NCT07478250

Brief Summary

As a result of chronic exposures to traumatic and stressful events, first responders are at elevated risk for experiencing post-traumatic stress disorder (PTSD) and other mental health problems. Resilience training can reduce the risk for developing mental health symptoms in first responders. The National Institute for Environmental Health Sciences and the Substance Abuse Mental Health Services Administration developed the Worker Resilience Training (WRT) program - a 4-hour interactive workshop to educate responders on the effects of traumatic exposures, PTSD and ways to increase adaptive coping resources and promote resilience. The investigators completed a randomized clinical trial (RCT) of the WRT for active responders (n = 167). Results indicated that the WRT, as compared to a waitlist control group, helped prevent the development of PTSD and depression symptoms, and improved important resilience indicators (i.e., healthy lifestyle behaviors, stress management, physical activity) over the course of three months. The proposed multi-site RCT seeks to build on our initial study by conducting a Stage III efficacy trial of the WRT workshop in N=800 first responders in New York (NY) and Texas (TX). Our specific aims are: Aim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year. Aim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop. Aim 3. To identify the target treatment mechanisms of the WRT for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop. Aim 4. To gather qualitative data to further inform a future effectiveness trial including perceptions about the use and potential impact of peer leaders delivering the program content, and perceptions about mode of program delivery via open-ended questions at follow-up. The investigators will use a cluster RCT design and multi-modal assessments including self-report measures, a web-based stress reactivity performance task, and real-time accelerometry. Participants in both conditions will also receive a booster session at 3 months post workshop to reinforce skills and intervention knowledge. This study will contribute to our understanding of how resilience training may serve to protect the mental health and functioning of first responders. This study has important clinical and public health implications, including preserving/strengthening mental health and reducing overall personal and financial costs. This study also takes a research to practice approach by working collaboratively with fire departments and EMS organizations in NY and TX. If successful, the investigators will work with these leaders to develop a method for annual WRT trainings to foster resilience and promote well-being long-term for first responders.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Study Progress3%
Apr 2026Jun 2030

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

April 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 12, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

PTSDTraumaResiliencefirst responders

Outcome Measures

Primary Outcomes (2)

  • Health Promoting Lifestyles Profile II (HPLPII)

    The Health Promoting Lifestyles Profile II is a 52 item self-report inventory of health behaviors and has been used in previous resilience building intervention studies. Participants rate the frequency of participation in each item on a 4-point Likert scale (never, sometimes, often or routinely; range: 1 - 4) with higher scores indicating better health promoting behaviors. The scale yields a healthy lifestyle behaviors total score and 6 subscale scores: spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management. The total healthy lifestyle behaviors score will be used as the primary outcome.

    Baseline, 1,3,6,9,12 months

  • Post-traumatic Stress Disorder Checklist-5 (PCL-5)

    The Post-traumatic Stress Disorder Checklist-5 is a 20-item self-report measure (scored 0-4 per item, total range 0-80) of current PTSD symptoms severity based on the DSM-5 criteria. The Post-traumatic Stress Disorder Checklist-5 is a widely-used and validated measure of PTSD symptom severity with higher scores indicating greater PTSD symptom severity. Participants are asked to rate problems they were bothered by in the past month on a scale of 1=not at all to 5=extremely. The investigators will utilize the Post-traumatic Stress Disorder Checklist-5 total score as a primary PTSD outcome.

    Baseline, 1,3,6,9,12 months

Study Arms (2)

Worker Resilience Training Program

EXPERIMENTAL

The WRT is a 4-hour workshop to aid in building resilience and preventing the development of mental health problems among first responders and other workers frequently exposed to trauma. The WRT includes empirically supported psychological techniques such as motivational interviewing, health behavior goal setting, stress management skills and relaxation training. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.

Behavioral: Worker Resilience Training Program

Fire and Medical Safety (FAMS)

ACTIVE COMPARATOR

The 4-hour FAMS program consists of a review of standard fire and emergency medical health and safety guidelines, skills, and procedures common across fire and EMS departments nationally. The FAMS program will cover topics that are typically presented to fire and EMS providers annually for continuing education or recertification purposes. The FAMS program will adapt content relevant to fire and EMS health and safety operations, fire suppression and safety, gear operation and maintenance, as well as patient medical assessment and care. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.

Behavioral: Fire and Medical Safety (FAMS)

Interventions

The WRT is a 4-hour workshop to aid in building resilience and preventing the development of mental health problems among first responders and other workers frequently exposed to trauma. The WRT includes empirically supported psychological techniques such as motivational interviewing, health behavior goal setting, stress management skills and relaxation training. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.

Worker Resilience Training Program

The 4-hour FAMS program consists of a review of standard fire and emergency medical health and safety guidelines, skills, and procedures common across fire and EMS departments nationally. The FAMS program will cover topics that are typically presented to fire and EMS providers annually for continuing education or recertification purposes. The FAMS program will adapt content relevant to fire and EMS health and safety operations, fire suppression and safety, gear operation and maintenance, as well as patient medical assessment and care. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.

Fire and Medical Safety (FAMS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active first responder at fire station or EMS organization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Texas A & M University

College Station, Texas, 77840, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Fires

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EnvironmentEnvironment and Public Health

Study Officials

  • Adam Gonzalez

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

April 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data will be shared via the NIMH data repository

Shared Documents
STUDY PROTOCOL, SAP

Locations