Clinical trial NCT05934136: Brain Health Program for Older Adults with Subjective Cognitive Decline
Official title: My Healthy Brain: a Group-Based Lifestyle Intervention to Modify Early Risk of Dementia in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Memory Loss (Excluding Dementia)
Healthy Lifestyle
Risk Reduction Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older
* 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 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 or schizoaffective 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 AND unwillingness to stop using personal digital monitoring device for duration of program
* Mindfulness or mind-body practice (\> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in \< 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in \< 3 months
* Average daily step count \> 5,000 steps
* More than 30 minutes of exercise daily

Primary outcomes:
measure: Credibility and Expectancy Questionnaire
timeFrame: 0 Weeks
measure: Client Satisfaction Questionnaire
timeFrame: 8 Weeks
measure: Rates of Recruitment and Enrollment
timeFrame: 0 Weeks
measure: Rates of Missing Outcomes Data
timeFrame: 8 Weeks
measure: Rates of Valid Activity Watch Data (10 or more hours of wear time)
timeFrame: 8 Weeks
measure: Rates of Ecological Momentary Assessment (EMA) Data
timeFrame: 8 Weeks
measure: Rates of Treatment Completion
timeFrame: 8 Weeks
measure: Rates of Therapist Fidelity to Intervention Procedures
timeFrame: 8 Weeks
measure: Rates of Staff Fidelity to Study Procedures
timeFrame: 8 Weeks
measure: Modified Patient Global Impression of Change at 8 weeks
timeFrame: 8 Weeks
measure: Rate of Adverse Events
timeFrame: 8 Weeks
Secondary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Cognitive Function Instrument
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Change in Step Count
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Physical Function
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Change in Total Sleep Time
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Pittsburgh Sleep Quality Index
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Mediterranean Eating Pattern for Americans Screener
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Alcohol Use
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: CDC Other Tobacco Product Use Questions
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 0 Weeks, 8 Weeks, 6 Months
Other outcomes:
measure: Measure of Cognitive Activities
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Memory Compensation Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Social Engagement and Activities Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Loneliness
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Depression and Anxiety
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Applied Mindfulness Process Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Cognitive Control and Flexibility Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Emotion Regulation Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction
timeFrame: 0 Weeks, 8 Weeks, 6 Months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Mace RA, Hopkins SW, Reynolds GO, Vranceanu AM. My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. J Clin Psychol Med Settings. 2022 Dec;29(4):818-830. doi: 10.1007/s10880-022-09843-2. Epub 2022 Jan 25.
citation: Mace RA, Greenberg J, Stauder M, Reynolds G, Vranceanu AM. My Healthy Brain: a multimodal lifestyle program to promote brain health. Aging Ment Health. 2022 May;26(5):980-991. doi: 10.1080/13607863.2021.1904828. Epub 2021 Mar 30.
citation: Mace RA, Popok PJ, Hopkins SW, Fishbein NS, Vranceanu AM. Adaptation and virtual feasibility pilot of a mindfulness-based lifestyle program targeting modifiable dementia risk factors in older adults. Aging Ment Health. 2023 Apr;27(4):695-707. doi: 10.1080/13607863.2022.2032600. Epub 2022 Feb 1.