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D040921: Stress Disorders, Traumatic

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 (60)


Name (Synonyms) Correlation
drug557 Brief cognitive intervention Wiki 0.26
drug871 Confinement and Communication During the COVID-19 Pandemic Wiki 0.19
drug491 Biological: mRNA-1273: 100 mcg Wiki 0.19
Name (Synonyms) Correlation
drug4066 quesionnair Wiki 0.19
drug1268 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.19
drug3155 Social Distancing Advertisements Wiki 0.19
drug1309 Feeling Good Digital App Wiki 0.19
drug1406 Goal Management Training (GMT) Wiki 0.19
drug3586 Unified Protocol for COVID-19 Parenting Stress (UP-COVID) Wiki 0.19
drug3872 efgartigimod PH20 SC Wiki 0.19
drug2661 Prolonged Exposure (PE) Wiki 0.19
drug4176 zinc Wiki 0.19
drug2836 Reconsolidation of Traumatic Memories (RTM) Wiki 0.19
drug510 Blood collection on their first consultation and 10 to 14 days later Wiki 0.19
drug998 Data collection and clinical testing of subjects Wiki 0.19
drug3731 Written Summary of Rounds Wiki 0.19
drug2697 Psychological treatment Wiki 0.19
drug3871 efgartigimod IV Wiki 0.19
drug3314 Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later Wiki 0.19
drug492 Biological: mRNA-1273: 50 mcg Wiki 0.19
drug3146 Sleep Education Wiki 0.19
drug3110 Serum tube collection Wiki 0.19
drug435 Background questionnaire Wiki 0.19
drug514 Blood for pharmacokinetic samples Wiki 0.19
drug2049 Mindful Self-Compassion Wiki 0.19
drug2600 Post Traumatic Stress Disorder questionnaire (PTSD-8) Wiki 0.19
drug449 Basic Body Awareness Therapy Wiki 0.19
drug2109 Muse headband with Myndlift app Wiki 0.19
drug2436 Patient Health Questionnaire (PHQ-9) Wiki 0.19
drug4104 sertraline Wiki 0.19
drug513 Blood for anti-drug antibody (ADA) Wiki 0.19
drug2015 Mental Health questionnaire Wiki 0.19
drug2150 Narrative Exposure Therapy Wiki 0.19
drug2125 NETosis markers Wiki 0.19
drug2164 Nasopharyngeal, oropharyngeal, or saliva swab Wiki 0.19
drug726 Cannabis, Medical Wiki 0.19
drug1791 LDAEP Wiki 0.19
drug572 Burnout Wiki 0.19
drug1397 Generalized Anxiety Disorder-7 (GAD 7) Wiki 0.19
drug2065 MinnRAP Peer Support Program Wiki 0.19
drug585 CBT-OSA Wiki 0.19
drug340 Attention Placebo Wiki 0.19
drug2413 PTSD Wiki 0.19
drug1640 Impact of COVID-19 questionnaire Wiki 0.19
drug3128 Simple cognitive task intervention Wiki 0.19
drug1972 Maslach Burnout Inventory (MBI) Wiki 0.19
drug2994 SHG Wiki 0.19
drug509 Blood collection on admission and longitudinally Wiki 0.19
drug2142 NT-I7 Wiki 0.19
drug4072 questionnaire filling Wiki 0.19
drug1244 Experiences in Close Relationship Scale questionnaire (ECR-S) Wiki 0.19
drug515 Blood for research purposes Wiki 0.19
drug724 Cannabidiol Wiki 0.13
drug2484 Phone call Wiki 0.13
drug422 BNT162b2 Wiki 0.13
drug421 BNT162b1 Wiki 0.11
drug776 Chloroquine Wiki 0.07
drug518 Blood sample Wiki 0.06
drug2505 Placebo Wiki 0.03
drug2741 Questionnaire Wiki 0.03

Correlated MeSH Terms (43)


