Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT

Study Overview
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Brief Summary
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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 0). 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.

Detailed Description
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This is a Randomised Controlled Trial informed by prior feasibility and pilot work (ClinicalTrials.gov IDs: NCT03509792, NCT04185155). The primary outcome is the number of intrusive memories of the traumatic event(s) (week 5). The intervention is delivered remotely (e.g. via smartphone) with potential remote support (e.g. by phone) to medical staff in Swedish hospitals.

Official Title
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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)

Conditions
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Intrusive Memories of Traumatic Event(s), Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Simple cognitive task intervention
* Behavioral: Attention Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or over Clinical work during the COVID-19 pandemic in hospital and care facilities (e.g. ICU, ambulance, intermediate care, ward) Experienced at least one traumatic event in relation to their clinical work as health care staff during the COVID-19 pandemic This/these event(s) at work meet(s) the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD): exposure to actual or threatened death, serious injury, or sexual violence by Directly experiencing the traumatic event(s) or Witnessing, in person, the event(s) as it occurred to others The traumatic event(s) occured since the start of the COVID-19 pandemic Report memory of the accident Fluent in spoken and written Swedish Alert and orientated Have sufficient physical mobility to use their smartphone Willing and able to provide informed consent and complete study procedures Willing and able to be contacted while the study is ongoing Have access to an internet enabled smartphone Experiences distressing intrusive memories (of a traumatic event in relation to their work as health care staff during the COVID-19 pandemic) Has experienced at least two such intrusive memories of a work-related traumatic event during the week before inclusion/exclusion Able and willing to briefly write down these intrusive memories (without going into any detail) Exclusion Criteria: Loss of consciousness of > 5 minutes in relation to the traumatic event Current intoxication during the traumatic event or in relation to study inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple cognitive task intervention<br>Session 1: A memory cue followed by playing the computer game Tetris (e.g. on own smartphone) with mental rotation instructions. Options to engage in self-administered/guided booster sessions per intrusive memory. | Behavioral: Simple cognitive task intervention<br>* Session 1: A memory cue followed by playing the computer game Tetris (e.g. on own smartphone) with mental rotation instructions. Options to engage in self-administered/guided booster sessions per intrusive memory.<br>|
| Placebo Comparator: Attention placebo<br>Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone). | Behavioral: Attention Placebo<br>* Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusive memories of traumatic event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days. | Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusive memories of traumatic event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days. | Week 0 and Week 1 | 
| Intrusion questionnaire - frequency item | 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. | Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up | 
| Intrusion questionnaire - characteristics | 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. | Baseline (Day 1), One week and 1, 3, and 6 month follow-up | 
| Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms | 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. | Baseline (Day 1), One week and 1, 3, and 6 month follow-up | 
| Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version | 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. | Baseline (Day 1), One week and 1, 3, and 6 month follow-up | 
| Characteristics of intrusive trauma memories | 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. | Baseline (Day 1), Week 1 and week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder, Digital Intervention, Intrusive Memories of Traumatic Event(s)