Simple Cognitive Task After Trauma EKUT RCT

Study Overview
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Brief Summary
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This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game Tetris) on intrusive memories (flashbacks) and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event 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 and less severe related clinical symptoms than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation and training aspects in a hospital context will also be explored. Patients use 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 ID: NCT03509792). The primary outcome is the number of intrusive memories of the traumatic event (week 5). The intervention is delivered in emergency departments of Swedish hospitals.

Official Title
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Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: EKUT (Enkel Kognitiv Uppgift Efter Trauma) - A Randomized Controlled Trial (RCT)

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Simple cognitive task
* Behavioral: Attention placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or over Experienced or witnessed a traumatic event resulting in admission to the emergency department Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD) in that (The person was exposed 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) Can be seen in the emergency department ca. 6 hours after the traumatic event (day 1) 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 following discharge to complete follow-up assessments Have access to an internet enabled smartphone Exclusion Criteria: Loss of consciousness of > 5 minutes Current intoxication Report a history of severe mental illness Current substance abuse or neurological condition Currently suicidal Other medical reasons (on advice by medical staff)

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<br>A memory cue followed by playing the computer game Tetris on own smartphone. Options to engage in self-administered booster sessions after day 1. | Behavioral: Simple cognitive task<br>* A memory cue followed by playing the computer game Tetris on own smartphone. Options to engage in self-administered booster sessions after day 1.<br>|
| Placebo Comparator: Attention placebo<br>Smartphone activity for same amount of time. | Behavioral: Attention placebo<br>* Smartphone activity for same amount of time.<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 | Number of intrusive memories of traumatic event 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 | Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days. | Week 1 | 
| Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms | Self-report measure that assesses subjective distress after a traumatic event (with reference to ED event). 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. | One week and 1, 3, and 6 month follow-up | 
| Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms | The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate worse severity. | One week and 1, 3, and 6 month follow-up | 
| Posttraumatic Stress Disorder Checklist 5 (PCL-5) | Full scale is a 20-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 yields a total symptom severity score which ranges from 0 to 80. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-5), cluster C - avoidance (items 6-7), cluster D - negative alterations in cognitions and mood (items 8-14), and cluster E - alterations in arousal and reactivity (items 15-20). Higher scores indicate worse severity. | One week and 1, 3, and 6 month follow-up | 
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | A 12-item self-rated questionnaire measuring difficulties due to health conditions, including mental or emotional problems (with reference to ED study event). Scores range from 1 (none) to 5 (extremely/cannot do). The maximum score of the WHODAS is 60, lower scores are better. 3 additional items measure on how many of the last 7 days (modified time scale) these difficulties occurred. | One week and 1, 3, and 6 month follow-up |