Dementia Prevention, Healthy Lifestyle Behaviors, Lifestyle Risk Reduction, Lifestyle (Sedentary Behavior and Physical Activity), Memory Loss (Excluding Dementia)
Conditions
Keywords
Cogntive Aging, Health Promotion, Mindfulness, Community Health Services, Feasibility Studies, Alzheimer Disease / prevention & control, Exercise, Diet, Sleep, Social Interaction, Cognitive Stimulation, Smoking, Alcohol Drinking
Brief summary
The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.
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 trial of a mindfulness-based lifestyle programs. Eligible older adults include: age ≥ 50, self-reported worry about changes in memory or thinking, and self-reported interest in improving lifestyle behaviors. Participants complete 8 weekly 90-minute sessions delivered by a clinical psychologist or trainee. All participants will wear an activity watch to support and monitor lifestyle changes during the program. 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 program, delivered in senior centers.
Interventions
BEHAVIORALMy Healthy Brain
My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist pr trainee. 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 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 participants wear an activity watch to monitor lifestyle changes during the program.
Sponsors
Massachusetts General Hospital
Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single arm, open pilot study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 50 * Subjective cognitive decline (SCD; e.g., forgetting information, getting lost, and repeating oneself) * Able to self-identify at least 1 modifiable lifestyle risk factors for dementia to change during the program (physically inactive, poor sleep, non-adherence to Mediterranean diet, alcohol use, tobacco use, socially isolated or lonely, mental inactivity) * Absence of significant cognitive impairment (assessed using Short Blessed Test71 ≤ 9) * Self-reported English proficiency/literacy * Ability and willingness to participate and complete all study-related activities
Exclusion criteria
* Dementia or other neurodegenerative disease per patient self-report or disclosure * Psychosis, uncontrolled schizophrenia or schizoaffective disorder, uncontrolled bipolar disorder, or uncontrolled substance dependence/abuse * Active self-report of suicidal ideation / high risk of suicide * Serious medical illness expected to worsen during the study * Self-reported safety issues with initiating lifestyle change
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Treatment Completion | 8 Weeks | We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent). |
| Client Satisfaction Questionnaire | 8 Weeks | Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Credibility and Expectancy Questionnaire | 0 Weeks | Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy (≥70% good, ≥ 80% excellent) |
| Rates of Recruitment | 0 Weeks | We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to screen divided by the total number contacted (≥70% good, ≥ 80% excellent). |
| Rate of Enrollment | 0 Weeks | Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent) |
| Rates of Valid Activity Watch Data (10 or more hours of wear time) | 8 Weeks | 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). |
| Rates of Missing Outcomes Data | 8 Weeks | 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 Staff Fidelity to Study Procedures | 8 Weeks | We will collect and report the number of protocol deviations. |
| Rate of Adverse Events | 8 Weeks | We will collect and report participant's self-reported adverse events. |
| Modified Patient Global Impression of Change | 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). |
Countries
United States
Outcome results
None listed