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

• ClinicalTrials.gov Identifier: NCT04537728
• Recruitment Status: Completed
• First Posted: September 3, 2020
• Last Update Posted: September 1, 2022
• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Brigham and Women's Hospital
• Information provided by (Responsible Party): Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 18, 2020
• First Posted Date: September 3, 2020
• Last Update Posted Date: September 1, 2022
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 30, 2020)

• 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
• 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.
• 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
• 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.
• 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.
• 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.
• Sleep: Actigraph measures of sleep [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
  change from baseline to post test
• 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.
• 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.
• 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.
• Physical Activity: Actigraph measures of activity [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
  change from baseline to post test
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Stress and Emotional Functioning: Heart Rate Variability (Actigraphy) [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
  change from baseline to post test
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Aging
• Mild Cognitive Impairment
• Dementia
• Old Age; Dementia
• Cognitive Decline

Intervention

Behavioral: My Healthy Brain Version 2

multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors

Other Name: MHBv2

Study Arms

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

Intervention: Behavioral: My Healthy Brain Version 2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 29, 2022): 11
• Original Estimated Enrollment (submitted: August 30, 2020): 20
• Actual Study Completion Date: December 31, 2021
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04537728
• Other Study ID Numbers: 2019P003657
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current

Collaborators

• Harvard Medical School (HMS and HSDM)
• Brigham and Women's Hospital

Investigators

• Principal Investigator: Ana-Maria Vranceanu, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: August 2022