StressNCT07016646
SH+ and Cash Assistance
A study testing Self-Help Plus (SH+) and cash transfer and Cash transfer in people with Stress and Depression Symptoms, run by Washington University School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This pilot project aims to evaluate the implementation outcomes and preliminary impacts of a combined low-intensity psychological intervention paired with cash assistance for Dari-speaking adult Afghan asylum-seeking women in Türkiye. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression Symptoms
- What is being tested?
- Self-Help Plus (SH+) and cash transfer and Cash transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 20 Sep 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The characteristics for recruited participants in this study will include
- being an Afghan refugee or asylum seeker residing in Türkiye,
- being a woman,
- being aged 18 or older,
- having the ability to read, speak, and consent in Dari,
- having high levels of psychological distress (scoring above 15 on the Farsi version of the Kessler-10 Psychological Distress Scale (K-10), and
- without an imminent risk of suicide (measured by WHO PM+ assessment tool).
Who cannot join
- Having an imminent risk of suicide (measured by WHO PM+ assessment tool)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afghan Refugees Solidarity Association ARSA
Kayseri, Kayseri, 38010
About this study
Official title: Combined Mental Health and Cash Transfer Intervention With Afghan Refugees in Turkiye
This pilot project aims to evaluate the implementation outcomes and preliminary impacts of a combined low-intensity psychological intervention paired with cash assistance for Dari-speaking adult Afghan asylum-seeking women in Türkiye. The psychological intervention utilized is Self Help Plus (SH+), developed by the World Health Organization (WHO) for individuals in low-resource settings experiencing high stress levels.
This pilot, which builds on a previous needs assessment, will deliver the SH+ intervention through five two-hour sessions, supplemented by a cash transfer of USD 300 or equal amount in Turkish Lira per participant (USD 60 or equal amount in Turkish Lira after each session) to 40 Afghan asylum-seeking women in Türkiye.
Read more
The study will test the feasibility, acceptability, and practicality of the combined SH+ and cash transfer intervention and evaluate its effectiveness in addressing the mental health needs of forcibly displaced individuals through a two-arm randomized trial. The first group will receive SH+ and cash transfer simultaneously, and the second group will receive the cash transfer at the same time as the first group then receive the SH+ intervention after a 3-month delay.
Our local partners in Türkiye are the Afghan Refugees Solidarity Association (ARSA) and Boğaziçi University. We have already obtained IRB approval from Boğaziçi University.
Read the detailed description
Afghan women asylum seekers and refugees who are already part of our ARSA's women's group will be screened for eligibility and enrollment in the study by a counselor from ARSA. The characteristics for recruited participants in this study will include a) being an Afghan refugee or asylum seeker residing in Türkiye, b) being a woman, c) being aged 18 or older, d) having the ability to read, speak, and consent in Dari, e) having high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale [K-10]), and f) without an imminent risk of suicide (measured by the WHO PM+ assessment tool).
At the end of the screening questionnaire, eligible participants will receive a written consent form in both English and Dari. Qualified participants will also be provided with an informational presentation about the study and given a week to review the consent form carefully. Recruitment will continue until 40 eligible participants have provided consent.
Following the screening and consent process, 40 eligible participants will be randomized to two arms according to the 1:1 principle with automatized randomization software.
Group 1 (Receiving SH+ and cash transfer simultaneously):
Participants will complete the baseline assessment 1 week before the intervention. They will then participate in 5 weekly 2-hour SH+ session in person at ARSA in a private conference room. With each session, they will receive a $60 or equal amount in Turkish Lira in cash transfer. The program will be delivered by bilingual community facilitators who have completed a 3-day training on SH+ by WHO-certified SH+ trainers. Each session will follow the SH+ manual and the SH+ illustrated guide.
Childcare will be provided in a separate child-friendly room in ARSA during the sessions to remove barriers to participation and ensure that participants can participate in the sessions without concerns about their children's safety and well-being.
One week after the completion of the sessions, participants will complete the post-assessment, consisting of the same questionnaires used in the baseline assessment in addition to the measures related to implementation outcomes.
Group 2 (Receiving SH+ followed by cash transfer with a 3 month delay):
Participants will complete the baseline assessment 1 week before Group 1 begins their simultaneous intervention. While Group 1 is receiving their intervention, participants in Group 2 will receive a $60 or equal amount in Turkish Lira in cash transfer every week for 5 weeks. One week after the completion of Group 1's sessions, participants in Group 2 will complete the post-assessment, consisting of the same questionnaires used in the baseline assessment but without the implementation outcome measures.
After 3 months, participants in Group 2 will receive the SH+ intervention at ARSA (5 weeks, one 2-hour session per week, delivered by bilingual trained community facilitators, childcare provided at ARSA). One week after the completion of Group 2's sessions, participants in Group 2 will complete the full post-assessment, consisting of the same questionnaires used in the baseline assessment in addition to the measures related to implementation outcomes.
Supervision for facilitators will be provided by Zeynep Ilkkursun, a clinical psychologist in Türkiye. However, sessions will not be observed or recorded, and fidelity will be checked through conversations during the supervision sessions.
Additionally, semi-structured interviews will be conducted with the Afghan refugees who received the SH+ and the community members who were trained to deliver the intervention to get feedback on the content and clarity. Results will allow the study team to evaluate and understand the appropriateness and clarity of the procedures.
- Conditions
- Stress, Depression Symptoms
- Being tested
- Self-Help Plus (SH+) and cash transfer, Cash transfer
- Keywords
- SH+, Cash Assistance, Afghan refugees, Turkiye
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help Plus (SH+) and cash transferCombination product
SH+: Self-Help Plus (SH+) is a five-session stress management program developed by the World Health Organization (WHO) for groups of up to 30 participants. It is facilitated by non-specialists who undergo brief training and use pre-recorded audio along with an illustrated guide, Doing What Matters in Times of Stress, to teach stress management techniques. Designed for adults experiencing stress, SH+ is adaptable to diverse living situations and circumstances. Research has demonstrated its effectiveness in alleviating psychological distress and preventing the onset of mental health disorders. Its flexible format makes it an excellent complement to other mental health interventions, whether as an initial step in a stepped care approach or as a community-based program integrated with broader community initiatives.
Cash Assistance: A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira after each session)
Cash transferOther
A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira each week for 5 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SH+ and cash assistance | Experimental | SH+: Self-Help Plus (SH+) is a five-session stress management program developed by the World Health Organization (WHO) for groups of up to 30 participants. It is facilitated by non-specialists who undergo brief training and use pre-recorded audio along with an illustrated guide, Doing What Matters in Times of Stress, to teach stress management techniques. Designed for adults experiencing stress, SH+ is adaptable to diverse living situations and circumstances. Research has demonstrated its effectiveness in alleviating psychological distress and preventing the onset of mental health disorders. Its flexible format makes it an excellent complement to other mental health interventions, whether as an initial step in a stepped care approach or as a community-based program integrated with broader community initiatives.
Cash Assistance: A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira after each session) Receives: Combination Product: Self-Help Plus (SH+) and cash transfer |
| Control: Cash Assistance | Active comparator | A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira each week for 5 weeks) Receives: Other: Cash transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kessler-10 Psychological Distress Scale (K-10)
Kessler-10 Psychological Distress Scale is a 10-item questionnaire that aims to measure psychological distress symptoms. Each of the 10 items are scored as 1, 2, 3, 4 and 5 to the response categories (1 = "none of the time" to 5= "all of the time"), providing a 10-50 severity score. Higher scores indicate higher levels of psychological distress. The Farsi version of the K-10 will be used in this study.
Measured: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Secondary outcomes (2)
Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 is a 9 item questionnaire that aims to measure the severity of depression symptoms. Each of the 9 items are scored as 0, 1, 2, and 3 to the response categories (0 = "not at all," to 3= "nearly every day"), providing a 0-27 severity score. Higher scores indicate decreased functional status and increased symptom-related difficulties. The Farsi version of the PHQ-9 will be used in the study.
Measured: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment
General Anxiety Disorder-7 (GAD-7)
General Anxiety Disorder-7 is a 7-item questionnaire that aims to measure anxiety symptoms. Each of the 7 items are scored as 0, 1, 2, and 3 to the response categories (0 = "not at all," to 3= "nearly every day"), providing a 0-21 severity score. Higher scores indicate higher levels of anxiety. The Farsi version of the GAD-7 will be used in this study.
