Clinical trial NCT04537728: My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
Official title: My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Mild Cognitive Impairment
Dementia
Old Age; Dementia
Cognitive Decline
Keywords: health
behavioral medicine
clinical psychology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Brigham and Women's Hospital
First posted: 2020-09-03
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (0 Weeks)
measure: Client Satisfaction Questionnaire (CSQ-3)
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Recruitment Feasibility
timeFrame: Baseline (0 Weeks)
measure: Program Acceptability
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Treatment Fidelity
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Assessment Feasibility
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Adherence to Actigraph
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Adherence to Lifestyle Behaviors
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary outcomes:
measure: Change in Healthy Aging
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Mindfulness: Cognitive and Affective Mindfulness Scale
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Mindfulness: Homework log
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Mindfulness: Five-Facet Mindfulness Questionnaire
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Sleep: Pittsburgh Sleep Quality Index
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Sleep: Jenkins Sleep Questionnaire
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Sleep: Actigraph measures of sleep
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Physical Activity: PROMIS Physical Function
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Physical Activity: Godin Leisure Time Exercise Questionnaire
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Physical Activity: Rapid Assessment of Physical Activity
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Physical Activity: Actigraph measures of activity
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Nutrition: Mediterranean Eating Pattern for Americans Screener
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Nutrition: MIND Diet Adherence Checklist
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Medication and Substance Use: Morisky Medication Adherence Scale
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Medication and Substance Use: Fagerstrom Test for Nicotine Depedence
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Stress and Emotional Functioning: Perceived Stress Scale
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Stress and Emotional Functioning: PROMIS Depression
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Stress and Emotional Functioning: PROMIS Anxiety
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Social Functioning: PROMIS Social Isolation
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Social Functioning: PROMIS Emotional Support
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Social Functioning: UCLA Loneliness Scale
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Cognitive Functioning: Everyday Cognition Scale
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Cognitive Functioning: PROMIS Cognition
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
measure: Cognitive Functioning: Montreal Cognitive Assessment
timeFrame: Baseline (0 Weeks), Post-Test (8 Weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: