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

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.

Condition or disease	Intervention/treatment	Phase
Aging; Mild Cognitive Impairment; Dementia; Old Age; Dementia; Cognitive Decline	Behavioral: My Healthy Brain Version 2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: August 31, 2021
• Actual Study Completion Date: December 31, 2021

Arms and Interventions

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 Name: MHBv2

Outcome Measures

Primary Outcome Measures :

1. Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (0 Weeks) ]
   percent of participants that score beyond scale midpoint
2. 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.
3. Recruitment Feasibility [ Time Frame: Baseline (0 Weeks) ]
   percent of referred patients meeting criteria to participate
4. Program Acceptability [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   percent of participants completing at least 6 sessions
5. Treatment Fidelity [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   percent of sessions rated as 100% adherent
6. Assessment Feasibility [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   percent of post-questionnaires completed
7. Adherence to Actigraph [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   percent of participants wearing Actiwatch ≥ 5 days per week
8. Adherence to Lifestyle Behaviors [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   percent of participants completing weekly homework

Secondary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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.
5. 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.
6. 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.
7. Sleep: Actigraph measures of sleep [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
   change from baseline to post test
8. 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.
9. 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.
10. 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.
11. Physical Activity: Actigraph measures of activity [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
    change from baseline to post test
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. Stress and Emotional Functioning: Heart Rate Variability (Actigraphy) [ Time Frame: Baseline (0 Weeks), Post-Test (8 Weeks) ]
    change from baseline to post test
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Harvard Medical School (HMS and HSDM)

Brigham and Women's Hospital

Investigators

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

More Information

• Responsible Party: Ana-Maria Vranceanu, PhD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04537728
• Other Study ID Numbers: 2019P003657
• First Posted: September 3, 2020
• Last Update Posted: September 1, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:

health; behavioral medicine; clinical psychology

Additional relevant MeSH terms:

Dementia; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders