CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 712 enrolled
Drug / intervention
Education Program +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06063174
NCT06063174N/ACompleted

Identifying Social, Molecular, & Immunological Processes for Mitigating Toxic Stress & Enhancing Personalized Resilience

University of California, Los Angeles·interventional·Posted Oct 2, 2023·Updated Apr 15, 2025

In Brief

A clinical study evaluating Education Program, Think Well Program, and 4 other interventions for Stress and 4 related conditions. Completed, enrolled 712 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202420252026
First PostedOct 2, 2023
Enrollment StartJun 30, 2023
Primary CompletionOct 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.8 years ago

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.

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.

Be Well Programbehavioral

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 Programbehavioral

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 Programbehavioral

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 Programbehavioral

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.