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

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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swedish Language Classes for Refugees, Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline phase ('A')

Intervention phase ('B')

Arm Description

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.

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 selfguided 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 number of intrusive memories of trauma
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) over one week.

Secondary Outcome Measures

Feasibility and acceptability ratings for using a smartphone game-play intervention
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.
Feasibility and acceptability - open ended questions
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"?
Self-guided intervention adherence - usage of the gameplay intervention in daily life
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).
Impact of intrusive memories on concentration, control, sleep and stress - ratings
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).
Rating of how long intrusive memories disrupted concentration on average
1 item assessing for how long intrusive memories disrupted concentration on average (<1 minute - > 60 minutes)
Impact of intrusive memories - open ended questions
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?"
Impact of the intervention on concentration, emotion and functioning - ratings
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).
Subjective impact of the intervention - open ended questions
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"?
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
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.

Full Information

First Posted
November 19, 2018
Last Updated
August 31, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03760601
Brief Title
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees: An Extension
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
August 26, 2019 (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 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.
Detailed Description
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.

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 optional replication (ABAB)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline phase ('A')
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention phase ('B')
Arm Type
Experimental
Arm 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) followed by instructions to engage in the task selfguided 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 number of intrusive memories of trauma
Description
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) over one week.
Time Frame
Change between 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 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.
Time Frame
Intervention week 1
Title
Feasibility and acceptability - open ended questions
Description
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"?
Time Frame
Intervention week 1
Title
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Description
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).
Time Frame
Intervention week 1
Title
Impact of intrusive memories on concentration, control, sleep and stress - ratings
Description
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).
Time Frame
Baseline week 1 and Intervention week 1
Title
Rating of how long intrusive memories disrupted concentration on average
Description
1 item assessing for how long intrusive memories disrupted concentration on average (<1 minute - > 60 minutes)
Time Frame
Baseline week 1 and Intervention week 1
Title
Impact of intrusive memories - open ended questions
Description
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?"
Time Frame
Baseline week 1 and Intervention week 1
Title
Impact of the intervention on concentration, emotion and functioning - ratings
Description
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).
Time Frame
Intervention week 1
Title
Subjective impact of the intervention - open ended questions
Description
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"?
Time Frame
Intervention week 1
Title
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Description
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.
Time Frame
Baseline week 1 and intervention week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 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, 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
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
Swedish Language Classes for Refugees, Clinics
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32525244
Citation
Kanstrup M, Kontio E, Geranmayeh A, Olofsdotter Lauri K, Moulds ML, Holmes EA. A single case series using visuospatial task interference to reduce the number of visual intrusive memories of trauma with refugees. Clin Psychol Psychother. 2021 Jan;28(1):109-123. doi: 10.1002/cpp.2489. Epub 2020 Jul 6.
Results Reference
result

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

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