Clinical trial NCT06449521: BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Disorder
Non Communicable Diseases
Keywords: Mental Health
Non communicable Diseases
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute of Mental Health (NIMH)
name: Ministry of Health and Population, Nepal
First posted: 2024-06-10
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The study will use a stepped-wedge randomized controlled trial design. Randomization process involves sequential rolling out of the intervention in four cluster every three months. Each cluster is a ward (population \~6000), which includes one CHW and at least one basic health care clinic, with regional referrals available to higher levels of care. The 20 wards will be randomly assigned (using a random number generator) to one of five steps. All clusters begin in the control condition; every three months, four clusters will transition to the intervention condition.

Note: We have not seen better option than this one in the drop down menu above.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 600 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.

Detailed description: 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 :

1. Assess the effectiveness of BECOME on depression and anxiety, and two NCDs (diabetes and hypertension) via a stepped-wedge cluster randomized trial.
2. Assess implementation outcomes of BECOME using the RE-AIM framework at the patient, provider, and health system levels
3. 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.

Research Method : mixed

Study sites : Bardibas and Chandragiri municipalities, Nepal

Specify type of Study This study is a type-II hybrid effectiveness- implementation study. The study will use a stepped-wedge randomized controlled trial design.

Study Population

Patient Participants: Individuals who are 40 years or above residing in Chandragiri and Bardibas Municipalities who have at least one NCD (hypertension and/or diabetes) and one Mental Health (depression and/or anxiety), and who give consent for the study participation.

Community health workers: Community health workers who are working in Chandragiri and Bardibas municipalities under the government pilot program following community health program guidelines 2078 endorsed by the Ministry of Health and Population. They are the community health nurses employed by municipalities. They are the trusted local member of the community who are trained and regularly supported and monitored by their supervisors. They work full-time and get a monthly salary for their service/work.

Primary care providers and health system leaders: who are working either in the health facilities of Chandragiri and Bardibas municipalities, municipal health office, and relevant stakeholders who are contributing to the community health program in different capacities.

Sampling unit

Since this is a stepped wedge cluster randomized controlled trial, we will use the cluster as our sampling unit while implementing the study.

Sample size

631 Participants; 20 CHWs; 5 Primary care providers; 6 Health system leaders

Description of study design:

The is a type-II hybrid effectiveness-implementation study design. The goal of the effectiveness aim is to evaluate the impact of the BECOME intervention against usual care while the implementation aim focuses on understanding the process of implementing the intervention in a real-world setting. Additionally, the study will conduct a comprehensive costing analysis to provide strategic inputs to support the long-term scale-up of BECOME.

The study will use a stepped-wedge cluster randomized controlled trial design. In this design, 20 clusters (wards) will be randomly assigned to one of five steps, with all clusters starting in the control phase prior to receiving the intervention. Every three months, four clusters will transition to the intervention condition, while the remaining clusters will remain in the control condition. This design allows for a gradual rollout of the intervention, which can help minimize the impact of any learning curves or logistical challenges that may arise during implementation.

The study will use an open cohort design, which means that enrollment will be kept open while the intervention is being offered. This approach helps to reflect real-world conditions and can compensate for attrition and for participants who may no longer meet the eligibility criteria when their cluster transitions to the treatment phase. By using this design, the study can capture the dynamic nature of the intervention and better understand its impact over time.

Overall, this study aims to evaluate the effectiveness and implementation of the BECOME intervention, as well as provide insights into the costs associated with implementing the intervention in a real-world setting. By using a stepped-wedge cluster randomized controlled trial design and an open cohort design, the study can capture a comprehensive picture of the intervention's impact and implementation process.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Significant cognitive problems/disability
* Pregnant women
* Postpartum (≤6 weeks) women

Primary outcomes:
measure: Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score
timeFrame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Secondary outcomes:
measure: Mean systolic blood pressure in millimeters of mercury (mmHg)
timeFrame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
measure: Mean diastolic blood pressure in millimeters of mercury (mmHg)
timeFrame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
measure: Fasting plasma glucose in milligrams per deciliter (mg/dL)
timeFrame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Possible
Study officials:
affiliation: University of California, San Francisco
name: Bibhav Acharya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Possible
name: Sabitri Sapkota Devkota, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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