NCT06698471Active, not recruiting
Relief From Stress Via Social Protection in Senegal
Relief From Stress Via Social Protection in Senegal (RESTORE): Study Protocol for a Pilot Feasibility Cluster-randomized Control Trial of Self-Help Plus (SH+) in Senegal.
Source: ClinicalTrials.gov · Last updated 2 May 2025
Brief summary (registry, in English)
Despite the growing prevalence of mental health disorders in low- and middle-income countries, significant barriers to seeking and accessing mental health services persist. Within lower income populations, the prevalence of mental health disorders and barriers to addressing them are worsened by poverty. Self-Help Plus is a group-based stress management program delivered using a task-sharing model and designed to circumvent barriers to addressing mental health concerns. Cultural adaptations of Self-Help Plus have been implemented in several countries and are considered cost-effective. However, to date, Self-Help Plus has not been adapted for Senegalese populations. The study detailed in this manuscript aims to assess the feasibility and acceptability of Self-Help Plus in lower income populations in Senegal. The study is a pilot feasibility cluster-randomized control trial of Self-Help Plus in four Senegalese communities. Clusters of social protection program beneficiaries will be randomly selected to receive five sessions of Self-Help Plus. The intervention will be delivered in groups of up to 30 beneficiaries and co-facilitated by two community workers. A combination of quantitative and qualitative research methods will be used to assess the feasibility and acceptability of both the Self-Help Plus intervention and randomized control trial procedures. The study sample will include social protection program beneficiaries in the treatment and control groups, Self-Help Plus facilitators, project staff supporting the training of facilitators, and the intervention supervisor. The findings of this study will be used to inform the potential integration of Self-Help Plus and/or similar mental health interventions into the national social protection program in Senegal.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 748 (actual)
- First submitted
- 22 Oct 2024
- Start date
- 24 Feb 2025
- Primary completion date
- Oct 2025
- Lead sponsor
- Georgetown University
- Diseases
- Depression
- NCT number
- NCT06698471
What you commit to
- Study type: Interventional
- Participants enrolled: 748
- From 24 Feb 2025 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients: Persons with a severe mental disorder or suicidality
Other
- Community Worker facilitators of the intervention
Who the study is looking for
- Community Worker facilitators of the intervention:
- Patients: Enrolled in the World Bank Social Protection Programme
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Recherche Pour le Développement Economique et Social (CRDES) Coordinator of this site? Confirm its status | Dakar | Senegal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.