Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT

Karolinska Institute

Status: Completed

Conditions: Intrusive Memories of Traumatic Event(s); Post Traumatic Stress Disorder

Treatments: Behavioral: Simple cognitive task intervention; Behavioral: Attention Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04460014

2020-03085

Details and patient eligibility

About

This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week 0). 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, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. 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 IDs: NCT03509792, NCT04185155). The primary outcome is the number of intrusive memories of the traumatic event(s) (week 5). The intervention is delivered remotely (e.g. via smartphone) with potential remote support (e.g. by phone) to medical staff in Swedish hospitals.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or over
• Clinical work during the COVID-19 pandemic in hospital and care facilities (e.g. ICU, ambulance, intermediate care, ward)
• Experienced at least one traumatic event in relation to their clinical work as health care staff during the COVID-19 pandemic
• This/these event(s) at work meet(s) the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD): exposure 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"
• The traumatic event(s) occured since the start of the COVID-19 pandemic
• 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 while the study is ongoing
• Have access to an internet enabled smartphone
• Experiences distressing intrusive memories (of a traumatic event in relation to their work as health care staff during the COVID-19 pandemic)
• Has experienced at least two such intrusive memories of a work-related traumatic event during the week before inclusion/exclusion
• Able and willing to briefly write down these intrusive memories (without going into any detail)

Exclusion criteria

• Loss of consciousness of > 5 minutes in relation to the traumatic event
• Current intoxication during the traumatic event or in relation to study inclusion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups, including a placebo group

Simple cognitive task intervention

Experimental group

Description:

Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions. Options to engage in self-administered/guided booster sessions per intrusive memory.

Treatment:

Behavioral: Simple cognitive task intervention

Attention placebo

Placebo Comparator group

Description:

Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).

Treatment:

Behavioral: Attention Placebo