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| Name | Class |
|---|---|
| World Bank | OTHER |
| Centre de Recherche Pour le Développement Economique et Social (CRDES) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | Treatment as usual from Health System in Senegal |
|
| Relief from Stress via Social Protection in Senegal | Experimental | Training community workers in Self Help Plus intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community worker training | Other | Training community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy |
|
| 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 |
| 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 |
| General Health Questionnaire-12 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed S Wahid, Doctor of Public Health | Georgetown University | Principal Investigator |
| Anne Hilger, PhD | World Bank | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche Pour le Développement Economique et Social (CRDES) | Dakar | Senegal |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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Cluster randomized controlled trial
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Participants and outcome assessors are masked to study arm
| Referral to Health System | Other | Referral to Health System of Senegal |
|
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 | Prior to 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 | Prior to 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 | Prior to 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 | Prior to 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 | Prior to 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 | 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 | 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 |
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 |