Name (Synonyms) Correlation
D013313 Stress Disorders, Post-Traumatic NIH 0.83
D004194 Disease NIH 0.30
D000068099 Trauma and Stressor Related Disorders NIH 0.26
Name (Synonyms) Correlation
D000067073 Psychological Trauma NIH 0.21
D000070627 Chronic Traumatic Encephalopathy NIH 0.19
D015775 Fractures, Stress NIH 0.19
D013285 Strabismus NIH 0.19
D005879 Tourette Syndrome NIH 0.19
D000070642 Brain Injuries, Traumatic NIH 0.13
D000690 Amyotrophic Lateral Sclerosis NIH 0.13
D000755 Anemia, Sickle Cell NIH 0.13
D003072 Cognition Disorders NIH 0.13
D016472 Motor Neuron Disease NIH 0.13
D000068376 Compassion Fatigue NIH 0.13
D001714 Bipolar Disorder NIH 0.13
D001008 Anxiety Disorders NIH 0.11
D001930 Brain Injuries, NIH 0.11
D001523 Mental Disorders NIH 0.11
D020181 Sleep Apnea, Obstructive NIH 0.11
D012640 Seizures NIH 0.11
D014947 Wounds and Injuries NIH 0.10
D005356 Fibromyalgia NIH 0.09
D001927 Brain Diseases NIH 0.09
D012891 Sleep Apnea, NIH 0.09
D000066553 Problem Behavior NIH 0.07
D010300 Parkinsonian NIH 0.07
D015212 Inflammatory Bowel Diseases NIH 0.07
D003424 Crohn Disease NIH 0.06
D019966 Substance-Related Disorders NIH 0.06
D059350 Chronic Pain NIH 0.06
D060825 Cognitive Dysfunction NIH 0.05
D012598 Scoliosi NIH 0.05
D009103 Multiple Sclerosis NIH 0.05
D016638 Critical Illness NIH 0.05
D003866 Depressive Disorder NIH 0.04
D013315 Stress, Psychological NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D003863 Depression, NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D013577 Syndrome NIH 0.02
D003141 Communicable Diseases NIH 0.01
D011014 Pneumonia NIH 0.01
D007239 Infection NIH 0.01

Correlated HPO Terms (14)


Name (Synonyms) Correlation
HP:0006802 Abnormal anterior horn cell morphology HPO 0.19
HP:0007354 Amyotrophic lateral sclerosis HPO 0.19
HP:0100754 Mania HPO 0.13
Name (Synonyms) Correlation
HP:0001250 Seizure HPO 0.11
HP:0002870 Obstructive sleep apnea HPO 0.11
HP:0010535 Sleep apnea HPO 0.09
HP:0001298 Encephalopathy HPO 0.09
HP:0002037 Inflammation of the large intestine HPO 0.07
HP:0000708 Behavioral abnormality HPO 0.07
HP:0012532 Chronic pain HPO 0.06
HP:0100280 Crohn's disease HPO 0.06
HP:0001268 Mental deterioration HPO 0.06
HP:0000716 Depressivity HPO 0.04
HP:0002090 Pneumonia HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 29 clinical trials


1 Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

NCT02641496
Conditions
  1. Obstructive Sleep Apnea
  2. PTSD
  3. Posttraumatic Stress Disorder
Interventions
  1. Behavioral: CBT-OSA
  2. Behavioral: Sleep Education
MeSH:Sleep Apnea Syndromes Sleep Apnea, Obstructive Stress Disorders, Traumatic Stress Disorders, Post-Traumatic
HPO:Obstructive sleep apnea Sleep apnea

Primary Outcomes

Description: The CPAP machine will measure the number of hours that the CPAP mask is on the participant's face and in use.

Measure: Time in hours of "mask-on" CPAP usage per night

Time: 1 year

Secondary Outcomes

Description: Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. The investigators hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report more improvement in the ease of performing everyday activities compared to that reported by those in the Education group.

Measure: Functional Outcomes of Sleep Questionnaire (FOSQ)

Time: 1 year

Description: Effect of CBT on Cognitive Outcomes. The CBT-OSA group will have better cognitive outcomes than the Education group over time. The California Verbal Learning Test-II, Delayed Recall Score is the cognitive outcome measure.

