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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)
Brigham and Women's Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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