Simple Cognitive Task After Trauma

NCT03509792 | Completed DMC

• 1 other identifier: 2017/2215-31
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of intrusive memories of traumatic event

  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

  One week and 1, 3, and 6month follow-up

• Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms

  One week 1, 3, and 6 month follow-up

• Perceived Stress Scale (PSS)

  1 month follow-up

• Work and Social Adjustment Scale (WSAS): Daily function

  [One week and 1, 3, and 6 month follow-up]

Other Outcomes (8)

• Feedback Questionnaire about Participation

  One week and 1, 3, and 6 month follow-up

• Implementation feedback

  Day 1, week 1, and 1, 3 and 6 month follow ups, through to study completion

• Credibility/expectancy questionnaire: Treatment credibility

  Day 1

Study Arms (2)

Simple cognitive task

EXPERIMENTAL

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

Attention placebo

PLACEBO COMPARATOR

Smartphone activity for same amount of time.

Behavioral: Attention placebo

Interventions

Simple cognitive task BEHAVIORAL

A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1.

Simple cognitive task

Attention placebo BEHAVIORAL

Smartphone activity for same amount of time.

Attention placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Loss of consciousness of \> 5 minutes
• Current intoxication
• Report a history of severe mental illness
• Current substance abuse or neurological condition
• Currently suicidal

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Akuten Huddinge Sjukhus

Stockholm, Solna, 171 76, Sweden

Location

Related Publications (2)

• 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.

  PMID: 33431807 RESULT

• 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.

  PMID: 34620249 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Emily Holmes, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Erik Andersson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 26, 2018
• Study Start: January 11, 2019
• Primary Completion: July 12, 2019
• Study Completion: December 20, 2019
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

SE (1)