Relief From Stress Via Social Protection in Senegal (RESTORE)

Georgetown University

Status: Not yet enrolling

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

Treatments: Other: Referral to Health System; Other: Community worker training

Study type: Interventional

Funder types: Other

Identifiers

NCT06698471

IRB#2575

Details and patient eligibility

About

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.

Full 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;

Enrollment: 1,575 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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: Does post training ENACT score apply here?
• Patients: Persons with a severe mental disorder or suicidality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,575 participants in 2 patient groups

Treatment as usual

Active Comparator group

Description:

Treatment as usual from Health System in Senegal

Treatment:

Other: Referral to Health System

Relief from Stress via Social Protection in Senegal

Experimental group

Description:

Training community workers in Self Help Plus intervention

Treatment:

Other: Community worker training