Post Traumatic Stress DisorderNCT04185155
Simple Cognitive Task After Trauma EKUT RCT
A study testing Simple cognitive task in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Simple cognitive task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2019to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Emergency Departments (e.g. FO Akut, Karolinska University Hospital Huddinge)
Huddinge, 14157
About this study
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)
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Simple cognitive task, Attention placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple cognitive taskBehavioural
A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1.
Attention placeboBehavioural
Smartphone activity for same amount of time.
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task | Experimental | A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1. Receives: Behavioral: Simple cognitive task |
| Attention placebo | Placebo comparator | Smartphone activity for same amount of time. Receives: Behavioral: Attention placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 5
Secondary outcomes (5)
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.
Measured: Week 1
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.
Measured: One week and 1, 3, and 6 month follow-up
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.
Measured: One week and 1, 3, and 6 month follow-up
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.
Measured: One week and 1, 3, and 6 month follow-up
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.
Measured: One week and 1, 3, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start10 Dec 2019
- Primary completion30 Apr 2020
- Study completion8 Jul 2020
Why it stopped: Halted prematurely - Covid-19 pandemic prevented recruitment/testing in ED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Holmes, Karolinska Institutet
- Investigators
- Emily Holmes, Prof, Principal investigator, Karolinska Institutet/Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185155
- Sponsor's protocol ID
- 2019-05380
- Other IDs
- 2019
- Status last verified
- Aug 2022
- First submitted
- 28 Nov 2019
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33971951
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04185155
- Acronym / sponsor ID
- 2019-05380
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely - Covid-19 pandemic prevented recruitment/testing in ED
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task | Experimental | Behavioral: Simple cognitive taskA memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1. |
| Attention placebo | Placebo comparator | Behavioral: Attention placeboSmartphone activity for same amount of time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Loss of consciousness of > 5 minutes
- Current intoxication
- Report a history of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple cognitive taskA memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1. | Behavioural | Simple cognitive task |
| Attention placeboSmartphone activity for same amount of time. | Behavioural | Attention placebo |
Primary outcome
Number of intrusive memories of traumatic event
Time frame: Week 5
Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
5 secondary outcomes
Number of intrusive memories of traumatic event
Time frame: Week 1
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms
Time frame: One week and 1, 3, and 6 month follow-up
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
Time frame: One week and 1, 3, and 6 month follow-up
Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: One week and 1, 3, and 6 month follow-up
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time frame: One week and 1, 3, and 6 month follow-up
Results and safety
The study was stopped early (reason given: Halted prematurely - Covid-19 pandemic prevented recruitment/testing in ED). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Results publication: PubMed 33971951Kanstrup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Holmes, Prof principal investigator
Karolinska Institutet/Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple cognitive task in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted prematurely - Covid-19 pandemic prevented recruitment/testing in ED). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intrusive memories of traumatic event (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.