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D001008: Anxiety Disorders

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 (119)


Name (Synonyms) Correlation
drug441 Baricitinib Wiki 0.23
drug4131 survey work Wiki 0.21
drug527 Blood sampling Wiki 0.17
Name (Synonyms) Correlation
drug871 Confinement and Communication During the COVID-19 Pandemic Wiki 0.15
drug948 Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms Wiki 0.15
drug491 Biological: mRNA-1273: 100 mcg Wiki 0.15
drug503 Blood D-dimer assay Wiki 0.15
drug484 Biological sampling Wiki 0.15
drug1268 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.15
drug1999 Meditation app usage Wiki 0.15
drug822 Cognitive Behavioural Group Therapy for Perinatal Anxiety Wiki 0.15
drug2398 PLACEBO GROUP Wiki 0.15
drug2325 Online Questionnaire Wiki 0.15
drug1309 Feeling Good Digital App Wiki 0.15
drug3539 Trivia Training Wiki 0.15
drug2091 Montmorrillonite Wiki 0.15
drug3853 covid-19 positive pregnant women Wiki 0.15
drug1430 HADS Wiki 0.15
drug510 Blood collection on their first consultation and 10 to 14 days later Wiki 0.15
drug2853 Relaxation Therapy Wiki 0.15
drug490 Biological: COVID-19 convalescent plasma Wiki 0.15
drug3047 Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] Wiki 0.15
drug3669 Virtual-Care Cognitive Behavioural Therapy Wiki 0.15
drug946 Cross Sectional study using scientifically validated psychometric Scales Wiki 0.15
drug492 Biological: mRNA-1273: 50 mcg Wiki 0.15
drug3623 VRC-SRSDNA015-00-VP Wiki 0.15
drug3110 Serum tube collection Wiki 0.15
drug435 Background questionnaire Wiki 0.15
drug514 Blood for pharmacokinetic samples Wiki 0.15
drug477 Biological Wiki 0.15
drug2600 Post Traumatic Stress Disorder questionnaire (PTSD-8) Wiki 0.15
drug1063 Digital intervention Wiki 0.15
drug388 BCG GROUP Wiki 0.15
drug476 Biocontainment Device For Aerosol Generating Procedures (Biobox) Wiki 0.15
drug446 Barrier box Wiki 0.15
drug2436 Patient Health Questionnaire (PHQ-9) Wiki 0.15
drug2679 Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki 0.15
drug513 Blood for anti-drug antibody (ADA) Wiki 0.15
drug279 Anxiety Reduction Training Wiki 0.15
drug807 Clinical interview Wiki 0.15
drug2163 Nasopharyngeal swabs Wiki 0.15
drug1708 Intervention App Wiki 0.15
drug1998 Meditation and Anxiety Reduction Training Wiki 0.15
drug3594 Urine Test Wiki 0.15
drug883 Control Blend Wiki 0.15
drug3867 e-Psychotherapy Wiki 0.15
drug3701 Waitlist Wiki 0.15
drug469 Best available treatment Wiki 0.15
drug507 Blood and derivatives. Wiki 0.15
drug3390 Telehealth CBT Wiki 0.15
drug2015 Mental Health questionnaire Wiki 0.15
drug497 Biosensors Wiki 0.15
drug3625 Vaccine Wiki 0.15
drug868 Computer task questionnaires Wiki 0.15
drug2164 Nasopharyngeal, oropharyngeal, or saliva swab Wiki 0.15
drug1662 Information-only intervention Wiki 0.15
drug508 Blood collection Wiki 0.15
drug486 Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Wiki 0.15
drug3841 computerized cognitive training (CCT) Wiki 0.15
drug511 Blood donation from convalescent donor Wiki 0.15
drug2421 Pandemic control measures Wiki 0.15
drug1786 Kundalini Yoga and Anxiety Reduction Training Wiki 0.15
drug1397 Generalized Anxiety Disorder-7 (GAD 7) Wiki 0.15
drug3072 Self-help guided by a lay provider Wiki 0.15
drug2065 MinnRAP Peer Support Program Wiki 0.15
drug394 BGB DXP593 Wiki 0.15
drug505 Blood Test Wiki 0.15
drug824 Cognitive Training Wiki 0.15
drug459 Berberine Wiki 0.15
drug517 Blood plasma Wiki 0.15
drug525 Blood samples (collection of 5 mL of blood in a dry tube) Wiki 0.15
drug1640 Impact of COVID-19 questionnaire Wiki 0.15
drug3766 a survey Wiki 0.15
drug3312 Survey administration Wiki 0.15
drug485 Biological test Wiki 0.15
drug1255 Exposure Therapy Wiki 0.15
drug888 Control for aerosol generating procedures Wiki 0.15
drug3526 Trauma-informed yoga video recording Wiki 0.15
drug509 Blood collection on admission and longitudinally Wiki 0.15
drug1161 Effortful Control Camp Wiki 0.15
drug1218 Essential Oil Blend Wiki 0.15
drug3700 Waiting list where participants wait for delayed treatment Wiki 0.15
drug2693 Psychoeducational intervention Wiki 0.15
drug512 Blood draw Wiki 0.15
drug2142 NT-I7 Wiki 0.15
drug337 Attention Bias Modification (ABM) Wiki 0.15
drug1244 Experiences in Close Relationship Scale questionnaire (ECR-S) Wiki 0.15
drug515 Blood for research purposes Wiki 0.15
drug499 Biospecimen collection Wiki 0.15
drug2489 Physical Exam Wiki 0.15
drug445 Baricitinib or Anakinra Wiki 0.15
drug3048 Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] Wiki 0.15
drug826 Cognitive behavioral therapy (CBT) Wiki 0.15
drug457 Behaviour Change Technique Intervention to Improve Quality of Life Wiki 0.15
drug496 Biosensor Wiki 0.15
drug521 Blood sample for serological test Wiki 0.15
drug518 Blood sample Wiki 0.14
drug524 Blood samples Wiki 0.11
drug821 Cognitive Behavioral Therapy Wiki 0.11
drug2812 Ravulizumab Wiki 0.11
drug3468 Throat swab Wiki 0.11
drug474 Bicalutamide 150 Mg Oral Tablet Wiki 0.11
drug458 Bemiparin Wiki 0.11
drug498 Biospecimen Collection Wiki 0.09
drug467 Best Supportive Care Wiki 0.09
drug644 COVID-19 RT-PCR Wiki 0.09
drug2680 Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki 0.09
drug2519 Placebo Administration Wiki 0.08
drug389 BCG Vaccine Wiki 0.08
drug2327 Online Survey Wiki 0.07
drug3034 Saliva collection Wiki 0.06
drug2742 Questionnaire Administration Wiki 0.06
drug2505 Placebo Wiki 0.04
drug3309 Survey Wiki 0.04
drug3231 Standard of care Wiki 0.03
drug2855 Remdesivir Wiki 0.03
drug895 Convalescent Plasma Wiki 0.03
drug3221 Standard of Care Wiki 0.02
drug1520 Hydroxychloroquine Wiki 0.02

Correlated MeSH Terms (28)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.22
D001010 Anxiety, Separation NIH 0.21
D000072861 Phobia, Social NIH 0.21
Name (Synonyms) Correlation
D000379 Agoraphobia NIH 0.21
D016584 Panic Disorder NIH 0.17
D004194 Disease NIH 0.17
D003863 Depression, NIH 0.15
D015775 Fractures, Stress NIH 0.15
D001248 Asthenopia NIH 0.15
D000067292 Alcohol Drinking in College NIH 0.15
D040921 Stress Disorders, Traumatic NIH 0.11
D009771 Obsessive-Compulsive Disorder NIH 0.11
D019964 Mood Disorders NIH 0.11
D013180 Sprains and Strains NIH 0.11
D009155 Mutism NIH 0.11
D003193 Compulsive Personality Disorder NIH 0.11
D000068376 Compassion Fatigue NIH 0.11
D010698 Phobic Disorders NIH 0.11
D013313 Stress Disorders, Post-Traumatic NIH 0.10
D013315 Stress, Psychological NIH 0.09
D000067073 Psychological Trauma NIH 0.09
D001523 Mental Disorders NIH 0.06
D000066553 Problem Behavior NIH 0.06
D019052 Depression, Postpartum NIH 0.05
D020521 Stroke NIH 0.04
D016638 Critical Illness NIH 0.02
D018352 Coronavirus Infections NIH 0.01
D045169 Severe Acute Respiratory Syndrome NIH 0.01

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0000756 Agoraphobia HPO 0.21
HP:0000716 Depressivity HPO 0.20
HP:0002300 Mutism HPO 0.11
Name (Synonyms) Correlation
HP:0000722 Obsessive-compulsive behavior HPO 0.09
HP:0000708 Behavioral abnormality HPO 0.06

Clinical Trials

Navigate: Correlations   HPO

There are 44 clinical trials


1 Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety

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

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

Primary Outcomes

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

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

Time: Baseline and 12-weeks

Secondary Outcomes

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

Measure: Pediatric Anxiety Rating Scale

Time: weeks 0, 3, 6, 9, 12
2 Neurally Targeted Interventions to Reduce Early Childhood Anxiety

Clinically significant anxiety affects up to 20% of preschool-aged children and often fails to respond to currently available treatments. Emerging science suggests that increasing brain capacity for "effortful control" (EC) may help anxious children to regulate emotion and behavior to improve outcomes. Thus, in the proposed study, children will be trained on EC tasks (including selective attention, response inhibition, etc.) to increase capacity for effortful control (EC) over fear behaviors. To determine whether EC training improves brain capacity to regulate fear, investigators will assess neurophysiological and behavioral indices of effortful control and fear reactivity before and after this training.

NCT03093376
Conditions
  1. Anxiety Disorders
Interventions
  1. Behavioral: Effortful Control Camp
  2. Behavioral: Waitlist
MeSH:Anxiety Disorders

Primary Outcomes

Description: Error-related negativity (ERN) is assessed through the "Zoo task", a "Go/No-Go" paradigm assessing effortful control. Children view a series of animals on a computer screen and are asked to press a button when a new animal appears (Go trials), unless the animal is an orangutan (i.e., inhibit button response, No-Go trials). The task includes 8 blocks, each containing 30 unique animals (Go trials) and 10 orangutans (No-Go trials) in random order. Event related potentials (ERP; direct responses to stimuli measured using electroencephalography) will be examined from fronto-central recording sites time-locked to error and correct response. Differentiation between these trial types is the primary ERN measure, but ERN in error trials will also be considered, as well as ERPs in correct trials. The number of No-Go errors and response times (RTs) to Go trials will also be considered in analyses, as performance can affect ERN amplitude.

Measure: Change from Baseline Error Related Negativity (ERN) at Post-Intervention

Time: approximately 10 weeks

Description: Preschool participants watch age appropriate film clips (four fearful, four neutral, and four happy clips). White noise bursts are presented at varying time points to elicit the startle eyeblink response (FPS), recorded from two electrodes under the left eye.

Measure: Change from Baseline Fear Potentiated Startle (FPS) at Post-Intervention

Time: approximately 10 weeks

Secondary Outcomes

Description: Assessed using the Spence Anxiety Scale for Preschoolers (Spence, Rapee, McDonald, & Ingram, 2001). This 34-item parent-report scale provides an overall measure of child anxiety.

Measure: Change in Anxiety Symptoms

Time: approximately 10 weeks
3 Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)

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

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

Primary Outcomes

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

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

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

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

Measure: Pediatric Anxiety Rating Scale

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

Secondary Outcomes

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

Measure: Client Satisfaction Questionnaire-8

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

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

Measure: Clinical Global Impression Scales

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

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

Measure: Child Sheehan Disability Scale

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

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

Measure: Homework Compliance Form

Time: Up to 6 months

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

Measure: Exposure Guide

Time: Up to 6 months

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

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

Time: Up to 6 months

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

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

Time: Up to 6 months

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

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

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

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

Measure: Top Problems Assessment (TPA)

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

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

Measure: Caregiver Strain Questionnaire (CSQ)

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

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

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

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

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

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

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

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

Measure: Randomization Debrief

Time: Administered at baseline

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

Measure: Treatment Expectancy

Time: Administered at baseline

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

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

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

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

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

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

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

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

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

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

Measure: Distress Intolerance Index

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

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

Measure: Parent Accommodation Scale (PAS)

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

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

Measure: Feedback Forms - Caregiver and Child Versions

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

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

Measure: End of Treatment Form

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

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

Measure: Sharing Study Findings

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

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

Measure: Treatment Attendance

Time: Up to 6 months

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

Measure: Reasons for Treatment Discontinuation form

Time: Administered only at discharge, up to 6-months into study
4 Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers

Few older adults receive treatment for Generalized Anxiety Disorder (GAD) despite a high prevalence in this population and significant associated health care costs. Although older adults generally prefer psychotherapy to medication for help with anxiety, face-to-face psychotherapy is difficult to access for many of them. Psychological guided self-help (GSH), which patients use by themselves at home under the supervision of a licensed mental health provider (e.g., psychologist), has been shown to be effective. However, the capacity of our health care system to respond adequately to the mental health needs of seniors has been questioned and cost-effective solutions are required. Because the therapist's role in GSH is limited to supporting the patient, it is conceivable that this role could be assumed by trained and supervised lay providers (LP) instead of licensed providers. If this approach is effective, it could help provide many older adults with much needed mental health treatment at a lower cost. The main objective of this project is to evaluate the effectiveness of GSH guided by LP for GAD in older adults. Participants will be assigned randomly to an experimental group, which will receive treatment immediately, or to a control group whose treatment will be delayed. Data will be obtained through clinician evaluations and self-assessment questionnaires. They will include socio-demographic characteristics, symptoms of GAD, variables related to anxiety, such as depression and sleep difficulties, and participants' perception of treatment. For the experimental group, data collection will take place at four different times: before treatment begins, after treatment ends, and at 6 and 12 months after the end of treatment. Control group participants will be assessed on three occasions: before and after the waiting period and after receiving treatment. The efficacy of GSH will be established by comparing the change in the two groups on the main variables. We will also identify the characteristics of patients associated with improvement during treatment and document their perception of treatment.

NCT03768544
Conditions
  1. Generalized Anxiety Disorder
Interventions
  1. Behavioral: Self-help guided by a lay provider
  2. Behavioral: Waiting list where participants wait for delayed treatment
MeSH:Anxiety Disorders

Primary Outcomes

Description: 16 items rated on a scale ranging from 1 to 5. A higher total score indicates a greater tendency to worry.

Measure: Change in Penn State Worry Questionnaire

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 7 items answered on a scale ranging from 0 to 3. A higher total score suggests greater severity.

Measure: Change in GAD-7

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Secondary Outcomes

Description: 27 items rated on a scale ranging from 1 to 5. A higher total score suggests higher intolerance to uncertainty.

Measure: Change in Intolerance to Uncertainty Inventory

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 12 items rated on a scale ranging from 1 to 5. A higher total score suggests more negative attitudes toward problems.

Measure: Change in Negative Problem Orientation Questionnaire

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 25 items rated on a scale ranging from 1 to 5. A higher total score suggests more likely use of cognitive avoidance.

Measure: Change in Cognitive Avoidance Questionnaire

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 25 items rated on a scale ranging from 1 to 5. A higher total score suggests a greater belief that worrying is useful.

Measure: Change in Why Worry Questionnaire

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 20 items rated as "agree" or "disagree". Minimum score = 0; Maximum score = 20. A higher total score is indicative of greater severity of symptoms.

Measure: Change in Geriatric Anxiety Inventory

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 30 items rated as "yes" or "no". Minimum score = 0; Maximum score = 30.A higher total score is indicative of greater severity of symptoms.

Measure: Change in Geriatric Depression Scale

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: 7 items rated on a scale ranging from 1 to 4. A higher total score suggests more severe insomnia.

Measure: Change in Insomnia Severity Index

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: Three self-rated items of family, work, and social impairment rated on a scale ranging from 0 to 10.

Measure: Change in Sheehan Disability Scale

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Other Outcomes

Description: Measures knowledge about anxiety. 22 items answered with one of three options - true, false or don't know. Minimum score = 0; maximum score = 22. Higher scores indicate higher mental health literacy of anxiety.

Measure: Change in Anxiety Literacy Questionnaire.

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: Each of the 6 items describes a specific situation for which individuals providing support are listed and perceived support is rated on a 6-point likert scale from "very dissatisfied" to "very satisfied".

Measure: Change in Short version of Sarason's Social Support Questionnaire

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: Measures participant's perception of treatment. 19 statements covering various aspects of treatment (modules, readings, exercises, telephone sessions, workload, organization and duration of treatment, and its usefulness). Each statement is evaluated on a four-point scale ranging from "strongly agree" to "absolutely disagree". A fifth possible answer, 'does not apply', is also provided.

Measure: Evaluation of treatment by participants

Time: Post treatment (15 weeks)

Description: Measures the dimensions of an individual's motivation for entering treatment. Twenty items are listed on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true).

Measure: Treatment Motivation Questionnaire

Time: Baseline and post treatment.

Description: Evaluates how each participant views the credibility of the treatment and the possible improvements that can be achieved from the treatment. The 6 items are listed on a 9-point Likert scale, with a higher score indicating more trust in the treatment.

Measure: Credibility/Expectancy Questionnaire

Time: Baseline and post treatment.

Description: Twelve items that assess the quality of the relationship between the participant and his LP. The WAI has two versions: one for the participant and another for the LP. The items are listed on a 7-point Likert scale, with higher scores indicative of greater alliance.

Measure: Working Alliance Inventory

Time: Post treatment (15 weeks).

Description: Twenty-four items evaluating six behaviors related to generalized anxiety, namely reassurance seeking, avoidance, control, procrastination, overplanning and checking. Items are rated on a five point Likert scale

Measure: Questionnaire of behavioral manifestations linked to anxiety

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Description: These items were added to describe the reality of the participants while considering the effects of the pandemic on their anxiety. Five questions are framed as "yes or no" with an open-ended description of their answer choice whereas four items are rated on a five-point Likert scale.

Measure: Nine items relating to COVID-19

Time: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
5 Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety

This study will assign eighteen participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll thirty-six age- and gender-matched anxious children assigned to CBT. The hypothesis of this trial is that CCT with CBT will further increase task control network (TCN) activation and connectivity. Both groups will have one CBT therapy session each week for 12 weeks. However, for participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to complete during the two weeks prior to the first CBT session and during the two weeks after the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes just prior to CBT sessions 4-12. Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment. Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval. Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.

NCT04157296
Conditions
  1. Anxiety Disorders
Interventions
  1. Behavioral: Cognitive behavioral therapy (CBT)
  2. Behavioral: computerized cognitive training (CCT)
MeSH:Anxiety Disorders

Primary Outcomes

Description: Pre- to post-CBT changes in brain activation and function connectivity in the task-control network including fronto-parietal and cingulo-opercular regions mediating cognitive control. Functional activation and connectivity of these brain regions are assessed using a conflict interference computer task performed during MRI scanning.

Measure: Change in Brain activation and connectivity in the task-control network (TCN)

Time: Baseline, 12 weeks (after therapy)

Secondary Outcomes

Description: This is a 50 question interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The total scores on this scale range from 0 to 30, with scores above 13 indicating clinically meaningful anxiety.

Measure: Change in Pediatric Anxiety Rating Score (PARS)

Time: Baseline, 12 weeks (after therapy)

Description: Pre- to post-CBT changes in the behavioral performance in a conflict interference task, as well as, composite score from tasks included in the NIH toolbox

Measure: Change in behavioral performance on the conflict interference task and tasks testing cognitive control capacity included in the NIH Toolbox.

Time: Baseline, 12 weeks (after therapy)
6 Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial

The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.

NCT04309097
Conditions
  1. Anxiety
  2. Digital Eye Strain
Interventions
  1. Behavioral: Digital intervention
  2. Behavioral: Information-only intervention
MeSH:Asthenopia Sprains and Strains Anxiety Disorders

Primary Outcomes

Description: Change in anxiety will be measured by the Spence Children's Anxiety Scale (SCAS) designed by Spence (1998). The SCAS (45-item) is self-report scale with a 4-point Likert type, consisting of 44 items and one open-ended question. Overall assessment is done by total score.

Measure: Change in anxiety

Time: Baseline & at 2 weeks

Secondary Outcomes

Description: Syndromes of digital eye strain will be measured with the Computer Vision Syndrome Questionnaire (CVS-Q) designed by Seguí et al (2015). The self-reported CVS-Q questionnaire (16-item) evaluates the frequency (never, occasionally or often/always) and the intensity (moderate or intense) of 16 symptoms: burning, itching, feeling of a foreign body, tearing, excessive blinking, eye redness, eye pain, heavy eyelids, dryness, blurred vision, double vision, difficulty focusing for near vision, increased sensitivity to light, colored halos around objects, feeling that sight is worsening, and headache. Overall assessment is done by total score.

Measure: Change in syndromes of digital eye strain

Time: Baseline & at 2 weeks

Description: The PROMIS pediatric sleep disturbance questionnaire (4-item), designed by Forrest et al (2018), assesses self-reported experiences of sleep disturbance over the past 7 days. Raw score will be converted to T-Score.

Measure: Change in sleeping quality

Time: Baseline & at 2 weeks

Description: Participants will be asked to indicate the average time in hours per day spent on each the following activities: reading, writing, computer/PAD use, smart phone, watching TV, and playing video games.

Measure: Changes in time (hour) spent on different near work activities

Time: Baseline & at 2 weeks
7 Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany

The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.

NCT04331106
Conditions
  1. Anxiety Related to the COVID-19 Pandemic
Interventions
  1. Diagnostic Test: Online Questionnaire
MeSH:Anxiety Disorders

Primary Outcomes

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Characteristics of COVID-19-related anxiety

Time: 1 day

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: COVID-19-related anxiety symptoms

Time: 1 day

Secondary Outcomes

Description: Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).

Measure: Self-efficacy and coping with COVID-19

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.

Measure: Consequences of COVID-19 in the last three weeks.

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller & Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.

Measure: General Illness Attitude

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.

Measure: Media reporting

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.

Measure: Ultra-brief screening scale for anxiety and depression

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Change in characteristics of COVID-19-related anxiety

Time: Ebaseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: Change in COVID-19-related anxiety symptoms

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months
8 Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers

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

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

Primary Outcomes

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

Measure: NIMH COVID Study survey - adult responses

Time: Biweekly online responses

Secondary Outcomes

Description: Ratings on measures of mental health symptoms and distress

Measure: DSM XC and KS survey

Time: Biweekly online self report
9 A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)

ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.

NCT04340219
Conditions
  1. Cancer
Interventions
  1. Other: Survey administration
MeSH:Anxiety Disorders

Primary Outcomes

Measure: Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).

Time: Week 0

Measure: Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression); in terms of proportions (0-4 vs ≥ 5).

Time: Week 0

Measure: Anxiety at baseline measured by the 7-item anxiety subscale of the DASS-21 (DASS-21-Anxiety); in terms of proportions (0-3 vs ≥ 4).

Time: Week 0

Measure: Stress at baseline measured by the 7-item stress subscale of the DASS-21 (DASS-21-Stress); in terms of proportions (0-7 vs ≥ 8).

Time: Week 0

Secondary Outcomes

Measure: Distress measured at baseline by the CPDI; in terms of continuous values.

Time: Week 0

Measure: Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.

Time: Week 0

Measure: Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.

Time: Week 0

Measure: Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 7-item physical health domain of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (WHOQOL-BREF-Physical health); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Psychological health); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 3-item social relationships domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Social relationships); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 8-item environment domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Environment); in terms of continuous values.

Time: Week 0

Measure: Overall perception of quality of life and overall perception of health at baseline measured by the two items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire-in terms of continuous values.

Time: Week 0

Measure: Change from baseline in distress measured by CDPI; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.

Time: 24 weeks

Measure: Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Physical health; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Psychological health; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in overall perception of quality of life and overall perception of health measured by the 2 items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire; in terms of continuous values.

Time: 24 weeks

Measure: The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics

Time: Week 0-6-12-24
10 Impact of a Minimal Psychoeducational Intervention Versus Standard of Care on Anxiety Among Hospitalized COVID-19 Patients in Denmark: a Randomized Clinical Trial

Background: There is limited knowledge on the psychological implications of COVID-19 among hospitalized patients and their close relatives. Moreover, evidence-based psychological interventions targeting hospitalized COVID-19 patients and their relatives are currently lacking. Objective: To test a minimal psychoeducational intervention versus standard of care for reducing anxiety among hospitalized COVID-19 patients. Methods and analysis: The trial is a Randomized Controlled Trial (RCT) with a 1 month and 3 month follow-up. Hospitalized COVID-19 patients are consecutively included at admission and randomized 1:1 to either an intervention or control group. Patients randomized to the intervention group will receive a minimal psychoeducational intervention just prior to discharge from the hospital. The goal of the intervention is that patients will be prepared and learn to interpret and react to physical and psychological symptoms that are related to recovering from a COVID-19 infection. Data is collected using standardized and validated patient reported outcome measures (PROMs) to assess mental health outcomes. The primary outcome is patient reported anxiety as assess by the Hospital Anxiety and Depression Scale. Perspectives: This study will provide a comprehensive understanding of the psychological implications of the COVID-19 outbreak. If successful, the minimal intervention is easily implemented in daily clinical practice.

NCT04351789
Conditions
  1. COVID-19
  2. Mental Health
  3. Psychoeducation
  4. Anxiety
Interventions
  1. Other: Psychoeducational intervention
MeSH:Anxiety Disorders

Primary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 1 month

Time: 1 month post discharge

Secondary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 3 months

Time: 3 months post discharge

Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 3 months

Time: 3 months post discharge

Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 3 months

Time: 3 months post discharge

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 12 months

Time: 12 months post discharge

Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 12 months

Time: 12 months post discharge

Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 12 months

Time: 12 months post discharge
11 The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS

Background/Objectives: Psychological anxiety has been associated with alterations in eating patterns. The 2020 global coronavirus pandemic has created a situation characterized by increased anxiety. The present international survey was designed to examine associations between exposure to quarantine/isolation measures, anxiety levels and changes in dietary patterns. Methods: The present study utilizes a Google Survey platform to conduct an international survey querrying dietary patterns before vs. after the coronavirus pandemic; anxiety during the pandemic; and demographic characteristics. The nutrition portion of the survey is based on the Mediterranean Diet Score while the anxiety estimate is based on the GAD-7. The survey is available in English, Hebrew, Spanish, Italian, French, Arabic and Russian. It has been distributed via social media. Anticipated Results: We believe that changes in dietary habits will be identified and that these will be associated with anxiety levels. Additionally, we believe that by-country differences will be identified. Discussion: The Google Survey format distributed by social media provides an almost immediate means of distributing the survey globally. The survey can only be completed if the respondent first indicates his/her informed consent. The convenience sample limits generalizability to individuals who volunteer to complete online surveys; however, we anticipate a large response which may mitigate this limitation.

NCT04353934
Conditions
  1. Dietary Habits
  2. Anxiety
MeSH:Coronavirus Infections Anxiety Disorders

Primary Outcomes

Description: The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)

Measure: The association between Mediterranean Diet Score and Anxiety Score

Time: through study completion, average six months

Description: Mediterranean Diet Score (MedDiet) will be calculated

Measure: The degree to which current dietary intake is consisten with the Mediterranean Diet

Time: through study completion, average six months

Secondary Outcomes

Description: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)

Measure: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety

Time: through study completion, average six months
12 Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial

The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population. At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms. Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms. In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total). Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.

NCT04365972
Conditions
  1. Anxiety
Interventions
  1. Behavioral: Attention Bias Modification (ABM)
MeSH:Anxiety Disorders

Primary Outcomes

Description: The COVID-19 anxiety inventory is a self-report questionnaire screening for concerns and fears regarding COVID-19 contagion. The Inventory consists of 6 items. Scores can range from 6 to 30, with higher scores denoting higher symptom severity.

Measure: Change from baseline of the total score of a novel COVID-19 anxiety inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

Secondary Outcomes

Description: The Health Anxiety Inventory (HAI) is a validated self-report measure assessing health anxiety. Total score can range from 0 to 42, with higher scores denoting higher symptom severity

Measure: Change from baseline of the total score of the Health Anxiety Inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

Description: The State Anxiety Inventory is a validated self-report measure for state anxiety. Total score can range from 20 to 80, with higher scores denoting higher levels of state anxiety.

Measure: Change from baseline of the total score of the State Anxiety Inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

Description: The PHQ-9 is a 9-item self-report scale for depression symptoms. Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.

Measure: Change from Baseline of the total score of the PHQ-9

Time: up to 2 days pre-treatment and 1-2 days post-treatment

Description: The GAD-7 is a 7-item self-report scale for generalized anxiety symptoms. Scores can range from 0 to 21, with higher scores reflecting more symptoms of generalized anxiety.

Measure: Change from Baseline of the total score of the GAD-7

Time: up to 2 days pre-treatment and 1-2 days post-treatment
13 Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic

This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.

NCT04369378
Conditions
  1. Anxiety
  2. Well-being
Interventions
  1. Behavioral: Meditation app usage
MeSH:Anxiety Disorders

Primary Outcomes

Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: Immediate post-intervention (compare with pre-intervention data)

Secondary Outcomes

Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions

Measure: Sleep habits

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions

Measure: Sleep habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: 2 months post-intervention (compare with immediate post-intervention data)
14 Parenting in a Pandemic: Parental Stress During the COVID-19 and Its Association With Depression and Anxiety

This study seeks to investigate the levels of parental stress across different demographic subgroups in the general parental population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of parental stress rates related to these non-pharmacological interventions (NPI's). In addition, the research will investigate the association between parental stress associated and psychopathology symptoms (i.e., depression and generalized anxiety). The aim of the project is to: - Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures on parental stress, with special focus on the school and kindergarten lockdowns. - Provide a foundation for policymakers and health-care professionals to employ interventions that protect families against possibly increased psychological stressors. - Help policymakers and healthcare professionals to better understand the association of demographic variables and other predictors on parental stress and parent-child dysfunction, which information necessary for evaluating the psychological impact of NPIs on parental stress and thus the framework under which decisions about school/kindergarten lockdowns are made.

NCT04377074
Conditions
  1. Parental Stress
  2. Depression
  3. Anxiety
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: Three items from the Danish Parental Stress Scale (PSS) was selected, which intends to be a short measure of perceived stress resulting from being a parent (Pontoppidan et al., 2018). The scale consists of nine items measuring parental stress where each is measured on a five-point Likert scale (1-5), with the scores ranging from 3 to 15. Higher scores indicate higher parental stress. The following three were chosen in this large-scale investigation: 1) I feel overwhelmed by the responsibility of being a parent. 2) The major source of stress in my life is my child(ren), and 3) It is difficult to balance different responsibilities because of my child(ren) (Pontoppidan et al., 2018).

Measure: Measure of parental stress

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 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. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 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. Higher scores indicate greater anxiety severity, and scores that are above the cutoff of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 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
15 Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses

Background: Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people. Objective: To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19. Eligibility: English-speaking adults age 18 and older Design: This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks. Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure. Participants will complete a set of surveys about the following: - Sociodemographic data, such age, race, and income - Education and work status - Mental and medical illness and treatment - Family medical history - Mood - COVID-19 experience - Anxiety - Substance and alcohol use - Attention control - Other mental health related topics. Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it. It will take about 1 hour to complete the surveys and the task. About 8 months later, participants will be contacted to repeat the surveys and task. Compensation is provided.

NCT04377100
Conditions
  1. Anxiety
  2. Healthy Volunteers
Interventions
  1. Behavioral: Computer task questionnaires
MeSH:Anxiety Disorders

Primary Outcomes

Description: To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.

Measure: Patterns of neural connectivity as predictors

Time: Baseline and 8 months later
16 Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

NCT04377412
Conditions
  1. Anxiety
  2. Depression
  3. Pregnancy Related
Interventions
  1. Other: Pandemic control measures
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points

Measure: Anxiety

Time: 4 months

Description: Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points

Measure: Depression

Time: 4 months
17 ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"

In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms

NCT04384887
Conditions
  1. COVID
  2. Anxiety
  3. Depression, Postpartum
Interventions
  1. Behavioral: covid-19 positive pregnant women
MeSH:Depression, Postpartum Depression Anxiety Disorders

Primary Outcomes

Description: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.

Measure: Evaluation of depression and anxiety score changes of covid-19 positive pregnants

Time: 4 months
18 Meditation and Yoga for Heightened Anxiety Related to COVID-19

This randomized clinical on-line study examines whether whether a daily practice of meditation or Kundalini Yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.

NCT04386291
Conditions
  1. Generalized Anxiety
  2. Health Anxiety
Interventions
  1. Behavioral: Anxiety Reduction Training
  2. Behavioral: Kundalini Yoga and Anxiety Reduction Training
  3. Behavioral: Meditation and Anxiety Reduction Training
MeSH:Anxiety Disorders

Primary Outcomes

Description: Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)

Measure: GAD-7

Time: Up to 32 weeks

Description: Health Anxiety 8-item scale (range 0-32, higher is worse)

Measure: Whiteley 8

Time: Up to 32 weeks

Secondary Outcomes

Description: Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)

Measure: PHQ-8

Time: Up to 32 weeks

Description: Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)

Measure: SS-8

Time: Up to 32 weeks

Description: An 8-item self-report measure of cognitive function (range 8-40, higher is worse)

Measure: Applied Cognition 1.0

Time: Up to 32 weeks

Description: A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)

Measure: PROMIS-4 Sleep Disturbance

Time: Up to 32 weeks

Description: Emotional Regulation Questionnaire - a 10-item measure of emotional regulation; the reappraisal subscale has a range: of 6-42, higher score is considered positive; while the suppression subscale has a range of 4-28, higher score considered negative. ..

Measure: ERQ

Time: Up to 32 weeks

Description: A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress)

Measure: Perceived Stress Scale

Time: Up to 32 weeks

Description: A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)

Measure: Brief Hypervigilance Scale

Time: Up to 32 weeks
19 Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period

Although coronaviruses (CoV) cause mild infections in the community, such as colds, they can also cause more severe infections. There are many subspecies of coronaviruses that can pass from animals to humans and can be transmitted between humans. One of these subspecies is COVID-19 (severe acute respiratory syndrome coronavirus 2), SARS-CoV-2, and has made a worldwide pandemic from the beginning of 2020. In this process, going out of the house, going to the hospital and being in the hospital brings with it the anxiety to get sick. In the period when the feeling of motherhood begins at the end of birth, the hospitalization of the baby for any reason and the separation of the mother and the baby can be an additional source of stress. This study was planned to determine the anxiety and anxiety levels of mothers who had a baby in the NICU during Coronavirus disease pandemic and the factors affecting them.

NCT04386798
Conditions
  1. Newborn
  2. Anxiety
Interventions
  1. Other: survey work
MeSH:Anxiety Disorders

Primary Outcomes

Description: During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.

Measure: Mothers' anxiety rate

Time: 30 days
20 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

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

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

Primary Outcomes

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

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

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

Measure: Post-traumatic stress syndrome

Time: 2 weeks

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

Measure: Insomnia

Time: 2 weeks

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

Measure: Self Efficacy

Time: 2 weeks
21 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

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

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

Primary Outcomes

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

Measure: Change in professional quality of life

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

Secondary Outcomes

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

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)
22 Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery

The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients: 1. The degree of anxiety and/or depression induced by their altered medical care trajectory. 2. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit 3. The occurrence of reduced access to medical and psychological help

NCT04406181
Conditions
  1. Anxiety and Fear
  2. Anxiety Depression
  3. Anxiety Postoperative
  4. Psychological Stress
Interventions
  1. Behavioral: HADS
  2. Behavioral: a survey
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

Time: 10 minutes

Description: The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

Time: 10 minutes

Description: The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Measure: Reduced access to medical and psychological help

Time: 10 minutes
23 Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically impacted the lives of children/adolescents (children) and families. The closure of schools, social and recreational activities, and modifications to work environments has led to significant changes in the way children and families are working, living and socializing. Although the impact on the mental health of children and families has not been well researched, it is anticipated that already stressed children and families with pre-COVID-19 mental health challenges are at significant risk for deterioration in their mental health. As such, the implementation, and evaluation (specifically: feasibility, acceptability and barriers) of virtual-care interventions to alleviate child and family anxiety and enhance family functioning are critical. Virtual-care also optimizes health equity initiatives in reducing social, economic and environmental barriers to services that can improve or maintain mental health (WHO, 2017; MOHLTC, 2018). The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility, participation barriers related to social determinants of health (SDH) and acceptability of this virtual-care intervention in addressing mental health challenges associated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this virtual-care intervention will enable future scale-up of this intervention during the post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.

NCT04408027
Conditions
  1. Anxiety Disorder of Childhood or Adolescence
Interventions
  1. Behavioral: Virtual-Care Cognitive Behavioural Therapy
MeSH:Anxiety Disorders

Primary Outcomes

Description: Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).

Measure: Participation Barriers

Time: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).

Description: Number of participants that were eligible for the study.

Measure: Number of Eligible Participants

Time: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants that were approached for the study.

Measure: Number of Participants Approached

Time: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants consented for the study.

Measure: Number of Participants Consented

Time: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.

Description: Rates of refusal for participation in the study.

Measure: Rates of Refusal

Time: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: Reasons for refusal for participation in the study.

Measure: Reasons for Refusal

Time: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: The average number of sessions completed in total will be captured to evaluate intervention adherence.

Measure: Number of Sessions Completed in Total

Time: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.

Measure: Adherence Index

Time: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.

Measure: Amount of time (in weeks) to complete the intervention

Time: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Intervention Acceptability

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Participant Satisfaction

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after First Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Sixth Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Final Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Secondary Outcomes

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic at Baseline

Time: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic after Final Intervention Session

Time: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).

Description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.

Measure: Efficacy of Virtual-Care CBT Intervention

Time: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).

Description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.

Measure: Clinician Virtual Care Experience

Time: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
24 dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.

This study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. Additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their perception of academic performance.

NCT04420416
Conditions
  1. Depression, Anxiety
Interventions
  1. Other: Survey
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70.

Measure: Academic Self-Concept Scale Score

Time: up to 3 months

Description: This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.

Measure: PHQ-9 Score

Time: up to 3 months

Description: This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.

Measure: GAD-7 Score

Time: up to 3 months

Description: Students' preference of classroom or online classes.

Measure: Preference of teaching method

Time: up to 3 months

Description: Students' perception of changes in their academic performance: got better, worse, or stayed the same.

Measure: Self perceived academic performance

Time: up to 3 months

Description: Students' perception of changes in their grades: got better, worse, or stayed the same.

Measure: Academic grades changes

Time: up to 3 months
25 Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)

The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.

NCT04421690
Conditions
  1. Generalized Anxiety Disorder
Interventions
  1. Behavioral: Cognitive Training
  2. Behavioral: Trivia Training
MeSH:Anxiety Disorders

Primary Outcomes

Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

Description: A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.

Measure: Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire

Time: Up to 10 weeks

Description: 5- item questionnaire that assess anxiety related to the Coronavirus.

Measure: Coronavirus Anxiety Scale

Time: Up to 10 weeks

Description: Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.

Measure: Anxiety - State-Trait Anxiety Inventory

Time: Up to 10 weeks

Secondary Outcomes

Description: During the intervention phase the cognitive training group will play games and will need to log the days and duration played.

Measure: Game-related experience- Sessions and duration played

Time: Up to 10 weeks

Description: 19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.

Measure: Circadian Rhythm- Morningness-Eveningness Questionnaire

Time: Up to 10 weeks

Description: Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.

Measure: Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale

Time: Up to 10 weeks

Description: Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.

Measure: Subjective Arousal- Pre-sleep Arousal Scale

Time: Up to 10 weeks

Description: Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.

Measure: Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale

Time: Up to 10 weeks

Description: Questionnaire assessing the experience of the game.

Measure: Game Engagement Questionnaire

Time: Up to 10 weeks

Description: 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

Measure: Mood-Depression-Beck Depression Inventory-II

Time: Up to 10 weeks

Description: 10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

Measure: Alcohol Use - Alcohol Use Disorder Test

Time: Baseline

Description: 7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.

Measure: Physical Activity - International Physical Activity Questionnaire

Time: Up to 10 weeks

Description: 10 question assessment measuring personality.

Measure: Personality - Big Five Inventory

Time: Baseline

Description: 20- item questionnaire assessing the effects of news and social media on perception of COVID-19.

Measure: COVID-19 related media exposure and risk questions

Time: Up to 10 weeks

Description: 16- item questionnaire about the use of the intervention.

Measure: Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire

Time: Up to 10 weeks

Description: This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.

Measure: Computer Proficiency- Computer Proficiency Questionnaire

Time: Baseline

Description: Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.

Measure: Subjective Behavioral Sleep- Insomnia Severity Index

Time: Up to 10 weeks

Description: 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

Measure: Beck Depression Inventory-2nd Edition

Time: Up to 10 weeks

Description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

Description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

Description: Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

Description: Online diaries completed each morning (~5 mins); diaries measure total sleep time

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

Description: Online diaries completed each morning (~5 mins); diaries measure sleep quality

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks
26 Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population

The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.

NCT04426266
Conditions
  1. Questionnaire Designs
  2. COVID-19 Pandemic
  3. Psychological Stress
  4. Coping Skills
  5. Two-Item Generalised Anxiety Disorder Scale
  6. Patient Health Questionnaire An
  7. Patient Health Questionnaire Anxiety and Depression Scale
  8. Health Status Index
  9. Subjective Health Complaint
  10. Mood
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: 6 items - age, sex, city of residence, marital status, level of education, employment status

Measure: sociodemopraphic factors

Time: 5 months

Description: Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress

Measure: perceived stress

Time: 5 months

Description: The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety

Measure: level of anxiety

Time: 5 months

Description: EQ5D-VAS, 1 item to examine health status

Measure: self-reported health state

Time: 5 months

Description: Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.

Measure: number of complaints

Time: 5 months

Description: Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations

Measure: strategies in coping with stressful situations

Time: 5 months

Description: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).

Measure: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic

Time: 5 months

Description: The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression

Measure: level of depression

Time: 5 months
27 Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic

Study description: The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic. This is the time period where the major pandemic protocols are lifted in Norway, following three months of strict pandemic mitigation protocols. The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period, to identify vulnerable subgroups with maintained symptoms three months following the pandemic. Hypotheses and research questions: Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2. Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education. Exploratory: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample

NCT04442204
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Other: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary 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. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

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. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.
28 The Impact of Information Sources on Mental Health During the COVID-19 Pandemic

Study description: The present study seeks to investigate the impact of various sources of information on psychopathology, and specifically health anxiety, depression, and general anxiety, during the COVID-19 pandemic. The study will investigate the divergent impact of various information sources on these psychopathological symptoms during the pandemic. Hypotheses and research questions: Hypothesis 1: Media consumption across all information sources will significantly be associated with depression and anxiety symptoms, with increased media consumption in general associated with higher levels of health anxiety, depression, and general anxiety. Hypothesis 2: Using social media and online interactive platforms to obtain news about the pandemic in comparison to using traditional media (e.g., TV, radio, and newspapers) will be associated with higher levels of health anxiety, depression, and general anxiety. Actively staying away from information will further significantly be associated with higher levels of higher levels of health anxiety, depression, and general anxiety. Research Question 1: Is there a differential effect among different information sources on health anxiety, depression and general anxiety? To what extend and how are different information sources related to symptoms of health anxiety, depression, and general anxiety. Exploratory: Additionally, we will exploratory investigate to what extent the amount of use of different information sources impact health anxiety, depression, and general anxiety. We will also examine effect sizes with part correlations, to investigate information sources with the most and least detrimental impact on health anxiety, depression, and general anxiety. Furthermore, we will report which information platforms participants reported as most useful with regards to information concerning how to best deal with the pandemic.

