Clinical trial NCT04185155: Simple Cognitive Task After Trauma EKUT RCT
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of intrusive memories of traumatic event
timeFrame: Week 5
Secondary outcomes:
measure: Number of intrusive memories of traumatic event
timeFrame: Week 1
measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: One week and 1, 3, and 6 month follow-up
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: One week and 1, 3, and 6 month follow-up
Other outcomes:
measure: Credibility/expectancy questionnaire
timeFrame: Day 1
measure: Subjective units of distress (SUDS)
timeFrame: Day 1
measure: Self-Rated initial intrusions
timeFrame: Day 1 and Day 2
measure: Feedback Questionnaire about Participation
timeFrame: 1 month follow-up
measure: Self Rated Health (SRH) rating
timeFrame: Day 1, one week and 1, 3, and 6 month follow-up
measure: Self Rated Sleep ratings
timeFrame: Day 1, one week and 1, 3, and 6 month follow-up
measure: Characteristics of intrusive trauma memories
timeFrame: Week 1 and week 5, 3 and 6 month follow-up
measure: Self Rated Functioning and social support ratings
timeFrame: One week, 1, 3, and 6 month follow up
measure: Intrusion questionnaire
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Adverse events
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Training evaluation checklists
timeFrame: Through study completion, an average of 1 year
Locations:
city: Huddinge
country: Sweden
facility: Emergency Departments (e.g. FO Akut, Karolinska University Hospital Huddinge)
Study officials:
affiliation: Karolinska Institutet/Uppsala University
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanstrup M, Singh L, Goransson KE, Gamble B, Taylor RS, Iyadurai L, Moulds ML, Holmes EA. A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19. BMC Res Notes. 2021 May 10;14(1):176. doi: 10.1186/s13104-021-05572-1.