Measure: California Verbal Learning Test, Second Edition (CVLT-II)

Time: 1 year

Description: Effect of CBT on PTSD. The CBT-OSA group will have fewer PTSD symptoms than the Education group over time. The PTSD Checklist for DSM-5 (PCL-5) will be the PTSD outcome measure.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: 1 year
2 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
3 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
4 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
5 An Electrophysiological Predictor of SSRI Response in Veterans With PTSD

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 3.25 years, until at least 94 participants complete the 17 week study.

NCT04183205
Conditions
  1. Posttraumatic Stress Disorder
Interventions
  1. Diagnostic Test: LDAEP
  2. Drug: Placebo
  3. Drug: sertraline
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80.

Measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Secondary Outcomes

Description: The QIDS-SR will be used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.

Measure: Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) Change

Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Description: The HAM-D is the most widely used clinician-administered scale for assessing severity of depression symptoms. The 6-item unidimensional core Melancholia subscale of the HAM-D will be used as the primary depression outcome variable.

Measure: Hamilton Depression Rating Scale (HAM-D) Change

Time: Administered at weeks 0, 2, 6 and 14

Description: DASS-21 is a 21-item measure that assesses the severity of a range of symptoms common to depression, anxiety, and stress. The total score can be used as a measure of general distress or depression, anxiety, and stress subscales can be scored separately.

Measure: Depression Anxiety Stress Scales (DASS-21) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Description: The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD. Participants will rate how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). The PCL-5 will be anchored to participants' worst traumatic event. In addition to the administration of these measures during the four assessment sessions, the PCL-5 will also be administered bi-weekly at each psychiatrist check-in visit.

Measure: PTSD Checklist for DSM-5 (PCL-5) Change

Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Description: The PANAS consists of two, 10-item mood scales that measure positive (e.g., 'enthusiastic') and negative (e.g., 'upset') affect separately.

Measure: The Positive and Negative Affect Schedule (PANAS) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Description: SCL-90-R measures the following nine primary psychiatric symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The Global Severity Index (GSI) is the average rating given to all 90 items and provides a measure of general psychopathology.

Measure: Symptom Checklist (SCL-90-R) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14
6 "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

NCT04341519
Conditions
  1. Corona Virus Infection
  2. Post-traumatic Stress Disorder
Interventions
  1. Behavioral: PTSD
  2. Behavioral: Burnout
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411

Measure: PTSD Family members sup 22

Time: 90 days

Secondary Outcomes

Description: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Family members

Time: 90 days

Description: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Patients

Time: 90 days

Description: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among Family members Symptoms of anxiety and depression using the HADS scale

Measure: HADS Family members

Time: 90 days

Description: Among Patients Symptoms of anxiety and depression using the HADS scale

Measure: HADS Patients

Time: 90 days

Description: Among Patients Mental and physical health-related quality of life as assessed by the SF36

Measure: SF36 Patients

Time: 90 days

Description: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Family members

Time: 90 days

Description: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Patients

Time: 90 days

Description: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers

Measure: MBI healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Job Strain as assessed by the Karasec instrument

Measure: Karasec instrument healthcare providers

Time: 2 months after official end of the Covid-19 peak
7 Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also aims to investigate predictors of trauma-symptoms.

NCT04374097
Conditions
  1. Post Traumatic Stress Disorder
  2. Anxiety
  3. Depression
MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL-5 is 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Secondary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

Measure: The Generalized Anxiety Disorder 7 (GAD-7)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway]

Description: Symptoms of health anxiety was measured with two items from the validated Health Anxiety Inventory (HAI), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus. All items used a Likert scale from 0-3, and the new total score of health anxiety had a range from 0-12.

Measure: Health anxiety

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway
8 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.
9 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.
10 Effectiveness of Basic Body Awareness Therapy in Survivors of Covid-19, Health Workers and Women Suffering From Gender-based Violence Regarding Post-traumatic Stress Disorders: A Randomized Clinical Trial

The aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.

