Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
712 participants
INTERVENTIONAL
2023-06-30
2024-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Biomarkers for Stress Vulnerability and Resilience
NCT05498207
Acute Stress Recovery
NCT05298189
WILD 5 Wellness, A 30-Day Intervention
NCT03328520
Healthy Mind Healthy You: A Study of Mindfulness
NCT03844321
Hair Biomarkers Study
NCT07011082
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Objective 2.1. Develop a behavioral intervention using existing programs, platforms, resources, and core components from trauma and resilience research that will target five stress-related domains (i.e., perceived stress, social relationships, diet, sleep, and physical activity) using cognitive restructuring and mindfulness, interpersonal skills training, personalized diet training, sleep training, and behavioral activation.
Objective 2.2. Assess the efficacy of the above-described intervention in about 425 high stress exposure participants from Goal 1. Following their baseline assessment, participants will be randomly assigned to receive (a) the personalized intervention (about 55 participants per stress-related domain), (b) stress \& health psychoeducation/active control group, or (c) nonactive control group. For participants receiving the intervention, the investigators will identify each person's most dysregulated biobehavioral process using the comprehensive biopsychosocial data obtained from Goal 1, focusing on five major stress-related domains: cognitive response style, social relationships, eating, sleep, and physical activity. The investigators will pilot the use of online coach-assisted personalized interventions to target a dysregulated domain for each participant. The investigators will also assess the efficacy of the intervention by comparing changes in outcomes by condition from baseline (prior to randomization) to immediately after the intervention, and then again several months following intervention completion. The primary outcome of interest will be perceived stress (PSS-10). The secondary outcomes of the RCT include five domain specific surveys: the Five-Factor Mindfulness Scale short form (cognitive response style), Conflict Scale and UCLA Loneliness Scale (social relationship domain), Salzburg Stress Eating Scale (eating domain), Insomnia Severity Index (sleeping domain), and International Physical Activity Questionnaire short form (IPAQ, physical activity domain). Exploratory outcomes include the multiomics measures (including untargeted metabolomics, lipidomics, immune proteins, cytokines and the microbiome), physiological measures from the wearable device (i.e., heart rate variability), and continuous glucose monitoring measures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
Education Program
12-week online psychoeducation program on environmental pollution exposures, the health impacts and sources of these exposures, and practical ways to reduce these exposures. Participants in the active control group will receive this form of intervention.
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.
No interventions assigned to this group
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.
Think Well Program
12-week online program in which participants learn to identify negative emotion and thinking patterns and participate in live online group coaching. Participants whose thinking style domain is dysregulated will be assigned to this intervention program.
Be Well Program
12-week online program in which participants learn about the importance of social relationships, connectedness, and interpersonal conflicts, and participate in live online group coaching. Participants whose social relationship/conflict domain is dysregulated will be assigned to this intervention program.
Eat Well Program
12-week online program in which participants learn about mindful eating and participate in live online group coaching. Participants whose diet domain is dysregulated will be assigned to this intervention program.
Sleep Well Program
12-week online program in which participants learn about the importance of good sleep and participate in live online group coaching. Participants whose sleep domain is dysregulated will be assigned to this intervention program.
Move Well Program
12-week online program in which participants learn about the importance of adequate physical activity for health and participate in live online group coaching. Participants whose physical activity domain is dysregulated will be assigned to this intervention program.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Education Program
12-week online psychoeducation program on environmental pollution exposures, the health impacts and sources of these exposures, and practical ways to reduce these exposures. Participants in the active control group will receive this form of intervention.
Think Well Program
12-week online program in which participants learn to identify negative emotion and thinking patterns and participate in live online group coaching. Participants whose thinking style domain is dysregulated will be assigned to this intervention program.
Be Well Program
12-week online program in which participants learn about the importance of social relationships, connectedness, and interpersonal conflicts, and participate in live online group coaching. Participants whose social relationship/conflict domain is dysregulated will be assigned to this intervention program.
Eat Well Program
12-week online program in which participants learn about mindful eating and participate in live online group coaching. Participants whose diet domain is dysregulated will be assigned to this intervention program.
Sleep Well Program
12-week online program in which participants learn about the importance of good sleep and participate in live online group coaching. Participants whose sleep domain is dysregulated will be assigned to this intervention program.