NCT04442360
Conditions
  1. Depression
  2. Generalized Anxiety
  3. Health Anxiety
Interventions
  1. Behavioral: Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
MeSH:Anxiety Disorders

Primary 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. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
29 Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study

This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety). Research Question: How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety? Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, we are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. We are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health

NCT04444336
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Behavioral: Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
MeSH:Anxiety Disorders

Primary 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. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: The Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
30 Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes

This project seeks to know the prevalence of mental health problems among undergraduate students, through internationally and nationally validated screening instruments. The project also aims to understand better the associated factors contributing to the mental health problems of this population. Through the critical analysis of the results, our proposal aims to establish the prevalence of anxiety, depression, suicidality and substance use, and the association with socioeconomic features, academic stress, sense of belonging to the university, interpersonal relationships, and sleep habits among other factors. Once finalized the study, the results obtained will be disseminated to the university community and published in peer-reviewed journals. The results will help the university authorities to design and implement measures to prevent mental health problems in this community.

NCT04447690
Conditions
  1. Student
  2. Mental Health
  3. Depression, Anxiety
  4. Depression
  5. Anxiety
  6. College Drinking
  7. Stress
MeSH:Depression Depressive Disorder Anxiety Disorders Alcohol Drinking in College
HPO:Depressivity

Primary Outcomes

Description: Self-reported symptoms with the Depression, Anxiety and Stress Scale (DASS-21), which have 21 items, each scoring between 0 and 3, the minimum score is 0 and the maximum score of 63. The cut-off score for the depression subscale is 6, Anxiety is 5, Stress is 6.

Measure: Depression, Anxiety and Stress Scale (DASS-21)

Time: Up to 4 weeks

Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. This scale has 6 items and each item has to be answered Yes or No. The total score is 6. A score of 0 is no ideation is present.

Measure: Columbia-Suicide Severity Rating Scale (C-SSRS)

Time: Up to 4 weeks

Description: Self-report of harmful alcohol drinking. 4 items. CAGE stands for: C: Have you felt the need to Cut down drinking? A: Have you ever felt Annoyed by criticism of drinking? G: Have you had Guilty feelings about drinking? E: Do you ever take a morning Eye opener (a drink first thing in the morning to steady your nerves or get rid of a hangover)? The range score goes from 0 to 4. The point cut off is >= 2.

Measure: CAGE

Time: Up to 4 weeks

Description: Adaptation of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) interview model, including prescription and nonprescription drugs and vaping. It has 8 items exploring the frequency of substance use in the last 3 months (daily, weekly, yearly) and the problems associated with the use. It explores the use of 10 kinds of drugs.

Measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Time: Up to 4 weeks

Secondary Outcomes

Description: Ad hoc self-report survey: Current age University enrollment year Current years of study Sex Gender Civil status Parenting and number of child(s) Nationality Etnicity Ocupational situation: only study, part-time worker, fulltime worker and study Carrer Maximum parents studies degree: analphabet, school, undergraduate, postgraduate; complete or incomplete studies. Payment of studies: credit, schollarship, self-pay Travel time from home to campus: minutes, hours.

Measure: Sociodemographic characteristics

Time: Up to 4 weeks

Description: Self-perception on a subjective analogous scale of physical health

Measure: General Health perception

Time: Up to 4 weeks

Description: Self-perception on a subjective analogous scale of mental health

Measure: General Menta Health perception

Time: Up to 4 weeks

Description: Ad hoc self-report survey of any previous chronic physical disease

Measure: History of chronic diseases

Time: Up to 4 weeks

Description: Ad hoc self-report survey of minutes of physical activity during the past week

Measure: Physical activity

Time: Up to 4 weeks

Description: Ad hoc self-report survey of time spent with friends or social gatherings

Measure: Social activities

Time: Up to 4 weeks

Description: Family functionality APGAR score: a 5-item measure of perceived family support in the domains of adaptation, partnership, growth, affection, and resolve. E.g. "I find that my family accepts my wishes to take on new activities or make changes in my lifestyle". Scores range from 0 to 10, being 10 a total satisfaction with family functionality.

Measure: Family functionality (APGAR)

Time: Up to 4 weeks

Description: Ad hoc self-report questionnaire of personal and family mental health history: Previous diagnosis of depression, bipolar disorder, panic attacks, anxiety disorders, eating disorders, ADHD. Current psychotherapy of psychiatric medication Family history of psychiatric disorders

Measure: History of personal and family mental health problems

Time: Up to 4 weeks

Description: Self-report of insomnia perception. it has 7 items, and responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores ranges from 0 to 28. A clinical Insomnia threshold score of 15.

Measure: Insomnia Severity Index (ISI)

Time: Up to 4 weeks

Description: Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.

Measure: University violence and bullying

Time: Up to 4 weeks

Description: Ad hoc self-report survey of sexual health, including sexual orientation, the current status of an emotional relationship, number of sex partners in the last year, history of Sexually Transmitted Disease (STD).

Measure: Sexuality and sexual health

Time: Up to 4 weeks

Description: Sense of Social and Academic Fit (SSAF) is a self-report questionnaire of 17 items, with responses on a Likert format from 1-7. It measures academic and social sense of belonging. The score is produced as the average of the scores reported in each item. The minimum score is 1 and the maximum score is 17. A higher score means higher sense of belonging.

Measure: Sense of Social and Academic Fit (SSAF)

Time: Up to 4 weeks

Description: Ad-hoc self-report survey of current perception and possible diagnosis of COVID-19: Fear or preoccupation about getting COVID-19 Sense of severity if diagnosed with COVID-19 Fear or preoccupation about a family member or friend to get COVID-19 Current diagnosis of COVID-19 A family member diagnosed with COVID19 Sense of compliance with social isolation and quarantine Persons living with (family, friends, alone) Frequency of: going out of home, gather with others, virtual socialization, keeping a routine, exercise realized, recreative activities, meditation or prayer, seek information about the situation of COVID19 Frequency of the following symptoms: nervousness, hopelessness, depression, amount of effort required to realize activities, self-value, anhedonia.

Measure: COVID-19 questions

Time: Up to 4 weeks
31 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
32 Social Anxiety Telehealth Therapy Study

The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.

NCT04450303
Conditions
  1. Social Anxiety
Interventions
  1. Behavioral: Telehealth CBT
MeSH:Anxiety Disorders

Primary Outcomes

Description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

Measure: Liebowitz Social Anxiety Scale (LSAS)

Time: 12 weeks

Description: Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.

Measure: Satisfaction with Therapy and Therapists Scale (STTS)

Time: 12 weeks

Description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Measure: UCLA Loneliness Scale version 3

Time: 12 weeks

Secondary Outcomes

Description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

Measure: Liebowitz Social Anxiety Scale (LSAS)

Time: 24 weeks

Description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Measure: UCLA Loneliness Scale version 3

Time: 24 weeks
33 Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga

This study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video. This study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness. The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.

NCT04453514
Conditions
  1. Anxiety
Interventions
  1. Behavioral: Trauma-informed yoga video recording
MeSH:Anxiety Disorders

Primary Outcomes

Description: Total number of participants

Measure: Number of participants enrolled over 3 months

Time: 3 months

Description: Count of participants enrolled each week

Measure: Number of participants enrolled per week over 3 months

Time: 3 months

Description: Proportion of participants who enroll out of the total who access the consent form

Measure: Proportion of participants who enroll in the study over 3 months

Time: 3 months

Description: Proportion of participants that reach the final page of the study out of the total who provided informed consent

Measure: Proportion of participants who complete the study over 3 months

Time: 3 months

Description: Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire

Measure: Proportion of missing data over 3 months

Time: 3 months

Description: Proportion of participants who self-report watching the video in its entirety and for whom time stamps show that the time elapsed on the page where the video is embedded is greater than or equal to 80% of the length of the video

Measure: Proportion of participants who complete the 45-minute video over 3 months

Time: 3 months

Secondary Outcomes

Description: The State Trait Anxiety Inventory (STAI) - Y6 is a 6-item, validated self-report questionnaire that assesses state anxiety when used with instructions that specify: "indicate how you feel right now, in this moment." Responses to each item are provided on a 4 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the mean of 6 items, multiplied by 20 to use the interpretation guide for the full STAI scale.

Measure: Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form

Time: immediately before/after

Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Mind subscale will be used.

Measure: Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)

Time: immediately before/after

Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Body subscale will be used.

Measure: Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)

Time: immediately before/after
34 Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.

In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic.

NCT04453566
Conditions
  1. COVID-19
  2. Life Satisfaction
  3. Anxiety
  4. Mental Health Wellness 1
  5. Athlete
  6. Stress
Interventions
  1. Other: Online Survey
MeSH:Anxiety Disorders

Primary Outcomes

Description: Sociodemographic information and training characteristics Participants asked to provide sociodemographic information. Also, the difference in training frequency, duration, and quality after COVID-19 pandemic measured via 22 self-created questions.

