DistressNCT07914127
Group Mental Health Intervention With Syrian Refugee Women in Turkey
A study testing Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy) in people with Distress, run by Brigham Young University at 1 site in Turkey (Türkiye).
Trial summary
This research examines whether a group intervention helps refugees manage distress while living in Turkey. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Distress
- What is being tested?
- Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2024to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born in Syria
- Must be interested in accessing psychological services
- Must be able to attend group sessions
Who cannot join
- Severe psychological distress
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Association for Social Development and Aid Mobilization
Ankara
About this study
Official title: Testing a Mental Health and Psychosocial Intervention Project With Refugee Women in Turkey
This research examines whether a group intervention helps refugees manage distress while living in Turkey.
Read the detailed description
This study tests a group mental health intervention with refugees residing in Turkey. The intervention is designed to decrease symptoms of emotional distress and increase wellbeing, social support, and successful adaptation. The group will be implemented with young adult women originally from Syria, between the ages of 18-30. The project will be implemented in collaboration with ASAM, an organization that provides psychological services to refugees and migrants across Turkey. This group project will be implemented within 5 ASAM offices located in different parts of the country. In each of the 5 sites, up to 30 participants will be enrolled in the project.
- Conditions
- Distress
- Being tested
- Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)
- Keywords
- Mental health, Refugee, Syria, Turkiye
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)Behavioural
This 5 week group intervention involves 90 minute sessions addressing emotion regulation, mindfulness, and coping with stress
| Study group | Role | What they receive |
|---|---|---|
| Initial intervention group (group 1) | Experimental | This group receives the intervention first Receives: Behavioral: Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy) |
| Waitlist control group (group 2) | Active comparator | This group receives the intervention second Receives: Behavioral: Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean Emotional Distress Score (from Refugee Health Screening-15)
Zero is equivalent to no distress and 56 indicates extreme distress on all measured items
Measured: Through study completion, up to 9 months
Secondary outcomes (5)
Change from Baseline in the Mean Mindfulness Score (from Kentucky Inventory of Mindfulness Skills)
4 is equivalent to no mindfulness and 20 indicates always being mindful on all measured items
Measured: Through study completion, up to 9 months
Change from Baseline in the Emotion Regulation Score (from Emotion Regulation Questionnaire- cognitive appraisal items)
0 is equivalent to high emotion regulation and 12 indicates low emotion regulation on all measured items
Measured: Through study completion, up to 9 months
Change from Baseline in Locus of Control Score
0 is equivalent to high locus of control and 8 indicates no locus of control on all measured items
Measured: Through study completion, up to 9 months
Change from Baseline in Empowerment Score
1 is equivalent to low empowerment and 5 indicates empowerment on all measured items
Measured: Through study completion, up to 9 months
Change from Baseline in Social Support Score
0 is equivalent to strong social support and 8 indicates low social support on all measured items
Measured: Through study completion, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start12 Aug 2024
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DistressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The second group is a waitlist control condition
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914127
- Sponsor's protocol ID
- IRB2022-213
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Mental Health and Psychosocial Intervention Project With Refugee Women in Turkey
- ClinicalTrials.gov ID
- NCT07914127
- Acronym / sponsor ID
- IRB2022-213
- Conditions
- Distress
- Keywords
- Mental health, Refugee, Syria, Turkiye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Collaborators
- University of Central Florida
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 3 Nov 2026 (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 research examines whether a group intervention helps refugees manage distress while living in Turkey.
Detailed description
This study tests a group mental health intervention with refugees residing in Turkey. The intervention is designed to decrease symptoms of emotional distress and increase wellbeing, social support, and successful adaptation. The group will be implemented with young adult women originally from Syria, between the ages of 18-30. The project will be implemented in collaboration with ASAM, an organization that provides psychological services to refugees and migrants across Turkey. This group project will be implemented within 5 ASAM offices located in different parts of the country. In each of the 5 sites, up to 30 participants will be enrolled in the project.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The second group is a waitlist control condition
| Arm | Type | Receives |
|---|---|---|
| Initial intervention group (group 1) | Experimental | Behavioral: Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)This group receives the intervention first |
| Waitlist control group (group 2) | Active comparator | Behavioral: Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)This group receives the intervention second |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Born in Syria
- Must be interested in accessing psychological services
- Must be able to attend group sessions
Key exclusion criteria (1 listed)
- Severe psychological distress
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 |
|---|---|---|
| Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy)This 5 week group intervention involves 90 minute sessions addressing emotion regulation, mindfulness, and coping with stress | Behavioural | Initial intervention group (group 1), Waitlist control group (group 2) |
Primary outcome
Change from Baseline in the Mean Emotional Distress Score (from Refugee Health Screening-15)
Time frame: Through study completion, up to 9 months
Zero is equivalent to no distress and 56 indicates extreme distress on all measured items
5 secondary outcomes
Change from Baseline in the Mean Mindfulness Score (from Kentucky Inventory of Mindfulness Skills)
Time frame: Through study completion, up to 9 months
Change from Baseline in the Emotion Regulation Score (from Emotion Regulation Questionnaire- cognitive appraisal items)
Time frame: Through study completion, up to 9 months
Change from Baseline in Locus of Control Score
Time frame: Through study completion, up to 9 months
Change from Baseline in Empowerment Score
Time frame: Through study completion, up to 9 months
Change from Baseline in Social Support Score
Time frame: Through study completion, up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping with Stress (Culturally-Adapted Cognitive Behavioral Therapy) in people with Distress, run by Brigham Young University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean Emotional Distress Score (from Refugee Health Screening-15) (time frame: Through study completion, up to 9 months). 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 3 Nov 2026.