跳至主要内容
临床试验/NCT07478250
NCT07478250尚未招募不适用

A Large-scale Efficacy Trial of a Resilience Training Program for First Responders

Stony Brook University2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
试验地点
2
主要终点
Health Promoting Lifestyles Profile II (HPLPII)

研究概览

简要总结

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.

详细描述

This study seeks to build on our initial study by conducting a Stage III efficacy trial of the Worker Resilience Training (WRT) workshop and monitoring outcomes over the course of one year in N=800 first responders in NY and TX. Specifically, the investigators will employ a stratified parallel group cluster randomized clinical trial (RCT) design to evaluate the efficacy of the WRT (intervention) compared to a Fire and Medical Safety (FAMS) workshop (time-matched control) for (1) engaging resilience targets (i.e., promoting healthy behaviors, stress management and physical activity), increasing perceived resilience and preventing deterioration in mental and occupational health and functioning in first responders; and (2) to evaluate mediators of the effect of the WRT program on mental and occupational health and functioning. Participants in both conditions will also receive a booster session at 3 months post workshop. Multi-modal assessments will be used including self-report measures, daily diary survey of skills practice, a web-based stress reactivity performance task, and real-time accelerometry.

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 (i.e., healthy lifestyle behaviors, stress management, physical activity and perceived resilience) 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active first responder at fire station or EMS organization

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Worker Resilience Training Program (Behavioral)

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.

干预措施: Fire and Medical Safety (FAMS) (Behavioral)

结局指标

主要结局

Health Promoting Lifestyles Profile II (HPLPII)

时间窗: Baseline, 1,3,6,9,12 months

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.

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

时间窗: Baseline, 1,3,6,9,12 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Gonzalez

Full Professor

Stony Brook University

研究点 (2)

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