My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Credibility and Expectancy Questionnaire (CEQ)
研究概览
简要总结
The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •English fluency/literacy
- •≥1 modifiable brain disease risk factor (outlined by JAMA)
- •Bluetooth 4.0 enabled smartphone
排除标准
- •Diagnosis of dementia; Montreal Cognitive Assessment < 18
- •Serious medical illness expected to worsen in next 6 months
- •Current suicidal ideation
- •Substance abuse
- •Untreated serious mental health conditions
- •Current use of digital monitoring device (eg. Fitbit)
- •Mindfulness practice (> 45 minutes/week) in the last three months
结局指标
主要结局
Credibility and Expectancy Questionnaire (CEQ)
时间窗: Baseline (0 Weeks)
percent of participants that score beyond scale midpoint
Treatment Fidelity
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of sessions rated as 100% adherent
Recruitment Feasibility
时间窗: Baseline (0 Weeks)
percent of referred patients meeting criteria to participate
Assessment Feasibility
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of post-questionnaires completed
Client Satisfaction Questionnaire (CSQ-3)
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Program Acceptability
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants completing at least 6 sessions
Adherence to Actigraph
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants wearing Actiwatch ≥ 5 days per week
Adherence to Lifestyle Behaviors
时间窗: Baseline (0 Weeks), Post-Test (8 Weeks)
percent of participants completing weekly homework
次要结局
- Mindfulness: Five-Facet Mindfulness Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: PROMIS Depression(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: PROMIS Social Isolation(Baseline (0 Weeks), Post-Test (8 Weeks))
- Change in Healthy Aging(Baseline (0 Weeks), Post-Test (8 Weeks))
- Mindfulness: Homework log(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: Actigraph measures of activity(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: Perceived Stress Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: Everyday Cognition Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: PROMIS Cognition(Baseline (0 Weeks), Post-Test (8 Weeks))
- Cognitive Functioning: Montreal Cognitive Assessment(Baseline (0 Weeks), Post-Test (8 Weeks))
- Mindfulness: Cognitive and Affective Mindfulness Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Pittsburgh Sleep Quality Index(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Jenkins Sleep Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Sleep: Actigraph measures of sleep(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: PROMIS Physical Function(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: Godin Leisure Time Exercise Questionnaire(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Morisky Medication Adherence Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: UCLA Loneliness Scale(Baseline (0 Weeks), Post-Test (8 Weeks))
- Physical Activity: Rapid Assessment of Physical Activity(Baseline (0 Weeks), Post-Test (8 Weeks))
- Nutrition: MIND Diet Adherence Checklist(Baseline (0 Weeks), Post-Test (8 Weeks))
- Nutrition: Mediterranean Eating Pattern for Americans Screener(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption(Baseline (0 Weeks), Post-Test (8 Weeks))
- Medication and Substance Use: Fagerstrom Test for Nicotine Depedence(Baseline (0 Weeks), Post-Test (8 Weeks))
- Social Functioning: PROMIS Emotional Support(Baseline (0 Weeks), Post-Test (8 Weeks))
- Stress and Emotional Functioning: PROMIS Anxiety(Baseline (0 Weeks), Post-Test (8 Weeks))
研究者
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital