A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees

Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1) Clinical Trial

Official title:

Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525158
• Other study ID #: 2017/978-31
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: February 26, 2018

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 26, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Brief cognitive intervention
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.

Locations

Country	Name	City	State
Sweden	Residental care home for young people	Stockholm
Sweden	Swedish Language Classes for Refugees	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline week 1 and Intervention week 1
Secondary	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"?	Intervention week 1
Secondary	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).	Intervention week 1
Secondary	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?"	Baseline week 1 and Intervention week 1