- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04537728
My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
August 29, 2022 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Massachusetts General Hospital Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline (0 Weeks)
|
percent of participants that score beyond scale midpoint
|
Baseline (0 Weeks)
|
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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Recruitment Feasibility
Time Frame: Baseline (0 Weeks)
|
percent of referred patients meeting criteria to participate
|
Baseline (0 Weeks)
|
Program Acceptability
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
percent of participants completing at least 6 sessions
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Treatment Fidelity
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
percent of sessions rated as 100% adherent
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Assessment Feasibility
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
percent of post-questionnaires completed
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Adherence to Actigraph
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
percent of participants wearing Actiwatch ≥ 5 days per week
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Adherence to Lifestyle Behaviors
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Mindfulness: Homework log
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Sleep: Jenkins Sleep Questionnaire
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Sleep: Actigraph measures of sleep
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
change from baseline to post test
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Physical Activity: PROMIS Physical Function
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Physical Activity: Godin Leisure Time Exercise Questionnaire
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Physical Activity: Rapid Assessment of Physical Activity
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Physical Activity: Actigraph measures of activity
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
change from baseline to post test
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Nutrition: Mediterranean Eating Pattern for Americans Screener
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Nutrition: MIND Diet Adherence Checklist
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Medication and Substance Use: Morisky Medication Adherence Scale
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Medication and Substance Use: Fagerstrom Test for Nicotine Depedence
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Stress and Emotional Functioning: Perceived Stress Scale
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Stress and Emotional Functioning: PROMIS Depression
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
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)
Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks)
|
change from baseline to post test
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Social Functioning: PROMIS Social Isolation
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Social Functioning: PROMIS Emotional Support
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Social Functioning: UCLA Loneliness Scale
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Cognitive Functioning: Everyday Cognition Scale
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Cognitive Functioning: PROMIS Cognition
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Cognitive Functioning: Montreal Cognitive Assessment
Time Frame: 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.
|
Baseline (0 Weeks), Post-Test (8 Weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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