NCT04396314
Conditions
  1. PostTraumatic Stress Disorder
Interventions
  1. Behavioral: Basic Body Awareness Therapy
  2. Behavioral: Psychological treatment
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The DTS is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. 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). It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters

Measure: Change in Davidson Trauma Scale (DTS)

Time: Baseline, 1 month , 3 months and 6 months follow up

Secondary Outcomes

Description: BDI consisting of 21 items with a score range from 0 to 63, with a higher score indicating a greater degree of depression.

Measure: Change in Beck Depression Inventory (BDI)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: Stai with statements scoring from 1 to 4; the whole score is from 0 to 60, with higher scores indicating a greater degree of anxiety

Measure: Change in State-Trait Anxiety Inventory (STAI)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: It measured quality of life, a generic tool whose scores range from 0 to 100; higher scores denote better quality of life. It contains 36 items grouped into eight subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health.

Measure: Change in Short Form 36 (SF36)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: VAS measures subjective characteristics that cannot be directly measured. The pain is measured from 0 to 10, with 0 representing "no pain" and 10 "unbearable pain".

Measure: Change in Visual Analogue Scale (VAS)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: Is an instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bedmate or roommate, these are not scored, nor reflected in the attached instrument.

Measure: Change in Pittsburgh Sleep Quality Index (PSQI)

Time: Baseline, 1 month , 3 months and 6 months follow up
11 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)
12 COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence. It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later. Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.

NCT04401046
Conditions
  1. Cancer
Interventions
  1. Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Measure: Score of the Impact of Event Scale Revisited scale

Time: at inclusion and 6 months later

Secondary Outcomes

Description: The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale

Measure: Factors associated with post-traumatic stress disorder

Time: at inclusion and 6 months later

Description: The measure of anxiety, measured by the State-Trait Anxiety Questionnaire

Measure: Measure of the patient's anxiety

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19

Time: at inclusion and 6 months later

Measure: proportion of patients stating that remote consultation is as useful as a face-to-face consultation

Time: at inclusion and 6 months later

Measure: proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)

Time: at inclusion and 6 months later

Measure: Score on the cancer recurrence scale

Time: at inclusion and 6 months later
13 Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

NCT04402229
Conditions
  1. Nurse
  2. Student
  3. Post Traumatic Stress Disorder
  4. COVID-19
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Proportion of students with IES-R> 22 PTSD-related symptoms. Impact of Event Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. ... The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.

Measure: Prevalence of PTSD-related symptoms assessed by the IES-R

Time: 1 month after the end of the French epidemic Covid-19 peak

Secondary Outcomes

Description: IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)

Measure: PTSD-related symptoms assessed by the IES-R in the total population of students nurses

Time: 1 month after the end of the French epidemic Covid-19 peak

Description: IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.

Measure: PTSD-related symptoms assessed by the IES-R according to student's years of school

Time: 1 month after the end of the French epidemic Covid-19 peak
14 Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry

Quarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine has already be linked to pejorative effects on mental health. In this study, we aim to evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.

NCT04405362
Conditions
  1. SARS-CoV 2
  2. Traumatic Stress Disorder
MeSH:Stress Disorders, Traumatic

Primary Outcomes

Description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

Time: at inclusion

Description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

Time: at 1 month after inclusion

Description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

Time: at 3 months after inclusion

Secondary Outcomes

Description: This self-questionnaire is intended to measure subjective post-traumatic stress after a traumatic situation (within 7 days) but is not a diagnostic tool. It includes 22 items rated from 0 (not at all) to 4 (extremely). There are 3 sub-scales: an avoidance subscale (items 5, 7, 8, 11, 12, 13, 17, 22): the sum of the scores on each of these items ranges from 0 to 35; Memory intrusion subscale (items 1, 2, 3, 6, 9, 14, 16 and 20): the sum of the scores on each of these items ranges from 0 to 40; a Hyperarousal/High Neurovegetative Activation subscale (items 4, 10, 15, 18, 19 and 21): the sum of the scores on each of these items ranges from 0 to 35. A total score of at least 22 suggests the presence of significant symptoms of acute stress. A score of 36 and above suggests the presence of post-traumatic stress disorder.

