Brain Health Program for Older Adults With Subjective Cognitive Decline

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Behavioral: My Healthy Brain 1
* Behavioral: My Healthy Brain 2


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My Healthy Brain 1<br>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<br>* 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.<br>|
| Active Comparator: My Healthy Brain 2<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |