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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06290778
Other study ID # Baylor IRB #023-445
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date August 2027

Study information

Verified date February 2024
Source Baylor Research Institute
Contact Suzy B Gulliver, PhD
Phone 5085249167
Email suzy.gulliver@bswhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 and clinical interview 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 480
Est. completion date August 2027
Est. primary completion date August 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 21 years of age or older - English speaking - Able to sign an informed consent form - Able to complete the structured interview and 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 30 days - Are currently dependent on substances other than tobacco or caffeine.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Unified Protocol
The Brief Transdiagnostic Treatment of Emotional Disorders Unified Protocol.
Psychoeducation
Psychoeducation regarding mental health challenges in fire service.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Baylor Research Institute Boston University, Texas A&M University, University of Pittsburgh

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD Symptoms PTSD Checklist-5 (PCL-5). Score Range: 0-80. Higher scores indicate greater severity. 6, 12, 18, and 24 months
Secondary Alcohol Use Disorder symptoms 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
Secondary Depression symptoms Patient Health Questionnaire (PHQ-9). Score Range: 0-27. Higher scores indicate greater severity. 6, 12, 18, and 24 months
Secondary Anxiety symptoms Generalized Anxiety Disorder (GAD-7). Score Range: 0-21. Higher scores indicate greater severity. 6, 12, 18, and 24 months
Secondary Functional Impairment Work and Social Adjustment Scale (WSAS). Score Range: 0-40. Higher scores indicate greater functional impairment. 6, 12, 18, and 24 months
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