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Active, Not Recruiting

NCT Number: NCT07424443

Pilot Study of a Brain Health Program in Senior Centers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Memory Loss (Excluding Dementia) Alcohol Drinking Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Dementia Prevention Drinking Behavior Healthy Lifestyle Behaviors Lifestyle (Sedentary Behavior and Physical Activity) Lifestyle Risk Reduction Memory Disorders Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Risk Reduction Behavior Sedentary Behavior Signs and Symptoms Smoking Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Healthy Brain

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. 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)

  2. 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).

  3. 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)

  4. 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).

  5. 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).

  6. Rates of Staff Fidelity to Study Procedures

    Time frame: 8 Weeks

    We will collect and report the number of protocol deviations.

  7. Rate of Adverse Events

    Time frame: 8 Weeks

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

  8. 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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