Measure: Sociodemographic information and training characteristics

Time: at inclusion

Description: The Beck Anxiety Inventory (Beck et al., 1988) has been widely used to measure the severity of anxiety by self-report and showed to has internal consistency and high test-retest reliability. The Turkish version of the BAI proved to be a reliable and valid measure (Ulusoy et al., 1993). The participant rates how much each symptom has bothered the participant in the past week in the 21-item self-report questionnaire. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (4).

Measure: The Beck Anxiety Inventory (BAI)

Time: one week

Description: The Visual Analogue Scale (0 not stressed at all - 10 maximum amount of stress) used to measure self-reported stress and anxiety in elite athletes before and during the COVID-19 pandemic. The VAS showed to be an efficient tool for assessing self-reported stress and anxiety.

Measure: The Visual Analogue Scale (VAS)

Time: at inclusion

Description: The 14-item version of PSS scale asks patients how often they had experienced thoughts and feelings such as control irritations and stress during the previous one month, with responses ranging from 0 (never) to 4 (very often). The Turkish PSS proved to be a reliable and valid tool to measure perceived stress. The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: one month

Description: The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985) is a 5-item measure designed to measure global cognitive judgments of one's life satisfaction. The answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.

Measure: Satisfaction with Life Scale

Time: at inclusion

Description: The BRUMs scale is based on the Profile of Mood States. The Turkish version of the BRUMS scale studied on Turkish athletes, 24-item measures and six subscales in the original version decreased to 19 items and four subscales: anger, depression, vigor, fatigue. The results of the study proved to be valid and reliable (Cakiroglu et al., 2016). Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within the subscale are summed and a score range from 0 to 16.

Measure: Brunel mood scale (BRUMS)

Time: at inclusion
35 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
36 Self-assessment of Anxiety Level and Oral Hygiene Practice in Dental Students of Cairo University During Covid-19 Pandemic

Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". Many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding Covid-19. This action can lead to negative psychological consequences among college students. Oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . There is a claim of potential connection between high bacterial load in the mouth and complications associated with Covid-19 infection. Bacteria present in the meta genome of patients severely infected with Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high bacterial load. Accordingly, the investigators assume that good oral hygiene better to be maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection . While there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 Dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. Thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien

NCT04460469
Conditions
  1. Anxiety
  2. Covid19
  3. Oral Hygiene
MeSH:Anxiety Disorders

Primary Outcomes

Description: By questionnaire

Measure: correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university

Time: 2 months
37 Online Delivery of Psychotherapy, Tailored to Patients' Suffering From Mental Health Problems Due to COVID-19

The recent COVID-19 pandemic has affected many aspects of individuals social life and its negative consequences on Canadian public health go far beyond the direct overload of the hospital care system. Self-isolation and financial uncertainty can significantly deteriorate individuals' mental health, which is only going to aggravate with prolonged physical distancing strategies. Adding to this is the personal and public trauma of lost lives and soon there will be an unprecedented epidemic of mental health problems with crushing effects on the public health sector and economy. To meet this huge new demand for an already strained health system, there is a need for innovative new approaches that significantly expand the capacity of care delivery. While it may not be possible in the short term to increase the number of mental healthcare providers or the number of hours they work, improving their time spent efficiently might be the solution. Virtual care and online delivery of psychotherapy, shown to be clinically effective, efficient and cost-effective, might be the perfect solution to address the high demand faced now. The investigators aim to establish the first academic online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care delivery could increase care capacity by four-folds. The findings from this project have the potential to influence clinical practice and policy and increase accessibility to care during COVID-19 pandemic, without sacrificing the quality of care.

NCT04476667
Conditions
  1. Mental Health Issue
  2. Covid19
  3. Anxiety Disorders
  4. Depression
Interventions
  1. Behavioral: e-Psychotherapy
MeSH:Depression Anxiety Disorders

Primary Outcomes

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)

Measure: Change in Stress

Time: Baseline, week 6, week 12

Description: 14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)

Measure: Change in Resilience

Time: Baseline, week 6, week 12

Description: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)

Measure: Change in Quality of Life Assessment

Time: Baseline, week 6, week 12

Description: Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 1

Time: Baseline, week 6, week 12

Description: Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)

Measure: Change in Symptom Severity - 2

Time: Baseline, week 6, week 12

Description: Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 3

Time: Baseline, week 6, week 12

Secondary Outcomes

Description: Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.

Measure: Qualitative Information: Healthcare Providers

Time: Week 12

Description: In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy. This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.

Measure: Qualitative Information: Personal, social, and cultural factors

Time: Week 12
38 Turkish Validity And Reliability of the SARS-CoV-2 Anxiety Scale

The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.

NCT04490473
Conditions
  1. Anxiety
  2. SARS-CoV Infection
Interventions
  1. Other: survey work
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Anxiety Disorders

Primary Outcomes

Description: anxiety increase in SARS-CoV-2 in humans.

Measure: Anxiety in SARS-CoV-2

Time: 4 weeks

Description: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.

Measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale

Time: 4 weeks
39 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
40 Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)

This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.

NCT04495803
Conditions
  1. Perinatal Anxiety
  2. Covid19
Interventions
  1. Other: Cognitive Behavioural Group Therapy for Perinatal Anxiety
MeSH:Anxiety Disorders

Primary Outcomes

Description: Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.

Measure: State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)

Time: 8 weeks

Secondary Outcomes

Description: Due to the level of ongoing uncertainty that exists surrounding COVID-19, changes in intolerance of uncertainty will be assessed by the 27-item IUS to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing intolerance of uncertainty. The IUS can be scored across two-factors, in addition to a total score. Factor 1 includes items assessing uncertainty as having negative behavioural and self-referent implications (e.g., uncertainty keeps me from living a full life) and Factor 2 assesses uncertainty as being unfair and spoiling things in life (e.g., I can't stand being taken by surprise). Items are rated on a 5-point Likert type scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).

Measure: Intolerance of Uncertainty Scale (IUS)

Time: 8 weeks

Description: Changes in worry symptoms will be assessed by the PSWQ. The PSWQ is a 16-item self-administered tool designed to assess worry symptoms. Items are assessed on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me), with higher scores indicating increased worry.

Measure: Penn State Worry Questionnaire (PSWQ)

Time: 8 weeks

Description: Changes in mood symptoms will be assessed through the EPDS. Items on the EPDS are rated from 0-3, with higher total scores indicating more depressive symptoms. Possible scores on the EPDS range from 0-30. A clinical cut-off of 13 is used to indicate probable depression.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: 8 weeks

Description: Changes in worry and anxiety associated with COVID-19 will be examined using the CSS. The CSS is a 36-item self-report scale designed to measure worry and anxiety associated with the novel COVID-19 pandemic. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The CSS has 5 subscales: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and traumatic stress symptoms.

Measure: COVID-19 Stress Scales (CSS)

Time: 8 weeks

Description: Changes in pregnancy-specific anxiety will be assessed with the PRAQ-R2. Items are scored on 5-point Likert scale. Respondents are asked to circle the answer that applies most accurately to their situation and higher scores are reflective of greater pregnancy-specific anxiety. The PRAQ-R2 contains three subscales: fear of giving birth, worries about bearing a handicapped child, and concern about own appearance.

Measure: Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)

Time: 8 weeks

Description: Changes in postpartum-specific anxiety will be assessed with the PSAS. Items are scored on a 4-point Likert scale (0-3), with higher scores indicating greater anxiety symptoms. The PSAS has 4 subscales: maternal competence and attachment, infant safety and welfare, practical infant care, and psychosocial adjustment to motherhood.

Measure: Postpartum Specific Anxiety Scale (PSAS)

Time: 8 weeks

Description: Changes in severity and impairment associated with anxiety will be assessed with the OASIS. Respondents are asked to circle that answer that best describes their experience over the past week and items are scored on a 5-point Likert scale.

Measure: Overall Anxiety Severity and Impairment Scale (OASIS)

Time: 8 weeks

Description: Changes in parenting self-efficacy will be assessed with the PSOC. The PSOC is a 17-item self-report scale, in which items are scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree), with higher scores reflecting greater parenting sense of competency.

Measure: Parenting Sense of Competence Scale (PSOC)

Time: 8 weeks

Description: Changes in relationship satisfaction and adjustment will be assessed with the ADAS. The ADAS is a 7-item self-report scale, in which six of the items are scored on a 6-point Likert Scale, with higher scores reflecting greater relationship satisfaction. Item seven provides a global 'overall happiness' rating and is scored on 7-point Likert Scale ranging from 0 (extremely unhappy) to 6 (perfect).

Measure: Abbreviated Dyadic Adjustment Scale (ADAS)

Time: 8 weeks

Description: Changes in perceived social support will be assessed with the SPS. Items are scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating higher levels of perceived social support. The SPS has 6 subscales assessing dimensions of attachment, social integration, reassurance of worth, guidance, nurturance and reliance.

Measure: Social Provisions Scale (SPS)

Time: 8 weeks

Description: Changed in maternal attachment and bonding to the fetus will be assessed with the MAAS. For each item, respondents are asked to indicate the frequency in which each experience has occurred within the previous two weeks. The MAAS has two subscales that assess dimensions of quality of attachment and intensity of preoccupation. Items are scored on a 5-point Likert scale and scores range from 19 to 95 with higher scores indicating a higher level of attachment to the fetus.

Measure: Maternal Antenatal Attachment Scale (MAAS)

Time: 8 weeks

Description: Changes in maternal bonding with the infant will be assessed with the PBQ. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), with higher scores indicating lower levels of bonding with the infant. The PBQ has four subscales: general bonding, rejection and pathological anger, anxiety about the infant, and incipient abuse.

Measure: Postpartum Bonding Questionnaire (PBQ)

Time: 8 weeks

Description: Client satisfaction of the augmented CBT for perinatal anxiety during a global pandemic will be assessed with the CSQ. Items are scored on a 4-point Likert scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services.

Measure: Client Satisfaction Questionnaire (CSQ)

Time: 8 weeks

Description: Changes in participants perceived level of stress will be assessed with the PSS. The PSS is a 14-item self-report scale, with items scored on a 5-point Likert scale from 0 to 4, with higher total scores indicating higher perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: 8 weeks
41 The Effect of Aromatherapy on COVID-19-induced Anxiety

The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with COVID-19 testing.

NCT04495842
Conditions
  1. Stress
  2. Covid19
  3. Anxiety
Interventions
  1. Other: Essential Oil Blend
  2. Other: Control Blend
MeSH:Anxiety Disorders

Primary Outcomes

Description: The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.

Measure: Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes

Time: Baseline and at 15 minutes
42 Correlation of Fear of COVID-19 Infection and Dental Treatment Anxiety Among Netizens: A Cross-sectional Study.

Purpose: COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19 airborne transmission is possible under circumstances in which procedures generate aerosols. Various dental treatment procedures can generate aerosols. This Cross Sectional Observational study was conducted with the following objectives: 1. Assessment of Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. 2. Assessment of Dental Anxiety among netizens in Al Qassim provincen using (MDA) Modified Dental Anxiety 5 item Likert Scale. Methods: Sample size was (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 & hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic & English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across Social media platforms. Statistical analysis is done using SPSS 22.00 software program.

NCT04497818
Conditions
  1. Covid19
  2. Fear
  3. Dental Anxiety
Interventions
  1. Other: Cross Sectional study using scientifically validated psychometric Scales
MeSH:Anxiety Disorders

Primary Outcomes

Description: Assessed Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Fear of COVID-19 infection

Time: 5th August 2020

Description: Assessed Dental Anxiety among netizens in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Dental Anxiety

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the Fear of COVID-19 with Dental Anxiety among Netizens in Qassim region. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of Fear of COVID-19 infection & Dental Anxiety

Time: 5th August 2020

Secondary Outcomes

Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Dental Anxiety

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of Age and Fear of COVID-19 infection The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 will be considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Fear of COVID-19 infection

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the Age and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Dental Anxiety.

Time: 5th August 2020
43 Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has begun, first in Wuhan, China, and then became a pandemic. The first SARS-CoV-2 case in Turkey was reported on March 11, 2020. People older than 65 years old became subject to lock down measures beginning on March 21, while people younger than 20 years old became subject to lock down measures beginning on April 03. A total lock down has been implemented a few times lasting between 3 to 4 days, especially at weekends. Several studies show that mental health problems could occur in public during the SARS-CoV-2 pandemic. Depression and anxiety are a commonly known mental health issue in post-stroke patients. This patient population, who usually have to spend most of their time at home, remained completely at home and socially isolated due to the precautions required by the pandemic. Based on the above research evidence; depression, anxiety and phobia of SARS-CoV-2 may increase in the post stroke patients due to being in risk group and effects of measures taken against SARS-CoV-2 pandemic. Therefore, we aimed to assess the depression, anxiety and SARS-CoV-2 phobia in post stroke patients during SARS-CoV-2 outbreak, and to explore the potential influence factors.

NCT04560413
Conditions
  1. SARS-CoV-2
  2. Post-stroke Depression
  3. Anxiety and Fear
MeSH:Stroke Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity Stroke

Primary Outcomes

Description: The Hospital Anxiety and Depression Scale evaluation includes a total of 14 questions (score range 0-3), which are scored to separately estimate anxiety and depressive status (7 questions each). The individual score for the anxiety and depression subscales may vary from 0 to 21. The aim of this scoring system is not to make an objective diagnosis, but to determine the current presence and tendency to anxiety or depression at the time of diagnosis. A HADS score of 8 to 10 is broadly accepted as indicating mild symptoms, a score between 11-16 suggests moderate anxiety or depression, and a score of 16 or more indicates severe anxiety or depressive symptoms

Measure: Hospital Anxiety and Depression Scale

Time: 3 months

Description: The Covid 19 Phobia Scale is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social

Measure: Covid 19 Phobia Scale

Time: 3 months
44 Community Applications of the MindShift App

Despite considerable, replicated evidence of the efficacy and effectiveness of cognitive behavioural therapy, there is an insufficient number of professionals (e.g., psychologists, psychiatrists) in North America to provide evidence-based psychotherapy to all who need it. For example, in light of the COVID-19 pandemic, there is a greater need for resources that are scalable to help a large portion of the public to manage anxiety and attendant psychological distress. One promising avenue to increase the availability of evidence-based mental healthcare relies on technological developments, such as smartphone-enabled apps, to disseminate principles derived from existing evidence-based psychotherapies. However, further research is needed to understand for whom and in what contexts internet- and smartphone-enabled resources are helpful. The present study will examine the utility of one such smartphone enabled app, MindShift, developed by Anxiety Canada in consultation with Canadian and American experts in evidence-based psychotherapy for anxiety disorders. Specifically, the main aim of the present study is to evaluate the effectiveness of the MindShift app to help users manage anxiety and related psychological distress as compared to anxiety and distress prior to app use. Two secondary, exploratory aims of the present study are to examine possible moderators that indicate for whom or in what contexts use of the MindShift app is particularly helpful. Adult participants 18 years of age and older will be recruited from Canada and the United States of America. Following informed consent, participants will complete baseline assessment of anxiety symptom severity, depressive symptom severity, daily functional impairment, quality of life, alcohol use, use of illicit psychoactive substances, stress associated with the COVID-19 pandemic, and demographic information. Following baseline assessment, participants will be instructed in downloading the MindShift app to their personal mobile phone running either iOS or Android OS software. Participants will then use the MindShift app as they choose for the 16-week duration of the study. Finally, participants will be asked to complete follow-up assessments 2, 4, 8, 12, and 16 weeks following baseline assessment. Follow-up assessments will assess anxiety symptom severity, depressive symptom severity, functional impairment, and quality of life satisfaction on the same measures administered at baseline.

NCT04562948
Conditions
  1. Anxiety
  2. Depression
  3. Anxiety Generalized
  4. Anxiety Disorders and Symptoms
MeSH:Anxiety Disorders

Primary Outcomes

Description: The Generalized Anxiety Disorder 7-item scale (GAD-7) assesses self-reported severity of generalized anxiety symptoms over the past 2 weeks, specifically symptoms associated with Generalized Anxiety Disorder. The minimum score is 0; the maximum score is 21. Higher scores indicate greater levels of symptom severity. The GAD-7 will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. The primary outcome measure is linear and non-linear change in generalized anxiety symptom severity over 16 weeks.

Measure: Linear and non-linear change in generalized anxiety severity over 16 weeks

Time: 16 weeks

Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) assesses self-reported severity of depressive symptoms over the past 2 weeks. The minimum score is 0; the maximum score is 27. Higher scores indicate greater levels of depressive symptom severity. The PHQ-9 will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in depressive symptom severity over 16 weeks.

Measure: Linear and non-linear change in depressive symptom severity over 16 weeks

Time: 16 weeks

Description: The Work and Social Adjustment Scale (WSAS) assesses self-reported global functional impairment related to physical and psychiatric distress. The minimum score is 0; the maximum score is 40. Higher scores indicate higher levels of functional impairment related to physical and psychiatric distress. The WSAS will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in functional impairment over 16 weeks.

Measure: Linear and non-linear change in functional impairment over 16 weeks

Time: 16 weeks

Description: The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) assesses one's perceived global quality of life.The minimum score is 16; the maximum score is 80. Higher scores indicate higher levels of life satisfaction. The Q-LES-Q-SF will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in life satisfaction over 16 weeks.

Measure: Linear and non-linear change in life satisfaction over 16 weeks

Time: 16 weeks

HPO Nodes


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Reports

Data processed on September 26, 2020.

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

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