SH+ and Cash Assistance

The Washington University

Status

Enrolling

Conditions

Depression Symptoms

Stress

Treatments

Combination Product: Self-Help Plus (SH+) and cash transfer

Other: Cash transfer

Study type

Interventional

Funder types

Other

Identifiers

NCT07016646

202308168

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Experimental: SH+ and cash assistance

Experimental group

Description:

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)

Treatment:

Combination Product: Self-Help Plus (SH+) and cash transfer

Control: Cash Assistance

Active Comparator group

Description:

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)

Treatment:

Other: Cash transfer