Measure: IES-R (Impact of Events Scale Revised)

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: closed-ended question: Yes /No

Measure: Presence of suicidal ideation during the past month at the different times of the study

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: questionnaire with a 28 item scaled and assesses somatic symptoms, anxiety and insomnia, social dysfunction and severe depression that ranges from a 'better/healthier than normal' option, through a 'same as usual' and a 'worse/more than usual' to a 'much worse/more than usual' option. The exact wording will depend upon the particular nature of the item.

Measure: Total score at GHQ-28 (General Health Questionnaire)

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: 13 questions rated from 0 to 3 to obtain a score from 0 to 39 The higher the score, the greater the symptomatology: 0 to 3 (no depression), 4 to 7 (mild depression), 8 to 15 (depression of moderate to moderate intensity), greater than 16 (severe depression).

Measure: Total score at BDI (Beck Depression Inventory)

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: 7 questions rated from 0 to 4 to obtain a score from 0 to 28 The higher the score, the greater the symptomatology: 0 to 7 (no insomnia), 8 to 14 (mild insomnia), 15 to 21 (moderate insomnia), 22 to 28 (severe insomnia).

Measure: Total score at ISI (Insomnia Severity Index)

Time: at inclusion, then at 1 month and 3 months after inclusion

Measure: Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.

Measure: Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

Time: at inclusion, then at 1 month and 3 months after inclusion

Description: Socio-demographic factors, linked to medical history and the experience of the epidemic.

Measure: Socio-demographic factors significantly associated with all scores

Time: at inclusion, then at 1 month and 3 months after inclusion
15 PTSD in Health Workers During COVID-19 Pandemia

The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.

NCT04424771
Conditions
  1. COVID
  2. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Maslach Burnout Inventory (MBI)
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.

Measure: Number of patients with diagnosis of PTSD.

Time: Through study completion, an average of 1 months
16 CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.

NCT04431856
Conditions
  1. Anxiety
  2. Depression
  3. Traumatic Stress Disorder
Interventions
  1. Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
  2. Behavioral: SHG
MeSH:Stress Disorders, Traumatic

Primary Outcomes

Description: The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).

Measure: Measure of Anxiety as assessed by the OASIS

Time: week 6 and week 12

Description: Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.

Measure: Measure of Depression as assessed by the ODSIS

Time: week 6 and week 12

Description: PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.

Measure: Measure of PTSD as assessed by the PCL-5

Time: week 6 and week 12

Secondary Outcomes

Description: The Egna Minnen Betraffande Uppfostran - Short Form (S-EMBU) is a 9-item measure that assesses parents' perception of their overprotection/control. Total scores ranging from 9 (low overcontrol) to 36 (high overcontrol).

Measure: Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU

Time: week 6 and week 12

Description: The Egna Minnen Betraffande Uppfostran - Short Form is a 7-item measure that assesses parents' perception of their rejection. Total score ranging from 7 (low rejection) to 28 (high rejection).

Measure: Measure of Parenting Rejection as assessed by the S-EMBU

Time: week 6 and week 12

Description: The Egna Minnen Betraffande Uppfostran - Short Form is a 6-item measure that assesses parents' perception of their emotional warmth. Total scores ranging from 6 (low warmth) to 24 (high warmth).

Measure: Measure of Parenting Emotional Warmth as assessed by the S-EMBU

Time: week 6 and week 12

Description: The Family Accommodation Scale - Anxiety (FASA) is a 13-item measure that assesses parent's accommodation of their child's anxiety related behaviors. Total scores range from 0 (low accommodation) to 52 (high accommodation).

Measure: Measure of Parent Accommodation for Child Anxiety as assessed by the FASA

Time: week 6 and week 12
17 PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.

