CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Attention PlaceboWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2258 Simple cognitive task intervention Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D040921 Stress Disorders, Traumatic NIH 0.22
D013313 Stress Disorders, Post-Traumatic NIH 0.20

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


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

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

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

Primary Outcomes

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

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

Time: Week 5

Secondary Outcomes

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

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

Time: Week 1

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

Measure: Intrusion questionnaire - frequency item

Time: Day 1, Day 2, Week 1 and 5 and 1, 3, and 6 month follow-up

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

Measure: Intrusion questionnaire - characteristics

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

Description: Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]). 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: Day 1, One week and 1, 3, and 6 month follow-up

Description: The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder. 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: Day 1, One week and 1, 3, and 6 month follow-up

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

Measure: Characteristics of intrusive trauma memories

Time: Week 1 and week 5

Description: A single item given before intervention/control procedure on day 1 measuring the number of intrusive memories during the previous week from 2 (min. 2 intrusive memories during the previous week is study inclusion criterion) to more than 7, and if more than 7 then a free text response field to specify the number of intrusive memories and any comments. Then 3 self-rated items measuring the level of distress, vividness or concentration disruption associated with the intrusions (11 point scales from 0 to 10).

Measure: Self-rated initial intrusions

Time: Day 1

Other Outcomes

Description: A single item measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10). High scores indicate higher level of concentration disruption.

Measure: Self-rated concentration disruption associated with intrusive memories

Time: Day 1, Day 2, Week 1 and Week 5, 1, 3, and 6 months follow-up

Description: 2 bespoke items including a question on impact on daily functioning associated with the intrusions and a question on perceived social support after the traumatic event. Both 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: Day 1, One week, 1, 3, and 6 month follow up

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

Measure: Appraisals of intrusive memories

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

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

Measure: Self-rated sleep ratings

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

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

Measure: Self Rated Health (SRH) rating

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

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

Measure: Questions related to work situation

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

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

Measure: Sick leave

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

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

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

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

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

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

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

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

Measure: Moral stress at work

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

Description: 6 self-report items measuring intention to leave job (5-point scale ranging from 1 "strongly agree" to 5 "strongly disagree") on two scales: intention to leave profession (items 1-3) and intention to leave workplace (items 4-6); and a single question about whether the above mentioned intentions are because of intrusive memories with a yes/no response. Items are summed per subscale. Potential subscale scores range from 3-15, with higher scores indicative of lower intention to leave job.

Measure: Intention to leave job

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

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

Measure: Adverse events

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

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

Measure: Future self questionnaire - shortened version

Time: 3 month follow-up

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

Measure: Time perspective questionnaire

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

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

Measure: Coping mechanisms

Time: Day 1

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

Measure: Credibility/expectancy questionnaire

Time: Day 1

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

Measure: Subjective Units of Distress (SUDS)

Time: Day 1

Description: 9 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.

Measure: Feedback questionnaire about participation

Time: 1 month follow-up


No related HPO nodes (Using clinical trials)