Measured: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Jun 2025
- Primary completion20 Aug 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- A pilot randomized controlled trial (RCT) will be conducted with a total of 40 participants. Participants will be randomly assigned to one of two groups: 20 individuals will receive both the Self-Help Plus (SH+) intervention and cash assistance, while the remaining 20 will receive cash assistance only and serve as the control group. One week after completing the intervention sessions, all participants-including those in the control group-will undergo post-intervention assessments, using the same questionnaires administered at baseline. To ensure ethical considerations and promote equity, the SH+ intervention will be offered to control group participants three months after the post-assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bogazici University
- Responsible party
- Principal investigator, Mitra Naseh, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016646
- Sponsor's protocol ID
- 202308168
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Mental Health and Cash Transfer Intervention With Afghan Refugees in Turkiye
- ClinicalTrials.gov ID
- NCT07016646
- Acronym / sponsor ID
- 202308168
- Conditions
- Stress, Depression Symptoms
- Keywords
- SH+, Cash Assistance, Afghan refugees, Turkiye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Bogazici University
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 12 Jun 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 pilot project aims to evaluate the implementation outcomes and preliminary impacts of a combined low-intensity psychological intervention paired with cash assistance for Dari-speaking adult Afghan asylum-seeking women in Türkiye. The psychological intervention utilized is Self Help Plus (SH+), developed by the World Health Organization (WHO) for individuals in low-resource settings experiencing high stress levels.
This pilot, which builds on a previous needs assessment, will deliver the SH+ intervention through five two-hour sessions, supplemented by a cash transfer of USD 300 or equal amount in Turkish Lira per participant (USD 60 or equal amount in Turkish Lira after each session) to 40 Afghan asylum-seeking women in Türkiye.
The study will test the feasibility, acceptability, and practicality of the combined SH+ and cash transfer intervention and evaluate its effectiveness in addressing the mental health needs of forcibly displaced individuals through a two-arm randomized trial. The first group will receive SH+ and cash transfer simultaneously, and the second group will receive the cash transfer at the same time as the first group then receive the SH+ intervention after a 3-month delay.
Our local partners in Türkiye are the Afghan Refugees Solidarity Association (ARSA) and Boğaziçi University. We have already obtained IRB approval from Boğaziçi University.
Detailed description
Afghan women asylum seekers and refugees who are already part of our ARSA's women's group will be screened for eligibility and enrollment in the study by a counselor from ARSA. The characteristics for recruited participants in this study will include a) being an Afghan refugee or asylum seeker residing in Türkiye, b) being a woman, c) being aged 18 or older, d) having the ability to read, speak, and consent in Dari, e) having high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale [K-10]), and f) without an imminent risk of suicide (measured by the WHO PM+ assessment tool).
At the end of the screening questionnaire, eligible participants will receive a written consent form in both English and Dari. Qualified participants will also be provided with an informational presentation about the study and given a week to review the consent form carefully. Recruitment will continue until 40 eligible participants have provided consent.
Following the screening and consent process, 40 eligible participants will be randomized to two arms according to the 1:1 principle with automatized randomization software.
Group 1 (Receiving SH+ and cash transfer simultaneously):
Participants will complete the baseline assessment 1 week before the intervention. They will then participate in 5 weekly 2-hour SH+ session in person at ARSA in a private conference room. With each session, they will receive a $60 or equal amount in Turkish Lira in cash transfer. The program will be delivered by bilingual community facilitators who have completed a 3-day training on SH+ by WHO-certified SH+ trainers. Each session will follow the SH+ manual and the SH+ illustrated guide.
Childcare will be provided in a separate child-friendly room in ARSA during the sessions to remove barriers to participation and ensure that participants can participate in the sessions without concerns about their children's safety and well-being.
One week after the completion of the sessions, participants will complete the post-assessment, consisting of the same questionnaires used in the baseline assessment in addition to the measures related to implementation outcomes.
Group 2 (Receiving SH+ followed by cash transfer with a 3 month delay):
Participants will complete the baseline assessment 1 week before Group 1 begins their simultaneous intervention. While Group 1 is receiving their intervention, participants in Group 2 will receive a $60 or equal amount in Turkish Lira in cash transfer every week for 5 weeks. One week after the completion of Group 1's sessions, participants in Group 2 will complete the post-assessment, consisting of the same questionnaires used in the baseline assessment but without the implementation outcome measures.
