An interventional study of Community worker training and Referral to Health System in Distress, Psychological, Depression - Major Depressive Disorder and Generalized Anxiety Disorder (GAD), sponsored by Georgetown University. Active, not recruiting at 1 site in Senegal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Georgetown University · Not applicable, Interventional, and Treatment
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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Treatment as usual from Health System in Senegal
Other: Referral to Health System
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
Referral to Health System of Senegal
Engagement
Of those who were offered the intervention, at least 25% attended one or more sessions.
Time frame: 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
Time frame: 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%
Time frame: From enrollment to the end of treatment at 5 weeks
General Health Questionnaire-12
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
Time frame: 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
Time frame: 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
Time frame: 5 months following initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Time frame: Prior to initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Time frame: 2 months following initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Time frame: 5 months following initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Time frame: Prior to initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Time frame: 2 months following initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Time frame: 5 months following initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Time frame: Prior to initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Time frame: 2 months following initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Time frame: 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
Time frame: Prior to initiation of treatment
Acceptance and Action Questionnaire
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
Time frame: 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
Time frame: 5 months following initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Time frame: Prior to initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Time frame: 2 months following initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 months following initiation of treatment
Plan to share: Undecided
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