NCT04442243
Conditions
  1. Post Traumatic Stress Disorder
  2. Anxiety
  3. Depression
MeSH:Str Stress Disorders, Traumatic Stress Disorders, Post-Traumatic
HPO:Strabismus

Primary Outcomes

Description: PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Secondary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

Measure: Generalized Anxiety Disorder 7 (GAD-7)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: WEMWBS short version consist of 7 items

Measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
18 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
19 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
20 A Randomized Control Trial Examining the Treatment Efficacy of a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder and Co-Morbid Conditions

This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder) in certain populations. Participants will be randomized to either GMT group treatment (with or without use of a mindfulness meditation aid), or a wait-list condition.

NCT04457271
Conditions
  1. PTSD
  2. Post-traumatic Stress Disorder
  3. Cognitive Impairment
  4. Cognitive Dysfunction
  5. Cognitive Deficit
Interventions
  1. Behavioral: Goal Management Training (GMT)
  2. Device: Muse headband with Myndlift app
MeSH:Cognitive Dysfunction Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Cognition Disorders
HPO:Cognitive impairment Mental deterioration

Primary Outcomes

Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

Measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment

Time: 9 weeks

Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

Measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment

Time: 12 weeks

Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from baseline to post-treatment assessment.

Time: 9 weeks

Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from post-treatment to 3-month follow-up assessment.

Time: 12 weeks

Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.

Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment

Time: 9 weeks

Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.

Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment

Time: 12 weeks

Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment

Time: 9 weeks

Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment

Time: 12 weeks
21 Reducing Intrusive Memories After Trauma Via a Simple Cognitive Intervention During COVID-19 in Hospital Staff: "EKUT-P" (Enkel Kognitiv Uppgift Efter Trauma Under COVID-19 - sjukvårdspersonal) - A Randomized Controlled Trial (RCT)

This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week -1). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.

NCT04460014
Conditions
  1. Intrusive Memories of Traumatic Event(s)
  2. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Simple cognitive task intervention
  2. Behavioral: Attention Placebo
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.

Measure: Number of intrusive memories of traumatic event(s)

Time: Week 5

Secondary Outcomes

Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.

Measure: Number of intrusive memories of traumatic event(s)

Time: Week -1 and Week 1

Description: A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.

Measure: Intrusion questionnaire - frequency item

Time: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up

Description: 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.

Measure: Intrusion questionnaire - characteristics

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.

Measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.

Measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: 2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.

Measure: Characteristics of intrusive trauma memories

Time: Baseline (Day 1), Week 1 and week 5

Other Outcomes

Description: Two items measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10) and the duration of disruption (< 1 min, 1-5 min, 5-10 min, 10-30 min, 30-60 min, > 60 min). High scores indicate higher level of concentration disruption and longer duration of disruption.

Measure: Self-rated concentration disruption associated with intrusive memories

Time: Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-up

Description: 3 bespoke items including a question on impact on work-related functioning, and one on daily functioning in other areas associated with the intrusions and a question on perceived social support after the traumatic event. All items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). Higher scores indicate higher level of functional impairment/perceived social support.

Measure: Self-rated functioning and social support ratings

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow up

Description: 6 self-report items (11-point scale from 0 to 100) measuring appraisals of intrusions on two subscales: psychological problems (items 1-3) and negative self-evaluations (items 4-6). Items for each subscale will be summed. Possible subscale scores range from 0 - 300, with higher values indicative of worse appraisals.

Measure: Appraisals of intrusive memories

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.

Measure: Self-rated sleep ratings

Time: Baseline (Day 1), one week and 1, 3, and 6 month follow-up

Description: A single item measuring perceived health status on a seven-point scale (from very good to very bad). The scale is reverse scored. High scores indicate good outcomes.

Measure: Self Rated Health (SRH) rating

Time: Baseline (Day 1), one week, and 1, 3, and 6 month follow-up

Description: 3 free text response field questions (e.g. which type of health care do you work with right now?) at Day 1 and two free text response field questions on whether the work situation changed and if yes, how, at one week, 1, 3, and 6 month follow-up.

Measure: Questions related to work situation

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 2 bespoke items measuring the total number and the number of full work days on sick leave because of reason for seeking health care. Higher numbers indicate more sick leave.

Measure: Sick leave

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 3 items measuring the frequency of feeling stressed, pressured, tensed at work during the previous week on a 5-point scale (from "never" to "several times per day"). Item scores are summed. Higher scores indicate higher levels of stress. Further, a single item measuring difficulties to let go of work-related thoughts during leisure time (from "very rarely or never" to "very often or always") and a single question about whether the above mentioned difficulties are because of intrusive memories with a yes/no response.

Measure: Stress and Energy Questionnaire (SEQ) - Stress subscale

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 9 self-report items (4-point scale from 1 "not at all" to 4 "all the time") measuring symptoms of burnout on three subscales: Exhaustion (items 1-3), disengagement (items 4-6) and inattentiveness (items 7-9). Subscale scores will be the mean of all items per subscale, the total burnout score will be the mean of all items (ranging from 1-4) with higher scores indicative of higher levels of exhaustion/disengagement/inattentiveness/burnout.

Measure: Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale

Time: Baseline (Day 1) and 6 month follow-up

Description: 5 self-report items measuring moral stress at work on a 4-point scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). All items are summed. Potential scores range from 5-20, with higher scores indicative of lower levels of moral stress.

Measure: Moral stress at work

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: A free text response field measuring the occurrence of any health problems since the last contact.

Measure: Adverse events

Time: One week and 1, 3, and 6 month follow-up

Description: A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity.

Measure: Future self questionnaire - shortened version

Time: 3 month follow-up

Description: 8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.

Measure: Time perspective questionnaire

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 2 free text response field questions (e.g. Are there any specific factors you think have made it easier for you to handle the COVID-19 situation and its consequences?) at Day 1.

Measure: Coping mechanisms

Time: Baseline (Day 1)

Description: 5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participant finds the intervention credible. High scores indicate greater credibility.

Measure: Credibility/expectancy questionnaire

Time: Day 1

Description: A bespoke manipulation check item measuring self-rated distress during the intervention/control procedure (11-point scale from 0 to 10) at 3 times during the intervention process. Higher scores indicate higher level of distress.

Measure: Subjective Units of Distress (SUDS)

Time: Day 1

Description: 8 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.

Measure: Feedback questionnaire about participation

Time: 1 month follow-up
22 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
23 Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.

NCT04476914
Conditions
  1. Respiratory Failure
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. Post Intensive Care Unit Syndrome
  5. Family Members
  6. Post Traumatic Stress Disorder
  7. Anxiety
  8. Depression
MeSH:Coronavirus Infections Severe Acute Respiratory Syn Severe Acute Respiratory Syndrome Respiratory Insufficiency Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)

Time: 90-120 days after admission of patient to the ICU

Secondary Outcomes

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety

Measure: Symptoms of Anxiety

Time: 90-120 days after admission of patient to the ICU

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression

Measure: Symptoms of Depression

Time: 90-120 days after admission of patient to the ICU

Description: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication

Measure: Family Satisfaction with Communication and Decision Making

Time: 90-120 days after admission of patient to the ICU
24 Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

NCT04491071
Conditions
  1. Stress Disorder
Interventions
  1. Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7)
  2. Diagnostic Test: Background questionnaire
  3. Diagnostic Test: Impact of COVID-19 questionnaire
  4. Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic
  5. Diagnostic Test: Mental Health questionnaire
  6. Diagnostic Test: Patient Health Questionnaire (PHQ-9)
  7. Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8)
  8. Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S)
MeSH:Anxiety Disorders Stress Disorders, Traumatic

Primary Outcomes

Description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety

Measure: Results of the Generalized Anxiety Disorder (GAD-7)

Time: 5 Minutes

Secondary Outcomes

Description: Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Mental Health questionnaire

Time: 5 minutes

Description: assess depression during the pandemic Scored between 0-27: Cut offs: 0-4 = None 5-9 = Mild depression 10-14 = Moderate depression 15-19 = Moderately severe depression 20-27 = Severe depression

Measure: Results of the Patient Health Questionnaire (PHQ-9)

Time: 5 minutes

Description: Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Post Traumatic Stress Disorder (PTSD-8)

Time: 5 minutes

Description: Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)

Time: 5 minutes
25 Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19

Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care. The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.

