A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial.
Ryan A Mace, Makenna E Law, Joshua E Cohen...
https://pubmed.ncbi.nlm.nih.gov/39571150Actively Recruiting
Phase Not Applicable
Age: 50Years +
All Genders
ID07424443
Prevention Starts Here: Piloting My Healthy Brain in Massachusetts Councils on Aging
Led by Massachusetts General Hospital · Updated on 2026-02-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
M
Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a brain health program designed for older adults who experience subjective cognitive decline, such as memory or thinking changes. This pilot study aims to assess how credible, acceptable, and feasible the program is when delivered in senior centers. The focus is on reducing lifestyle risk factors linked to dementia by promoting healthy behaviors. The program, called My Healthy Brain, is an 8-week group intervention with weekly 90-minute sessions led by a clinical psychologist or trainee. Each session covers topics related to brain health, including physical activity, sleep, diet, mental and social stimulation, alcohol use, and smoking. Participants also wear an activity watch to monitor lifestyle changes throughout the program. Participants will be involved in weekly sessions and wear the activity watch to support behavior tracking. Researchers will measure how many complete the program and their satisfaction with it. Other assessments include recruitment rates, adherence to procedures, and any adverse events. The study also evaluates participants' impressions of change after the 8 weeks, with all activities conducted in English.
CONDITIONS
Brief Title
Pilot Study of a Brain Health Program in Senior Centers
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 50 or older
- Self-reported subjective cognitive decline, such as forgetting information or getting lost
- Able to identify at least one lifestyle risk factor for dementia to change (e.g., inactivity, poor sleep, diet, alcohol, smoking, social isolation, mental inactivity)
- No significant cognitive impairment (Short Blessed Test score 9 or less)
- Proficient in English and able to read and understand it
- Willing and able to participate and complete all study activities
You will not qualify if you...
- Diagnosis or self-report of dementia or other neurodegenerative diseases
- Psychosis, uncontrolled schizophrenia, schizoaffective disorder, bipolar disorder, or substance dependence/abuse
- Active suicidal thoughts or high suicide risk
- Serious medical illness expected to worsen during the study
- Safety concerns about starting lifestyle changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 8 weeks
Participants attend an 8-week group program with weekly 90-minute sessions led by a clinical psychologist or trainee focusing on brain health and lifestyle changes. Participants wear an activity watch to support and monitor lifestyle changes during the program.
Weekly visits for 8 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
M
My Healthy Brain Clinical Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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