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| Name | Class |
|---|---|
| Massachusetts Association of Councils on Aging and Senior Center Directors, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| My Healthy Brain | Experimental | My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist or 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Healthy Brain | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Client Satisfaction Questionnaire | Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent) | 8 Weeks |
| 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 (≥70% good, ≥ 80% excellent) | 0 Weeks |
| Rates of Recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39571150 | Background | 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. |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D040242 | Risk Reduction Behavior |
| D000544 | Alzheimer Disease |
| D012907 | Smoking |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Single arm, open pilot study
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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). |
| 0 Weeks |
| Rate of Enrollment | Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent) | 0 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 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 Staff Fidelity to Study Procedures | We will collect and report the number of protocol deviations. | 8 Weeks |
| Rate of Adverse Events | We will collect and report participant's self-reported adverse events. | 8 Weeks |
| Modified Patient Global Impression of Change | 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |