Clinical trial NCT04460014: Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT
Official title: Reducing Intrusive Memories After Trauma Via a Simple Cognitive Intervention During COVID-19 in Hospital Staff: "EKUT-P" (Enkel Kognitiv Uppgift Efter Trauma Under COVID-19 - sjukvårdspersonal) - A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Traumatic Event(s)
Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
Digital Intervention
Intrusive Memories of Traumatic Event(s)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 5
Secondary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 0 and Week 1
measure: Intrusion questionnaire - frequency item
timeFrame: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up
measure: Intrusion questionnaire - characteristics
timeFrame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms
timeFrame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version
timeFrame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
measure: Characteristics of intrusive trauma memories
timeFrame: Baseline (Day 1), Week 1 and week 5
Other outcomes:
measure: Self-rated concentration disruption associated with intrusive memories
timeFrame: Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-up
measure: Concentration and memory difficulties
timeFrame: 6 month follow-up
measure: Self-rated functioning and social support ratings
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow up
measure: Appraisals of intrusive memories
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Self-rated sleep ratings
timeFrame: Baseline (Day 1), one week and 1, 3, and 6 month follow-up
measure: Self Rated Health (SRH) rating
timeFrame: Baseline (Day 1), one week, and 1, 3, and 6 month follow-up
measure: Questions related to work situation
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Sick leave
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Stress and Energy Questionnaire (SEQ) - Stress subscale
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale
timeFrame: Baseline (Day 1) and 6 month follow-up
measure: Moral stress at work
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Adverse events
timeFrame: One week and 1, 3, and 6 month follow-up
measure: Future self questionnaire - shortened version
timeFrame: 3 month follow-up
measure: Time perspective questionnaire
timeFrame: Baseline (Day 1), One week, 1, 3, and 6 month follow-up
measure: Coping mechanisms
timeFrame: Baseline (Day 1)
measure: WHODAS 2.0
timeFrame: 6 month follow-up
measure: Credibility/expectancy questionnaire
timeFrame: Day 1
measure: Subjective Units of Distress (SUDS)
timeFrame: Day 1
measure: Feedback questionnaire about participation
timeFrame: 1 month follow-up
Locations:
city: Huddinge
country: Sweden
facility: Hospital units across Sweden (e.g. FO Akut, Karolinska University Hospital Huddinge)
Study officials:
affiliation: Karolinska Institutet/Uppsala University
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
References: