Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| D040921 | Stress Disorders, Traumatic NIH | 0.19 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.17 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week -1). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.
Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Measure: Number of intrusive memories of traumatic event(s) Time: Week 5Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Measure: Number of intrusive memories of traumatic event(s) Time: Week -1 and Week 1Description: A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.
Measure: Intrusion questionnaire - frequency item Time: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-upDescription: 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.
Measure: Intrusion questionnaire - characteristics Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
Measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.
Measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: 2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.
Measure: Characteristics of intrusive trauma memories Time: Baseline (Day 1), Week 1 and week 5Description: Two items measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10) and the duration of disruption (< 1 min, 1-5 min, 5-10 min, 10-30 min, 30-60 min, > 60 min). High scores indicate higher level of concentration disruption and longer duration of disruption.
Measure: Self-rated concentration disruption associated with intrusive memories Time: Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-upDescription: 3 bespoke items including a question on impact on work-related functioning, and one on daily functioning in other areas associated with the intrusions and a question on perceived social support after the traumatic event. All items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). Higher scores indicate higher level of functional impairment/perceived social support.
Measure: Self-rated functioning and social support ratings Time: Baseline (Day 1), One week, 1, 3, and 6 month follow upDescription: 6 self-report items (11-point scale from 0 to 100) measuring appraisals of intrusions on two subscales: psychological problems (items 1-3) and negative self-evaluations (items 4-6). Items for each subscale will be summed. Possible subscale scores range from 0 - 300, with higher values indicative of worse appraisals.
Measure: Appraisals of intrusive memories Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
Measure: Self-rated sleep ratings Time: Baseline (Day 1), one week and 1, 3, and 6 month follow-upDescription: A single item measuring perceived health status on a seven-point scale (from very good to very bad). The scale is reverse scored. High scores indicate good outcomes.
Measure: Self Rated Health (SRH) rating Time: Baseline (Day 1), one week, and 1, 3, and 6 month follow-upDescription: 3 free text response field questions (e.g. which type of health care do you work with right now?) at Day 1 and two free text response field questions on whether the work situation changed and if yes, how, at one week, 1, 3, and 6 month follow-up.
Measure: Questions related to work situation Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 2 bespoke items measuring the total number and the number of full work days on sick leave because of reason for seeking health care. Higher numbers indicate more sick leave.
Measure: Sick leave Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 3 items measuring the frequency of feeling stressed, pressured, tensed at work during the previous week on a 5-point scale (from "never" to "several times per day"). Item scores are summed. Higher scores indicate higher levels of stress. Further, a single item measuring difficulties to let go of work-related thoughts during leisure time (from "very rarely or never" to "very often or always") and a single question about whether the above mentioned difficulties are because of intrusive memories with a yes/no response.
Measure: Stress and Energy Questionnaire (SEQ) - Stress subscale Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 9 self-report items (4-point scale from 1 "not at all" to 4 "all the time") measuring symptoms of burnout on three subscales: Exhaustion (items 1-3), disengagement (items 4-6) and inattentiveness (items 7-9). Subscale scores will be the mean of all items per subscale, the total burnout score will be the mean of all items (ranging from 1-4) with higher scores indicative of higher levels of exhaustion/disengagement/inattentiveness/burnout.
Measure: Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale Time: Baseline (Day 1) and 6 month follow-upDescription: 5 self-report items measuring moral stress at work on a 4-point scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). All items are summed. Potential scores range from 5-20, with higher scores indicative of lower levels of moral stress.
Measure: Moral stress at work Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: A free text response field measuring the occurrence of any health problems since the last contact.
Measure: Adverse events Time: One week and 1, 3, and 6 month follow-upDescription: A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity.
Measure: Future self questionnaire - shortened version Time: 3 month follow-upDescription: 8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.
Measure: Time perspective questionnaire Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 2 free text response field questions (e.g. Are there any specific factors you think have made it easier for you to handle the COVID-19 situation and its consequences?) at Day 1.
Measure: Coping mechanisms Time: Baseline (Day 1)Description: 5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participant finds the intervention credible. High scores indicate greater credibility.
Measure: Credibility/expectancy questionnaire Time: Day 1Description: A bespoke manipulation check item measuring self-rated distress during the intervention/control procedure (11-point scale from 0 to 10) at 3 times during the intervention process. Higher scores indicate higher level of distress.
Measure: Subjective Units of Distress (SUDS) Time: Day 1Description: 8 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.
Measure: Feedback questionnaire about participation Time: 1 month follow-upAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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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