Relief From Stress Via Social Protection in Senegal

NCT06698471 | Active Not Recruiting

• 1 other identifier: IRB#2575
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Engagement

  Of those who were offered the intervention, at least 25% attended one or more sessions.

  From enrollment to the end of treatment at 5 weeks

• Retention

  At least 50% of the ever-attended beneficiaries attended at least any 4 intervention sessions

  From enrollment to the end of treatment at 5 weeks

• Fidelity

  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%

  From enrollment to the end of treatment at 5 weeks

Secondary Outcomes (21)

• General Health Questionnaire-12

  Prior to initiation of treatment

• General Health Questionnaire-12

  2 months following initiation of treatment

• General Health Questionnaire-12

  5 months following initiation of treatment

• Patient Health Questionnaire-9

  Prior to initiation of treatment

• Patient Health Questionnaire-9

  2 months following initiation of treatment

Other Outcomes (9)

• Culture-specific measure of distress - Thinking too much

  Prior to initiation of treatment

• Culture-specific measure of distress - Thinking too much

  2 months following initiation of treatment

• Culture-specific measure of distress - Thinking too much

  5 months following initiation of treatment

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual from Health System in Senegal

Other: Referral to Health System

Relief from Stress via Social Protection in Senegal

EXPERIMENTAL

Training community workers in Self Help Plus intervention

Other: Community worker training

Interventions

Community worker training OTHER

Training community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy

Relief from Stress via Social Protection in Senegal

Referral to Health System OTHER

Referral to Health System of Senegal

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead
• World Bank: collaborator
• Centre de Recherche Pour le Développement Economique et Social (CRDES): collaborator

Study Sites (1)

Centre de Recherche Pour le Développement Economique et Social (CRDES)

Dakar, Senegal

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Syed S Wahid, Doctor of Public Health

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Anne Hilger, PhD

  World Bank

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are masked to study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 21, 2024
• Study Start: February 24, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-03

Locations

SE (1)