NCT03525158

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

April 12, 2018

Last Update Submit

September 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Intervention week 1

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

    Intervention week 1

  • Impact of intrusive memories on concentration, control, sleep and stress

    Baseline week 1 and Intervention week 1

Study Arms (1)

Baseline phase ('A') and Intervention phase ('B')

OTHER

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).

Behavioral: Brief cognitive intervention

Interventions

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.

Baseline phase ('A') and Intervention phase ('B')

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Exhibit psychotic symptoms or other symptoms of severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Residental care home for young people

Stockholm, Sweden

Location

Swedish Language Classes for Refugees

Stockholm, Sweden

Location

Study Officials

  • Emily Holmes, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single case experimental AB design with or without optional replication (ABAB) (ie no random assignment)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 15, 2018

Study Start

June 20, 2017

Primary Completion

February 26, 2018

Study Completion

February 26, 2018

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations