Simple Cognitive Task After Trauma EKUT RCT
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: Simple cognitive taskBehavioral: Attention placebo
- Registration Number
- NCT04185155
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simple cognitive task Simple cognitive task A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1. Attention placebo Attention placebo Smartphone activity for same amount of time.
- Primary Outcome Measures
Name Time Method Number of intrusive memories of traumatic event Week 5 Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
- Secondary Outcome Measures
Name Time Method Posttraumatic Stress Disorder Checklist 5 (PCL-5) One week and 1, 3, and 6 month follow-up 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.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) One week and 1, 3, and 6 month follow-up 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.
Number of intrusive memories of traumatic event Week 1 Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms One week and 1, 3, and 6 month follow-up 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.
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms One week and 1, 3, and 6 month follow-up 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.
Trial Locations
- Locations (1)
Emergency Departments (e.g. FO Akut, Karolinska University Hospital Huddinge)
🇸🇪Huddinge, Sweden