Relief From Stress Via Social Protection in Senegal

Not Applicable

Active, not recruiting

• Conditions: Distress, Psychological; Depression - Major Depressive Disorder; Generalized Anxiety Disorder (GAD)

• Registration Number: NCT06698471
• Lead Sponsor: Georgetown University

Brief Summary

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.

Detailed Description

The primary objective of the pilot feasibility cluster-randomized controlled trial is to assess the feasibility and acceptability of both the Self-Help Plus intervention and trial procedures through the collection of quantitative and qualitative data. The study will include two trial arms: (1) a control treatment-as-usual arm and (2) an intervention arm that will receive the adapted Self Help Plus intervention. The findings of the research detailed in this protocol may be used to inform the design of a potential larger randomized control trial powered to assess the effectiveness of Self-Help Plus in Senegalese populations. Additional secondary objectives of the pilot feasibility study are listed below.

1. Assess feasibility of cluster randomization procedure to limit biases and risk of contamination;

2. Determine recruitment and retention rates for Self-Help Plus sessions;

3. Evaluate the feasibility and acceptability of intervention delivery by Self-Help Plus trained non-specialists;

4. Assess the safety of an abbreviated training curriculum (during training, intervention delivery, and supervision);

5. Assess feasibility and acceptability of outcome measures;

6. Assess ethics and safety of trial procedures using the adverse event protocol;

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Study Start: 2025-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

• Community Worker facilitators of the intervention:
• Patients: Enrolled in the World Bank Social Protection Programme

Exclusion Criteria

• Community Worker facilitators of the intervention
• Patients: Persons with a severe mental disorder or suicidality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Engagement	From enrollment to the end of treatment at 5 weeks	Of those who were offered the intervention, at least 25% attended one or more sessions.
Retention	From enrollment to the end of treatment at 5 weeks	At least 50% of the ever-attended beneficiaries attended at least any 4 intervention sessions
Fidelity	From enrollment to the end of treatment at 5 weeks	Fidelity to intervention elements at the level of 75% or greater according to the mean fidelity checklist for intervention elements across all sessions. Number of feasibility domains: n=15; higher is better, scored on 0-100%

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	5 months following initiation of treatment	Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
General Health Questionnaire-12	5 months following initiation of treatment	Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
Generalized Anxiety Disorder-7	5 months following initiation of treatment	Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Brief Resilience Scale	5 months following initiation of treatment	Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Acceptance and Action Questionnaire	5 months following initiation of treatment	Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
Self Efficacy	5 months following initiation of treatment	Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Locus of control questionnaire	5 months following initiation of treatment	Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control

Trial Locations

Locations (1)

Centre de Recherche Pour le Développement Economique et Social (CRDES); 🇸🇳 Dakar, Senegal