Prevention Starts Here: Piloting My Healthy Brain in Massachusetts Councils on Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rates of Treatment Completion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
My Healthy Brain
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.
干预措施: My Healthy Brain (Behavioral)
结局指标
主要结局
Rates of Treatment Completion
时间窗: 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
时间窗: 8 Weeks
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)
次要结局
- Credibility and Expectancy Questionnaire(0 Weeks)
- Rates of Recruitment(0 Weeks)
- Rate of Enrollment(0 Weeks)
- Rates of Valid Activity Watch Data (10 or more hours of wear time)(8 Weeks)
- Rates of Missing Outcomes Data(8 Weeks)
- Rates of Staff Fidelity to Study Procedures(8 Weeks)
- Rate of Adverse Events(8 Weeks)
- Modified Patient Global Impression of Change(8 Weeks)
研究者
Ryan A., Mace, PHD
Assistant Professor of Psychology
Massachusetts General Hospital