Intrusive Memories of Traumatic Event(s)NCT04460014
Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT
A study testing Simple cognitive task intervention in people with Intrusive Memories of Traumatic Event(s) and 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 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrusive Memories of Traumatic Event(s), Post Traumatic Stress Disorder
- What is being tested?
- Simple cognitive task intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2020to 31 Oct 2022
- 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
- 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
Show all 15Show fewer
- 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)
Who cannot join
- Loss of consciousness of > 5 minutes in relation to the traumatic event
- Current intoxication during the traumatic event or in relation to study inclusion
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hospital units across Sweden (e.g. FO Akut, Karolinska University Hospital Huddinge)
Huddinge, 14157
About this study
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)
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.
Read the 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.
- Being tested
- Simple cognitive task intervention, Attention Placebo
- Keywords
- Post Traumatic Stress Disorder, Digital Intervention, Intrusive Memories of Traumatic Event(s)
- 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 task interventionBehavioural
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.
Attention PlaceboBehavioural
Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task intervention | Experimental | 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. Receives: Behavioral: Simple cognitive task intervention |
| Attention placebo | Placebo comparator | Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone). 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(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.
Measured: Week 5
Secondary outcomes (6)
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.
Measured: Week 0 and Week 1
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.
Measured: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up
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.
Measured: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
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.
Measured: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
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.
Measured: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
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.
Measured: Baseline (Day 1), Week 1 and week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start30 Sep 2020
- Primary completion16 Jun 2022
- Study completion31 Oct 2022
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 Intrusive Memories of Traumatic Event(s)Studies 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
- 164 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
- NCT04460014
- Sponsor's protocol ID
- 2020-03085
- Status last verified
- Nov 2022
- First submitted
- 6 Jul 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanstrup M, Singh L, Leehr EJ, Goransson KE, Pihlgren SA, Iyadurai L, Dahl O, Falk AC, Lindstrom V, Hadziosmanovic N, Gabrysch K, Moulds ML, Holmes EA. A guided single session intervention to reduce intrusive memories of work-related trauma: a randomised controlled trial with healthcare workers in the COVID-19 pandemic. BMC Med. 2024 Sep 19;22(1):403. doi: 10.1186/s12916-024-03569-8.
PubMed 39300443Ahmed Pihlgren S, Johansson L, Holmes EA, Kanstrup M. Exploring healthcare workers' experiences of a simple intervention to reduce their intrusive memories of psychological trauma: an interpretative phenomenological analysis. Eur J Psychotraumatol. 2024;15(1):2328956. doi: 10.1080/20008066.2024.2328956. Epub 2024 Mar 27.
PubMed 38533843
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04460014
- Acronym / sponsor ID
- 2020-03085
- Keywords
- Post Traumatic Stress Disorder, Digital Intervention, Intrusive Memories of Traumatic Event(s)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Jul 2020 (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 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.
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 intervention | Experimental | Behavioral: Simple cognitive task interventionSession 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. |
| Attention placebo | Placebo comparator | Behavioral: Attention PlaceboSession 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Loss of consciousness of > 5 minutes in relation to the traumatic event
- Current intoxication during the traumatic event or in relation to study inclusion
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 task interventionSession 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. | Behavioural | Simple cognitive task intervention |
| Attention PlaceboSession 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone). | Behavioural | Attention placebo |
Primary outcome
Number of intrusive memories of traumatic event(s)
Time frame: Week 5
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
6 secondary outcomes
Number of intrusive memories of traumatic event(s)
Time frame: Week 0 and Week 1
Intrusion questionnaire - frequency item
Time frame: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up
Intrusion questionnaire - characteristics
Time frame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms
Time frame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version
Time frame: Baseline (Day 1), One week and 1, 3, and 6 month follow-up
Characteristics of intrusive trauma memories
Time frame: Baseline (Day 1), Week 1 and week 5
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 15 Nov 2022.
- Derived from this study: PubMed 39300443Kanstrup M, Singh L, Leehr EJ, Goransson KE, Pihlgren SA, Iyadurai L, Dahl O, Falk AC, Lindstrom V, Hadziosmanovic N, Gabrysch K, Moulds ML, Holmes EA. A guided single session intervention to reduce intrusive memories of work-related trauma: a randomised controlled trial with healthcare workers in the COVID-19 pandemic. BMC Med. 2024 Sep 19;22(1):403. doi: 10.1186/s12916-024-03569-8.
- Derived from this study: PubMed 38533843Ahmed Pihlgren S, Johansson L, Holmes EA, Kanstrup M. Exploring healthcare workers' experiences of a simple intervention to reduce their intrusive memories of psychological trauma: an interpretative phenomenological analysis. Eur J Psychotraumatol. 2024;15(1):2328956. doi: 10.1080/20008066.2024.2328956. Epub 2024 Mar 27.
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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 intervention in people with Intrusive Memories of Traumatic Event(s) and 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 15 inclusion and 2 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 15 Nov 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(s) (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 NCT04460014, 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 15 Nov 2022.