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Brain Health Program for Older Adults With Subjective Cognitive Decline

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
My Healthy Brain 1
My Healthy Brain 2
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Memory Loss (Excluding Dementia)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Concerns about memory or thinking (subjective cognitive decline, SCD) Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6 Telephone Interview for Cognitive Status ≥ 28 Functional Assessment Questionnaire < 9 English fluency/literacy Ability and willingness to participate via live video Clearance by medical doctor for study participation 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 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 New mindfulness practice (> 45 min/wk) or cognitive-behavioral therapy in the last 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    My Healthy Brain 1

    My Healthy Brain 2

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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.
    Client Satisfaction Questionnaire
    Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
    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).
    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).
    Rates of Valid Activity Watch Data (7 or more hours of wear time)
    We will assess the feasibility of collecting valid activity watch data by calculating the proportion of valid days (7 or more hours of wear time) divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).
    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 text-based surveys completed divided by the total number of surveys sent during the program (≥ 70% good, ≥ 80% excellent).
    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
    A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition. Higher Z and Index Scores indicate greater cognitive functioning on each domain.
    Cognitive Function Instrument
    14-item self-report of cognitive and functional status. Higher total scores (min=0, max=14) indicate greater subjective cognitive complaints.
    Change in Step Count
    Activity watch change in steps count during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher step count totals indicate greater physical activity (walking).
    PROMIS Physical Function
    8-item self-report of daily functioning. Higher T scores (mean = 50, sd = 10) indicate greater physical function.
    Change in Total Sleep Time
    Activity watch change in total sleep time during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher total minutes indicate greater sleep time.
    Pittsburgh Sleep Quality Index
    9-item self-report of sleep patterns and overall quality. Higher total scores (min=0, max=21) indicate greater sleep disturbance (>4 = clinically significant).
    Mediterranean Eating Pattern for Americans Screener
    16-item self-report of adherence to Mediterranean dietary recommendations. Higher total scores (min=0, max=21) indicate greater intake/adherence of Mediterranean foods.
    PROMIS Alcohol Use
    7-item self-report of at-risk drinking. Higher T scores (mean = 50, sd = 10) indicate greater problematic alcohol use.
    CDC Other Tobacco Product Use Questions
    2-item self-report of the frequency and use of 6 common tobacco products (1=Less than once a month, 5=Daily or almost daily).
    PROMIS Satisfaction with Social Roles and Activities
    8-item self-report measure of satisfaction of performing usual social roles and activities. Higher T scores (mean = 50, sd = 10) indicate greater satisfaction with social roles and activities.

    Full Information

    First Posted
    June 22, 2023
    Last Updated
    August 7, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05934136
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Memory Loss (Excluding Dementia), Healthy Lifestyle, Risk Reduction Behavior

