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

August 31, 2022 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: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • Stockholm, Sweden
        • Swedish Language Classes for Refugees, Clinics

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_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, 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

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: 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.
EXPERIMENTAL: 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 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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change between baseline week 1 and Intervention week 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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.
Intervention week 1
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"?
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 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 - 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).
Baseline week 1 and Intervention week 1
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)
Baseline week 1 and Intervention week 1
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?"
Baseline week 1 and Intervention week 1
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).
Intervention week 1
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"?
Intervention week 1
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.
Baseline week 1 and intervention week 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/2149-32

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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