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

Primary Purpose

Aging, Mild Cognitive Impairment, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Healthy Brain Version 2
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring health, behavioral medicine, clinical psychology

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

My Healthy Brain Version 2

Arm Description

an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Healthy Aging
change from baseline to post test; measured by Brain Health Behaviors Checklist
Mindfulness: Cognitive and Affective Mindfulness Scale
change from baseline to post test; Scores range from 12-48, with higher values reflecting greater mindfulness qualities.
Mindfulness: Homework log
change from baseline to post test; measured by self-reported number of minutes practiced
Mindfulness: Five-Facet Mindfulness Questionnaire
change from baseline to post test; Scores range from 15-75, with higher scores indicating greater mindfulness.
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.
Sleep: Jenkins Sleep Questionnaire
change from baseline to post test; scores range from 0-20, with higher scores indicating greater sleep disruption.
Sleep: Actigraph measures of sleep
change from baseline to post test
Physical Activity: PROMIS Physical Function
change from baseline to post test; scores range from 4-16, with higher scores signifying greater physical function.
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.
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.
Physical Activity: Actigraph measures of activity
change from baseline to post test
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.
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.
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.
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.
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.
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.
Stress and Emotional Functioning: PROMIS Depression
change from baseline to post test; scores range from 8-40, with higher scores indicating greater depression.
Stress and Emotional Functioning: PROMIS Anxiety
change from baseline to post test; scores range from 8-40, with higher scores indicating greater anxiety.
Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)
change from baseline to post test
Social Functioning: PROMIS Social Isolation
change from baseline to post test; scores range from 6-30, with higher scores indicating greater social isolation.
Social Functioning: PROMIS Emotional Support
change from baseline to post test; scores range from 4-16, with higher scores indicating lower emotional support.
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.
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.
Cognitive Functioning: PROMIS Cognition
change from baseline to post test; scores range from 8-40, with higher scores indicating greater patient-perceived cognitive deficits.
Cognitive Functioning: Montreal Cognitive Assessment
change from baseline to post test; scores range from 0-30, with higher scores representing greater global cognitive capacity.

Full Information

First Posted
August 18, 2020
Last Updated
August 29, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04537728
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mild Cognitive Impairment, Dementia, Old Age; Dementia, Cognitive Decline
Keywords
health, behavioral medicine, clinical psychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
My Healthy Brain Version 2
Arm Type
Experimental
Arm Description
an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD
Intervention Type
Behavioral
Intervention Name(s)
My Healthy Brain Version 2
Other Intervention Name(s)
MHBv2
Intervention Description
multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors
Primary Outcome Measure Information:
Title
Credibility and Expectancy Questionnaire (CEQ)
Description
percent of participants that score beyond scale midpoint
Time Frame
Baseline (0 Weeks)
Title
Client Satisfaction Questionnaire (CSQ-3)
Description
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)
Title
Recruitment Feasibility
Description
percent of referred patients meeting criteria to participate
Time Frame
Baseline (0 Weeks)
Title
Program Acceptability
Description
percent of participants completing at least 6 sessions
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Treatment Fidelity
Description
percent of sessions rated as 100% adherent
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Assessment Feasibility
Description
percent of post-questionnaires completed
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Adherence to Actigraph
Description
percent of participants wearing Actiwatch ≥ 5 days per week
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Adherence to Lifestyle Behaviors
Description
percent of participants completing weekly homework
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary Outcome Measure Information:
Title
Change in Healthy Aging
Description
change from baseline to post test; measured by Brain Health Behaviors Checklist
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Mindfulness: Cognitive and Affective Mindfulness Scale
Description
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)
Title
Mindfulness: Homework log
Description
change from baseline to post test; measured by self-reported number of minutes practiced
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Mindfulness: Five-Facet Mindfulness Questionnaire
Description
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)
Title
Sleep: Pittsburgh Sleep Quality Index
Description
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)
Title
Sleep: Jenkins Sleep Questionnaire
Description
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)
Title
Sleep: Actigraph measures of sleep
Description
change from baseline to post test
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Physical Activity: PROMIS Physical Function
Description
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)
Title
Physical Activity: Godin Leisure Time Exercise Questionnaire
Description
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)
Title
Physical Activity: Rapid Assessment of Physical Activity
Description
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)
Title
Physical Activity: Actigraph measures of activity
Description
change from baseline to post test
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Nutrition: Mediterranean Eating Pattern for Americans Screener
Description
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)
Title
Nutrition: MIND Diet Adherence Checklist
Description
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)
Title
Medication and Substance Use: Morisky Medication Adherence Scale
Description
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)
Title
Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption
Description
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)
Title
Medication and Substance Use: Fagerstrom Test for Nicotine Depedence
Description
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)
Title
Stress and Emotional Functioning: Perceived Stress Scale
Description
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)
Title
Stress and Emotional Functioning: PROMIS Depression
Description
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)
Title
Stress and Emotional Functioning: PROMIS Anxiety
Description
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)
Title
Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)
Description
change from baseline to post test
Time Frame
Baseline (0 Weeks), Post-Test (8 Weeks)
Title
Social Functioning: PROMIS Social Isolation
Description
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)
Title
Social Functioning: PROMIS Emotional Support
Description
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)
Title
Social Functioning: UCLA Loneliness Scale
Description
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)
Title
Cognitive Functioning: Everyday Cognition Scale
Description
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)
Title
Cognitive Functioning: PROMIS Cognition
Description
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)
Title
Cognitive Functioning: Montreal Cognitive Assessment
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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