My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Recruitment Feasibility
Study Overview
Brief Summary
The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 60 years
- •English fluency/literacy
- •≥1 modifiable brain disease risk factor (outlined by JAMA)
- •Bluetooth 4.0 enabled smartphone
Exclusion Criteria
- •Diagnosis of dementia; Montreal Cognitive Assessment < 18
- •Serious medical illness expected to worsen in next 6 months
- •Current suicidal ideation
- •Substance abuse
- •Untreated serious mental health conditions
- •Current use of digital monitoring device (eg. Fitbit)
- •Mindfulness practice (> 45 minutes/week) in the last three months
Arms & Interventions
My Healthy Brain Version 2
an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD
Intervention: My Healthy Brain Version 2 (Behavioral)
Outcomes
Primary Outcomes
Recruitment Feasibility
Time Frame: Baseline (0 Weeks)
percent of referred patients meeting criteria to participate
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline (0 Weeks)
percent of participants that score beyond scale midpoint
Treatment Fidelity
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of sessions rated as 100% adherent
Assessment Feasibility
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of post-questionnaires completed
Client Satisfaction Questionnaire (CSQ-3)
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Program Acceptability
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants completing at least 6 sessions
Adherence to Actigraph
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants wearing Actiwatch ≥ 5 days per week
Adherence to Lifestyle Behaviors
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants completing weekly homework
Secondary Outcomes
- Physical Activity: Rapid Assessment of Physical Activity(Baseline (0 Weeks), Post-Test (8 Weeks))
- Nutrition: MIND Diet Adherence Checklist(Baseline (0 Weeks), Post-Test (8 Weeks))
- Nutrition: Mediterranean Eating Pattern for Americans Screener(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Fagerstrom Test for Nicotine Depedence(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: PROMIS Emotional Support(Baseline (0 Weeks), Post-Test (8 Weeks))
- Mindfulness: Cognitive and Affective Mindfulness Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Pittsburgh Sleep Quality Index(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: PROMIS Depression(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: Godin Leisure Time Exercise Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Morisky Medication Adherence Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: UCLA Loneliness Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Mindfulness: Five-Facet Mindfulness Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Change in Healthy Aging(Baseline (0 Weeks), Post-Test (8 Weeks))
- Mindfulness: Homework log(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: Actigraph measures of activity(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: Perceived Stress Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: PROMIS Social Isolation(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: Everyday Cognition Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: PROMIS Cognition(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: Montreal Cognitive Assessment(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Jenkins Sleep Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Actigraph measures of sleep(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: PROMIS Physical Function(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: PROMIS Anxiety(Baseline (0 Weeks), Post-Test (8 Weeks))
Investigators
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital