A Type II Hybrid Implementation-effectiveness Study of BECOME (BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases) Delivered by Community Health Workers in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score
研究概览
简要总结
Common mental health disorders (CMDs) and noncommunicable diseases (NCDs) pose significant public health challenges, especially in resource-limited settings like Nepal. The coexistence of CMDs and NCDs is prevalent, tied together by shared behavioral risk factors including stress, isolation, tobacco use, low physical activity, poor diet, and treatment non-adherence. Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs. While the World Health Organization (WHO) recommends three behavioral interventions-evidence-based stress reduction (EBSR) for stress and anxiety, behavioral activation (BA) for depression, and motivational interviewing (MI) for healthy behaviors-availability remains scarce in low-resource settings.
This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) in Nepal. BECOME, delivered by community health workers (CHWs), integrates EBSR, BA, and MI to improve mental health and address NCDs. The study employs a stepped-wedge cluster randomized trial, with 20 clusters randomly assigned to five steps, starting in the control condition. Transitioning every three months, clusters gradually adopt the intervention, minimizing logistical challenges during implementation.
The study targets 700 patient participants (age 40 years and above with at least one CMD and NCD) from Bardibas and Chandragiri municipalities, involving 20 CHWs, five primary care providers (PCPs), and six health system leaders. CHWs identify potential participants, with research staff assessing eligibility, obtaining informed consent, and conducting baseline assessments using a digital REDCap tool. CHWs undergo BECOME intervention training, delivering it to consenting patient participants (30 per CHW). Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs. Additionally, qualitative components, following the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework, include focus group discussions (FGDs) with CHWs and Key Informant Interviews (KIIs) with patient participants, PCPs, and health system leaders to assess implementation mechanisms, outcomes, and clinical impact.
The study, if successful, aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs.
详细描述
General Objective :
To evaluate the effectiveness and implementation of a program called BECOME on depression and/or anxiety, and two NCDs using a stepped-wedge cluster randomized trial (SWCRT) and the RE-AIM framework.
Specific Objective :
- Assess the effectiveness of BECOME on depression and anxiety, and two NCDs (diabetes and hypertension) via a stepped-wedge cluster randomized trial.
- Assess implementation outcomes of BECOME using the RE-AIM framework at the patient, provider, and health system levels
- Conduct a comprehensive costing analysis to provide strategic inputs to support long-term scale up of BECOME.
Study Variables Dependent variable; Primary outcome: depression and anxiety severity, Secondary outcome: Diabetes (as measured by fasting plasma glucose) and hypertension (as measured by systolic and diastolic blood pressure) Independent variable; Demographics (for example, age, sex) Stress, Isolation and withdrawal, Quality of Life, Tobacco Use, Diet Quality, Physical activity, Medication and follow up adherence, Environmental factors- access to care (community-based and higher intensity clinical care), social support, life style.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is a stepped wedge cluster randomized controlled trial. Since participants will receive routine care when they are not receiving the BECOME intervention (which the investigators will randomly allocate using a stepped wedge fashion), the investigators will blind outcome assessors for the follow-up assessment every three months until 12 months of follow up post intervention.
But, it's important to note that our response to masking outcome assessors cannot be recorded in above option.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women age ≥ 40 years
- •Living in the target wards with no intention of leaving in the next 2.5 yrs
- •Anxiety (HSCL-25 anxiety subscale score ≥1.75) and/or Depression (HSCL-25 depression subscale score ≥1.75)
- •At least one Non-communicable disease (NCD) based on WHO PEN criteria; either Hypertension (HTN) (SBP ≥130mmHg and/or DBP ≥80mmHg) and/or Diabetes Mellitus (DM) (fasting plasma glucose (FPG) ≥126mg/dl or random plasma glucose ≥200mg/dl)
排除标准
- •Significant cognitive problems/disability
- •Pregnant women
- •Postpartum (≤6 weeks) women
研究组 & 干预措施
Single arm- stepped wedge implementation
All participants enrolled in the study will receive intervention in a stepped wedge fashion. This means that every three months, four clusters will transition to the intervention phase until all clusters (a total of 20) in the study have received intervention. Participants will receive routine usual care when their clusters are in the control phase. This includes the Government of Nepal's (GoN) current protocols at the home/community level. CHWs will monitor for CMD and NCD symptoms and red flags every three months, provide health education, and refer individuals to health facilities.
干预措施: BECOME intervention (Behavioral)
结局指标
主要结局
Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score
时间窗: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
The Hopkins Symptom Checklist-25 is a measure of symptoms of anxiety and depression. This instrument consists of two different subscales; one for anxiety symptoms and the other for depression. The scale for each question includes four response categories ("Not at all," "A little," "Quite a bit," and "Extremely," rated 1 to 4, respectively). The scores range from 1 to 4. Higher score shows higher severity of anxiety and depression symptoms.
次要结局
- Fasting plasma glucose in milligrams per deciliter (mg/dL)(First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.)
- Mean diastolic blood pressure in millimeters of mercury (mmHg)(First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.)
- Mean systolic blood pressure in millimeters of mercury (mmHg)(First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.)