Mental Health DisorderBECOMENCT06449521
BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal
A study testing BECOME intervention in people with Mental Health Disorder and Non Communicable Diseases, run by Possible at 1 site in Nepal.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mental Health Disorder, Non Communicable Diseases
- What is being tested?
- BECOME intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteNepal
- Study dates
- 16 Jul 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Significant cognitive problems/disability
- Pregnant women
- Postpartum (≤6 weeks) women
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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 :
- 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.
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, investigators will use the cluster as our sampling unit while implementing the study.
Sample size
700 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.
- Conditions
- Mental Health Disorder, Non Communicable Diseases
- Being tested
- BECOME intervention
- Keywords
- Mental Health, Non communicable Diseases
- Medical subject headings
- Mental Disorders, Noncommunicable Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BECOME interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm- stepped wedge implementation | Other | 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. Receives: Behavioral: BECOME intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Secondary outcomes (3)
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.
Measured: 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)
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.
Measured: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Fasting plasma glucose in milligrams per deciliter (mg/dL)
Fasting plasma glucose will be measured by portable glucometer machine.
Measured: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start16 Jul 2024
- Primary completionJan 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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: The investigators have not seen better option than this one in the drop down menu above.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
- Responsible party
- Sponsor
- Investigators
- Bibhav Acharya, MD, Principal investigator, University of California, San FranciscoSabitri Sapkota Devkota, PhD, Principal investigator, Possible
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449521
- Sponsor's protocol ID
- BECOMEPossible
- Other IDs
- 1R01MH133231-01
- Acronym
- BECOME
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share ONLY the de identified data through NIH designated data repositories consistent with data sharing under the NIH GDS policy. The investigators will include the clinical data of those research participants who will provide consent for sharing their data.
Publications
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/
PubMed 27786430Hettema 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.
PubMed 21114344Lai 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.
PubMed 20091612Li 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.
PubMed 31973759Heckman 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.
PubMed 20675688Lundahl 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.
PubMed 24001658Sayegh 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.
PubMed 28437121Anthonisen 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.
PubMed 15710956Sigdel K, Nepal J, Shrestha A, Rai B, Yogi B, Schillinger D, Sharma D, Prajapati D, Heylen E, Niraula HK, Shrestha J, Dhimal M, Sah NK, Baral PP, Limbu P, Nepal P, Paudel P, Nepali S, Poudel S, Joshi S, Tiwari S, Shrestha S, Sapkota S, Acharya B. A type II hybrid implementation-effectiveness study of the BECOME intervention: integrating Behavioral Community-Based Approaches for Mental Health and Non-Communicable Diseases delivered by community health workers-study protocol for a stepped wedge cluster randomized controlled trial. Trials. 2026 Jan 24;27(1):142. doi: 10.1186/s13063-026-09457-1.
PubMed 41580851
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06449521
- Acronym / sponsor ID
- BECOME / BECOMEPossible
- Conditions
- Mental Health Disorder, Non Communicable Diseases
- Keywords
- Mental Health, Non communicable Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- PossibleUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- 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.
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, investigators will use the cluster as our sampling unit while implementing the study.
Sample size
700 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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: The investigators have not seen better option than this one in the drop down menu above.
| Arm | Type | Receives |
|---|---|---|
| Single arm- stepped wedge implementation | Other | Behavioral: BECOME interventionAll 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Significant cognitive problems/disability
- Pregnant women
- Postpartum (≤6 weeks) women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BECOME interventionThe 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. | Behavioural | Single arm- stepped wedge implementation |
Primary outcome
Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score
Time frame: 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.
3 secondary outcomes
Mean systolic blood pressure in millimeters of mercury (mmHg)
Time frame: 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)
Time frame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Fasting plasma glucose in milligrams per deciliter (mg/dL)
Time frame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 27786430mhGAP 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/
- Background: PubMed 21114344Hettema 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.
- Background: PubMed 20091612Lai 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.
- Background: PubMed 31973759Li 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.
- Background: PubMed 20675688Heckman 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.
- Background: PubMed 24001658Lundahl 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.
- Background: PubMed 28437121Sayegh 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.
- Background: PubMed 15710956Anthonisen 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.
- Derived from this study: PubMed 41580851Sigdel K, Nepal J, Shrestha A, Rai B, Yogi B, Schillinger D, Sharma D, Prajapati D, Heylen E, Niraula HK, Shrestha J, Dhimal M, Sah NK, Baral PP, Limbu P, Nepal P, Paudel P, Nepali S, Poudel S, Joshi S, Tiwari S, Shrestha S, Sapkota S, Acharya B. A type II hybrid implementation-effectiveness study of the BECOME intervention: integrating Behavioral Community-Based Approaches for Mental Health and Non-Communicable Diseases delivered by community health workers-study protocol for a stepped wedge cluster randomized controlled trial. Trials. 2026 Jan 24;27(1):142. doi: 10.1186/s13063-026-09457-1.
- Individual participant dataSharing planned: Yes. The investigators will share ONLY the de identified data through NIH designated data repositories consistent with data sharing under the NIH GDS policy. The investigators will include the clinical data of those research participants who will provide consent for sharing their data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bibhav Acharya, MD principal investigator
University of California, San Francisco
Sabitri Sapkota Devkota, PhD principal investigator
Possible
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BECOME intervention in people with Mental Health Disorder and Non Communicable Diseases, run by Possible at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score (time frame: First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449521, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.