Move Well Program
12-week online program in which participants learn about the importance of adequate physical activity for health and participate in live online group coaching. Participants whose physical activity domain is dysregulated will be assigned to this intervention program.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Be able to understand and agree to comply with planned study procedures in English.
2. Participants must be aged 18 or over.
3. Participants must reside in the state of California.
Exclusion Criteria
History of disease(s):
1. Has a positive test result for human immunodeficiency virus (HIV) types 1 or 2 antibodies.
2. Has had a heart attack or stroke within the past year.
3. 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.
1. Prednisolone (e.g., Omnipred, Pred Mild, Pred Forte, Orapred ODT, Veripred 20, Millipred DP)
2. Prednisone (e.g., Prednisone Intensol, Deltasone, Rayos)
3. Betamethasone (e.g., Celestone Soluspan, Sernivo, Diprolene AF, ReadySharp Betamethasone, Betaloan SUIK, Beta-1)
4. Dexamethasone (e.g., Ozurdex, Maxidex, DexPak 6 Day/10 day/13 Day, LoCort, ZonaCort, ReadySharp dexamethasone, DoubleDex)
5. Hydrocortisone (e.g., Hydrocort, Alphosyl, Aquacort, Cortef, Cortenema, and Solu-Cortef)
6. Methylprednisolone (e.g., Depo-Medrol, Solu-Medrol, Medrol, ReadySharp Methylprednisolone, P-Care D80, and P-Care D40)
7. Deflazacort (e.g., Emflaza)
8. 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
9. Monoclonal antibody therapy
* Infliximab (Remicade)
* Etanercept (Enbrel, Benepali, Erelzi)
* Adalimumab (Humira)
* Secukinumab (Cosentyx)
* Tofacitinib (Xeljanz)
* Rituximab (Rituxan)
* Other Monoclonal antibody therapy not listed above
10. Intravenous immunoglobulin treatment (IVIG)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
University of California, San Francisco
OTHER
California Initiative to Advance Precision Medicine
OTHER
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
George M. Slavich, PhD
Lead Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George M Slavich, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Michael P Snyder, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Alicia F Lieberman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Shannon Thyne, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles County Department of Public Health
Patricia E Lester, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Atul J Butte, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Los Angeles
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hughes K, Bellis MA, Hardcastle KA, Sethi D, Butchart A, Mikton C, Jones L, Dunne MP. The effect of multiple adverse childhood experiences on health: a systematic review and meta-analysis. Lancet Public Health. 2017 Aug;2(8):e356-e366. doi: 10.1016/S2468-2667(17)30118-4. Epub 2017 Jul 31.
California Department of Public Health and Department of Social Services. Adverse Childhood Experiences Data Report: Behavioral Risk Factor Surveillance System (BRFSS), 2011-2017: An Overview of Adverse Childhood Experiences in California. (2020). doi:10.48019/PEAM8812.
Hargreaves MK, Mouton CP, Liu J, Zhou YE, Blot WJ. Adverse Childhood Experiences and Health Care Utilization in a Low-Income Population. J Health Care Poor Underserved. 2019;30(2):749-767. doi: 10.1353/hpu.2019.0054.
Birn RM, Roeber BJ, Pollak SD. Early childhood stress exposure, reward pathways, and adult decision making. Proc Natl Acad Sci U S A. 2017 Dec 19;114(51):13549-13554. doi: 10.1073/pnas.1708791114. Epub 2017 Dec 4.
Slavich GM. Social Safety Theory: A Biologically Based Evolutionary Perspective on Life Stress, Health, and Behavior. Annu Rev Clin Psychol. 2020 May 7;16:265-295. doi: 10.1146/annurev-clinpsy-032816-045159. Epub 2020 Mar 6.
Slavich GM, Way BM, Eisenberger NI, Taylor SE. Neural sensitivity to social rejection is associated with inflammatory responses to social stress. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14817-22. doi: 10.1073/pnas.1009164107. Epub 2010 Aug 2.
Cohodes EM, Kitt ER, Baskin-Sommers A, Gee DG. Influences of early-life stress on frontolimbic circuitry: Harnessing a dimensional approach to elucidate the effects of heterogeneity in stress exposure. Dev Psychobiol. 2021 Mar;63(2):153-172. doi: 10.1002/dev.21969. Epub 2020 Mar 29.
