An interventional study of My Healthy Brain 1 and My Healthy Brain 2 in Memory Loss (Excluding Dementia), Healthy Lifestyle and Risk Reduction Behavior, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.
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 randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. 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 programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.
Exclusion Criteria:
My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. 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 1 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 1 participants wear an activity watch to monitor lifestyle changes during the program.
Behavioral: My Healthy Brain 1
My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.
Behavioral: My Healthy Brain 2
My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. 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 1 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 1 participants wear an activity watch to monitor lifestyle changes during the program.
My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.
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.
Time frame: 0 Weeks
Client Satisfaction Questionnaire
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
Time frame: 8 Weeks
Rates of Recruitment and Enrollment
We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to participate divided by the total number contacted (≥70% good, ≥ 80% excellent).
Time frame: 0 Weeks
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
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
Rates of Ecological Momentary Assessment (EMA) Data
We will assess the feasibility of collecting ecological momentary assessment (EMA) of daily mindfulness practice by calculating the proportion of participants who complete at least 5 out of 7 daily surveys per week (≥ 70% good, ≥ 80% excellent).
Time frame: 8 Weeks
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
Rates of Therapist Fidelity to Intervention Procedures
We will assess the fidelity of therapists to the intervention procedures by calculating the proportion of sessions with completed audio recordings, progress notes, and checklist with 100% of content delivered divided by the total number of sessions (≥ 75% good, 100% excellent).
Time frame: 8 Weeks
Rates of Staff Fidelity to Study Procedures
We will assess the fidelity of staff to the study procedures by counting the frequency of protocol deviations (\<5 deviations good, 0 deviations excellent).
Time frame: 8 Weeks
Modified Patient Global Impression of Change at 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).
Time frame: 8 Weeks
Rate of Adverse Events
We will assess the safety of the study by founding the number and severity of adverse events (mild in ≤ 10% of participants = good, none = excellent).
Time frame: 8 Weeks
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition. Higher Z and Index Scores indicate greater cognitive functioning on each domain.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Cognitive Function Instrument
14-item self-report of cognitive and functional status. Higher total scores (min=0, max=14) indicate greater subjective cognitive complaints.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Change in Step Count
Activity watch change in steps count during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher step count totals indicate greater physical activity (walking).
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Physical Function
8-item self-report of daily functioning. Higher T scores (mean = 50, sd = 10) indicate greater physical function.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Change in Total Sleep Time
Activity watch change in total sleep time during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher total minutes indicate greater sleep time.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Pittsburgh Sleep Quality Index
9-item self-report of sleep patterns and overall quality. Higher total scores (min=0, max=21) indicate greater sleep disturbance (\>5 = clinically significant).
Time frame: 0 Weeks, 8 Weeks, 6 Months
Mediterranean Eating Pattern for Americans Screener
16-item self-report of adherence to Mediterranean dietary recommendations. Higher total scores (min=0, max=21) indicate greater intake/adherence of Mediterranean foods.
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Alcohol Use
7-item self-report of at-risk drinking. Higher T scores (mean = 50, sd = 10) indicate greater problematic alcohol use.
Time frame: 0 Weeks, 8 Weeks, 6 Months
CDC Other Tobacco Product Use Questions
2-item self-report of the frequency and use of 6 common tobacco products (1=Less than once a month, 5=Daily or almost daily).
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Satisfaction with Social Roles and Activities
8-item self-report measure of satisfaction of performing usual social roles and activities. Higher T scores (mean = 50, sd = 10) indicate greater satisfaction with social roles and activities.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Measure of Cognitive Activities
10-item self-report measure of frequency of certain cognitive activities (e.g. reading newspapers, playing music, etc). Higher total scores (min=0, max=10) indicate greater participation in cognitively stimulating activities.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Memory Compensation Questionnaire
13-item self-report that assesses the variety and extent to which an individual compensates for actual or perceived memory losses. Higher total scores (min=0, max=65) indicate greater utilization of memory compensation strategies.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Godin Leisure-Time Exercise Questionnaire
3-item self-report of weekly engagement in light, moderate, and vigorous physical activities. Higher average scores indicate greater engagement in total physical activity.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Social Engagement and Activities Questionnaire
10-item self-report measure of perceived frequency of specific social activities. Higher total scores (min=0, max=50) indicate greater participation in socially engaging activities.
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Loneliness
5-item self-report of perceived loneliness. Higher T scores (mean = 50, sd = 10) indicate greater perceived loneliness.
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Depression and Anxiety
4-item self-reports of each construct. Higher T scores (mean = 50, sd = 10) indicate greater depression and anxiety.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Applied Mindfulness Process Scale
15-item self-report of using basic mindfulness principles. Higher total scores (min=0, max=60) indicate greater utilization in daily mindfulness activities.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Cognitive Control and Flexibility Questionnaire
13-item self-report of control over unwanted experiences. Higher total scores (min=13, max=52) indicate greater daily utilization of cognitive control and flexibility.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Emotion Regulation Questionnaire
10-item self-report of emotion regulation strategies. Higher total scores (min=10, max=70) indicate greater utilization of emotional regulation strategies.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction
27-item self report of motivation and perceived self-efficacy of lifestyle and health behavior change for dementia risk reduction. Higher total scores (min=27, max=135) indicate greater motivation to alter lifestyle factors and health behaviors to reduce risk of dementia.
Time frame: 0 Weeks, 8 Weeks, 6 Months
Plan to share: No
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Massachusetts General Hospital