Simple Cognitive Task After Trauma EKUT RCT

NCT ID: NCT04185155

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2020-07-08

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Simple cognitive task

Intervention Type: 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.

Attention placebo

Smartphone activity for same amount of time.

Group Type: PLACEBO_COMPARATOR

Attention placebo

Intervention Type: BEHAVIORAL

Smartphone activity for same amount of time.

Interventions

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.

Intervention Type: BEHAVIORAL

Attention placebo

Smartphone activity for same amount of time.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Emily Holmes

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Holmes, Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet/Uppsala University

Locations

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

Huddinge, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 33971951 (View on PubMed)

Other Identifiers

2019-05380

Identifier Type: -

Identifier Source: org_study_id