Depression - Major Depressive Disorder, Distress, Psychological, Generalized Anxiety Disorder (GAD)
Conditions
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;
Interventions
OTHERCommunity worker training
Training community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy
OTHERReferral to Health System
Referral to Health System of Senegal
Sponsors
World Bank
Centre de Recherche Pour le Développement Economique et Social (CRDES)
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors are masked to study arm
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 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 | 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% |
| Engagement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 | Prior to initiation of treatment | Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms |
| Acceptance and Action Questionnaire | Prior to initiation of treatment | Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility |
| Self Efficacy | Prior to initiation of treatment | Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy |
| Locus of control questionnaire | Prior to initiation of treatment | Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control |
| Brief Resilience Scale | Prior to initiation of treatment | Brief resilience measure. Score range: 0-30; Higher score indicates better resilience |
| General Health Questionnaire-12 | Prior to initiation of treatment | Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being |
| Patient Health Questionnaire-9 | Prior to initiation of treatment | Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Culture-specific measure of distress - Thinking too much | 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 well being - Heart has felt calm | 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 distress - Feelings that hurt the heart | Prior to initiation of treatment | Exploratory 1-item culture-specific measure of distress; Score range: 0-5; Higher score indicates worse psychological well-being |
Countries
Senegal
Outcome results
None listed