Simple Cognitive Task After Trauma EKUT RCT

NCT04185155 | Terminated DMC

• 1 other identifier: 2019-05380
• Study Type: interventional
• Target: 16
• 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 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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Number of intrusive memories of traumatic event

  Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.

  Week 5

Secondary Outcomes (5)

• Number of intrusive memories of traumatic event

  Week 1

• 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

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

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

• Posttraumatic Stress Disorder Checklist 5 (PCL-5)

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

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

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

Other Outcomes (11)

• Credibility/expectancy questionnaire

  Day 1

• Subjective units of distress (SUDS)

  Day 1

• Self-Rated initial intrusions

  Day 1 and Day 2

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
• 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

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
• Other medical reasons (on advice by medical staff)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Emergency Departments (e.g. FO Akut, Karolinska University Hospital Huddinge)

Huddinge, 14157, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33971951 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/Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 4, 2019
• Study Start: December 10, 2019
• Primary Completion: April 30, 2020
• Study Completion: July 8, 2020
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

SE (1)