Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health

NCT07543341 | Completed DMC

• 2 other identifiers: BECOMESupplement3R01MH133231-02S1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Non Communicable Diseases; Dementia

Keywords

Dementia; Mental Health; Non Communicable Diseases; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability and feasibility of the adapted intervention (BECOME-D)

  First in baseline assessment followed by immediate post intervention assessment and then 2 months post intervention.

Study Arms (1)

Single-arm intervention study

OTHER

Behavioral: BECOME-D Intervention

Interventions

BECOME-D Intervention BEHAVIORAL

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.

Single-arm intervention study

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• years and above
• provide their consent to participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Possible: lead
• University of California, San Francisco: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health and Population, Nepal: collaborator

Study Sites (1)

Possible

Kathmandu, Bagmati, Nepal

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psychological Well-Being; Noncommunicable Diseases; Dementia

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bibhav Acharya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sabitri Sapkota, PhD

  Possible

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: June 20, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: In alignment with parent study (NCT06449521).
• 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.

Locations

NE (1)