Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder

• Registration Number: NCT05751473
• Lead Sponsor: University of Michigan

Brief Summary

This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).

The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Study Start: 2023-05-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

• Are employees at an orginization served by a participating EAP
• Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
• Have had psychotropic medication stability for at least 4 weeks

Inclusion criteria for the qualitative portion of the study:

• Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder

Exclusion Criteria

• Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
• High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
• Need for detoxification
• Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
• Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
• Patients who do not speak English will be excluded for logistical reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score	baseline to 6 months	The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)	baseline to 6 months	This is an 8-item questionnaire that participants complete. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)	baseline to 6 months	The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 visual analog scale (VAS).
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)	baseline to 6 months	This is a 9-item questionnaire that participants select responses from not at all (0) to nearly every day (3), the minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Change in Burnout based on the Oldenburg Burnout Inventory	baseline to 6 months	This is a 16-question inventory that assesses burnout. The self-report rating scale is 1-4 for each symptom.The minimum and maximum values are 16 and 64, with higher scores indicating worse outcome.

Trial Locations

Locations (12)

Detroit Fire Department; 🇺🇸 Detroit, Michigan, United States

Health Management Systems of America; 🇺🇸 Detroit, Michigan, United States

West Bloomfield Fire Department; 🇺🇸 West Bloomfield, Michigan, United States

Houston Fire Department; 🇺🇸 Houston, Texas, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States

Tanner Health System; 🇺🇸 Carrollton, Georgia, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

Cope NewYork-Presbyterian; 🇺🇸 New York, New York, United States

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