Clinical trial NCT06698471: Relief From Stress Via Social Protection in Senegal
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distress, Psychological
Depression - Major Depressive Disorder
Generalized Anxiety Disorder (GAD)
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: World Bank
name: Centre de Recherche Pour le Développement Economique et Social (CRDES)
First posted: 2024-11-21
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

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;

Eligibility criteria: 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

Primary outcomes:
measure: Engagement
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Retention
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Fidelity
timeFrame: From enrollment to the end of treatment at 5 weeks
Secondary outcomes:
measure: General Health Questionnaire-12
timeFrame: Prior to initiation of treatment
measure: General Health Questionnaire-12
timeFrame: 2 months following initiation of treatment
measure: General Health Questionnaire-12
timeFrame: 5 months following initiation of treatment
measure: Patient Health Questionnaire-9
timeFrame: Prior to initiation of treatment
measure: Patient Health Questionnaire-9
timeFrame: 2 months following initiation of treatment
measure: Patient Health Questionnaire-9
timeFrame: 5 months following initiation of treatment
measure: Generalized Anxiety Disorder-7
timeFrame: Prior to initiation of treatment
measure: Generalized Anxiety Disorder-7
timeFrame: 2 months following initiation of treatment
measure: Generalized Anxiety Disorder-7
timeFrame: 5 months following initiation of treatment
measure: Brief Resilience Scale
timeFrame: Prior to initiation of treatment
measure: Brief Resilience Scale
timeFrame: 2 months following initiation of treatment
measure: Brief Resilience Scale
timeFrame: 5 months following initiation of treatment
measure: Acceptance and Action Questionnaire
timeFrame: Prior to initiation of treatment
measure: Acceptance and Action Questionnaire
timeFrame: 2 months following initiation of treatment
measure: Acceptance and Action Questionnaire
timeFrame: 5 months following initiation of treatment
measure: Self Efficacy
timeFrame: Prior to initiation of treatment
measure: Self Efficacy
timeFrame: 2 months following initiation of treatment
measure: Self Efficacy
timeFrame: 5 months following initiation of treatment
measure: Locus of control questionnaire
timeFrame: Prior to initiation of treatment
measure: Locus of control questionnaire
timeFrame: 2 months following initiation of treatment
measure: Locus of control questionnaire
timeFrame: 5 months following initiation of treatment
Other outcomes:
measure: Culture-specific measure of distress - Thinking too much
timeFrame: Prior to initiation of treatment
measure: Culture-specific measure of distress - Thinking too much
timeFrame: 2 months following initiation of treatment
measure: Culture-specific measure of distress - Thinking too much
timeFrame: 5 months following initiation of treatment
measure: Culture-specific measure of distress - Feelings that hurt the heart
timeFrame: Prior to initiation of treatment
measure: Culture-specific measure of distress - Feelings that hurt the heart
timeFrame: 2 months following initiation of treatment
measure: Culture-specific measure of distress - Feelings that hurt the heart
timeFrame: 5 months following initiation of treatment
measure: Culture-specific measure of well being - Heart has felt calm
timeFrame: Prior to initiation of treatment
measure: Culture-specific measure of well being - Heart has felt calm
timeFrame: 2 months following initiation of treatment
measure: Culture-specific measure of well being - Heart has felt calm
timeFrame: 5 months following initiation of treatment
Locations:
city: Dakar
country: Senegal
facility: Centre de Recherche Pour le Développement Economique et Social (CRDES)
Study officials:
affiliation: Georgetown University
name: Syed S Wahid, Doctor of Public Health
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Anne Hilger, PhD
role: PRINCIPAL_INVESTIGATOR
References: