Back to resultsSimple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT
Primary Purpose
Intrusive Memories of Traumatic Event(s), Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Simple cognitive task intervention
Attention Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Intrusive Memories of Traumatic Event(s) focused on measuring Post Traumatic Stress Disorder, Digital Intervention, Intrusive Memories of Traumatic Event(s)
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
Sites / Locations
- Hospital units across Sweden (e.g. FO Akut, Karolinska University Hospital Huddinge)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simple cognitive task intervention
Attention placebo
Arm 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.
Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Intrusion questionnaire - frequency item
A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.
Intrusion questionnaire - characteristics
5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week.
The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms
Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version
The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.
Characteristics of intrusive trauma memories
2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04460014
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrusive Memories of Traumatic Event(s), Post Traumatic Stress Disorder
Keywords
Post Traumatic Stress Disorder, Digital Intervention, Intrusive Memories of Traumatic Event(s)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simple cognitive task intervention
Arm Type
Experimental
Arm 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.
Arm Title
Attention placebo
Arm Type
Placebo Comparator
Arm Description
Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).
Intervention Type
Behavioral
Intervention Name(s)
Simple cognitive task intervention
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Placebo
Intervention Description
Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).
Primary Outcome Measure Information:
Title
Number of intrusive memories of traumatic event(s)
Description
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
Number of intrusive memories of traumatic event(s)
Description
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Time Frame
Week 0 and Week 1
Title
Intrusion questionnaire - frequency item
Description
A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.
Time Frame
Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up
Title
Intrusion questionnaire - characteristics
Description
5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week.
The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.
Time Frame
Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Title
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms
Description
Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
Time Frame
Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Title
Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version
Description
The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.
Time Frame
Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Title
Characteristics of intrusive trauma memories
Description
2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.
Time Frame
Baseline (Day 1), Week 1 and week 5
Other Pre-specified Outcome Measures:
Title
Self-rated concentration disruption associated with intrusive memories
Description
Two items measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10) and the duration of disruption (< 1 min, 1-5 min, 5-10 min, 10-30 min, 30-60 min, > 60 min). High scores indicate higher level of concentration disruption and longer duration of disruption.
Time Frame
Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-up
Title
Concentration and memory difficulties
Description
Eleven items assess the extent of concentration and memory difficulties during the previous four weeks, using a 5-point scale (1 'Virtually every day' to 5 'Never'). Total scores range from 11 to 55; higher scores indicate less concentration and memory difficulties.
Time Frame
6 month follow-up
Title
Self-rated functioning and social support ratings
Description
3 bespoke items including a question on impact on work-related functioning, and one on daily functioning in other areas associated with the intrusions and a question on perceived social support after the traumatic event. All items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). Higher scores indicate higher level of functional impairment/perceived social support.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow up
Title
Appraisals of intrusive memories
Description
6 self-report items (11-point scale from 0 to 100) measuring appraisals of intrusions on two subscales: psychological problems (items 1-3) and negative self-evaluations (items 4-6). Items for each subscale will be summed. Possible subscale scores range from 0 - 300, with higher values indicative of worse appraisals.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Self-rated sleep ratings
Description
Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
Time Frame
Baseline (Day 1), one week and 1, 3, and 6 month follow-up
Title
Self Rated Health (SRH) rating
Description
A single item measuring perceived health status on a seven-point scale (from very good to very bad). The scale is reverse scored. High scores indicate good outcomes.
Time Frame
Baseline (Day 1), one week, and 1, 3, and 6 month follow-up
Title
Questions related to work situation
Description
3 free text response field questions (e.g. which type of health care do you work with right now?) at Day 1 and two free text response field questions on whether the work situation changed and if yes, how, at one week, 1, 3, and 6 month follow-up.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Sick leave
Description
2 bespoke items measuring the total number and the number of full work days on sick leave because of reason for seeking health care. Higher numbers indicate more sick leave.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Stress and Energy Questionnaire (SEQ) - Stress subscale
Description
3 items measuring the frequency of feeling stressed, pressured, tensed at work during the previous week on a 5-point scale (from "never" to "several times per day"). Item scores are summed. Higher scores indicate higher levels of stress. Further, a single item measuring difficulties to let go of work-related thoughts during leisure time (from "very rarely or never" to "very often or always") and a single question about whether the above mentioned difficulties are because of intrusive memories with a yes/no response.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale
Description
9 self-report items (4-point scale from 1 "not at all" to 4 "all the time") measuring symptoms of burnout on three subscales: Exhaustion (items 1-3), disengagement (items 4-6) and inattentiveness (items 7-9). Subscale scores will be the mean of all items per subscale, the total burnout score will be the mean of all items (ranging from 1-4) with higher scores indicative of higher levels of exhaustion/disengagement/inattentiveness/burnout.
Time Frame
Baseline (Day 1) and 6 month follow-up
Title
Moral stress at work
Description
5 self-report items measuring moral stress at work on a 4-point scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). All items are summed. Potential scores range from 5-20, with higher scores indicative of lower levels of moral stress.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Adverse events
Description
A free text response field measuring the occurrence of any health problems since the last contact.
Time Frame
One week and 1, 3, and 6 month follow-up
Title
Future self questionnaire - shortened version
Description
A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity.
Time Frame
3 month follow-up
Title
Time perspective questionnaire
Description
8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.
Time Frame
Baseline (Day 1), One week, 1, 3, and 6 month follow-up
Title
Coping mechanisms
Description
2 free text response field questions (e.g. Are there any specific factors you think have made it easier for you to handle the COVID-19 situation and its consequences?) at Day 1.
Time Frame
Baseline (Day 1)
Title
WHODAS 2.0
Description
12 self-rated items assessing functioning in six life domains: 1) cognition, 2) mobility, 3) personal care 4) relations, 5) daily activities and 6) participation in society. Each item is rated on a 5-point scale, from 1 ("none") to 5 ("extreme or cannot do") and summed; a higher sum score indicates worse functioning. An additional three questions are asked at the end regarding the frequency and impact of these items.
Time Frame
6 month follow-up
Title
Credibility/expectancy questionnaire
Description
5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participant finds the intervention credible. High scores indicate greater credibility.
Time Frame
Day 1
Title
Subjective Units of Distress (SUDS)
Description
A bespoke manipulation check item measuring self-rated distress during the intervention/control procedure (11-point scale from 0 to 10) at 3 times during the intervention process. Higher scores indicate higher level of distress.
Time Frame
Day 1
Title
Feedback questionnaire about participation
Description
8 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.
Time Frame
1 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Holmes, Prof
Organizational Affiliation
Karolinska Institutet/Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital units across Sweden (e.g. FO Akut, Karolinska University Hospital Huddinge)
City
Huddinge
ZIP/Postal Code
14157
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT
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