Back to resultsA Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
Primary Purpose
Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Brief cognitive intervention
Sponsored by
About this trial
This is an interventional other trial for Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
Eligibility Criteria
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
Sites / Locations
- Residental care home for young people
- Swedish Language Classes for Refugees
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Baseline phase ('A') and Intervention phase ('B')
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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"?
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).
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?"
Full Information
NCT ID
NCT03525158
First Posted
April 12, 2018
Last Updated
September 16, 2020
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03525158
Brief Title
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
Official Title
Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
February 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case experimental AB design with or without optional replication (ABAB) (ie no random assignment)
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline phase ('A') and Intervention phase ('B')
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brief cognitive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the occurrence of intrusive memories of trauma from baseline week to intervention week
Description
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.
Time Frame
Baseline week 1 and Intervention week 1
Secondary Outcome Measure Information:
Title
Feasibility and acceptability ratings for using a smartphone game-play intervention
Description
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"?
Time Frame
Intervention week 1
Title
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Description
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).
Time Frame
Intervention week 1
Title
Impact of intrusive memories on concentration, control, sleep and stress
Description
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?"
Time Frame
Baseline week 1 and Intervention week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Holmes, Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residental care home for young people
City
Stockholm
Country
Sweden
Facility Name
Swedish Language Classes for Refugees
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
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A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
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