My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices

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 Overview

• Status: Completed
• Conditions: Dementia; Aging; Mild Cognitive Impairment; Cognitive Decline; Old Age; Dementia
• Intervention / Treatment: Behavioral: My Healthy Brain Version 2

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My Healthy Brain Version 2; an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD	Behavioral: My Healthy Brain Version 2; multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors; Other Names: MHBv2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility and Expectancy Questionnaire (CEQ)	percent of participants that score beyond scale midpoint	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
Recruitment Feasibility	percent of referred patients meeting criteria to participate	Baseline (0 Weeks)
Program Acceptability	percent of participants completing at least 6 sessions	Baseline (0 Weeks), Post-Test (8 Weeks)
Treatment Fidelity	percent of sessions rated as 100% adherent	Baseline (0 Weeks), Post-Test (8 Weeks)
Assessment Feasibility	percent of post-questionnaires completed	Baseline (0 Weeks), Post-Test (8 Weeks)
Adherence to Actigraph	percent of participants wearing Actiwatch ≥ 5 days per week	Baseline (0 Weeks), Post-Test (8 Weeks)
Adherence to Lifestyle Behaviors	percent of participants completing weekly homework	Baseline (0 Weeks), Post-Test (8 Weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Healthy Aging	change from baseline to post test; measured by Brain Health Behaviors Checklist	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
Mindfulness: Homework log	change from baseline to post test; measured by self-reported number of minutes practiced	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.	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.	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
Sleep: Actigraph measures of sleep	change from baseline to post test	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
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.	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
Physical Activity: Actigraph measures of activity	change from baseline to post test	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (0 Weeks), Post-Test (8 Weeks)
Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)	change from baseline to post test	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.	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.	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.	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.	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.	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.	Baseline (0 Weeks), Post-Test (8 Weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: health; behavioral medicine; clinical psychology
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 2019P003657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No