Clinical trial NCT03509792: Simple Cognitive Task After Trauma
Official title: Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 42
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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of intrusive memories of traumatic event
timeFrame: Week 1
Secondary outcomes:
measure: Number of intrusive memories of traumatic event
timeFrame: 1 month
measure: Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster
timeFrame: One week and 1, 3, and 6month follow-up
measure: Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
timeFrame: One week 1, 3, and 6 month follow-up
measure: Perceived Stress Scale (PSS)
timeFrame: 1 month follow-up
measure: Work and Social Adjustment Scale (WSAS): Daily function
timeFrame: [One week and 1, 3, and 6 month follow-up]
Other outcomes:
measure: Feedback Questionnaire about Participation
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Implementation feedback
timeFrame: Day 1, week 1, and 1, 3 and 6 month follow ups, through to study completion
measure: Credibility/expectancy questionnaire: Treatment credibility
timeFrame: Day 1
measure: Self Rated Health (SRH) rating
timeFrame: baseline, one week and 1, 3, and 6 month follow-up
measure: Self rated Sleep ratings
timeFrame: baseline, one week and 1, 3, and 6 month follow-up
measure: Adverse events
timeFrame: One week 1, 3, and 6 month follow-up
measure: Characteristics and sensory modality of intrusive trauma memories
timeFrame: One week and 1 month follow-up
measure: M.I.N.I 7.0.0 (Mini International Neuropsychiatric Interview version 7.0.0) - Section H. Posttraumatic stress disorder (PTSD)
timeFrame: 1, 3, and 6 month follow-up
Locations:
city: Stockholm
country: Sweden
facility: Akuten Huddinge Sjukhus
state: Solna
Study officials:
affiliation: Karolinska Institutet
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Erik Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanstrup M, Singh L, Goransson KE, Widoff J, Taylor RS, Gamble B, Iyadurai L, Moulds ML, Holmes EA. Reducing intrusive memories after trauma via a brief cognitive task intervention in the hospital emergency department: an exploratory pilot randomised controlled trial. Transl Psychiatry. 2021 Jan 11;11(1):30. doi: 10.1038/s41398-020-01124-6.
citation: Kanstrup M, Rudman A, Goransson K, Andersson E, Lauri KO, Rapoport E, Sunnergard L, Bragesjo M, Andersson E, Iyadurai L, Holmes EA. Reaching people soon after a traumatic event: an exploratory observational feasibility study of recruitment in the emergency department to deliver a brief behavioral intervention via smartphone to prevent intrusive memories of trauma. Pilot Feasibility Stud. 2021 Oct 7;7(1):184. doi: 10.1186/s40814-021-00916-x.