NCT03760601

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

November 19, 2018

Last Update Submit

August 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change between baseline week 1 and Intervention week 1

Secondary Outcomes (9)

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

    Intervention week 1

  • Feasibility and acceptability - open ended questions

    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 - ratings

    Baseline week 1 and Intervention week 1

  • Rating of how long intrusive memories disrupted concentration on average

    Baseline week 1 and Intervention week 1

  • +4 more secondary outcomes

Study Arms (2)

Baseline phase ('A')

NO INTERVENTION

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')

EXPERIMENTAL

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

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.

Intervention phase ('B')

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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, Arabic or Farsi
  • Able to attend five to six 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 (1)

Swedish Language Classes for Refugees, Clinics

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

Study Officials

  • Emily Holmes, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single case experimental AB design with optional replication (ABAB)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emily Holmes

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 30, 2018

Study Start

March 25, 2019

Primary Completion

June 20, 2019

Study Completion

August 26, 2019

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations