SH+ and Cash Assistance

NCT07016646 | Completed

• 1 other identifier: 202308168
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Depression Symptoms

Keywords

SH+; Cash Assistance; Afghan refugees; Turkiye

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment

• General Anxiety Disorder-7 (GAD-7)

  Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)

Study Arms (2)

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)

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)

Other: Cash transfer

Interventions

Cash transfer OTHER

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)

Control: Cash Assistance

Self-Help Plus (SH+) and cash transfer COMBINATION_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)

Experimental: SH+ and cash assistance

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants identifying as adult female Afghan asylum seekers and refugees are eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Having an imminent risk of suicide (measured by WHO PM+ assessment tool)

Sponsors & Collaborators

• Bogazici University: collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Afghan Refugees Solidarity Association ARSA

Kayseri, Kayseri, 38010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to their study arm due to the nature of the intervention, but outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: June 12, 2025
• Study Start: June 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: September 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)