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

NCT05751473 | Recruiting

• 2 other identifiers: HUM002192601R01MH126693-01
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 12

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).

Conditions

Post Traumatic Stress Disorder

Keywords

Employee Assistance Programs; Frontline Healthcare Workers; Prolonged Exposure for Primary Care; First Responders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Burnout based on the Oldenburg Burnout Inventory

  baseline to 6 months

• Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)

  baseline to 6 months

• Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)

  baseline to 6 months

• Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)

  baseline to 6 months

Study Arms (2)

Prolonged Exposure for Primary Care

EXPERIMENTAL

Behavioral: Prolonged Exposure for Primary Care (PE-PC)

EAP Treatment as Usual (TAU)

ACTIVE COMPARATOR

Employee Assistance Programs standard treatment.

Behavioral: EAP Treatment as Usual (TAU)

Interventions

Prolonged Exposure for Primary Care (PE-PC) BEHAVIORAL

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.

Prolonged Exposure for Primary Care

EAP Treatment as Usual (TAU) BEHAVIORAL

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.

EAP Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (12)

Sharp Healthcare

San Diego, California, 92129, United States

WITHDRAWN

Tanner Health System

Carrollton, Georgia, 30117, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Detroit Fire Department

Detroit, Michigan, 48226, United States

RECRUITING

Health Management Systems of America

Detroit, Michigan, 48226, United States

RECRUITING

Michigan State University

East Lansing, Michigan, 48824-1037, United States

RECRUITING

West Bloomfield Fire Department

West Bloomfield, Michigan, 48322, United States

ACTIVE NOT RECRUITING

Cope NewYork-Presbyterian

New York, New York, 10017, United States

RECRUITING

University of Cincinati Health

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

ProMedica

Fremont, Ohio, 43420, United States

RECRUITING

Houston Fire Department

Houston, Texas, 77002, United States

RECRUITING

Related Publications (1)

• Sripada RK, Garlick J, Hemphill N, Walters HM, Ganoczy D, Kim HM, Zivin K, Nevedal AL, Avallone KM, Cigrang JA, Rauch SAM. Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108174. doi: 10.1016/j.cct.2025.108174. Epub 2025 Dec 4.

  PMID: 41352531 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Rebecca Sripada, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Garlick

CONTACT

734-232-2663; jgarlick@med.umich.edu

Naomi Hemphill

CONTACT

hnaomi@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: May 16, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)