Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health (NCT07543341) | Clinical Trial Compass
CompletedNot Applicable
Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health
Nepal12 participantsStarted 2025-06-20
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments
Timeframe: 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.