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Completed

NCT Number: NCT04537728

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

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.

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Key information

Conditions

Aging Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Old Age; Dementia Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Healthy Brain Version 2

Behavioral

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

Other names: MHBv2

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 3, 2020
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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