Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health (BECOME-D)

Adapting Evidence-based Behavioral Interventions to Address Non-communicable Diseases and Common Mental Health Conditions Among People With Dementia or Mild Cognitive Impairment

This pilot study aims to adapt the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) to address the unique needs of individuals with dementia or mild cognitive impairment (PwD/MCIs) and their caregivers. Coexisting NCDs and CMDs in individuals with dementia can worsen cognitive functions, intensify neuropsychiatric symptoms, increase caregiver burden, and decrease overall quality of life. While Alzheimer's Disease and Related Dementias cannot be cured, managing these co-occurring conditions can slow disease progression and reduce caregiver stress. Our study will be focused on helping people with dementia or mild cognitive impairment (PwD/MCI) manage non-communicable diseases (NCDs) like diabetes and hypertension, and common mental disorders (CMDs) such as depression and anxiety by delivering skills-based behavioral interventions, adapted to the cognitive capacities of people with dementia and mild cognitive impairment (PwD/MCI) and the needs of their caregivers. The parent BECOME trial (NCT06449521) integrates behavioral activation, evidence-based stress reduction, and motivational interviewing to target depression, anxiety, and behavioral changes, respectively, delivered by community health workers (CHWs). This supplement seeks to tailor the BECOME manual into a dyadic intervention for people with dementia or mild cognitive impairment and their caregivers and conduct a pilot study to examine the acceptability and feasibility of the adapted intervention.

Study Overview

• Status: Completed
• Conditions: Dementia; Mental Health; Non Communicable Diseases
• Intervention / Treatment: Behavioral: BECOME-D Intervention

Detailed Description

General Objective: To adapt evidence-based behavioral interventions for people with cognitive impairment and dementia to address non-communicable diseases and common mental health conditions.

Specific Objectives:

1. To adapt BECOME intervention into dyadic format based on iterative feedback from a multidisciplinary dementia advisory board.
2. To assess the preliminary acceptability and feasibility of the adapted intervention among 5 dyads of PwD/MCIs and their caregivers, and CHW.

Research method: Mixed

Study site: The parent study, BECOME (NCT06449521), is being conducted in two municipalities of Nepal, Chandragiri and Bardibas. For this pilot study, the investigators will recruit from Chandragiri municipality only.

Study Population:

Patient participants: Individuals ≥60 year with cognitive impairment as indicated at a score of 22 or lower on RUDAS ; 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.

Care giver: Family members identified as the primary caregiver of the PwD/MCI participants

Community health workers. Community health workers who are working in Chandragiri 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 monthly salary for their service/work.

Sampling unit: Individual

Sample size:

5 dyads of PwD/MCI and their caregiver (N=10) that the investigators can provide our intervention to within the 1 year timeframe.

Community health worker =1

Sampling Technique: Purposive

Description of study design:

This is a pilot formative study to adapt an existing intervention, called BECOME for people with dementia or mild cognitive impairment (PwD/MCI).

An adapted intervention will be delivered to five dyads (PwD/MCI and their caregivers) over about 3 months. The intervention will include 7-9 in-person sessions delivered by a CHW. Qualitative and quantitative assessments will be conducted at baseline, post-intervention, and 2 months after the completion of the intervention. Qualitative data, gathered through semi-structured interviews with dyads and the CHW, will assess acceptability, safety, and feasibility of the intervention, focusing on barriers and facilitators to engagement and suggestions for improvement. Quantitative data will include outcome measures related to depression, anxiety, NCD management (diabetes and high blood pressure), quality of life, and health behaviors for PwD/MCI and caregivers. The investigators will compare data collected at baseline with information collected post intervention and 2 months after the intervention.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal
      • Possible

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For Patient participant :

• Adult men and women age: ≥60 year with cognitive impairment as indicated at a score of 22 or lower on RUDAS
• living in the target wards with no intention of leaving in the next 2.5 yrs
• anxiety (HSCL-25 anxiety subscale ≥1.75) and/or depression (HSCL-25 depression subscale ≥1.75) AND
• at least one non-communicable disease (NCD) based on WHO PEN criteria: Hypertension (HTN) (SBP ≥130 and/or DBP ≥80) and/or Diabetes Mellitus (DM) (fasting plasma glucose (FPG) ≥126mg/dl or random plasma glucose ≥200mg/dl).

