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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- Engagement
研究概览
简要总结
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.
详细描述
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;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are masked to study arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community Worker facilitators of the intervention:
- •Patients: Enrolled in the World Bank Social Protection Programme
排除标准
- •Community Worker facilitators of the intervention
- •Patients: Persons with a severe mental disorder or suicidality
结局指标
主要结局
Engagement
时间窗: 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
时间窗: 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
时间窗: 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%
次要结局
- Patient Health Questionnaire-9(5 months following initiation of treatment)
- Acceptance and Action Questionnaire(5 months following initiation of treatment)
- Self Efficacy(5 months following initiation of treatment)
- Locus of control questionnaire(5 months following initiation of treatment)
- General Health Questionnaire-12(5 months following initiation of treatment)
- Generalized Anxiety Disorder-7(5 months following initiation of treatment)
- Brief Resilience Scale(5 months following initiation of treatment)