Mental HealthBECOME-DNCT07543341
Adapting Behavioral Interventions for Dementia to Address NCDs and Mental Health
A study testing BECOME-D Intervention in people with Mental Health and Non Communicable Diseases, run by Possible at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mental Health, Non Communicable Diseases, Dementia
- What is being tested?
- BECOME-D Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNepal
- Study dates
- 24 Jun 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting Evidence-based Behavioral Interventions to Address Non-communicable Diseases and Common Mental Health Conditions Among People With Dementia or Mild Cognitive Impairment
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.
Read the detailed description
General Objective: To adapt evidence-based behavioral interventions for people with cognitive impairment and dementia to address non-communicable diseases and common mental health conditions.
Specific Objectives:
- To adapt BECOME intervention into dyadic format based on iterative feedback from a multidisciplinary dementia advisory board.
- To assess the preliminary acceptability and feasibility of the adapted intervention among 5 dyads of PwD/MCIs and their caregivers, and CHW.
Research method: Mixed
Study site: The parent study, BECOME (NCT06449521), is being conducted in two municipalities of Nepal, Chandragiri and Bardibas. For this pilot study, the investigators will recruit from Chandragiri municipality only.
Study Population:
Patient participants: Individuals ≥60 year with cognitive impairment as indicated at a score of 22 or lower on RUDAS ; residing in Chandragiri and Bardibas Municipalities who have at least one NCD (hypertension and/or diabetes) and one Mental Health (depression and/or anxiety), and who give consent for the study participation.
Care giver: Family members identified as the primary caregiver of the PwD/MCI participants
Community health workers. Community health workers who are working in Chandragiri municipalities under the government pilot program following community health program guidelines 2078 endorsed by the Ministry of Health and Population. They are the community health nurses employed by municipalities. They are the trusted local member of the community who are trained and regularly supported and monitored by their supervisors. They work full-time and get monthly salary for their service/work.
Sampling unit: Individual
Sample size:
5 dyads of PwD/MCI and their caregiver (N=10) that the investigators can provide our intervention to within the 1 year timeframe.
Community health worker =1
Sampling Technique: Purposive
Description of study design:
This is a pilot formative study to adapt an existing intervention, called BECOME for people with dementia or mild cognitive impairment (PwD/MCI).
An adapted intervention will be delivered to five dyads (PwD/MCI and their caregivers) over about 3 months. The intervention will include 7-9 in-person sessions delivered by a CHW. Qualitative and quantitative assessments will be conducted at baseline, post-intervention, and 2 months after the completion of the intervention. Qualitative data, gathered through semi-structured interviews with dyads and the CHW, will assess acceptability, safety, and feasibility of the intervention, focusing on barriers and facilitators to engagement and suggestions for improvement. Quantitative data will include outcome measures related to depression, anxiety, NCD management (diabetes and high blood pressure), quality of life, and health behaviors for PwD/MCI and caregivers. The investigators will compare data collected at baseline with information collected post intervention and 2 months after the intervention.
- Conditions
- Mental Health, Non Communicable Diseases, Dementia
- Being tested
- BECOME-D Intervention
- Keywords
- Dementia, Mental Health, Non Communicable Diseases, Behavioral Intervention
- Medical subject headings
- Psychological Well-Being, Noncommunicable Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BECOME-D InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm intervention study | Other | Not described Receives: Behavioral: BECOME-D Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments
For this pilot study, the investigators will create a dementia advisory board with 8-10 individuals including clinicians with expertise in dementia care (1-2), NCDs (1), and CMDs (1), at least two members who are PwD/MCI, their caregivers, and local community leaders who are involved in awareness-raining and advocacy work for PwD/MCI and their caregivers. 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 from this formative study and provide suggestions to make any changes prior to future studies. The overarching goal is to adapt the BECOME interventional manual (developed under the parent R01) to meet the unique needs of people with dementia and their caregivers: making it accessible and relevant to people with cognitive challenges; and transforming the target of the intervention from a singular patient to the dyad.
Measured: 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.
Secondary outcomes (1)
Acceptability and feasibility of the adapted intervention (BECOME-D)
The investigators will assess the preliminary acceptability, feasibility and safety of the adapted intervention content among PwD/MCI, their caregivers, and the CHW. The dyads will complete both qualitative and quantitative assessments at baseline, immediately after the intervention and 2 months after the intervention. The final assessments will focus on challenges and facilitators for continuing to utilize lessons learned during the intervention period.
