Stress & Resilience Study

NCT06063174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2025-04-15

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • George M Slavich, PhD · University of California, Los Angeles

  • Michael P Snyder, PhD · Stanford University

  • Alicia F Lieberman, PhD · University of California, San Francisco

  • Shannon Thyne, MD · Los Angeles County Department of Public Health

  • Patricia E Lester, MD · University of California, Los Angeles

  • Atul J Butte, MD,PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063174 on ClinicalTrials.gov