Relief From Stress Via Social Protection in Senegal (RESTORE)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distress, Psychological; Depression - Major Depressive Disorder; Generalized Anxiety Disorder (GAD)
• Intervention / Treatment: Other: Referral to Health System; Other: Community worker training

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 Type: Interventional
• Enrollment (Actual): 748
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Senegal
  • Dakar, Senegal
    • Centre de Recherche Pour le Développement Economique et Social (CRDES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual; Treatment as usual from Health System in Senegal	Other: Referral to Health System; Referral to Health System of Senegal
Experimental: Relief from Stress via Social Protection in Senegal; Training community workers in Self Help Plus intervention	Other: Community worker training; Training community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Health Questionnaire-12	Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being	Prior to initiation of treatment
Patient Health Questionnaire-9	Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms	Prior to initiation of treatment
Generalized Anxiety Disorder-7	Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms	Prior to initiation of treatment
Brief Resilience Scale	Brief resilience measure. Score range: 0-30; Higher score indicates better resilience	Prior to initiation of treatment
Acceptance and Action Questionnaire	Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility	Prior to initiation of treatment
Self Efficacy	Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy	Prior to initiation of treatment
Locus of control questionnaire	Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control	Prior to initiation of treatment
General Health Questionnaire-12	Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being	2 months following initiation of treatment
General Health Questionnaire-12	Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being	5 months following initiation of treatment
Patient Health Questionnaire-9	Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms	2 months following initiation of treatment
Patient Health Questionnaire-9	Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms	5 months following initiation of treatment
Generalized Anxiety Disorder-7	Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms	2 months following initiation of treatment
Generalized Anxiety Disorder-7	Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms	5 months following initiation of treatment
Brief Resilience Scale	Brief resilience measure. Score range: 0-30; Higher score indicates better resilience	2 months following initiation of treatment
Brief Resilience Scale	Brief resilience measure. Score range: 0-30; Higher score indicates better resilience	5 months following initiation of treatment
Acceptance and Action Questionnaire	Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility	2 months following initiation of treatment
Acceptance and Action Questionnaire	Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility	5 months following initiation of treatment
Self Efficacy	Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy	2 months following initiation of treatment
Self Efficacy	Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy	5 months following initiation of treatment
Locus of control questionnaire	Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control	2 months following initiation of treatment
Locus of control questionnaire	Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control	5 months following initiation of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Culture-specific measure of distress - Thinking too much	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	Prior to initiation of treatment
Culture-specific measure of distress - Thinking too much	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	2 months following initiation of treatment
Culture-specific measure of distress - Thinking too much	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	5 months following initiation of treatment
Culture-specific measure of distress - Feelings that hurt the heart	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	Prior to initiation of treatment
Culture-specific measure of distress - Feelings that hurt the heart	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	2 months following initiation of treatment
Culture-specific measure of distress - Feelings that hurt the heart	Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being	5 months following initiation of treatment
Culture-specific measure of well being - Heart has felt calm	Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being	Prior to initiation of treatment
Culture-specific measure of well being - Heart has felt calm	Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being	2 months following initiation of treatment
Culture-specific measure of well being - Heart has felt calm	Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being	5 months following initiation of treatment

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: World Bank; Centre de Recherche Pour le Développement Economique et Social (CRDES)
• Investigators: Principal Investigator: Syed S Wahid, Doctor of Public Health, Georgetown University; Principal Investigator: Anne Hilger, PhD, World Bank

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: IRB#2575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No