Pilot Study of a Brain Health Program in Senior Centers

February 13, 2026 updated by: Ryan A., Mace, PHD, Massachusetts General Hospital

Prevention Starts Here: Piloting My Healthy Brain in Massachusetts Councils on Aging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Treatment Completion
Time Frame: 8 Weeks
We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).
8 Weeks
Client Satisfaction Questionnaire
Time Frame: 8 Weeks
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Missing Outcomes Data
Time Frame: 8 Weeks
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).
8 Weeks
Rates of Valid Activity Watch Data (10 or more hours of wear time)
Time Frame: 8 Weeks
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).
8 Weeks
Credibility and Expectancy Questionnaire
Time Frame: 0 Weeks
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)
0 Weeks
Rates of Recruitment
Time Frame: 0 Weeks
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).
0 Weeks
Rate of Enrollment
Time Frame: 0 Weeks
Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent)
0 Weeks
Rates of Staff Fidelity to Study Procedures
Time Frame: 8 Weeks
We will collect and report the number of protocol deviations.
8 Weeks
Rate of Adverse Events
Time Frame: 8 Weeks
We will collect and report participant's self-reported adverse events.
8 Weeks
Modified Patient Global Impression of Change
Time Frame: 8 Weeks
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).
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P002540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lifestyle Risk Reduction

Clinical Trials on My Healthy Brain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe