My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
- Conditions
- DementiaMild Cognitive ImpairmentAgingOld Age; DementiaCognitive Decline
- Interventions
- Behavioral: My Healthy Brain Version 2
- Registration Number
- NCT04537728
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- Age ≥ 60 years
- English fluency/literacy
- ≥1 modifiable brain disease risk factor (outlined by JAMA)
- Bluetooth 4.0 enabled smartphone
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description My Healthy Brain Version 2 My Healthy Brain Version 2 an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD
- Primary Outcome Measures
Name Time Method Credibility and Expectancy Questionnaire (CEQ) Baseline (0 Weeks) percent of participants that score beyond scale midpoint
Treatment Fidelity Baseline (0 Weeks), Post-Test (8 Weeks) percent of sessions rated as 100% adherent
Recruitment Feasibility Baseline (0 Weeks) percent of referred patients meeting criteria to participate
Assessment Feasibility Baseline (0 Weeks), Post-Test (8 Weeks) percent of post-questionnaires completed
Client Satisfaction Questionnaire (CSQ-3) 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 Baseline (0 Weeks), Post-Test (8 Weeks) percent of participants completing at least 6 sessions
Adherence to Actigraph Baseline (0 Weeks), Post-Test (8 Weeks) percent of participants wearing Actiwatch ≥ 5 days per week
Adherence to Lifestyle Behaviors Baseline (0 Weeks), Post-Test (8 Weeks) percent of participants completing weekly homework
- Secondary Outcome Measures
Name Time Method Mindfulness: Five-Facet Mindfulness Questionnaire Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; Scores range from 15-75, with higher scores indicating greater mindfulness.
Stress and Emotional Functioning: PROMIS Depression Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 8-40, with higher scores indicating greater depression.
Change in Healthy Aging Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; measured by Brain Health Behaviors Checklist
Mindfulness: Homework log Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; measured by self-reported number of minutes practiced
Physical Activity: Actigraph measures of activity Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test
Stress and Emotional Functioning: Perceived Stress Scale Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-40, with higher scores indicating greater perceived stress.
Social Functioning: PROMIS Social Isolation Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 6-30, with higher scores indicating greater social isolation.
Cognitive Functioning: Everyday Cognition Scale Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 12-60, with higher scores indicating worse cognitive ability to perform everyday tasks.
Cognitive Functioning: PROMIS Cognition Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 8-40, with higher scores indicating greater patient-perceived cognitive deficits.
Cognitive Functioning: Montreal Cognitive Assessment Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-30, with higher scores representing greater global cognitive capacity.
Mindfulness: Cognitive and Affective Mindfulness Scale Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; Scores range from 12-48, with higher values reflecting greater mindfulness qualities.
Sleep: Pittsburgh Sleep Quality Index Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test;Total scores range from 0 to 21, with higher scores indicating greater sleep disturbance.
Sleep: Jenkins Sleep Questionnaire Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-20, with higher scores indicating greater sleep disruption.
Sleep: Actigraph measures of sleep Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test
Physical Activity: PROMIS Physical Function Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 4-16, with higher scores signifying greater physical function.
Stress and Emotional Functioning: Heart Rate Variability (Actigraphy) Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test
Physical Activity: Godin Leisure Time Exercise Questionnaire Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0 to no upper limit, with higher scores indicating greater activity level.
Medication and Substance Use: Morisky Medication Adherence Scale Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-4 with higher scores indicating greater adherence to medication regiment.
Social Functioning: UCLA Loneliness Scale Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-24, with higher scores indicating stronger perceptions of loneliness and social isolation.
Physical Activity: Rapid Assessment of Physical Activity Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; the highest score with an affirmative response is used for scoring, with higher scores indicating greater physical activity.
Nutrition: MIND Diet Adherence Checklist Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range greater than or equal to 0, with higher scores indicating creater adherence to MIND diet.
Nutrition: Mediterranean Eating Pattern for Americans Screener Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-16, with higher scores indicating a greater adherence to the Mediterranean diet.
Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; Scores range from 0-12, with higher scores indicating more hazardous drinking.
Medication and Substance Use: Fagerstrom Test for Nicotine Depedence Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 0-10, with higher total scores indicating greater physical dependence on nicotine.
Social Functioning: PROMIS Emotional Support Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 4-16, with higher scores indicating lower emotional support.
Stress and Emotional Functioning: PROMIS Anxiety Baseline (0 Weeks), Post-Test (8 Weeks) change from baseline to post test; scores range from 8-40, with higher scores indicating greater anxiety.
Trial Locations
- Locations (1)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States