- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03525158
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Residental care home for young people
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Stockholm, Sweden
- Swedish Language Classes for Refugees
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Exhibit psychotic symptoms or other symptoms of severe mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Baseline phase ('A') and Intervention phase ('B')
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). |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the occurrence of intrusive memories of trauma from baseline week to intervention week
Time Frame: Baseline week 1 and Intervention week 1
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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.
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Baseline week 1 and Intervention week 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability ratings for using a smartphone game-play intervention
Time Frame: Intervention week 1
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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"?
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Intervention week 1
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Self-guided intervention adherence - usage of the gameplay intervention in daily life
Time Frame: Intervention week 1
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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).
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Intervention week 1
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Impact of intrusive memories on concentration, control, sleep and stress
Time Frame: Baseline week 1 and Intervention week 1
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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?"
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Baseline week 1 and Intervention week 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/978-31
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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