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    My Healthy Brain 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    My Healthy Brain 2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    My Healthy Brain 1
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    My Healthy Brain 2
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Credibility and Expectancy Questionnaire
    Description
    Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy.
    Time Frame
    0 Weeks
    Title
    Client Satisfaction Questionnaire
    Description
    Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
    Time Frame
    8 Weeks
    Title
    Rates of Recruitment and Enrollment
    Description
    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).
    Time Frame
    0 Weeks
    Title
    Rates of Missing Outcomes Data
    Description
    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).
    Time Frame
    8 Weeks
    Title
    Rates of Valid Activity Watch Data (7 or more hours of wear time)
    Description
    We will assess the feasibility of collecting valid activity watch data by calculating the proportion of valid days (7 or more hours of wear time) divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).
    Time Frame
    8 Weeks
    Title
    Rates of Ecological Momentary Assessment (EMA) Data
    Description
    We will assess the feasibility of collecting ecological momentary assessment (EMA) of daily mindfulness practice by calculating the proportion of text-based surveys completed divided by the total number of surveys sent during the program (≥ 70% good, ≥ 80% excellent).
    Time Frame
    8 Weeks
    Title
    Rates of Treatment Completion
    Description
    We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).
    Time Frame
    8 Weeks
    Title
    Rates of Therapist Fidelity to Intervention Procedures
    Description
    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).
    Time Frame
    8 Weeks
    Title
    Rates of Staff Fidelity to Study Procedures
    Description
    We will assess the fidelity of staff to the study procedures by counting the frequency of protocol deviations (<5 deviations good, 0 deviations excellent).
    Time Frame
    8 Weeks
    Title
    Modified Patient Global Impression of Change at 8 weeks
    Description
    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).
    Time Frame
    8 Weeks
    Title
    Rate of Adverse Events
    Description
    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).
    Time Frame
    8 Weeks
    Secondary Outcome Measure Information:
    Title
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
    Description
    A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition. Higher Z and Index Scores indicate greater cognitive functioning on each domain.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Cognitive Function Instrument
    Description
    14-item self-report of cognitive and functional status. Higher total scores (min=0, max=14) indicate greater subjective cognitive complaints.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Change in Step Count
    Description
    Activity watch change in steps count during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher step count totals indicate greater physical activity (walking).
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    PROMIS Physical Function
    Description
    8-item self-report of daily functioning. Higher T scores (mean = 50, sd = 10) indicate greater physical function.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Change in Total Sleep Time
    Description
    Activity watch change in total sleep time during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher total minutes indicate greater sleep time.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Pittsburgh Sleep Quality Index
    Description
    9-item self-report of sleep patterns and overall quality. Higher total scores (min=0, max=21) indicate greater sleep disturbance (>4 = clinically significant).
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Mediterranean Eating Pattern for Americans Screener
    Description
    16-item self-report of adherence to Mediterranean dietary recommendations. Higher total scores (min=0, max=21) indicate greater intake/adherence of Mediterranean foods.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    PROMIS Alcohol Use
    Description
    7-item self-report of at-risk drinking. Higher T scores (mean = 50, sd = 10) indicate greater problematic alcohol use.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    CDC Other Tobacco Product Use Questions
    Description
    2-item self-report of the frequency and use of 6 common tobacco products (1=Less than once a month, 5=Daily or almost daily).
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    PROMIS Satisfaction with Social Roles and Activities
    Description
    8-item self-report measure of satisfaction of performing usual social roles and activities. Higher T scores (mean = 50, sd = 10) indicate greater satisfaction with social roles and activities.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Other Pre-specified Outcome Measures:
    Title
    Measure of Cognitive Activities
    Description
    10-item self-report measure of frequency of certain cognitive activities (e.g. reading newspapers, playing music, etc). Higher total scores (min=0, max=10) indicate greater participation in cognitively stimulating activities.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Memory Compensation Questionnaire
    Description
    13-item self-report that assesses the variety and extent to which an individual compensates for actual or perceived memory losses. Higher total scores (min=0, max=65) indicate greater utilization of memory compensation strategies.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Godin Leisure-Time Exercise Questionnaire
    Description
    3-item self-report of weekly engagement in light, moderate, and vigorous physical activities. Higher average scores indicate greater engagement in total physical activity.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Social Engagement and Activities Questionnaire
    Description
    10-item self-report measure of perceived frequency of specific social activities. Higher total scores (min=0, max=50) indicate greater participation in socially engaging activities.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    PROMIS Loneliness
    Description
    5-item self-report of perceived loneliness. Higher T scores (mean = 50, sd = 10) indicate greater perceived loneliness.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    PROMIS Depression and Anxiety
    Description
    4-item self-reports of each construct. Higher T scores (mean = 50, sd = 10) indicate greater depression and anxiety.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Applied Mindfulness Process Scale
    Description
    15-item self-report of using basic mindfulness principles. Higher total scores (min=0, max=60) indicate greater utilization in daily mindfulness activities.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Cognitive Control and Flexibility Questionnaire
    Description
    13-item self-report of control over unwanted experiences. Higher total scores (min=13, max=52) indicate greater daily utilization of cognitive control and flexibility.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Emotion Regulation Questionnaire
    Description
    10-item self-report of emotion regulation strategies. Higher total scores (min=10, max=70) indicate greater utilization of emotional regulation strategies.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months
    Title
    Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction
    Description
    27-item self report of motivation and perceived self-efficacy of lifestyle and health behavior change for dementia risk reduction. Higher total scores (min=27, max=135) indicate greater motivation to alter lifestyle factors and health behaviors to reduce risk of dementia.
    Time Frame
    0 Weeks, 8 Weeks, 6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Concerns about memory or thinking (subjective cognitive decline, SCD) Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6 Telephone Interview for Cognitive Status ≥ 28 Functional Assessment Questionnaire < 9 English fluency/literacy Ability and willingness to participate via live video Clearance by medical doctor for study participation 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 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 New mindfulness practice (> 45 min/wk) or cognitive-behavioral therapy in the last 3 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ryan A Mace, PhD
    Phone
    617-724-7030
    Email
    rmace@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chris Lyons
    Email
    clyons9@mgh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35079948
    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.
    Results Reference
    result
    PubMed Identifier
    33784902
    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.
    Results Reference
    result
    PubMed Identifier
    35100922
    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.
    Results Reference
    result

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    Brain Health Program for Older Adults With Subjective Cognitive Decline

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