Simple Cognitive Task After Trauma

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 clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation aspects in a new 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 an explorative pilot study, which will guide the design of a future Randomised Controlled Trial. The main aim of the present study is not a statistical significance test, the results will be descriptive, and will include pilot analyses to obtain an estimate of effect size between groups of the current primary outcome measure.

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)

Conditions
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Post-traumatic Stress Disorders

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 for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian) Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) (The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence by Direct exposure or Witnessing the trauma) ) Can be seen in the emergency department within 6 hours after the traumatic event Report memory of the accident Fluent in Swedish Alert and orientated Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands). 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 in addition to point above can be seen in the emergency department within 6 hours after the traumatic event, from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event 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

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: None (Open Label)


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 diary daily (morning, afternoon, evening and night) for 7 days | Week 1 | 

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 diary daily (morning, afternoon, evening and night) for 7 days | 1 month | 
| Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster | Full scale is a 22-item self-report measure that assesses subjective distress after a traumatic events. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score (ranging from 0 to 88) and subscale scores are calculated for the Intrusion, Avoidance, and Hyperarousal subscales summed. Higher scores indicate worse outcome. Our secondary outcome measure is the Intrusion subscale. | One week and 1, 3, and 6month 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 1, 3, and 6 month follow-up | 
| Perceived Stress Scale (PSS) | Measures the perception of stress and the degree to which situations in one's life are appraised as stressful. The 14 items aims to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are rated on a 5-point scale ranging from 0 (never) to 4 (very often) and summed to a total score of 56. Seven items concerns positive experiences and are hence reversed in scoring. Higher scores indicate worse severity. | 1 month follow-up | 
| Work and Social Adjustment Scale (WSAS): Daily function | The Work & Social Adjustment Scale is a simple 5-item measure of general social impairment which grew out of a study of change during psychotherapy. The maximum score of the WSAS is 40, lower scores are better. | [One week and 1, 3, and 6 month follow-up] |