Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07543341

Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health

Conditions: Mental Health, Non Communicable Diseases, Dementia

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Possible

Location: Possible Kathmandu Bagmati

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07543341). StuddyBuddy aggregates publicly available trial information.