BECOME-D Intervention Pilot for Dementia, NCDs, Mental Health
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov has registered a new pilot study (NCT07543341) evaluating the BECOME-D behavioral intervention adapted for individuals with dementia or mild cognitive impairment and their caregivers. The study targets co-occurring noncommunicable diseases (diabetes, hypertension) and common mental disorders (depression, anxiety) using community health worker-delivered skills-based training adapted to cognitive capacities. This is a research study registration with no compliance obligations for external parties.
What changed
This ClinicalTrials.gov registration documents a new pilot study rather than imposing regulatory obligations. The BECOME-D intervention adapts the parent BECOME trial (NCT06449521) into a dyadic format for people with dementia or mild cognitive impairment and their caregivers, delivered by community health workers. Healthcare providers and researchers interested in dementia care, behavioral interventions, or community health worker models may wish to monitor this study for future evidence on NCD and mental health management in cognitively impaired populations. No compliance deadlines or penalties are associated with this study registration.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health
N/A NCT07543341 Kind: NA Apr 21, 2026
Abstract
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 feas...
Conditions: Mental Health, Non Communicable Diseases, Dementia
Interventions: BECOME-D Intervention
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