Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health

NCT07543341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Ministry of Health and Population, Nepal

    collaborator OTHER_GOV
  • Possible

    lead OTHER

Principal Investigators

  • Bibhav Acharya, MD · University of California, San Francisco

  • Sabitri Sapkota, PhD · Possible

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2025-11-10
Completion
2025-11-10

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543341 on ClinicalTrials.gov