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Active, not recruitingNCT07424443Updated Jun 15, 2026

Pilot Study of a Brain Health Program in Senior Centers

An interventional study of My Healthy Brain in Memory Loss (Excluding Dementia), Lifestyle (Sedentary Behavior and Physical Activity) and Lifestyle Risk Reduction, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.

Read the detailed description

The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot trial of a mindfulness-based lifestyle programs. Eligible older adults include: age ≥ 50, self-reported worry about changes in memory or thinking, and self-reported interest in improving lifestyle behaviors. Participants complete 8 weekly 90-minute sessions delivered by a clinical psychologist or trainee. All participants will wear an activity watch to support and monitor lifestyle changes during the program. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program, delivered in senior centers.

02

Conditions studied

  • Memory Loss (Excluding Dementia)
  • Lifestyle (Sedentary Behavior and Physical Activity)
  • Lifestyle Risk Reduction
  • Healthy Lifestyle Behaviors
  • Dementia Prevention

Keywords

  • Cogntive Aging
  • Health Promotion
  • Mindfulness
  • Community Health Services
  • Feasibility Studies
  • Alzheimer Disease / prevention & control
  • Exercise
  • Diet
  • Sleep
  • Social Interaction
  • Cognitive Stimulation
  • Smoking
  • Alcohol Drinking
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥ 50
  • Subjective cognitive decline (SCD; e.g., forgetting information, getting lost, and repeating oneself)
  • Able to self-identify at least 1 modifiable lifestyle risk factors for dementia to change during the program (physically inactive, poor sleep, non-adherence to Mediterranean diet, alcohol use, tobacco use, socially isolated or lonely, mental inactivity)
  • Absence of significant cognitive impairment (assessed using Short Blessed Test71 ≤ 9)
  • Self-reported English proficiency/literacy
  • Ability and willingness to participate and complete all study-related activities

Exclusion criteria

Exclusion Criteria:

  • Dementia or other neurodegenerative disease per patient self-report or disclosure
  • Psychosis, uncontrolled schizophrenia or schizoaffective disorder, uncontrolled bipolar disorder, or uncontrolled substance dependence/abuse
  • Active self-report of suicidal ideation / high risk of suicide
  • Serious medical illness expected to worsen during the study
  • Self-reported safety issues with initiating lifestyle change
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    My Healthy Brain

    My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist or trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program.

    Behavioral: My Healthy Brain

Interventions

  • BehavioralMy Healthy Brain

    My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist pr trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program.

05

What researchers measure

Primary outcomes

  1. Rates of Treatment Completion

    We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).

    Time frame: 8 Weeks

  2. Client Satisfaction Questionnaire

    Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)

    Time frame: 8 Weeks

Secondary outcomes

  1. Credibility and Expectancy Questionnaire

    Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy (≥70% good, ≥ 80% excellent)

    Time frame: 0 Weeks

  2. Rates of Recruitment

    We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to screen divided by the total number contacted (≥70% good, ≥ 80% excellent).

    Time frame: 0 Weeks

  3. Rate of Enrollment

    Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent)

    Time frame: 0 Weeks

  4. Rates of Valid Activity Watch Data (10 or more hours of wear time)

    We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).

    Time frame: 8 Weeks

  5. Rates of Missing Outcomes Data

    We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent).

    Time frame: 8 Weeks

  6. Rates of Staff Fidelity to Study Procedures

    We will collect and report the number of protocol deviations.

    Time frame: 8 Weeks

  7. Rate of Adverse Events

    We will collect and report participant's self-reported adverse events.

    Time frame: 8 Weeks

  8. Modified Patient Global Impression of Change

    The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved).

    Time frame: 8 Weeks

06

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
07

References and documents

Publications

  • Mace RA, Law ME, Cohen JE, Ritchie CS, Okereke OI, Hoeppner BB, Brewer JA, Bartels SJ, Vranceanu AM; My Healthy Brain Team. A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149. PubMed 39571150 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07424443
Lead sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.
Responsible party
Ryan A., Mace, PHD (Assistant Professor of Psychology, Massachusetts General Hospital) — Principal investigator
First posted
Feb 20, 2026
Start date
Jan 6, 2026
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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