurodevelopmental Disorders Developmental Disabilities
HPO:Autism Autistic behavior

Primary Outcomes

Measure: Percentage of Participants with Adverse Events in Part 1

Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)

Measure: Percentage of Participants with Adverse Events in Part 2

Time: From randomization up to 8 weeks

Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

Time: From randomization up to 8 weeks

Secondary Outcomes

Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: CL/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: V/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Ae of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Fe of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: CLR of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14
36 Feasibility Trial of Narrative Exposure Therapy (NET) for Pregnant Women With Posttraumatic Stress Disorder (PTSD)

Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented. Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures. Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention. Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment. Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews. With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).

NCT04525469
Conditions
  1. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Narrative Exposure Therapy
MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.

Measure: Feasibility via recruitment rate

Time: Screening to enrollment (Week 1)

Description: Investigators will calculate the mean number of sessions attended and the dropout rate, recording reason for drop out, such as participants' desire to withdraw from the NET treatment vs. medical complications of pregnancy or early delivery.

Measure: Feasibility via retention rate (sessions completed/dropout rate)

Time: Week 1 (NET Session 1) to Week 6 (NET Session 6)

Description: Investigators will calculate the mean number of follow-up questionnaires completed.

Measure: Feasibility via retention rate (completion of follow-up questionnaires)

Time: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)

Description: Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).

Measure: Acceptability of the NET intervention via participant satisfaction

Time: 1 Week Post-treatment (Post-treatment evaluation)

Description: Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.

Measure: Acceptability of the NET intervention via participant expectancy

Time: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)

Description: Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.

Measure: Acceptability of the NET intervention via perceived benefit

Time: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)

Description: Primary outcome will include qualitative feedback regarding aspects of the NET intervention and its acceptability during pregnancy and in preparation for the transition to parenthood via a study-developed qualitative interview.

Measure: Acceptability of the NET intervention via qualitative feedback

Time: Upon study completion (up to 10 months) or upon early withdrawal from intervention

Description: Investigators will use the Posttraumatic Check List for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.

Measure: Change in Symptoms of PTSD

Time: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)

Secondary Outcomes

Description: Investigators will use the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure for depression screening in the perinatal period.

Measure: Change in Symptoms of Perinatal Depression

Time: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
37 Taste and Smell Impairment in Critically Ill COVID-19 Patients

Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

NCT04532632
Conditions
  1. Smell Disorder
  2. Taste Disorders
  3. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Taste Disorders Olfaction Disorders Disease
HPO:Anosmia

Primary Outcomes

Description: incidence of taste and smell impairment in critically ill subjects

Measure: taste and smell impairment

Time: up to 3 months
38 Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care. Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.

NCT04542083
Conditions
  1. COVID-19
  2. Acute Cardiovascular Condition
  3. Acute Neurovascular Condition
  4. Stroke
  5. Acute Myocardial Infarction
MeSH:Stroke Myocardial Infarction Infarction Disease
HPO:Myocardial infarction Stroke

Primary Outcomes

Description: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Measure: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Time: 1 day

Secondary Outcomes

Description: Specific mortality rate.

Measure: Specific mortality rate.

Time: 1 day
39 Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)

The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD). Primary objectives: To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients. Secondary objectives: - To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients - To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change Exploratory objectives: - To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains - To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains - To evaluate whether there is a correlation between changes across symptom domains - To evaluate whether there is a correlation in raw score across symptom domains within each period Research Methods: Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire. Questionnaire items A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD. The questionnaire items include: Items investigating Mood/Energy before and after COVID 19 out break Items investigating Sleep habits before and after COVID 19 out break Items investigating Neurological symptoms before and after COVID 19 out break Items investigating daily functioning before and after COVID 19 out break Items investigating Exercise habits before and after COVID 19 out break No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric

NCT04565080
Conditions
  1. Parkinson's Disease
  2. Functional Movement Disorders
  3. COVID-19
MeSH:Parkinson Disease Movement Disorders Disease Conversion Disorder
HPO:Abnormality of movement

Primary Outcomes

Description: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Measure: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Time: December 2021

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook