BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal

Mental Health Disorder Clinical Trial

— BECOME  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449521
• Other study ID #: BECOMEPossible
• Secondary ID: 1R01MH133231-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: April 2028

Study information

• Verified date: June 2024
• Source: Possible
• Contact: Bibhav Acharya, MD
• Phone: +1 917 653 9385
• Email: Bibhav.Acharya[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Non Communicable Diseases
• Noncommunicable Diseases

Intervention

Behavioral:
• BECOME intervention
The intervention, BECOME, includes: a) Evidence-based stress reduction (EBSR): as recommended in the WHO mhGAP guidelines, diaphragmatic breathing and body scan will be used to manage stress and anxiety. b) Behavioral activation (BA): as recommended in the mhGAP guidelines, this evidence-based strategy will increase the time that patients spend engaging in pleasurable activities to both treat depression and increase physical activity, depending on their cognitive and physical capabilities (e.g., going to a neighbor's house for tea or walking to the local market). c) Motivational interviewing (MI): an evidence-based patient-interaction strategy that increases the patient's internal motivation to engage in healthy behaviors (e.g., quit tobacco) both to prompt change (if they are not engaging in healthy behaviors) and maintain them (if they are already engaged in healthy behaviors), as recommended by Package of Essential Noncommunicable disease interventions) PEN protocols.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Possible	Ministry of Health and Population, Nepal, National Institute of Mental Health (NIMH), University of California, San Francisco

References & Publications (8)

Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005. — View Citation

Heckman CJ, Egleston BL, Hofmann MT. Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control. 2010 Oct;19(5):410-6. doi: 10.1136/tc.2009.033175. Epub 2010 Jul 30. — View Citation

Hettema JE, Hendricks PS. Motivational interviewing for smoking cessation: a meta-analytic review. J Consult Clin Psychol. 2010 Dec;78(6):868-84. doi: 10.1037/a0021498. — View Citation

Lai DT, Cahill K, Qin Y, Tang JL. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006936. doi: 10.1002/14651858.CD006936.pub2. — View Citation

Li Z, Chen Q, Yan J, Liang W, Wong WCW. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res. 2020 Jan 23;20(1):57. doi: 10.1186/s12913-019-4776-8. — View Citation

Lundahl B, Moleni T, Burke BL, Butters R, Tollefson D, Butler C, Rollnick S. Motivational interviewing in medical care settings: a systematic review and meta-analysis of randomized controlled trials. Patient Educ Couns. 2013 Nov;93(2):157-68. doi: 10.1016/j.pec.2013.07.012. Epub 2013 Aug 1. — View Citation

mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/ — View Citation

Sayegh CS, Huey SJ, Zara EJ, Jhaveri K. Follow-up treatment effects of contingency management and motivational interviewing on substance use: A meta-analysis. Psychol Addict Behav. 2017 Jun;31(4):403-414. doi: 10.1037/adb0000277. Epub 2017 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score	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.	First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Secondary	Mean systolic blood pressure in millimeters of mercury (mmHg)	The two consecutive measurements of systolic blood pressure (SBP) measured at the interval of 3 minutes will be used to calculate the mean systolic blood pressure. Portable digital blood pressure machine will be used for the measurement.	First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Secondary	Mean diastolic blood pressure in millimeters of mercury (mmHg)	The two consecutive measurements of diastolic blood pressure (DBP) measured at the interval of 3 minutes will be used to calculate the mean diastolic blood pressure. Portable digital blood pressure machine will be used for the measurement.	First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Secondary	Fasting plasma glucose in milligrams per deciliter (mg/dL)	Fasting plasma glucose will be measured by portable glucometer machine.	First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.