Gee DG, Casey BJ. The Impact of Developmental Timing for Stress and Recovery. Neurobiol Stress. 2015 Jan 1;1:184-194. doi: 10.1016/j.ynstr.2015.02.001.
Miller TR, Waehrer GM, Oh DL, Purewal Boparai S, Ohlsson Walker S, Silverio Marques S, Burke Harris N. Adult health burden and costs in California during 2013 associated with prior adverse childhood experiences. PLoS One. 2020 Jan 28;15(1):e0228019. doi: 10.1371/journal.pone.0228019. eCollection 2020.
Waehrer GM, Miller TR, Silverio Marques SC, Oh DL, Burke Harris N. Disease burden of adverse childhood experiences across 14 states. PLoS One. 2020 Jan 28;15(1):e0226134. doi: 10.1371/journal.pone.0226134. eCollection 2020.
Bhushan D, Kotz K, McCall J, etal. Road map for Resilience: The California Surgeon General's Report on Adverse Childhood Experiences, Toxic Stress, and Health.(2020). doi:10.48019/PEAM8812
Giano Z, Wheeler DL, Hubach RD. The frequencies and disparities of adverse childhood experiences in the U.S. BMC Public Health. 2020 Sep 10;20(1):1327. doi: 10.1186/s12889-020-09411-z.
Dwyer-Lindgren L, Bertozzi-Villa A, Stubbs RW, Morozoff C, Mackenbach JP, van Lenthe FJ, Mokdad AH, Murray CJL. Inequalities in Life Expectancy Among US Counties, 1980 to 2014: Temporal Trends and Key Drivers. JAMA Intern Med. 2017 Jul 1;177(7):1003-1011. doi: 10.1001/jamainternmed.2017.0918.
Stork BR, Akselberg NJ, Qin Y, Miller DC. Adverse Childhood Experiences (ACEs) and Community Physicians: What We've Learned. Perm J. 2020;24:19.099. doi: 10.7812/TPP/19.099. Epub 2020 Jan 24.
Valderhaug TG, Slavich GM. Assessing Life Stress: A Critical Priority in Obesity Research and Treatment. Obesity (Silver Spring). 2020 Sep;28(9):1571-1573. doi: 10.1002/oby.22911. Epub 2020 Jul 29.
Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.
Wang YA, Rhemtulla M. Power analysis for parameter estimates in structural equation modeling:A discussion and tutorial. Adv Methods Pract Psychol Sci. doi:10.31234/osf.io/pj67b
Shields GS, Spahr CM, Slavich GM. Psychosocial Interventions and Immune System Function: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Psychiatry. 2020 Oct 1;77(10):1031-1043. doi: 10.1001/jamapsychiatry.2020.0431.
Kivimaki M, Steptoe A. Effects of stress on the development and progression of cardiovascular disease. Nat Rev Cardiol. 2018 Apr;15(4):215-229. doi: 10.1038/nrcardio.2017.189. Epub 2017 Dec 7.
Truelsen T, Nielsen N, Boysen G, Gronbaek M; Copenhagen City Heart Study. Self-reported stress and risk of stroke: the Copenhagen City Heart Study. Stroke. 2003 Apr;34(4):856-62. doi: 10.1161/01.STR.0000062345.80774.40. Epub 2003 Mar 13.
Slavich GM, Irwin MR. From stress to inflammation and major depressive disorder: a social signal transduction theory of depression. Psychol Bull. 2014 May;140(3):774-815. doi: 10.1037/a0035302. Epub 2014 Jan 13.
Chiang JJ, Park H, Almeida DM, Bower JE, Cole SW, Irwin MR, McCreath H, Seeman TE, Fuligni AJ. Psychosocial stress and C-reactive protein from mid-adolescence to young adulthood. Health Psychol. 2019 Mar;38(3):259-267. doi: 10.1037/hea0000701.
Weyh C, Kruger K, Strasser B. Physical Activity and Diet Shape the Immune System during Aging. Nutrients. 2020 Feb 28;12(3):622. doi: 10.3390/nu12030622.
Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.
Adamantidis A, de Lecea L. Sleep and metabolism: shared circuits, new connections. Trends Endocrinol Metab. 2008 Dec;19(10):362-70. doi: 10.1016/j.tem.2008.08.007. Epub 2008 Oct 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OPR21101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.