Back to resultsSimple Cognitive Task After Trauma
Primary Purpose
Post-traumatic Stress Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Simple cognitive task
Attention placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post-traumatic Stress Disorders
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or over
- Experienced or witnessed a traumatic event resulting in admission to the emergency department for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
- Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) ("The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by "Direct exposure" or "Witnessing the trauma") )
- Can be seen in the emergency department within 6 hours after the traumatic event
- Report memory of the accident
- Fluent in Swedish
- Alert and orientated
- Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands).
- 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
- in addition to point above "can be seen in the emergency department within 6 hours after the traumatic event", from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event
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
Sites / Locations
- Akuten Huddinge Sjukhus
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 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 diary daily (morning, afternoon, evening and night) for 7 days
Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster
Full scale is a 22-item self-report measure that assesses subjective distress after a traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores are calculated for the Intrusion, Avoidance, and Hyperarousal subscales summed. Higher scores indicate worse outcome. Our secondary outcome measure is the Intrusion subscale.
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.
Perceived Stress Scale (PSS)
Measures the perception of stress and the degree to which situations in one's life are appraised as stressful. The 14 items aims to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are rated on a 5-point scale ranging from 0 ("never") to 4 ("very often") and summed to a total score of 56. Seven items concerns positive experiences and are hence reversed in scoring. Higher scores indicate worse severity.
Work and Social Adjustment Scale (WSAS): Daily function
The Work & Social Adjustment Scale is a simple 5-item measure of general social impairment which grew out of a study of change during psychotherapy. The maximum score of the WSAS is 40, lower scores are better.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03509792
Brief Title
Simple Cognitive Task After Trauma
Official Title
Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
December 20, 2019 (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 clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation aspects in a new hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.
Detailed Description
This is an explorative pilot study, which will guide the design of a future Randomised Controlled Trial. The main aim of the present study is not a statistical significance test, the results will be descriptive, and will include pilot analyses to obtain an estimate of effect size between groups of the current primary outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (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 diary daily (morning, afternoon, evening and night) for 7 days
Time Frame
Week 1
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 diary daily (morning, afternoon, evening and night) for 7 days
Time Frame
1 month
Title
Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster
Description
Full scale is a 22-item self-report measure that assesses subjective distress after a traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores are calculated for the Intrusion, Avoidance, and Hyperarousal subscales summed. Higher scores indicate worse outcome. Our secondary outcome measure is the Intrusion subscale.
Time Frame
One week and 1, 3, and 6month 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 1, 3, and 6 month follow-up
Title
Perceived Stress Scale (PSS)
Description
Measures the perception of stress and the degree to which situations in one's life are appraised as stressful. The 14 items aims to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are rated on a 5-point scale ranging from 0 ("never") to 4 ("very often") and summed to a total score of 56. Seven items concerns positive experiences and are hence reversed in scoring. Higher scores indicate worse severity.
Time Frame
1 month follow-up
Title
Work and Social Adjustment Scale (WSAS): Daily function
Description
The Work & Social Adjustment Scale is a simple 5-item measure of general social impairment which grew out of a study of change during psychotherapy. The maximum score of the WSAS is 40, lower scores are better.
Time Frame
[One week and 1, 3, and 6 month follow-up]
Other Pre-specified Outcome Measures:
Title
Feedback Questionnaire about Participation
Description
22 bespoke items including questions about study participation e.g. how burdensome was it to participate in the study?" rated on 9-point scale from 1 (never) to 9 (always); and those 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 comments about what it was like to take part in the study.
Time Frame
One week and 1, 3, and 6 month follow-up
Title
Implementation feedback
Description
Observation and qualitative interviews with participants, study team and staff regarding implementation of the procedures
Time Frame
Day 1, week 1, and 1, 3 and 6 month follow ups, through to study completion
Title
Credibility/expectancy questionnaire: Treatment credibility
Description
5 item questionnaire (11 item scale from 0 to 10) that rates to what degree the participants finds the intervention credible. High scores indicate greater credibility. A free text response field about activities engaged in during the assigned condition.
Time Frame
Day 1
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
baseline, 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 in the last month 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 ranges from 0 - 8, with higher values indicative of better sleep.
Time Frame
baseline, one week and 1, 3, and 6 month follow-up
Title
Adverse events
Description
Adverse events and potential side effects associated with intervention
Time Frame
One week 1, 3, and 6 month follow-up
Title
Characteristics and sensory modality of intrusive trauma memories
Description
7 self rated bespoke items measuring characteristics and sensory modality of intrusive memories: 1 self rated question regarding the presence and the extent of each of 7 sensory modalities in the intrusive memories (visual, auditory, tactile, somatic, olfactory, taste, and other sensations) measured on a scale from 1 (none) to 5 (extreme). 3 self rated items measuring the level of distress, vividness or disruption (functional impairment) associated with the intrusions (11 point scales from 0 to 10). High scores indicate higher level of distress/vividness/disruption.
Time Frame
One week and 1 month follow-up
Title
M.I.N.I 7.0.0 (Mini International Neuropsychiatric Interview version 7.0.0) - Section H. Posttraumatic stress disorder (PTSD)
Description
Section H of MINI 7.0.0 (a short symptom interview) will be assessed at follow-ups to assess current symptoms of posttraumatic stress disorder. Section H consists of a minimum of 1 and maximum of 19 items, which continue depending on response to previous question). Higher scores indicate worse symptoms
Time Frame
1, 3, and 6 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
Experienced or witnessed a traumatic event resulting in admission to the emergency department for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) ("The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by "Direct exposure" or "Witnessing the trauma") )
Can be seen in the emergency department within 6 hours after the traumatic event
Report memory of the accident
Fluent in Swedish
Alert and orientated
Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands).
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
in addition to point above "can be seen in the emergency department within 6 hours after the traumatic event", from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Holmes, Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Andersson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akuten Huddinge Sjukhus
City
Stockholm
State/Province
Solna
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33431807
Citation
Kanstrup M, Singh L, Goransson KE, Widoff J, Taylor RS, Gamble B, Iyadurai L, Moulds ML, Holmes EA. Reducing intrusive memories after trauma via a brief cognitive task intervention in the hospital emergency department: an exploratory pilot randomised controlled trial. Transl Psychiatry. 2021 Jan 11;11(1):30. doi: 10.1038/s41398-020-01124-6.
Results Reference
result
PubMed Identifier
34620249
Citation
Kanstrup M, Rudman A, Goransson K, Andersson E, Lauri KO, Rapoport E, Sunnergard L, Bragesjo M, Andersson E, Iyadurai L, Holmes EA. Reaching people soon after a traumatic event: an exploratory observational feasibility study of recruitment in the emergency department to deliver a brief behavioral intervention via smartphone to prevent intrusive memories of trauma. Pilot Feasibility Stud. 2021 Oct 7;7(1):184. doi: 10.1186/s40814-021-00916-x.
Results Reference
result
Learn more about this trial
Simple Cognitive Task After Trauma
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