Post-traumatic Stress DisordersNCT03509792
Simple Cognitive Task After Trauma
A study testing Simple cognitive task in people with Post-traumatic Stress Disorders, 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 Disorders
- 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
- 42 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2019to 20 Dec 2019
- 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 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
Show all 12Show fewer
- 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
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
Trial locations and contacts
1 site in 1 country.
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)
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.
Read the 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.
- Conditions
- Post-traumatic Stress Disorders
- 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 diary daily (morning, afternoon, evening and night) for 7 days
Measured: Week 1
Secondary outcomes (5)
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
Measured: 1 month
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.
Measured: One week and 1, 3, and 6month 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 1, 3, and 6 month follow-up
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.
Measured: 1 month follow-up
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.
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 posted26 Apr 2018
- Study start11 Jan 2019
- Primary completion12 Jul 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisordersStudies 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
- None (open label)
- Enrolment
- 42 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 InstitutetErik Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509792
- Sponsor's protocol ID
- 2017/2215-31
- Status last verified
- Aug 2022
- First submitted
- 5 Mar 2018
- 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, 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.
PubMed 33431807Kanstrup 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.
PubMed 34620249
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)
- ClinicalTrials.gov ID
- NCT03509792
- Acronym / sponsor ID
- 2017/2215-31
- Conditions
- Post-traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 26 Apr 2018 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 (12 listed)
- 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
Key exclusion criteria (5 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 1
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for 7 days
5 secondary outcomes
Number of intrusive memories of traumatic event
Time frame: 1 month
Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster
Time frame: One week and 1, 3, and 6month follow-up
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms
Time frame: One week 1, 3, and 6 month follow-up
Perceived Stress Scale (PSS)
Time frame: 1 month follow-up
Work and Social Adjustment Scale (WSAS): Daily function
Time frame: [One week and 1, 3, and 6 month follow-up]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Results publication: PubMed 33431807Kanstrup 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 publication: PubMed 34620249Kanstrup 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.
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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
Erik Andersson, PhD principal investigator
Karolinska Institutet
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 Disorders, 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 12 inclusion and 5 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 1). 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 NCT03509792, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 27 Oct 2026.