IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- Effectiveness coverage
研究概览
简要总结
The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(A) Contact Coverage Outcome
- •Inclusion Criteria
- •Adults (>18 years)
- •Residing in the clusters included in the trial
- •Speak English or one of the local languages (Konkani, Marathi, Hindi)
排除标准
- •Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
- •Patients who present to the health centre for emergency medical attention
- •Patients with active psychotic symptoms
- •(B) Effectiveness Coverage Outcome
- •Inclusion Criteria
- •Adults (>18 years);
- •Residing in the clusters included in the trial
- •Speak English or one of the local languages (Konkani, Marathi, Hindi).
- •Screen positive for moderately severe or severe depression (total score >14) on the Patient Health Questionnaire-9 items (PHQ-9)
- •Exclusion Criteria
- •Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
- •Patients who present to the health centre for emergency medical attention
- •Patients with active psychotic symptoms
研究组 & 干预措施
Community Model
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
干预措施: Community Intervention (Behavioral)
Community Model
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
干预措施: Healthy Activity Program (HAP) (Behavioral)
Facility Model
The HAP, a manualized and evidence-based psychological treatment based on behavioural activation, will be delivered by existing healthcare workers (called counsellors from here onwards) within the health centres who will be trained to deliver the HAP.
干预措施: Healthy Activity Program (HAP) (Behavioral)
结局指标
主要结局
Effectiveness coverage
时间窗: Three months post recruitment
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Contact coverage
时间窗: During recruitment
Patient Health Questionnaire 9 items (PHQ-9) score \>4. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
次要结局
- Sustained effectiveness(Six months post recruitment)
- Client Service Receipt Inventory(3- and 6- months post recruitment)
- Remission(Six months post recruitment)
- Response to treatment(Six months post recruitment)
- WHO Disability Assessment Schedule (WHODAS 2.0)(Baseline, 3- and 6- months post recruitment)
- Survey form for collecting costs of receiving HAP intervention to patients(3 months post recruitment)
- Inventory form for collecting system-level economic costs of delivering interventions(Monthly, through study completion up to approximately 12 months)
- Depression awareness(Baseline, 6, 12 and 18 months of implementation)
- Perceived social support(3- and 6- months post recruitment)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline, 3- and 6-months post-recruitment)
- Treatment completion(Across 12 months of implementation)
- Behavioral activation(Baseline, 3- and 6- months post recruitment.)