Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)NCT03760601
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees: An Extension
A study testing Brief cognitive intervention in people with Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
- What is being tested?
- Brief cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2019to 26 Aug 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refugee or asylum seeker
- Experiencing intrusive memories of trauma
- Have access to a smartphone
- Able to speak or read the study material in Swedish, English, Arabic or Farsi
- Able to attend five to six meetings with a researcher
Who cannot join
- Exhibit psychotic symptoms or other symptoms of severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay: An Extension
This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.
Read the detailed description
This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.
- Being tested
- Brief cognitive intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cognitive interventionBehavioural
A one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game play) with instructions to engage in the task self-guided in the subsequent week.
| Study group | Role | What they receive |
|---|---|---|
| Baseline phase ('A') | No intervention | Measurements collected in a pen-and-paper diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. |
| Intervention phase ('B') | Experimental | A one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game-play) followed by instructions to engage in the task selfguided over the subsequent week. Measurements collected in a pen-and-paper diary four times a day over one week following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Receives: Behavioral: Brief cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of intrusive memories of trauma
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) over one week.
Measured: Change between baseline week 1 and Intervention week 1
Secondary outcomes (9)
Feasibility and acceptability ratings for using a smartphone game-play intervention
Feasibility and Acceptability of the intervention assessed with 10 self-rated items, e.g. "Would you recommend playing Tetris to a friend?". Scores range from 0 - 10 with higher scores indicating greater acceptability/ feasibility.
Measured: Intervention week 1
Feasibility and acceptability - open ended questions
Two items with open-ended follow-up questions: "How did you feel about playing Tetris after you had an intrusive memory?" and "Why"? or "How much would you prefer an intervention that is delivered by a computer/ smartphone compared to seeing a doctor/psychologist in person?" and "Why"?
Measured: Intervention week 1
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Usage of the gameplay intervention assessed with 4 self-rated items: 1. Did you play Tetris in the last week since the last meeting? (Yes/No). 2. If yes, how many days did you play Tetris in the last week since we first practiced the game together? 3. How long did you spend playing Tetris at a time? (<10 min - >30 min), 4. How often did you manage to play Tetris after you experienced an intrusive memory? (11-point scale; 0 = not at all; 10 = every time).
Measured: Intervention week 1
Impact of intrusive memories on concentration, control, sleep and stress - ratings
A bespoke measure of 6 self-rated items to assess the impact of intrusive memories on concentration, control, sleep and stress (all rated on an 11-point scale): 2 items assessing experienced concentration difficulties due to intrusive memories and in general ( high scores indicating more concentration difficulties);1 item assessing feeling of control over intrusive memories (0 = no control; 10 = in full control); 2 items assessing sleep disturbances due to intrusive memories (higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
Measured: Baseline week 1 and Intervention week 1
Rating of how long intrusive memories disrupted concentration on average
1 item assessing for how long intrusive memories disrupted concentration on average (<1 minute - > 60 minutes)
Measured: Baseline week 1 and Intervention week 1
Impact of intrusive memories - open ended questions
Two open-ended questions are included: "How do intrusive memories interfere with your concentration?" and "How do intrusive memories interfere with your ability to settle in to this country and learn new skills, e.g. a new language?"
Measured: Baseline week 1 and Intervention week 1
Impact of the intervention on concentration, emotion and functioning - ratings
A bespoke measure comprising 3 self-rated items to assess the impact of the intervention on concentration, emotion and functioning at the time of playing (11-point scale, 0= not helpful, 10= very helpful).
Measured: Intervention week 1
Subjective impact of the intervention - open ended questions
2 open ended questions about the subjective impact of the intervention in the shorter, and longer term: "How would you describe the impact of this intervention in the short term?"; "How would you describe the impact of this intervention in the longer term"?
Measured: Intervention week 1
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
A 12 item self-rated questionnaire asking about difficulties due to health conditions, including mental or emotional problems. Scores range from 1 to 5 where 1=none and 5=extreme or cannot do.
Measured: Baseline week 1 and intervention week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start25 Mar 2019
- Primary completion20 Jun 2019
- Study completion26 Aug 2019
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 Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single case experimental AB design with optional replication (ABAB)
- Masking
- None (open label)
- Enrolment
- 5 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760601
- Sponsor's protocol ID
- 2018/2149-32
- Status last verified
- Aug 2022
- First submitted
- 19 Nov 2018
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanstrup M, Kontio E, Geranmayeh A, Olofsdotter Lauri K, Moulds ML, Holmes EA. A single case series using visuospatial task interference to reduce the number of visual intrusive memories of trauma with refugees. Clin Psychol Psychother. 2021 Jan;28(1):109-123. doi: 10.1002/cpp.2489. Epub 2020 Jul 6.
PubMed 32525244
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
- Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay: An Extension
- ClinicalTrials.gov ID
- NCT03760601
- Acronym / sponsor ID
- 2018/2149-32
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 30 Nov 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 use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.
Detailed description
This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single case experimental AB design with optional replication (ABAB)
| Arm | Type | Receives |
|---|---|---|
| Baseline phase ('A') | No intervention | –Measurements collected in a pen-and-paper diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. |
| Intervention phase ('B') | Experimental | Behavioral: Brief cognitive interventionA one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game-play) followed by instructions to engage in the task selfguided over the subsequent week. Measurements collected in a pen-and-paper diary four times a day over one week following the intervention for the primary outcome (occurrence of intrusive memories of trauma). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refugee or asylum seeker
- Experiencing intrusive memories of trauma
- Have access to a smartphone
- Able to speak or read the study material in Swedish, English, Arabic or Farsi
- Able to attend five to six meetings with a researcher
Key exclusion criteria (1 listed)
- Exhibit psychotic symptoms or other symptoms of severe mental illness
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 |
|---|---|---|
| Brief cognitive interventionA one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game play) with instructions to engage in the task self-guided in the subsequent week. | Behavioural | Intervention phase ('B') |
Primary outcome
Change in number of intrusive memories of trauma
Time frame: Change between baseline week 1 and Intervention week 1
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) over one week.
9 secondary outcomes
Feasibility and acceptability ratings for using a smartphone game-play intervention
Time frame: Intervention week 1
Feasibility and acceptability - open ended questions
Time frame: Intervention week 1
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Time frame: Intervention week 1
Impact of intrusive memories on concentration, control, sleep and stress - ratings
Time frame: Baseline week 1 and Intervention week 1
Rating of how long intrusive memories disrupted concentration on average
Time frame: Baseline week 1 and Intervention week 1
Impact of intrusive memories - open ended questions
Time frame: Baseline week 1 and Intervention week 1
Impact of the intervention on concentration, emotion and functioning - ratings
Time frame: Intervention week 1
Subjective impact of the intervention - open ended questions
Time frame: Intervention week 1
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time frame: Baseline week 1 and intervention week 1
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 32525244Kanstrup M, Kontio E, Geranmayeh A, Olofsdotter Lauri K, Moulds ML, Holmes EA. A single case series using visuospatial task interference to reduce the number of visual intrusive memories of trauma with refugees. Clin Psychol Psychother. 2021 Jan;28(1):109-123. doi: 10.1002/cpp.2489. Epub 2020 Jul 6.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cognitive intervention in people with Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1), 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 5 inclusion and 1 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. 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?
Change in number of intrusive memories of trauma (time frame: Change between baseline week 1 and Intervention 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 NCT03760601, 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.