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

Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs

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).

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure for Primary Care (PE-PC); Behavioral: EAP Treatment as Usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naomi Hemphill; Email: hnaomi@med.umich.edu
• Study Contact Backup: Name: James Garlick; Phone Number: 734-232-2663; Email: jgarlick@med.umich.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92129
      • Withdrawn
      • Sharp HealthCare
  • Georgia
    • Carrollton, Georgia, United States, 30117
      • Recruiting
      • Tanner Health System
      • Contact: Rachel M Walker, Ed.S., LPC, CEAP, CCC; Phone Number: 770-834-8327; Email: rawalker@tanner.org
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: James Garlick; Email: jgarlick@umich.edu
      • Contact: Naomi Hemphill; Email: hnaomi@umich.edu
      • Principal Investigator: Rebecca Sripada, PhD
    • Detroit, Michigan, United States, 48202
      • Active, not recruiting
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48226
      • Recruiting
      • Detroit Fire Department
      • Contact: Lennette Wood; Phone Number: 313-530-2912; Email: Woodl4116@detroitmi.gov
    • Detroit, Michigan, United States, 48226
      • Recruiting
      • Health Management Systems of America
      • Contact: Monique Jones, LMSW, CEAP; Phone Number: 800-847-7240; Email: monique.jones@hmsanet.com
    • East Lansing, Michigan, United States, 48824-1037
      • Recruiting
      • Michigan State University
      • Contact: Jon Novello, LMSW,ACSW; Phone Number: 517-355-4509; Email: novelloj@msu.edu
      • Principal Investigator: Jon Novello, LMSW,ACSW
    • West Bloomfield, Michigan, United States, 48322
      • Active, not recruiting
      • West Bloomfield Fire Department
  • New York
    • New York, New York, United States, 10017
      • Recruiting
      • Cope NewYork-Presbyterian
      • Contact: Randy Martin, PhD; Phone Number: 646-988-1763; Email: rdm4002@med.cornell.edu
      • Principal Investigator: Randy Martin, PhD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • University of Cincinati Health
      • Contact: Lisa Melink, MA,LPCC; Phone Number: 513-585-6094; Email: lisa.melink@uchealth.com
      • Principal Investigator: Lisa Melink, MA,LPCC
    • Fremont, Ohio, United States, 43420
      • Recruiting
      • Promedica
      • Contact: Chris Tafelski, LPCC,CEAP; Phone Number: 211219 419-291-1219; Email: Christopher.tafelski@promedica.org
      • Principal Investigator: Chris Tafelski, LPCC,CEAP
  • Texas
    • Houston, Texas, United States, 77002
      • Recruiting
      • Houston Fire Department
      • Contact: Leah Belsches, PsyD; Phone Number: 832-405-6865; Email: leah.belsches@houstontx.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure for Primary Care	Behavioral: Prolonged Exposure for Primary Care (PE-PC); Treatment will be given by telehealth or in person, depending on the participant preference. Content is drawn from the Full Prolonged Exposure model and condensed so as to deliver the most efficacious components in a brief format. There will be 4-6 weekly 30-minute sessions. Treatment follows the standardized PE-PC manual and workbook. At the end of the final session, the counselor and participant will review treatment progress and either conclude treatment or refer the participant to outside mental healthcare for more intensive treatment. Participants will complete surveys and complete homework during and following the study.
Active Comparator: EAP Treatment as Usual (TAU); Employee Assistance Programs standard treatment.	Behavioral: EAP Treatment as Usual (TAU); Treatment will be given by telehealth or in person, depending on the participant preference and current EAP practices (4-6 weeks). This will be the standard of care practice at each EAP site. Usually, this includes up to six sessions of solution focused therapy, and referrals to an established network of community providers who specialize in PTSD treatment. All PTSD care received during the study will be collected and monitored as TAU. The type of TAU used will reflect the current practice in EAPs and will not be constrained in the study design. EAP staff will monitor and record all EAP care received, including tracking no shows and cancellations. Study team members will document care received outside of the EAP (including psychiatric medications) by self-report. Participants will complete surveys and complete homework during and following the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score	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.	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Burnout based on the Oldenburg Burnout Inventory	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.	baseline to 6 months
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)	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).	baseline to 6 months
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)	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.	baseline to 6 months
Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)	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.	baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Rebecca Sripada, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Prolonged Exposure for Primary Care; First Responders; Employee Assistance Programs; Frontline Healthcare Workers
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HUM00219260; 1R01MH126693-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No