Brain Health Program for Older Adults With Subjective Cognitive Decline

NCT05934136 | Completed DMC

• 1 other identifier: 2023P001770
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Loss (Excluding Dementia); Healthy Lifestyle; Risk Reduction Behavior

Outcome Measures

Primary Outcomes (11)

• Credibility and Expectancy Questionnaire

  Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy.

  0 Weeks

• Client Satisfaction Questionnaire

  Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.

  8 Weeks

• Rates of Recruitment and Enrollment

  We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to participate divided by the total number contacted (≥70% good, ≥ 80% excellent).

  0 Weeks

• Rates of Missing Outcomes Data

  We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent).

  8 Weeks

• Rates of Valid Activity Watch Data (10 or more hours of wear time)

  We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).

  8 Weeks

• Rates of Ecological Momentary Assessment (EMA) Data

  We will assess the feasibility of collecting ecological momentary assessment (EMA) of daily mindfulness practice by calculating the proportion of participants who complete at least 5 out of 7 daily surveys per week (≥ 70% good, ≥ 80% excellent).

  8 Weeks

• Rates of Treatment Completion

  We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).

  8 Weeks

• Rates of Therapist Fidelity to Intervention Procedures

  We will assess the fidelity of therapists to the intervention procedures by calculating the proportion of sessions with completed audio recordings, progress notes, and checklist with 100% of content delivered divided by the total number of sessions (≥ 75% good, 100% excellent).

  8 Weeks

• Rates of Staff Fidelity to Study Procedures

  We will assess the fidelity of staff to the study procedures by counting the frequency of protocol deviations (\<5 deviations good, 0 deviations excellent).

  8 Weeks

• Modified Patient Global Impression of Change at 8 weeks

  The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved).

  8 Weeks

• Rate of Adverse Events

  We will assess the safety of the study by founding the number and severity of adverse events (mild in ≤ 10% of participants = good, none = excellent).

  8 Weeks

Secondary Outcomes (10)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  0 Weeks, 8 Weeks, 6 Months

• Cognitive Function Instrument

  0 Weeks, 8 Weeks, 6 Months

• Change in Step Count

  0 Weeks, 8 Weeks, 6 Months

• PROMIS Physical Function

  0 Weeks, 8 Weeks, 6 Months

• Change in Total Sleep Time

  0 Weeks, 8 Weeks, 6 Months

Other Outcomes (10)

• Measure of Cognitive Activities

  0 Weeks, 8 Weeks, 6 Months

• Memory Compensation Questionnaire

  0 Weeks, 8 Weeks, 6 Months

• Godin Leisure-Time Exercise Questionnaire

  0 Weeks, 8 Weeks, 6 Months

Study Arms (2)

My Healthy Brain 1

EXPERIMENTAL

My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program.

Behavioral: My Healthy Brain 1

My Healthy Brain 2

ACTIVE COMPARATOR

My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.

Behavioral: My Healthy Brain 2

Interventions

My Healthy Brain 1 BEHAVIORAL

My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program.

My Healthy Brain 1

My Healthy Brain 2 BEHAVIORAL

My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.

My Healthy Brain 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 35079948 RESULT

• 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.

  PMID: 33784902 RESULT

• 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.

  PMID: 35100922 RESULT

• Mace RA, Law ME, Cohen JE, Ritchie CS, Okereke OI, Hoeppner BB, Brewer JA, Bartels SJ, Vranceanu AM; My Healthy Brain Team. A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149.

  PMID: 39571150 DERIVED

MeSH Terms

Conditions

Memory Disorders; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 6, 2023
• Study Start: January 16, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)