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Completed

NCT Number: NCT03760601

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

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 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Language Classes for Refugees, Clinics

Stockholm, Sweden

About this study

This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, Arabic or Farsi
  • Able to attend five to six meetings with a researcher

Exclusion criteria

  • Exhibit psychotic symptoms or other symptoms of severe mental illness

Treatment and study plan

Brief cognitive intervention

Behavioral

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 outcomes

  1. Change in number of intrusive memories of trauma

    Time frame: Change between 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) over one week.

Secondary outcomes

  1. Feasibility and acceptability ratings for using a smartphone game-play intervention

    Time frame: Intervention week 1

    Feasibility and Acceptability of the intervention assessed with 10 self-rated items, e.g. "Would you recommend playing Tetris to a friend?". Scores range from 0 - 10 with higher scores indicating greater acceptability/ feasibility.

  2. Feasibility and acceptability - open ended questions

    Time frame: Intervention week 1

    Two items with 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"?

  3. Self-guided intervention adherence - usage of the gameplay intervention in daily life

    Time frame: Intervention week 1

    Usage of the gameplay intervention 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).

  4. Impact of intrusive memories on concentration, control, sleep and stress - ratings

    Time frame: Baseline week 1 and Intervention week 1

    A bespoke measure of 6 self-rated items to assess the impact of intrusive memories on concentration, control, sleep and stress (all rated on an 11-point scale): 2 items assessing experienced concentration difficulties due to intrusive memories and in general ( high scores indicating more concentration difficulties);1 item assessing feeling of control over intrusive memories (0 = no control; 10 = in full control); 2 items assessing sleep disturbances due to intrusive memories (higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).

  5. Rating of how long intrusive memories disrupted concentration on average

    Time frame: Baseline week 1 and Intervention week 1

    1 item assessing for how long intrusive memories disrupted concentration on average (<1 minute - > 60 minutes)

  6. Impact of intrusive memories - open ended questions

    Time frame: Baseline week 1 and Intervention week 1

    Two open-ended questions are 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, e.g. a new language?"

  7. Impact of the intervention on concentration, emotion and functioning - ratings

    Time frame: Intervention week 1

    A bespoke measure comprising 3 self-rated items to assess the impact of the intervention on concentration, emotion and functioning at the time of playing (11-point scale, 0= not helpful, 10= very helpful).

  8. Subjective impact of the intervention - open ended questions

    Time frame: Intervention week 1

    2 open ended questions about the subjective impact of the intervention in the shorter, and longer term: "How would you describe the impact of this intervention in the short term?"; "How would you describe the impact of this intervention in the longer term"?

  9. World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

    Time frame: Baseline week 1 and intervention week 1

    A 12 item self-rated questionnaire asking about difficulties due to health conditions, including mental or emotional problems. Scores range from 1 to 5 where 1=none and 5=extreme or cannot do.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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