Post-traumatic Stress Disorder (PTSD)NCT06773338
The Impact of Playing Tetris on Migrants' Mental Health
A study testing Tetris in people with Post-traumatic Stress Disorder (PTSD) and Anxiety Symptoms, run by Tilburg University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Anxiety Symptoms, Depression Symptoms
- What is being tested?
- Tetris
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Dec 2024to 7 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Minors (under the age of 18).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Tihomir Sabchev, Dr. contact
2 sites in 2 countries
Greece1 site, 1 recruiting
- Not yet recruiting
Upinion (online)
The Hague, NL, 2511 CJ
Mario Braakman, Prof., +31629514366, Mario.Braakman@tilburguniversity.edu
Netherlands1 site, 1 recruiting
- Recruiting
Upinion/the humanity Hub
The Hague, NL, 2511 CJ
Mario Braakman, Prof., +31629514366, Mario.Braakman@tilburguniversity.edu
About this study
Official title: Does Playing Tetris Prevent the Development of Post-Traumatic Stress Disorder or Related Anxiety and Depressive Symptoms During and After Migration?
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.
- Being tested
- Tetris, No intervention
- Keywords
- Post-traumatic stress disorder, PTSD, Anxiety, Depression, Refugees, Asylum seekers, Migrants, Tetris, Longitudinal
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrisBehavioural
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.
No interventionOther
Participants do not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrolment to the end of the study (40 weeks)
Anxiety and depression symptoms
The investigators use the Kessler Psychological Distress Scale
Measured: From enrolment to the end of the study (40 weeks)
Secondary outcomes (1)
Post-migration living difficulties
In the course of the study, the investigators measure variation in post-migration living difficulties such as separation from family, social isolation, language barriers, etc. Participants are presented a checklist of items and asked to identify for each item if it has been a problem for them over the last month, with 4 possible answers for each item: 1) not a problem; 2) minor problem; 3) serious problem; 4) very serious problem.
In addition, participants are asked if over the last month they have 1) been victimised in any way ; 2) had any negative experiences involving bureaucratic personnel or state officials; 3) had experiences that made them feel happy and gave them hope for the future (open questions).
Measured: From enrolment to the end of the study (40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start17 Dec 2024
- Primary completion7 Dec 2025 (estimated)
- Study completion7 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting tot steun VCVGZ
- Responsible party
- Principal investigator, Mario Braakman, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773338
- Sponsor's protocol ID
- TLS_RP1253
- Other IDs
- IC2024-1, 300.6700 3613, 305.6700 3614
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Playing Tetris Prevent the Development of Post-Traumatic Stress Disorder or Related Anxiety and Depressive Symptoms During and After Migration?
- ClinicalTrials.gov ID
- NCT06773338
- Acronym / sponsor ID
- TLS_RP1253
- Keywords
- Post-traumatic stress disorder, PTSD, Anxiety, Depression, Refugees, Asylum seekers, Migrants, Tetris
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- Stichting tot steun VCVGZ
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 7 Dec 2025 (estimated)
- Study completion
- 7 Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment tetris group | Other | Behavioral: TetrisRandomly selected participants who reply to mental health and migration-related difficulties questionnaires are asked to play Tetris during the research. |
| Control group | Other | Other: No interventionRandomly selected participants who reply to mental health and migration-related difficulties questionnaires, but do not play Tetris during the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Minors (under the age of 18).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrisRandomly 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. | Behavioural | Treatment tetris group |
| No interventionParticipants do not receive any intervention. | Other | Control group |
Primary outcome
Post-traumatic stress disorder
Time frame: From enrolment to the end of the study (40 weeks)
The investigators use the Primary Care Post-Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders fifth edition (PC-PTSD-5)
Anxiety and depression symptoms
Time frame: From enrolment to the end of the study (40 weeks)
The investigators use the Kessler Psychological Distress Scale
1 secondary outcome
Post-migration living difficulties
Time frame: From enrolment to the end of the study (40 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tihomir Sabchev, Dr. contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetris in people with Post-traumatic Stress Disorder (PTSD) and Anxiety Symptoms, run by Tilburg University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Braakman, Prof. (+31629514366, Mario.Braakman@tilburguniversity.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress disorder (time frame: From enrolment to the end of the study (40 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.