Identifying Social, Molecular, & Immunological Processes for Mitigating Toxic Stress & Enhancing Personalized Resilience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Change in PSS-10
研究概览
简要总结
Goal 1: The investigators will quantify lifetime stress burden and examine mechanisms linking Adverse Childhood Experiences (ACEs) and health. The investigators will quantify the early life and total lifetime stress burden of a representative sample of about 725 adults (aged 18+) across northern and southern California. In addition, the investigators will examine how prior life stress exposure and current stress levels are associated with differences in psychosocial, immune, metabolic, physiologic, and clinical outcomes for all participants at baseline.
Goal 2: The investigators will develop and test a biopsychosocial intervention using existing programs, platforms, resources, and core components from trauma and resilience research that will target five stress-related domains (i.e., cognitive response style, social relationships, eating, sleep, and physical activity) using cognitive restructuring and mindfulness, interpersonal skills training, mindful eating training, sleep training, and behavioral activation/mobility training. The investigators will then assess the efficacy and acceptability of the intervention in about 425 high stress exposure participants from Goal 1. Following their baseline assessment, about 425 participants will be randomly assigned to receive for 12 weeks (a) personalized intervention, (b) environmental education (active control) or (c) nothing (non-active control). The investigators will also assess the efficacy of the personalized intervention by comparing changes in outcomes by condition from baseline (prior to randomization) to immediately after the intervention, and then again after 12 weeks following intervention completion. The interventions will be entirely online/remote.
详细描述
Aim 1: The investigators will quantify lifetime stress burden and examine mechanisms linking Adverse Childhood Experiences (ACEs) and health. The investigators will quantify the early life and total lifetime stress burden of a representative sample of about 725 adults (aged 18+) across California. In addition, the investigators will examine how prior life stress exposure and current stress levels are associated with differences in psychosocial, immune, metabolic, physiologic, and clinical outcomes for all participants at baseline.
Objective 1.1. Characterize associations between stress levels and psychosocial and clinical functioning by collecting self-report data from participants (see below) and by using any available electronic health records.
Objective 1.2. Examine cross-sectional relations between stress levels and physiological, biological, and behavioral processes using (1) immune and metabolic functioning assessed by non-invasive blood microsampling and the investigators' unique multi-omics approach, and (2) continuously monitored physiologic and behavioral functioning using smartwatches that have the ability to assess a variety of physiologic & behavioral processes (e.g., cardiac function, sleep, activity levels).
Objective 1.3. Develop a Personal Health Dashboard for processing data with an algorithm that will generate personalized results to inform individualized health risk assessments and provide an opportunity to deliver tailored clinical feedback and biopsychosocial resiliency training by targeting five key stress-related risk factors (see Aim 2).
Aim 2: Reduce ACEs-related health disparities by developing and testing a behavioral intervention for about 425 of the higher stress participants from Aim 1. To reduce negative stress-related effects and bolster resilience, the investigators will examine the acceptability and effectiveness of a 12 week, online, precision behavioral intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A participant must meet all of the following criteria to be eligible to participate in this study:
- •Be able to understand and agree to comply with planned study procedures in English.
- •Participants must be aged 18 or over.
- •Participants must reside in the state of California.
排除标准
- •A participant who meets any of the following criteria will be excluded from participation in this study:
- •History of disease(s):
- •Has a positive test result for human immunodeficiency virus (HIV) types 1 or 2 antibodies.
- •Has had a heart attack or stroke within the past year.
- •Has had and/or been treated for any type of cancer in the past two years.
- •Medication(s):
- •Participants who check off any of the following medications and/or treatment listed below over the past month will be excluded in the study.
- •Prednisolone (e.g., Omnipred, Pred Mild, Pred Forte, Orapred ODT, Veripred 20, Millipred DP)
- •Prednisone (e.g., Prednisone Intensol, Deltasone, Rayos)
- •Betamethasone (e.g., Celestone Soluspan, Sernivo, Diprolene AF, ReadySharp Betamethasone, Betaloan SUIK, Beta-1)
- •Dexamethasone (e.g., Ozurdex, Maxidex, DexPak 6 Day/10 day/13 Day, LoCort, ZonaCort, ReadySharp dexamethasone, DoubleDex)
- •Hydrocortisone (e.g., Hydrocort, Alphosyl, Aquacort, Cortef, Cortenema, and Solu-Cortef)
- •Methylprednisolone (e.g., Depo-Medrol, Solu-Medrol, Medrol, ReadySharp Methylprednisolone, P-Care D80, and P-Care D40)
- •Deflazacort (e.g., Emflaza)
- •Immunomodulators
- •Cyclosporine (Sandimmune, Neoral, Gengraf, Restasis MultiDose)
- •Tacrolimus (Protopic, Envarsus XR, Astagraf XL, Prograf)
- •Methotrexate (Rheumatrex, Trexall, Otrexup (PF), Xatmep, Rasuvo, Mexate, MTX)
- •Azathioprine (Immuran, Azasan)
- •Mercaptopurine (6-MP, Purinethol, Purixan)
- •Other Immunomodulators not listed above
- •Monoclonal antibody therapy
- •Infliximab (Remicade)
- •Etanercept (Enbrel, Benepali, Erelzi)
- •Adalimumab (Humira)
- •Secukinumab (Cosentyx)
- •Tofacitinib (Xeljanz)
- •Rituximab (Rituxan)
- •Other Monoclonal antibody therapy not listed above
- •Intravenous immunoglobulin treatment (IVIG)
研究组 & 干预措施
Baseline-Only
Baseline-only condition will be cross-sectional, and participants will be only completing the first portion of the study. Participants in this arm will be asked to wear a research-grade smartwatch for at least one week and complete the baseline package at one time point which includes self-reported questionnaires, micro-blood collection, and optional stool collection.
Active Control
Active control condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants in the active control group will receive a 12 week psychoeducation training on stress and health called the Environmental Education Program.
干预措施: Education Program (Behavioral)
Nonactive Control
Nonactive control condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants in the nonactive control group will not be receiving any forms of intervention. Participants in this program called the Follow-up Program will be tracked over 12 weeks in parallel to participants receiving an intervention and another 12 weeks after.
CAL STAR Personalized Intervention
CAL STAR Personalized Intervention condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants will be assigned to one of the five CAL STAR Personalized Intervention training programs (Think Well, Be Well, Eat Well, Sleep Well, Move Well programs) depending on their score on a self-reported survey called Consequences of Stress Scale (CSS). Based on the CSS score, a participant will be assigned to one of the five programs to work on a domain that is dysregulated when they are stressed. When eligible for multiple, their availability to attend coaching sessions and preferences will be accounted for, or they will be randomly assigned to conditions for which they are eligible.
干预措施: Think Well Program (Behavioral)
CAL STAR Personalized Intervention
CAL STAR Personalized Intervention condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants will be assigned to one of the five CAL STAR Personalized Intervention training programs (Think Well, Be Well, Eat Well, Sleep Well, Move Well programs) depending on their score on a self-reported survey called Consequences of Stress Scale (CSS). Based on the CSS score, a participant will be assigned to one of the five programs to work on a domain that is dysregulated when they are stressed. When eligible for multiple, their availability to attend coaching sessions and preferences will be accounted for, or they will be randomly assigned to conditions for which they are eligible.
干预措施: Be Well Program (Behavioral)
CAL STAR Personalized Intervention
CAL STAR Personalized Intervention condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants will be assigned to one of the five CAL STAR Personalized Intervention training programs (Think Well, Be Well, Eat Well, Sleep Well, Move Well programs) depending on their score on a self-reported survey called Consequences of Stress Scale (CSS). Based on the CSS score, a participant will be assigned to one of the five programs to work on a domain that is dysregulated when they are stressed. When eligible for multiple, their availability to attend coaching sessions and preferences will be accounted for, or they will be randomly assigned to conditions for which they are eligible.
干预措施: Eat Well Program (Behavioral)
CAL STAR Personalized Intervention
CAL STAR Personalized Intervention condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants will be assigned to one of the five CAL STAR Personalized Intervention training programs (Think Well, Be Well, Eat Well, Sleep Well, Move Well programs) depending on their score on a self-reported survey called Consequences of Stress Scale (CSS). Based on the CSS score, a participant will be assigned to one of the five programs to work on a domain that is dysregulated when they are stressed. When eligible for multiple, their availability to attend coaching sessions and preferences will be accounted for, or they will be randomly assigned to conditions for which they are eligible.
干预措施: Sleep Well Program (Behavioral)
CAL STAR Personalized Intervention
CAL STAR Personalized Intervention condition will be longitudinal. Participants in this arm will be asked to wear a research-grade smartwatch for at least 24 weeks and complete the baseline package as well as two follow-ups over a period of 24 weeks. After completing the baseline package, participants will be assigned to one of the five CAL STAR Personalized Intervention training programs (Think Well, Be Well, Eat Well, Sleep Well, Move Well programs) depending on their score on a self-reported survey called Consequences of Stress Scale (CSS). Based on the CSS score, a participant will be assigned to one of the five programs to work on a domain that is dysregulated when they are stressed. When eligible for multiple, their availability to attend coaching sessions and preferences will be accounted for, or they will be randomly assigned to conditions for which they are eligible.
干预措施: Move Well Program (Behavioral)
结局指标
主要结局
Change in PSS-10
时间窗: PSS-10 will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).
The primary endpoint will be the change in Perceived Stress Scale (PSS-10) score between the nonactive control, active control, and the treatment groups (combined) from screening to Follow-up 1 \& 2. A meaningful clinically significant score in the PSS-10 score is a difference of 5 points. The range of the PSS-10 is 0-40, with higher scores indicating more perceived stress. As such PSS-10 change scores could range from -40 to 40. A positive PSS-10 change score indicates increased stress and is a negative outcome. A negative PSS-10 change score indicates decreased stress and is a positive outcome.
次要结局
- Change in Five-Factor Mindfulness Scale short form (cognitive response style domain)(Five-Factor Mindfulness scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
- Change in CSS subscale Score(Consequences of Stress scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
- Change in Insomnia Severity Index (sleeping domain)(Insomnia Severity Index scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
- Change in Conflict Scale and UCLA Loneliness Scale (social relationship domain)(Five-Factor Mindfulness scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
- Change in International Physical Activity Questionnaire short form (physical activity domain)(International Physical Activity Questionnaire scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
- Change in Salzburg Stress Eating Scale (eating domain)(Salzburg Stress Eating scale will be assessed at all three time points during the baseline period (first 1-3 weeks of the study), follow-up1 (after 12-week intervention), and follow-up2 (at 24 week mark from baseline).)
研究者
George M. Slavich, PhD
Lead Principal Investigator
University of California, Los Angeles