Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)NCT03525158
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
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 2 sites 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 16 to 25 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
- 4 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Jun 2017to 26 Feb 2018
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, 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 or Arabic
- Able to attend three meetings with a researcher
Who cannot join
- Exhibit psychotic symptoms or other symptoms of severe mental illness
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Residental care home for young people
Stockholm
Swedish Language Classes for Refugees
Stockholm
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
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 or without 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.
- 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') and Intervention phase ('B') | Other | Baseline phase ('A'): 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'): 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 self-guided 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 the occurrence of intrusive memories of trauma from baseline week to intervention week
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and one week during the intervention phase.
Measured: Baseline week 1 and Intervention week 1
Secondary outcomes (3)
Feasibility and acceptability ratings for using a smartphone game-play intervention
Feasibility and Acceptability of the intervention was assessed with 10 self-rated items, e.g. "Would you recommend playing Tetris to a friend?". Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility. Two items had 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 was 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
7 self-rated items were used to assess the impact of intrusive memories on concentration, control, sleep and stress: 2 items assessed experienced concentration difficulties due to intrusive memories and in general (11-point scale; high scores indicating more concentration difficulties); 1 item assessed for how long intrusive memories disrupted concentration (<1 min - >60 min), 1 item assessed feeling of control over intrusive memories (11-point scale, 0 = no control; 10 = in full control); 2 items assessed sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessed to what degree intrusive memories affected stress levels (11-point scale, 0 = not at all; 10 = affected very much). Two open-ended questions were 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, such as a new language?"
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 posted15 May 2018
- Study start20 Jun 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single case experimental AB design with or without optional replication (ABAB) (ie no random assignment)
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT03525158
- Sponsor's protocol ID
- 2017/978-31
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. 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
- ClinicalTrials.gov ID
- NCT03525158
- Acronym / sponsor ID
- 2017/978-31
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 15 May 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 or without 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental AB design with or without optional replication (ABAB) (ie no random assignment)
| Arm | Type | Receives |
|---|---|---|
| Baseline phase ('A') and Intervention phase ('B') | Other | Behavioral: Brief cognitive interventionBaseline phase ('A'): 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'): 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 self-guided 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
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 or Arabic
- Able to attend three 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 | Baseline phase ('A') and Intervention phase ('B') |
Primary outcome
Change in the occurrence of intrusive memories of trauma from baseline week to intervention week
Time frame: 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) for one week during the baseline phase and one week during the intervention phase.
3 secondary outcomes
Feasibility and acceptability ratings for using a smartphone game-play intervention
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
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 18 Sep 2020.
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
2 sites 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 2 sites 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the occurrence of intrusive memories of trauma from baseline week to intervention week (time frame: 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?
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 18 Sep 2020.