After 3 months, participants in Group 2 will receive the SH+ intervention at ARSA (5 weeks, one 2-hour session per week, delivered by bilingual trained community facilitators, childcare provided at ARSA). One week after the completion of Group 2's sessions, participants in Group 2 will complete the full post-assessment, consisting of the same questionnaires used in the baseline assessment in addition to the measures related to implementation outcomes.
Supervision for facilitators will be provided by Zeynep Ilkkursun, a clinical psychologist in Türkiye. However, sessions will not be observed or recorded, and fidelity will be checked through conversations during the supervision sessions.
Additionally, semi-structured interviews will be conducted with the Afghan refugees who received the SH+ and the community members who were trained to deliver the intervention to get feedback on the content and clarity. Results will allow the study team to evaluate and understand the appropriateness and clarity of the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot randomized controlled trial (RCT) will be conducted with a total of 40 participants. Participants will be randomly assigned to one of two groups: 20 individuals will receive both the Self-Help Plus (SH+) intervention and cash assistance, while the remaining 20 will receive cash assistance only and serve as the control group. One week after completing the intervention sessions, all participants-including those in the control group-will undergo post-intervention assessments, using the same questionnaires administered at baseline. To ensure ethical considerations and promote equity, the SH+ intervention will be offered to control group participants three months after the post-assessment.
| Arm | Type | Receives |
|---|---|---|
| Experimental: SH+ and cash assistance | Experimental | Combination Product: Self-Help Plus (SH+) and cash transferSH+: Self-Help Plus (SH+) is a five-session stress management program developed by the World Health Organization (WHO) for groups of up to 30 participants. It is facilitated by non-specialists who undergo brief training and use pre-recorded audio along with an illustrated guide, Doing What Matters in Times of Stress, to teach stress management techniques. Designed for adults experiencing stress, SH+ is adaptable to diverse living situations and circumstances. Research has demonstrated its effectiveness in alleviating psychological distress and preventing the onset of mental health disorders. Its flexible format makes it an excellent complement to other mental health interventions, whether as an initial step in a stepped care approach or as a community-based program integrated with broader community initiatives. Cash Assistance: A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira after each session) |
| Control: Cash Assistance | Active comparator | Other: Cash transferA cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira each week for 5 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The characteristics for recruited participants in this study will include
- being an Afghan refugee or asylum seeker residing in Türkiye,
- being a woman,
- being aged 18 or older,
- having the ability to read, speak, and consent in Dari,
Key exclusion criteria (1 listed)
- Having an imminent risk of suicide (measured by WHO PM+ assessment tool)
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 |
|---|---|---|
| Self-Help Plus (SH+) and cash transferSH+: Self-Help Plus (SH+) is a five-session stress management program developed by the World Health Organization (WHO) for groups of up to 30 participants. It is facilitated by non-specialists who undergo brief training and use pre-recorded audio along with an illustrated guide, Doing What Matters in Times of Stress, to teach stress management techniques. Designed for adults experiencing stress, SH+ is adaptable to diverse living situations and circumstances. Research has demonstrated its effectiveness in alleviating psychological distress and preventing the onset of mental health disorders. Its flexible format makes it an excellent complement to other mental health interventions, whether as an initial step in a stepped care approach or as a community-based program integrated with broader community initiatives. Cash Assistance: A cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira after each session) | Combination product | Experimental: SH+ and cash assistance |
| Cash transferA cash transfer of $300 or equal amount in Turkish Lira per participant ($60 or equal amount in Turkish Lira each week for 5 weeks) | Other | Control: Cash Assistance |
Primary outcome
Kessler-10 Psychological Distress Scale (K-10)
Time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Kessler-10 Psychological Distress Scale is a 10-item questionnaire that aims to measure psychological distress symptoms. Each of the 10 items are scored as 1, 2, 3, 4 and 5 to the response categories (1 = "none of the time" to 5= "all of the time"), providing a 10-50 severity score. Higher scores indicate higher levels of psychological distress. The Farsi version of the K-10 will be used in this study.
2 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment
General Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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 Self-Help Plus (SH+) and cash transfer and Cash transfer in people with Stress and Depression Symptoms, run by Washington University School of Medicine 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 7 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 18 Dec 2025. 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?
Kessler-10 Psychological Distress Scale (K-10) (time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)). 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 18 Dec 2025.