For Caregiver:

• A family member identified as the primary caregiver of the PwD/MCI
• 18 years and older
• provide their consent to participate in the study.

For Community Health Worker (CHW):

• CHW working in the community health program in the identified study cluster.
• 18 years and above
• provide their consent to participate in the study

Exclusion Criteria:

For Patient Participants:

• Participants who cannot provide consent
• Participants who will score 3 or less on the 3-item questionnaire that assesses potential participants' ability to provide consent to participate in research.

For Caregiver:

- The primary caregivers who do not provide consent to participate in our study.

For Community Health Worker (CHW):

- CHWs who do not provide consent to participate in our study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single-arm intervention study

Behavioral: BECOME-D Intervention; The original BECOME intervention (NCT06449521) integrates three evidence-based components: evidence-based stress reduction (EBSR), including diaphragmatic breathing and body scan techniques recommended by WHO mhGAP guidelines; behavioral activation (BA), which promotes engagement in pleasurable and physically active behaviors to address depression; and motivational interviewing (MI), which enhances patients' intrinsic motivation to adopt and maintain healthy behaviors such as improved diet, smoking cessation, physical activity, and treatment adherence, in line with PEN protocols. Depending on co-morbidities, the intervention consists of 6-8 sessions lasting approximately 30 minutes each. The adapted BECOME-D intervention adds a psychoeducation session focused on dementia and related symptoms and extends session duration to about 45 minutes to support better comprehension, resulting in a total of 7-9 weekly sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments	For this pilot study, the investigators will create a dementia advisory board with 8-10 individuals including clinicians with expertise in dementia care (1-2), NCDs (1), and CMDs (1), at least two members who are PwD/MCI, their caregivers, and local community leaders who are involved in awareness-raining and advocacy work for PwD/MCI and their caregivers. The advisory board will meet at least monthly during the first 4 months to provide direct input and feedback to adapt the intervention. The advisory board will meet again during month 12 to discuss lessons learned from this formative study and provide suggestions to make any changes prior to future studies. The overarching goal is to adapt the BECOME interventional manual (developed under the parent R01) to meet the unique needs of people with dementia and their caregivers: making it accessible and relevant to people with cognitive challenges; and transforming the target of the intervention from a singular patient to the dyad.	The advisory board will meet at least monthly during the first 4 months to provide direct input and feedback to adapt the intervention. The advisory board will meet again during month 12 to discuss lessons learned.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and feasibility of the adapted intervention (BECOME-D)	The investigators will assess the preliminary acceptability, feasibility and safety of the adapted intervention content among PwD/MCI, their caregivers, and the CHW. The dyads will complete both qualitative and quantitative assessments at baseline, immediately after the intervention and 2 months after the intervention. The final assessments will focus on challenges and facilitators for continuing to utilize lessons learned during the intervention period.	First in baseline assessment followed by immediate post intervention assessment and then 2 months post intervention.

Collaborators and Investigators

• Sponsor: Possible
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Francisco; Ministry of Health and Population, Nepal
• Investigators: Principal Investigator: Bibhav Acharya, MD, University of California, San Francisco; Principal Investigator: Sabitri Sapkota, PhD, Possible

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Dementia; Behavioral Intervention; Non Communicable Diseases
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction; Noncommunicable Diseases; Dementia; Psychological Well-Being
• Other Study ID Numbers: BECOMESupplement; 3R01MH133231-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: In alignment with parent study (NCT06449521).
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No