Brain Health Program for Older Adults With Subjective Cognitive Decline

Healthy Lifestyle Clinical Trial

Official title:

My Healthy Brain: A Group-Based Lifestyle Intervention to Modify Early Risk of Dementia in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934136
• Other study ID #: 2023P001770
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Ryan A Mace, PhD
• Phone: 617-724-7030
• Email: rmace[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Healthy Lifestyle
• Memory Disorders
• Memory Loss (Excluding Dementia)
• Risk Reduction Behavior

Intervention

Behavioral:
• My Healthy Brain 1
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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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/s10880-022-0 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure of Cognitive Activities	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.	0 Weeks, 8 Weeks, 6 Months
Other	Memory Compensation Questionnaire	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.	0 Weeks, 8 Weeks, 6 Months
Other	Godin Leisure-Time Exercise Questionnaire	3-item self-report of weekly engagement in light, moderate, and vigorous physical activities. Higher average scores indicate greater engagement in total physical activity.	0 Weeks, 8 Weeks, 6 Months
Other	Social Engagement and Activities Questionnaire	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.	0 Weeks, 8 Weeks, 6 Months
Other	PROMIS Loneliness	5-item self-report of perceived loneliness. Higher T scores (mean = 50, sd = 10) indicate greater perceived loneliness.	0 Weeks, 8 Weeks, 6 Months
Other	PROMIS Depression and Anxiety	4-item self-reports of each construct. Higher T scores (mean = 50, sd = 10) indicate greater depression and anxiety.	0 Weeks, 8 Weeks, 6 Months
Other	Applied Mindfulness Process Scale	15-item self-report of using basic mindfulness principles. Higher total scores (min=0, max=60) indicate greater utilization in daily mindfulness activities.	0 Weeks, 8 Weeks, 6 Months
Other	Cognitive Control and Flexibility Questionnaire	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.	0 Weeks, 8 Weeks, 6 Months
Other	Emotion Regulation Questionnaire	10-item self-report of emotion regulation strategies. Higher total scores (min=10, max=70) indicate greater utilization of emotional regulation strategies.	0 Weeks, 8 Weeks, 6 Months
Other	Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction	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.	0 Weeks, 8 Weeks, 6 Months
Primary	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
Primary	Client Satisfaction Questionnaire	Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.	8 Weeks
Primary	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
Primary	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
Primary	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).	8 Weeks
Primary	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).	8 Weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	Cognitive Function Instrument	14-item self-report of cognitive and functional status. Higher total scores (min=0, max=14) indicate greater subjective cognitive complaints.	0 Weeks, 8 Weeks, 6 Months
Secondary	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).	0 Weeks, 8 Weeks, 6 Months
Secondary	PROMIS Physical Function	8-item self-report of daily functioning. Higher T scores (mean = 50, sd = 10) indicate greater physical function.	0 Weeks, 8 Weeks, 6 Months
Secondary	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	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).	0 Weeks, 8 Weeks, 6 Months
Secondary	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	PROMIS Alcohol Use	7-item self-report of at-risk drinking. Higher T scores (mean = 50, sd = 10) indicate greater problematic alcohol use.	0 Weeks, 8 Weeks, 6 Months
Secondary	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).	0 Weeks, 8 Weeks, 6 Months
Secondary	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.	0 Weeks, 8 Weeks, 6 Months