Clinical Trial

Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health

Study acronym: BECOME-D
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-15.
Trial Details
NCT Number NCT07543341
Lead Sponsor Possible
Collaborators: University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
Conditions Mental Health, Non Communicable Diseases, Dementia
Enrollment 12 participants
Start Date 2025-06-20
Primary Completion 2025-11-10 (estimated)
Study Completion 2025-11-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-24