Centre de Recherche Pour le Développement Economique et Social (CRDES)
Dakar, Senegal
Active, Not Recruiting
NCT Number: NCT06698471
Relief From Stress Via Social Protection 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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Key information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
- Assess feasibility of cluster randomization procedure to limit biases and risk of contamination;
- Determine recruitment and retention rates for Self-Help Plus sessions;
- Evaluate the feasibility and acceptability of intervention delivery by Self-Help Plus trained non-specialists;
- Assess the safety of an abbreviated training curriculum (during training, intervention delivery, and supervision);
- Assess feasibility and acceptability of outcome measures;
- Assess ethics and safety of trial procedures using the adverse event protocol;
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Community worker training
OtherTraining community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy
Referral to Health System
OtherReferral to Health System of Senegal
Primary outcomes
-
Engagement
Time frame: 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
Time frame: 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
Time frame: 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 outcomes
-
General Health Questionnaire-12
Time frame: Prior to initiation of treatment
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
-
General Health Questionnaire-12
Time frame: 2 months following initiation of treatment
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
-
General Health Questionnaire-12
Time frame: 5 months following initiation of treatment
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
-
Patient Health Questionnaire-9
Time frame: Prior to initiation of treatment
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
-
Patient Health Questionnaire-9
Time frame: 2 months following initiation of treatment
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
-
Patient Health Questionnaire-9
Time frame: 5 months following initiation of treatment
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
-
Generalized Anxiety Disorder-7
Time frame: Prior to initiation of treatment
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
-
Generalized Anxiety Disorder-7
Time frame: 2 months following initiation of treatment
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
-
Generalized Anxiety Disorder-7
Time frame: 5 months following initiation of treatment
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
-
Brief Resilience Scale
Time frame: Prior to initiation of treatment
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
-
Brief Resilience Scale
Time frame: 2 months following initiation of treatment
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
-
Brief Resilience Scale
Time frame: 5 months following initiation of treatment
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
-
Acceptance and Action Questionnaire
Time frame: Prior to initiation of treatment
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
-
Acceptance and Action Questionnaire
Time frame: 2 months following initiation of treatment
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
-
Acceptance and Action Questionnaire
Time frame: 5 months following initiation of treatment
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
-
Self Efficacy
Time frame: Prior to initiation of treatment
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
-
Self Efficacy
Time frame: 2 months following initiation of treatment
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
-
Self Efficacy
Time frame: 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
Time frame: Prior to initiation of treatment
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
-
Locus of control questionnaire
Time frame: 2 months following initiation of treatment
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
-
Locus of control questionnaire
Time frame: 5 months following initiation of treatment
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
Other outcomes
-
Culture-specific measure of distress - Thinking too much
Time frame: Prior to initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of distress - Thinking too much
Time frame: 2 months following initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of distress - Thinking too much
Time frame: 5 months following initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of distress - Feelings that hurt the heart
Time frame: Prior to initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of distress - Feelings that hurt the heart
Time frame: 2 months following initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of distress - Feelings that hurt the heart
Time frame: 5 months following initiation of treatment
Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being
-
Culture-specific measure of well being - Heart has felt calm
Time frame: Prior to initiation of treatment
Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being
-
Culture-specific measure of well being - Heart has felt calm
Time frame: 2 months following initiation of treatment
Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being
-
Culture-specific measure of well being - Heart has felt calm
Time frame: 5 months following initiation of treatment
Exploratory 1-item culture-specific measure of well being; Score range: 0-3; Higher score indicates better well being
Sponsors and collaborators
Lead sponsor
Georgetown University
Other
Collaborators
- Centre de Recherche Pour le Développement Economique et Social (CRDES)
- World Bank
Registry information
Official study 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.
Acronym: RESTORE
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 21, 2024
- Registry last updated
- May 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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