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AgingNCT04537728

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

A study testing My Healthy Brain Version 2 in people with Aging and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Aging, Mild Cognitive Impairment, Dementia
What is being tested?
My Healthy Brain Version 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60 years
  • English fluency/literacy
  • ≥1 modifiable brain disease risk factor (outlined by JAMA)
  • Bluetooth 4.0 enabled smartphone

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Being tested
My Healthy Brain Version 2
Keywords
health, behavioral medicine, clinical psychology
Medical subject headings
Cognitive Dysfunction, Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Healthy Brain Version 2Behavioural

    Also called MHBv2

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

Study groups in NCT04537728
Study groupRoleWhat they receive
My Healthy Brain Version 2Experimentalan 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD
Receives: Behavioral: My Healthy Brain Version 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Credibility and Expectancy Questionnaire (CEQ)

    percent of participants that score beyond scale midpoint

    Measured: Baseline (0 Weeks)

  2. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  3. Recruitment Feasibility

    percent of referred patients meeting criteria to participate

    Measured: Baseline (0 Weeks)

  4. Program Acceptability

    percent of participants completing at least 6 sessions

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  5. Treatment Fidelity

    percent of sessions rated as 100% adherent

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  6. Assessment Feasibility

    percent of post-questionnaires completed

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  7. Adherence to Actigraph

    percent of participants wearing Actiwatch ≥ 5 days per week

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  8. Adherence to Lifestyle Behaviors

    percent of participants completing weekly homework

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

Secondary outcomes (26)

  1. Change in Healthy Aging

    change from baseline to post test; measured by Brain Health Behaviors Checklist

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  2. Mindfulness: Cognitive and Affective Mindfulness Scale

    change from baseline to post test; Scores range from 12-48, with higher values reflecting greater mindfulness qualities.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  3. Mindfulness: Homework log

    change from baseline to post test; measured by self-reported number of minutes practiced

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  4. Mindfulness: Five-Facet Mindfulness Questionnaire

    change from baseline to post test; Scores range from 15-75, with higher scores indicating greater mindfulness.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  5. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  6. Sleep: Jenkins Sleep Questionnaire

    change from baseline to post test; scores range from 0-20, with higher scores indicating greater sleep disruption.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  7. Sleep: Actigraph measures of sleep

    change from baseline to post test

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  8. Physical Activity: PROMIS Physical Function

    change from baseline to post test; scores range from 4-16, with higher scores signifying greater physical function.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  9. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  10. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  11. Physical Activity: Actigraph measures of activity

    change from baseline to post test

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  12. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  13. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  14. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  15. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  16. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  17. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  18. Stress and Emotional Functioning: PROMIS Depression

    change from baseline to post test; scores range from 8-40, with higher scores indicating greater depression.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  19. Stress and Emotional Functioning: PROMIS Anxiety

    change from baseline to post test; scores range from 8-40, with higher scores indicating greater anxiety.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  20. Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)

    change from baseline to post test

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  21. Social Functioning: PROMIS Social Isolation

    change from baseline to post test; scores range from 6-30, with higher scores indicating greater social isolation.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  22. Social Functioning: PROMIS Emotional Support

    change from baseline to post test; scores range from 4-16, with higher scores indicating lower emotional support.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  23. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  24. 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.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  25. Cognitive Functioning: PROMIS Cognition

    change from baseline to post test; scores range from 8-40, with higher scores indicating greater patient-perceived cognitive deficits.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

  26. Cognitive Functioning: Montreal Cognitive Assessment

    change from baseline to post test; scores range from 0-30, with higher scores representing greater global cognitive capacity.

    Measured: Baseline (0 Weeks), Post-Test (8 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04537728
Sponsor's protocol ID
2019P003657
Status last verified
Aug 2022
First submitted
18 Aug 2020
Last updated
1 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schroeder MW, Frumkin MR, Mace RA. Proof-of-concept for integrating multimodal digital health assessments into lifestyle interventions for older adults with dementia risk factors. J Behav Med. 2025 Apr;48(2):373-384. doi: 10.1007/s10865-024-00546-7. Epub 2025 Jan 20.

    PubMed 39833389

Questions about this trial

What is this clinical trial studying?

A study testing My Healthy Brain Version 2 in people with Aging and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Credibility and Expectancy Questionnaire (CEQ) (time frame: Baseline (0 Weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.

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