Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

712

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jun 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 30, 2023

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed

26 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed

Last Updated

April 15, 2025

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

September 6, 2023

Last Update Submit

April 10, 2025

Conditions

Stress Stress, Psychological Stress, Physiological Stress, Emotional Stress Reaction

Keywords

StressImmunologyPsychosocialClinicalResilience

Outcome Measures

Primary Outcomes (1)

Change in PSS-10
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.
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).

Secondary Outcomes (6)

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 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 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 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).
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).
+1 more secondary outcomes

Study Arms (4)

Baseline-Only

NO INTERVENTION

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 COMPARATOR

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.

Behavioral: Education Program

Nonactive Control

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Think Well ProgramBehavioral: Be Well ProgramBehavioral: Eat Well ProgramBehavioral: Sleep Well ProgramBehavioral: Move Well Program

Interventions

Education ProgramBEHAVIORAL

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.

Active Control

Think Well ProgramBEHAVIORAL

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.