Brain Health Program for Older Adults with Subjective Cognitive Decline

Last updated: February 20, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Memory Problems

Treatment

My Healthy Brain 1

My Healthy Brain 2

Clinical Study ID

NCT05934136
2023P001770
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 orolder

  • Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6

  • Telephone Interview for Cognitive Status-41 ≥ 31

  • Functional Assessment Questionnaire < 9

  • English fluency/literacy

  • Ability and willingness to participate via live video

  • No self-reported safety issues with initiating lifestyle changes during the study

Exclusion

Exclusion Criteria:

  • Mild cognitive impairment, dementia, or neurodegenerative disease

  • Psychotropic medications (e.g., antidepressant) change in the last 3 months

  • Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia orschizoaffective disorder

  • Current self-report of suicidal ideation

  • Serious medical illness expected to worsen in 6 months (e.g., cancer)

  • Use of digital monitoring device (e.g., Fitbit) in the last 3 moths ANDunwillingness to stop using personal digital monitoring device for duration ofprogram

  • Mindfulness or mind-body practice (> 45 min/wk) focused on lifestyle,cognitive-behavioral therapy in < 3 months, or participation in a lifestyleprevention program (ex: diabetes prevention) in < 3 months

  • Average daily step count > 5,000 steps

  • More than 30 minutes of exercise daily

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: My Healthy Brain 1
Phase:
Study Start date:
January 16, 2024
Estimated Completion Date:
November 01, 2025

Study Description

The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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