NCT06773338

Brief Summary

This study examines if playing Tetris prevents the development of Post-traumatic stress disorder or related anxiety and depressive symptoms. The investigators recruit 300 participants in total in Greece and in the Netherlands. The participants are immigrants who have applied for asylum at any point in the past. The participants are asked to answer three questionnaires (on Post-traumatic stress disorder, related anxiety and depressive symptoms, and post-migration living difficulties) on a recurring basis - once every 4 weeks, 12 times in total. Half of the participants (treatment group) are randomly selected to play Tetris after completing the questionnaires. Participants in the treatment group are instructed to play Tetris for at least 15 minutes while trying to remember bad things that recently happened to them. Tetris is administered at three instances and participants in the treatment group are encouraged to play Tetris in case of experiencing any traumatic events or having any intrusive memories during the course of the study.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

December 17, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 19, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Post-traumatic stress disorderPTSDAnxietyDepressionRefugeesAsylum seekersMigrantsTetrisLongitudinal

Outcome Measures

Primary Outcomes (2)

  • Post-traumatic stress disorder

    The investigators use the Primary Care Post-Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders fifth edition (PC-PTSD-5)

    From enrolment to the end of the study (40 weeks)

  • Anxiety and depression symptoms

    The investigators use the Kessler Psychological Distress Scale

    From enrolment to the end of the study (40 weeks)

Secondary Outcomes (1)

  • Post-migration living difficulties

    From enrolment to the end of the study (40 weeks)

Study Arms (2)

Treatment tetris group

OTHER

Randomly selected participants who reply to mental health and migration-related difficulties questionnaires are asked to play Tetris during the research.

Behavioral: Tetris

Control group

OTHER

Randomly selected participants who reply to mental health and migration-related difficulties questionnaires, but do not play Tetris during the research.

Other: No intervention

Interventions

TetrisBEHAVIORAL

Randomly selected participants (migrants) are asked to play Tetris for at least 15 minutes on several occasions. These participants are asked while playing Tetris to try and remember bad events that recently happened to them. The participants play the classic version of the Tetris game directly on their mobile phone.

Treatment tetris group

Participants do not receive any intervention.

Control group

Eligibility Criteria

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

You may qualify if:

  • Arabic-speaking immigrants of any gender who have applied for asylum in Greece or in the Netherlands, regardless of the outcome of their asylum application and their current residency status (rejected asylum seekers, recognized refugees, undocumented migrants).

You may not qualify if:

  • Minors (under the age of 18).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Upinion (online)

The Hague, NL, 2511 CJ, Greece

NOT YET RECRUITING

Upinion/the humanity Hub

The Hague, NL, 2511 CJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Tihomir Sabchev, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 14, 2025

Study Start

December 17, 2024

Primary Completion

December 7, 2025

Study Completion

December 7, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

In accordance with Tilburg University's standards and considering the sensitivity of the data collected from asylum seekers, the availability for reuse of the data will be subject to careful consideration and protection of privacy. The availability of the data for reuse will be determined on a case-by-case basis, taking into consideration the consent obtained from participants, any legal or ethical restrictions, and the level of identifiability of the data. To protect the privacy and confidentiality of the asylum seekers, data sharing will be done in a controlled manner.The availability of the data for reuse will be determined on a case-by-case basis, taking into consideration the consent obtained from participants, any legal or ethical restrictions, and the level of identifiability of the data.

Locations