Emotional Well-being and Biomarkers of Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect (v1.0) and PROMIS Meaning and Purpose (v1.0)
研究概览
简要总结
This randomized control study is designed to understand the role of a positive psychology intervention (PARK: Positive Affect Regulation sKills) in biological aging and well-being. PARK provides a series of positive emotion skills in a self-guided online format, making the program accessible and convenient.
Our main aims are:
Aim 1: To explore the effects of PARK on psychological well-being (e.g., depression, anxiety, positive affect).
Aim 2: To explore the effects of PARK on biological age as defined by DNA methylation (DNAm) GrimAge and electrocardiogram-age (ECG-age), as well as physiological well-being in adults (e.g., cardiovascular, endocrine, musculoskeletal functioning, etc.).
详细描述
The skills in the Positive Psychology Intervention (PPI), PARK (e.g., gratitude, mindful awareness and nonjudgement, and self-compassion) are designed to promote positive emotion, which has been shown to provide resilience against stress. Positive emotion, independent of stress and negative emotion, has also been associated with a lower risk of mortality and better health behaviors such as likelihood of physical activity and healthy eating. This randomized control study will compare baseline well-being scores to post-online intervention at 3 months, 6 months, and 12 months post-baseline. Secondarily, measures of biological aging (DNAm GrimAge and ECG-age) and physiological functioning measures of cardiovascular, musculoskeletal, and endocrine functioning will be explored from baseline to post-intervention measures 3 and 12 months later.
Research will be based in Northwestern's Feinberg School of Medicine through the Potocsnak Human Longevity Lab and the Department of Medical Social Sciences (MSS), with all study procedures conducted in-person at the Human Longevity Lab or online. Eligibility screening, consent, and assessments will be conducted on REDCap. Consenting participants randomized to the treatment group will receive access to the online PARK platform within two weeks. The intervention consists of a positive skills course (including weekly lessons and daily skills practice) and daily emotion check-ins, hosted by BrightOutcome. The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-70
- •Speaks and reads English
- •Able to access the online platform through their phone, a public device (i.e., at the library) or at home.
- •Lives in the Chicagoland area
- •Willing/able to travel to the Human Longevity Lab for in-person visits
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Vulnerable Populations
- •Pre-existing heart disease (prevalent coronary heart and cerebrovascular disease or heart failure)
- •Type 2 diabetes
- •Severe psychiatric illness
研究组 & 干预措施
Positive Emotion Skills Intervention
Participants will receive the 6-week online intervention, PARK (Positive Affect Regulation sKills Course).
干预措施: Positive Emotion Skills Intervention (Behavioral)
Waitlist Control
The waitlist control condition will receive usual care in the Human Longevity Lab, which consists of a feedback report on biological age and lifestyle counseling from a clinical provider at the end of the study period. Control condition participants will have the option to gain access to the PARK platform and learn positive emotion skills after their study participation is completed at the end of 12 months.
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect (v1.0) and PROMIS Meaning and Purpose (v1.0)
时间窗: Baseline, 3 months, 6 months, 12 months
Computer Adaptive Testing measure of positive emotion and purpose. Higher scores mean a better outcome (i.e., more positive emotion). Scores can range from 9-85, and a t-score of 50 represents the mean score for the United States general population with a standard deviation of 10.
PROMIS Depression (v1.0), Anxiety (v1.0), Social Isolation (v2.0)
时间窗: baseline and 3, 6, 12 months post-baseline
Computer Adaptive Testing measures of psychosocial well-being. Higher scores mean a worse outcome (i.e., more anxiety or depression). Scores can range from 9-85, and a t-score of 50 represents the mean score for the United States general population with a standard deviation of 10.
次要结局
- Biological Age: DNA methylation GrimAge(Baseline, 3 months, 12 months)
- ECG-age (electrocardiogram-age)(Baseline, 3 months, 12 months)
- Telomere Length(Baseline, 3 months, 12 months)
研究者
Judith Moskowitz
Professor
Northwestern University