- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290778
Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees (PEER UP)
The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:
- Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
- Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
- Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?
Participants will:
- Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
- Complete a questionnaire prior to the workshop.
- Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.
Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76708
- MacArthur Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 21 years of age or older
- English speaking
- Able to sign an informed consent form
- Able to complete the self-report assessment
- Willing to be contacted to complete post and follow-up assessments
Exclusion Criteria:
- Pregnant
- Have plans to relocate within two months of protocol initiation
- Report psychotic symptoms or suicidal behavior within the past 2 weeks
- Are currently dependent on substances other than tobacco or caffeine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Unified Protocol
This workshop includes education regarding basic human emotions, why we have emotions, how they help us, how they can get in the way, and how they are related to psychological health problems, including among firefighters.
Skills that are helpful in managing strong or unwanted emotions will be taught and practiced during the workshop.
A workshop manual will be provided.
Brief videos summarizing the material will be emailed over the course of the month following the workshop.
|
The Brief Transdiagnostic Treatment of Emotional Disorders Unified Protocol.
|
|
Active Comparator: Psychoeducation
This workshop provides education regarding signs and symptoms of psychological health challenges that are most commonly experienced by firefighters.
These include posttraumatic stress, depression, anxiety, and alcohol and substance misuse.
This workshop is a standard part of fire academy training.
A workshop manual will be provided.
Brief videos summarizing the material will be emailed over the course of the month following the workshop.
|
Psychoeducation regarding mental health challenges in fire service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Symptoms
Time Frame: 6, 12, 18, and 24 months
|
PTSD Checklist-5 (PCL-5).
Score Range: 0-80.
Higher scores indicate greater severity.
|
6, 12, 18, and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Use Disorder symptoms
Time Frame: 6, 12, 18, and 24 months
|
Alcohol Use Disorders Identification Test (AUDIT).
Score Range: 0-40.
Higher scores indicate a higher likelihood of alcohol dependence.
|
6, 12, 18, and 24 months
|
|
Depression symptoms
Time Frame: 6, 12, 18, and 24 months
|
Patient Health Questionnaire (PHQ-9).
Score Range: 0-27.
Higher scores indicate greater severity.
|
6, 12, 18, and 24 months
|
|
Anxiety symptoms
Time Frame: 6, 12, 18, and 24 months
|
Generalized Anxiety Disorder (GAD-7).
Score Range: 0-21.
Higher scores indicate greater severity.
|
6, 12, 18, and 24 months
|
|
Functional Impairment
Time Frame: 6, 12, 18, and 24 months
|
Work and Social Adjustment Scale (WSAS).
Score Range: 0-40.
Higher scores indicate greater functional impairment.
|
6, 12, 18, and 24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Baylor IRB #023-445
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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