Measured: First in baseline assessment followed by immediate post intervention assessment and then 2 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start24 Jun 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
- Responsible party
- Sponsor
- Investigators
- Bibhav Acharya, MD, Principal investigator, University of California, San FranciscoSabitri Sapkota, PhD, Principal investigator, Possible
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543341
- Sponsor's protocol ID
- BECOMESupplement
- Other IDs
- 3R01MH133231-02S1
- Acronym
- BECOME-D
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share ONLY the de identified data through NIH designated data repositories consistent with data sharing under the NIH GDS policy. The investigators will include the clinical data of those research participants who will provide consent for sharing their data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Evidence-based Behavioral Interventions to Address Non-communicable Diseases and Common Mental Health Conditions Among People With Dementia or Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07543341
- Acronym / sponsor ID
- BECOME-D / BECOMESupplement
- Conditions
- Mental Health, Non Communicable Diseases, Dementia
- Keywords
- Dementia, Mental Health, Non Communicable Diseases, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PossibleUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General Objective: To adapt evidence-based behavioral interventions for people with cognitive impairment and dementia to address non-communicable diseases and common mental health conditions.
Specific Objectives:
- To adapt BECOME intervention into dyadic format based on iterative feedback from a multidisciplinary dementia advisory board.
- To assess the preliminary acceptability and feasibility of the adapted intervention among 5 dyads of PwD/MCIs and their caregivers, and CHW.
Research method: Mixed
Study site: The parent study, BECOME (NCT06449521), is being conducted in two municipalities of Nepal, Chandragiri and Bardibas. For this pilot study, the investigators will recruit from Chandragiri municipality only.
Study Population:
Patient participants: Individuals ≥60 year with cognitive impairment as indicated at a score of 22 or lower on RUDAS ; residing in Chandragiri and Bardibas Municipalities who have at least one NCD (hypertension and/or diabetes) and one Mental Health (depression and/or anxiety), and who give consent for the study participation.
Care giver: Family members identified as the primary caregiver of the PwD/MCI participants
Community health workers. Community health workers who are working in Chandragiri municipalities under the government pilot program following community health program guidelines 2078 endorsed by the Ministry of Health and Population. They are the community health nurses employed by municipalities. They are the trusted local member of the community who are trained and regularly supported and monitored by their supervisors. They work full-time and get monthly salary for their service/work.
Sampling unit: Individual
Sample size:
5 dyads of PwD/MCI and their caregiver (N=10) that the investigators can provide our intervention to within the 1 year timeframe.
Community health worker =1
Sampling Technique: Purposive
Description of study design:
This is a pilot formative study to adapt an existing intervention, called BECOME for people with dementia or mild cognitive impairment (PwD/MCI).
An adapted intervention will be delivered to five dyads (PwD/MCI and their caregivers) over about 3 months. The intervention will include 7-9 in-person sessions delivered by a CHW. Qualitative and quantitative assessments will be conducted at baseline, post-intervention, and 2 months after the completion of the intervention. Qualitative data, gathered through semi-structured interviews with dyads and the CHW, will assess acceptability, safety, and feasibility of the intervention, focusing on barriers and facilitators to engagement and suggestions for improvement. Quantitative data will include outcome measures related to depression, anxiety, NCD management (diabetes and high blood pressure), quality of life, and health behaviors for PwD/MCI and caregivers. The investigators will compare data collected at baseline with information collected post intervention and 2 months after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm intervention study | Other | Behavioral: BECOME-D Intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- A family member identified as the primary caregiver of the PwD/MCI
Key exclusion criteria (7 listed)
- 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.
- The primary caregivers who do not provide consent to participate in our study.
- CHWs who do not provide consent to participate in our study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BECOME-D InterventionThe 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. | Behavioural | Single-arm intervention study |
Primary outcome
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments
Time frame: 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.
For this pilot study, the investigators will create a dementia advisory board with 8-10 individuals including clinicians with expertise in dementia care (1-2), NCDs (1), and CMDs (1), at least two members who are PwD/MCI, their caregivers, and local community leaders who are involved in awareness-raining and advocacy work for PwD/MCI and their caregivers. 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 from this formative study and provide suggestions to make any changes prior to future studies. The overarching goal is to adapt the BECOME interventional manual (developed under the parent R01) to meet the unique needs of people with dementia and their caregivers: making it accessible and relevant to people with cognitive challenges; and transforming the target of the intervention from a singular patient to the dyad.
1 secondary outcome
Acceptability and feasibility of the adapted intervention (BECOME-D)
Time frame: First in baseline assessment followed by immediate post intervention assessment and then 2 months post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will share ONLY the de identified data through NIH designated data repositories consistent with data sharing under the NIH GDS policy. The investigators will include the clinical data of those research participants who will provide consent for sharing their data.
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bibhav Acharya, MD principal investigator
University of California, San Francisco
Sabitri Sapkota, PhD principal investigator
Possible
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BECOME-D Intervention in people with Mental Health and Non Communicable Diseases, run by Possible at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.