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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Credibility and Expectancy Questionnaire (CEQ)
percent of participants that score beyond scale midpoint
Time frame: Baseline (0 Weeks)
Client Satisfaction Questionnaire (CSQ-3)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Recruitment Feasibility
percent of referred patients meeting criteria to participate
Time frame: Baseline (0 Weeks)
Program Acceptability
percent of participants completing at least 6 sessions
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Treatment Fidelity
percent of sessions rated as 100% adherent
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Assessment Feasibility
percent of post-questionnaires completed
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Adherence to Actigraph
percent of participants wearing Actiwatch ≥ 5 days per week
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Adherence to Lifestyle Behaviors
percent of participants completing weekly homework
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Change in Healthy Aging
change from baseline to post test; measured by Brain Health Behaviors Checklist
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Mindfulness: Cognitive and Affective Mindfulness Scale
change from baseline to post test; Scores range from 12-48, with higher values reflecting greater mindfulness qualities.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Mindfulness: Homework log
change from baseline to post test; measured by self-reported number of minutes practiced
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Mindfulness: Five-Facet Mindfulness Questionnaire
change from baseline to post test; Scores range from 15-75, with higher scores indicating greater mindfulness.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Sleep: Pittsburgh Sleep Quality Index
change from baseline to post test;Total scores range from 0 to 21, with higher scores indicating greater sleep disturbance.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Sleep: Jenkins Sleep Questionnaire
change from baseline to post test; scores range from 0-20, with higher scores indicating greater sleep disruption.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Sleep: Actigraph measures of sleep
change from baseline to post test
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Physical Activity: PROMIS Physical Function
change from baseline to post test; scores range from 4-16, with higher scores signifying greater physical function.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
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Physical Activity: Godin Leisure Time Exercise Questionnaire
change from baseline to post test; scores range from 0 to no upper limit, with higher scores indicating greater activity level.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Physical Activity: Rapid Assessment of Physical Activity
change from baseline to post test; the highest score with an affirmative response is used for scoring, with higher scores indicating greater physical activity.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Physical Activity: Actigraph measures of activity
change from baseline to post test
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Nutrition: Mediterranean Eating Pattern for Americans Screener
change from baseline to post test; scores range from 0-16, with higher scores indicating a greater adherence to the Mediterranean diet.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Nutrition: MIND Diet Adherence Checklist
change from baseline to post test; scores range greater than or equal to 0, with higher scores indicating creater adherence to MIND diet.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Medication and Substance Use: Morisky Medication Adherence Scale
change from baseline to post test; scores range from 0-4 with higher scores indicating greater adherence to medication regiment.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption
change from baseline to post test; Scores range from 0-12, with higher scores indicating more hazardous drinking.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Medication and Substance Use: Fagerstrom Test for Nicotine Depedence
change from baseline to post test; scores range from 0-10, with higher total scores indicating greater physical dependence on nicotine.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Stress and Emotional Functioning: Perceived Stress Scale
change from baseline to post test; scores range from 0-40, with higher scores indicating greater perceived stress.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Stress and Emotional Functioning: PROMIS Depression
change from baseline to post test; scores range from 8-40, with higher scores indicating greater depression.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Stress and Emotional Functioning: PROMIS Anxiety
change from baseline to post test; scores range from 8-40, with higher scores indicating greater anxiety.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)
change from baseline to post test
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Social Functioning: PROMIS Social Isolation
change from baseline to post test; scores range from 6-30, with higher scores indicating greater social isolation.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Social Functioning: PROMIS Emotional Support
change from baseline to post test; scores range from 4-16, with higher scores indicating lower emotional support.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Social Functioning: UCLA Loneliness Scale
change from baseline to post test; scores range from 0-24, with higher scores indicating stronger perceptions of loneliness and social isolation.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Cognitive Functioning: Everyday Cognition Scale
change from baseline to post test; scores range from 12-60, with higher scores indicating worse cognitive ability to perform everyday tasks.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Cognitive Functioning: PROMIS Cognition
change from baseline to post test; scores range from 8-40, with higher scores indicating greater patient-perceived cognitive deficits.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)
Cognitive Functioning: Montreal Cognitive Assessment
change from baseline to post test; scores range from 0-30, with higher scores representing greater global cognitive capacity.
Time frame: Baseline (0 Weeks), Post-Test (8 Weeks)