NCT07424443

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 3, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 13, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Cogntive AgingHealth PromotionMindfulnessCommunity Health ServicesFeasibility StudiesAlzheimer Disease / prevention & controlExerciseDietSleepSocial InteractionCognitive StimulationSmokingAlcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • 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).

    8 Weeks

  • Client Satisfaction Questionnaire

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

    8 Weeks

Secondary Outcomes (8)

  • Credibility and Expectancy Questionnaire

    0 Weeks

  • Rates of Recruitment

    0 Weeks

  • Rate of Enrollment

    0 Weeks

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

    8 Weeks

  • Rates of Missing Outcomes Data

    8 Weeks

  • +3 more secondary outcomes

Study Arms (1)

My Healthy Brain

EXPERIMENTAL

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

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.

My Healthy Brain

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39571150BACKGROUND

MeSH Terms

Conditions

Memory DisordersSedentary BehaviorMotor ActivityRisk Reduction BehaviorAlzheimer DiseaseSmokingAlcohol Drinking

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDrinking Behavior

Central Study Contacts

My Healthy Brain Clinical Research Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single arm, open pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

March 3, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations