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Simple Cognitive Task After Trauma EKUT RCT

Primary Purpose

Post Traumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Simple cognitive task
Attention placebo
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Emergency Departments (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

Attention placebo

Arm 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.

Smartphone activity for same amount of time.

Outcomes

Primary Outcome Measures

Number of intrusive memories of traumatic event
Number of intrusive memories of traumatic event 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
Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms
Self-report measure that assesses subjective distress after a traumatic event (with reference to ED event). 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.
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate worse severity.
Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Full scale is a 20-item self-report measure that assesses current symptoms of post-traumatic stress disorder. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 yields a total symptom severity score which ranges from 0 to 80. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-5), cluster C - avoidance (items 6-7), cluster D - negative alterations in cognitions and mood (items 8-14), and cluster E - alterations in arousal and reactivity (items 15-20). Higher scores indicate worse severity.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
A 12-item self-rated questionnaire measuring difficulties due to health conditions, including mental or emotional problems (with reference to ED study event). Scores range from 1 ("none") to 5 ("extremely/cannot do"). The maximum score of the WHODAS is 60, lower scores are better. 3 additional items measure on how many of the last 7 days (modified time scale) these difficulties occurred.

Full Information

First Posted
November 28, 2019
Last Updated
August 31, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04185155
Brief Title
Simple Cognitive Task After Trauma EKUT RCT
Official Title
Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma) - A Randomized Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Halted prematurely - Covid-19 pandemic prevented recruitment/testing in ED
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
July 8, 2020 (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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple cognitive task
Arm Type
Experimental
Arm 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.
Arm Title
Attention placebo
Arm Type
Placebo Comparator
Arm Description
Smartphone activity for same amount of time.
Intervention Type
Behavioral
Intervention Name(s)
Simple cognitive task
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Attention placebo
Intervention Description
Smartphone activity for same amount of time.
Primary Outcome Measure Information:
Title
Number of intrusive memories of traumatic event
Description
Number of intrusive memories of traumatic event 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
Description
Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Time Frame
Week 1
Title
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms
Description
Self-report measure that assesses subjective distress after a traumatic event (with reference to ED event). 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
One week and 1, 3, and 6 month follow-up
Title
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
Description
The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate worse severity.
Time Frame
One week and 1, 3, and 6 month follow-up
Title
Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Description
Full scale is a 20-item self-report measure that assesses current symptoms of post-traumatic stress disorder. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 yields a total symptom severity score which ranges from 0 to 80. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-5), cluster C - avoidance (items 6-7), cluster D - negative alterations in cognitions and mood (items 8-14), and cluster E - alterations in arousal and reactivity (items 15-20). Higher scores indicate worse severity.
Time Frame
One week and 1, 3, and 6 month follow-up
Title
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Description
A 12-item self-rated questionnaire measuring difficulties due to health conditions, including mental or emotional problems (with reference to ED study event). Scores range from 1 ("none") to 5 ("extremely/cannot do"). The maximum score of the WHODAS is 60, lower scores are better. 3 additional items measure on how many of the last 7 days (modified time scale) these difficulties occurred.
Time Frame
One week and 1, 3, and 6 month follow-up
Other Pre-specified Outcome Measures:
Title
Credibility/expectancy questionnaire
Description
5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participants 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
Self-Rated initial intrusions
Description
A question measuring the presence of intrusive memories with a yes/no response, and if yes then a free text response field to specify the number of intrusive memories and any comments, then 3 self rated items measuring the level of distress, vividness or concentration disruption associated with the intrusions (11 point scales from 0 to 10) given before intervention/control procedure in ED on day 1 and remotely on day 2.
Time Frame
Day 1 and Day 2
Title
Feedback Questionnaire about Participation
Description
7 bespoke items including questions about study participation e.g. how acceptable was it to do the task at the emergency department? 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 our last contact; and items with a free text response field e.g. do you have any other comments.
Time Frame
1 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). High scores indicate good outcomes.
Time Frame
Day 1, one week and 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 ED 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 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (0 - 4) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
Time Frame
Day 1, one week and 1, 3, and 6 month follow-up
Title
Characteristics of intrusive trauma memories
Description
3 self rated items measuring the level of distress, vividness and concentration disruption associated with the intrusions (11 point scales from 0 to 10) rated within the diary at week 1 and 5 and in platform at 3 and 6 months. High scores indicate higher level of distress/vividness/concentration disruption.
Time Frame
Week 1 and week 5, 3 and 6 month follow-up
Title
Self Rated Functioning and social support ratings
Description
2 bespoke items including a question on impact on daily functioning associated with the intrusions and a question on perceived social support after the traumatic event. Both items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). High scores indicate higher level of functional impairment/perceived social support.
Time Frame
One week, 1, 3, and 6 month follow up
Title
Intrusion questionnaire
Description
6 self rated items measuring the frequency of unwanted memories of the trauma in the previous week on a 7-point scale (from never to many times a day) and the level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the unwanted memories of the trauma on a 11-point scale (from 0 to 100). High scores indicate more unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and more different triggers.
Time Frame
One week and 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
Training evaluation checklists
Description
To assess the researcher's training and adherence to study protocol. Uses competency items rated on a 7-point scale (from "absence" to "excellence", high scores indicate higher level of competency); factual questions as a yes/no response; and items with a free text response field for other feedback and comments.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
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
Emergency Departments (e.g. FO Akut, Karolinska University Hospital Huddinge)
City
Huddinge
ZIP/Postal Code
14157
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33971951
Citation
Kanstrup M, Singh L, Goransson KE, Gamble B, Taylor RS, Iyadurai L, Moulds ML, Holmes EA. A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19. BMC Res Notes. 2021 May 10;14(1):176. doi: 10.1186/s13104-021-05572-1.
Results Reference
result

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Simple Cognitive Task After Trauma EKUT RCT

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