NCT04537728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 18, 2020

Last Update Submit

August 29, 2022

Conditions

AgingMild Cognitive ImpairmentDementiaOld Age; DementiaCognitive Decline

Keywords

healthbehavioral medicineclinical psychology

Outcome Measures

Primary Outcomes (8)

  • Credibility and Expectancy Questionnaire (CEQ)

    percent of participants that score beyond scale midpoint

    Baseline (0 Weeks)

  • 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.

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

  • Recruitment Feasibility

    percent of referred patients meeting criteria to participate

    Baseline (0 Weeks)

  • Program Acceptability

    percent of participants completing at least 6 sessions

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

  • Treatment Fidelity

    percent of sessions rated as 100% adherent

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

  • Assessment Feasibility

    percent of post-questionnaires completed

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

  • Adherence to Actigraph

    percent of participants wearing Actiwatch ≥ 5 days per week

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

  • Adherence to Lifestyle Behaviors

    percent of participants completing weekly homework

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

Secondary Outcomes (26)

  • Change in Healthy Aging

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

  • Mindfulness: Cognitive and Affective Mindfulness Scale

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

  • Mindfulness: Homework log

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

  • Mindfulness: Five-Facet Mindfulness Questionnaire

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

  • Sleep: Pittsburgh Sleep Quality Index

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

  • +21 more secondary outcomes

Study Arms (1)

My Healthy Brain Version 2

EXPERIMENTAL

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

Interventions

My Healthy Brain Version 2BEHAVIORAL

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

Also known as: MHBv2
My Healthy Brain Version 2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 39833389DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Ana-Maria Vranceanu, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 3, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)