Covid 19 Research using Clinical Trials (Home Page)
Report for D000067073: Psychological Trauma NIH
(Synonyms: Psychological Trauma)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1226 | Health Enhancement Program Wiki | 0.58 |
| drug442 | Blood plasma Wiki | 0.58 |
| drug1767 | MinnRAP Peer Support Program Wiki | 0.58 |
| drug1406 | Infant Mental Health-Home Visiting Wiki | 0.58 |
| drug2756 | Sudarshan Kriya Yoga (SKY) Wiki | 0.58 |
| drug476 | Brief cognitive intervention Wiki | 0.41 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000068376 | Compassion Fatigue NIH | 0.82 |
| D015775 | Fractures, Stress NIH | 0.58 |
| D000068099 | Trauma and Stressor Related Disorders NIH | 0.41 |
| D000073397 | Occupational Stress NIH | 0.33 |
| D040921 | Stress Disorders, Traumatic NIH | 0.22 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.21 |
| D004194 | Disease NIH | 0.20 |
| D001523 | Mental Disorders NIH | 0.12 |
| D013315 | Stress, Psychological NIH | 0.12 |
| D014947 | Wounds and Injuries NIH | 0.11 |
| D001008 | Anxiety Disorders NIH | 0.09 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness (BREATH): an RCT for Frontline Hospital and Long-term Care Home Staff Managing the COVID-19 Pandemic
This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).
NCT04368676 Job St Job Stress Workplace Stress Compassion Fatigue Psychological Trauma Healthcare Workers Healthcare Providers Other: Sudarshan Kriya Yoga (SKY) Other: Health Enhancement Program MeSH:Compassion Fatigue Occupational Stress Psychological Trauma
Primary Outcomes
Description: The number of participants recruited per month will be calculated as a feasibility measure.
Measure: Rate of participant recruitment Time: 1 yearDescription: The retention rate of participants will be calculated as a feasibility measure.
Measure: Rate of retention Time: 1 yearDescription: The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms.
Measure: Completeness of data entry Time: 1 yearDescription: The cost of both study interventions will be calculated to assess the total study cost for interventions and the cost per participant. This information will be used as a feasibility measure.
Measure: Cost of interventions Time: 1 yearDescription: The total of unexpected costs will be calculated as a feasibility measure.
Measure: Unexpected costs Time: 1 yearSecondary Outcomes
Description: The Athens Insomnia Scale will be used to assess insomnia. This scale is an 8-item, self-rated measure of the extent of sleep difficulties over the last 30 days with each item representing a different aspect of sleep (e.g. "Overall Quality of Sleep"). Ratings are from 0 to 4, with 0 being no difficulty with the item and 4 being the most difficulty with the item. Higher overall scores on this scale indicate higher difficulties with sleep.
Measure: Change in Athens Insomnia Scale Time: Change from Week 0 to week 3 and to week 5Description: The Generalized Anxiety Disorder 7-item scale (each scored 0-3) is a self-rated measure of anxiety and has been validated for the diagnosis of Generalized Anxiety Disorder in the adult population. Scores range from 0 to 21. Higher scores indicate greater anxiety symptoms (5-9, mild anxiety; 10-14, moderate anxiety; 15-21 severe anxiety).
Measure: Change in Generalized Anxiety Disorder 7-item scale Time: Change from Week 0 to week 3 and to week 5Description: The Patient Health Questionnaire (PHQ-9) is a 9-item, self-rated measure of depression which has been validated for screening a major depressive episode in adults. Total scores indicate various levels of depression: 0-4, no depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.
Measure: Change in Patient Health Questionnaire 9 Time: Change from Week 0 to week 3 and to week 5Description: The Connor-Davidson Resilience Scale (CD-RISC) is a brief self-rated assessment tool that comprises of 10 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Higher scores reflect greater resilience, which is a measure of one's ability to cope with stress. The scale demonstrated strong reliability and validity and has been studied in a variety of populations including medical personnel, nurses, social workers and physicians).
Measure: Change in Connor-Davidson Resilience Scale Time: Change from Week 0 to week 3 and to week 52 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Test of Replication to a New Population
This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.
NCT04394156 Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma, Psychological Trauma and Stressor Related Disorders Mental Disorder Behavioral: Brief cognitive intervention MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Disorders Psychological Trauma Trauma and Stressor Related Disorders Wounds and Injuries
Primary Outcomes
Description: Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.
Measure: Frequency of intrusive memories Time: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.Secondary Outcomes
Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.
Measure: Concentration Time: Baseline, 2-weeks post-intervention and 2-months post-interventionDescription: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.
Measure: Social and Occupational Activity Tally (SOAT) Time: Baseline, 2-weeks post-intervention and 2-months post-interventionDescription: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.
Measure: Dissociation Time: Baseline, 2-weeks post-intervention and 2-months post-interventionDescription: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.
Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Time: Baseline and 2-weeks post-interventionDescription: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.
Measure: Patient Health Questionnaire (PHQ-9) Time: Baseline and 2-weeks post-interventionDescription: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.
Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version Time: Baseline and 2-weeks post-interventionOther Outcomes
Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.
Measure: Self-Guided Intervention Adherence Questionnaire Time: Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.
Measure: Feedback Questionnaire Time: 1-week post-intervention.3 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 Stress Stress Disorder Stress, Psychological Trauma, Psychological Anxiety Anxiety State Post Traumatic Stress Disorder Secondary Traumatic Stress Professional Quality of Life Stress Related Disorder Stress Reaction Stress Risk Mental Resilience Emotional Resilience 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)