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

NCT04460014 | Completed DMC

• 1 other identifier: 2020-03085
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Post Traumatic Stress Disorder; Digital Intervention; Intrusive Memories of Traumatic Event(s)

Outcome Measures

Primary Outcomes (1)

• Number of intrusive memories of traumatic event(s)

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

  Week 5

Secondary Outcomes (6)

• Number of intrusive memories of traumatic event(s)

  Week 0 and Week 1

• Intrusion questionnaire - frequency item

  Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up

• Intrusion questionnaire - characteristics

  Baseline (Day 1), One week and 1, 3, and 6 month follow-up

• Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms

  Baseline (Day 1), One week and 1, 3, and 6 month follow-up

• Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version

  Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Other Outcomes (19)

• Self-rated concentration disruption associated with intrusive memories

  Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-up

• Concentration and memory difficulties

  6 month follow-up

• Self-rated functioning and social support ratings

  Baseline (Day 1), One week, 1, 3, and 6 month follow up

Study Arms (2)

Simple cognitive task intervention

EXPERIMENTAL

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.

Behavioral: Simple cognitive task intervention

Attention placebo

PLACEBO COMPARATOR

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

Behavioral: Attention Placebo

Interventions

Simple cognitive task intervention BEHAVIORAL

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.

Simple cognitive task intervention

Attention Placebo BEHAVIORAL

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

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
• 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)
• Able and willing to briefly write down these intrusive memories (without going into any detail)

You may not qualify if:

• Loss of consciousness of \> 5 minutes in relation to the traumatic event

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Hospital units across Sweden (e.g. FO Akut, Karolinska University Hospital Huddinge)

Huddinge, 14157, Sweden

Location

Related Publications (2)

• Kanstrup M, Singh L, Leehr EJ, Goransson KE, Pihlgren SA, Iyadurai L, Dahl O, Falk AC, Lindstrom V, Hadziosmanovic N, Gabrysch K, Moulds ML, Holmes EA. A guided single session intervention to reduce intrusive memories of work-related trauma: a randomised controlled trial with healthcare workers in the COVID-19 pandemic. BMC Med. 2024 Sep 19;22(1):403. doi: 10.1186/s12916-024-03569-8.

  PMID: 39300443 DERIVED

• Ahmed Pihlgren S, Johansson L, Holmes EA, Kanstrup M. Exploring healthcare workers' experiences of a simple intervention to reduce their intrusive memories of psychological trauma: an interpretative phenomenological analysis. Eur J Psychotraumatol. 2024;15(1):2328956. doi: 10.1080/20008066.2024.2328956. Epub 2024 Mar 27.

  PMID: 38533843 DERIVED

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: July 6, 2020
• First Posted: July 7, 2020
• Study Start: September 30, 2020
• Primary Completion: June 16, 2022
• Study Completion: October 31, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

SE (1)