Simple Cognitive Task After Trauma EKUT RCT

Karolinska Institute

Status: Terminated

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Simple cognitive task; Behavioral: Attention placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04185155

2019-05380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups, including a placebo group

Simple cognitive task

Experimental group

Description:

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

Treatment:

Behavioral: Simple cognitive task

Attention placebo

Placebo Comparator group

Description:

Smartphone activity for same amount of time.

Treatment:

Behavioral: Attention placebo