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

September 16, 2020 updated by: Emily Holmes, Karolinska Institutet

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden
        • Residental care home for young people
      • Stockholm, Sweden
        • Swedish Language Classes for Refugees

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability ratings for using a smartphone game-play intervention
Time Frame: Intervention week 1
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
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Time Frame: Intervention week 1
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
Impact of intrusive memories on concentration, control, sleep and stress
Time Frame: Baseline week 1 and Intervention week 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

February 26, 2018

Study Completion (Actual)

February 26, 2018

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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