NCT04501445
Conditions
  1. Family Members
  2. Post Intensive Care Unit Syndrome
  3. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Written Summary of Rounds
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) initial

Time: Measured once upon enrollment

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Anxiety and Depression initial

Time: Measured once upon enrollment

Secondary Outcomes

Description: Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

Measure: Surrogate Satisfaction with the Patient's ICU Care:

Time: Measured once upon enrollment

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Anxiety and Depression final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)

Description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms

Measure: Interview initial

Time: Measured once upon enrollment

Description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms

Measure: Interview final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)
26 Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial

The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.

NCT04504877
Conditions
  1. Covid19
  2. Burn Out
  3. Post Traumatic Stress Disorder
Interventions
  1. Drug: Cannabidiol
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: To assess the emotional exhaustion dimension of the burnout syndrome, based on nine items, scored from 0 ("never") to 6 ("every day")

Measure: aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey

Time: Through study completion, over time during the study period (day 0-28)

Description: It is a self-report measure widely used to assess PTSD symptoms, according to the DSM-5 criteria. The reduced version of this instrument will be used (8 items)

Measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

Time: Through study completion, over time during the study period (day 0-28)

Secondary Outcomes

Description: brief measure for assessing generalized anxiety disorder

Measure: Brief measure for assessing generalized anxiety disorder: The GAD-7

Time: Through study completion, over time during the study period (day 0-28)

Description: Evaluate depressive symptoms o

Measure: PHQ-9: Patient´s Health Questionnaire-9

Time: Through study completion, over time during the study period (day 0-28)

Description: Laboratory parameters, including the change in proinflammatory cytokine concentrations

Measure: Change in proinflammatory cytokine concentration

Time: Through study completion, over time during the study period (day 0-28)

Description: Occurrence of side effects

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: Through study completion, over time during the study period (day 0-28)
27 Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome

Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means: 1. For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs. 2. For the less severe patients, personals of non-busy units have been transferred in busier ones. All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms. In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

NCT04511780
Conditions
  1. Critical Illness
  2. Covid19
  3. Stress Disorders, Post-Traumatic
Interventions
  1. Other: questionnaire filling
MeSH:Critical Illness Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)

Measure: Post-Traumatic Stress Disorder

Time: 3-6 month after the Covid-19 outbreak

Secondary Outcomes

Description: HADS scale (Hospital Anxiety and Depression Scale)

Measure: anxiety and depression

Time: 3-6 month after the Covid-19 outbreak

Description: Score MBI (Burn out syndrome)

Measure: Burn out

Time: 3-6 month after the Covid-19 outbreak
28 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)
29 Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

NCT04558437
Conditions
  1. Post Traumatic Stress Disorder (PTSD)
  2. Anxiety
  3. Depression
  4. Epidemic Disease
  5. COVID19
Interventions
  1. Other: Questionnaire
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)

Measure: Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).

Time: 6 months

Secondary Outcomes

Description: Rate of respondents with an Anxiety Disorder defined as score higher or equal to 8 for the HAD-A subscale (Hospital Anxiety and Depression - Anxiety subscale) independently at each measure (inclusion, M3 and M6)

Measure: Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).

Time: baseline, 3 months and 6 months

Description: Rate of respondents with a Depressive Disorder defined as score higher or equal to 8 for the HAD-D subscale (Hospital Anxiety and Depression - Depression subscale) independently at each measure (inclusion, M3 and M6)

Measure: Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).

Time: baseline, 3 months and 6 months

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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.

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