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Recruiting NCT05751473

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

No phase Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prolonged Exposure for Primary Care (PE-PC), EAP Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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 m
  • 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 EA

Primary outcome measures

  • Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score [Time frame: baseline to 6 months]
Secondary outcome measures (4)
  • Change in Burnout based on the Oldenburg Burnout Inventory [Time frame: baseline to 6 months]
  • Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH) [Time frame: baseline to 6 months]
  • Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9) [Time frame: baseline to 6 months]
  • Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8) [Time frame: baseline to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Sharp Healthcare — San Diego
  • Tanner Health System — Carrollton
  • University of Michigan — Ann Arbor
  • Henry Ford Health System — Detroit
  • Detroit Fire Department — Detroit
  • Health Management Systems of America — Detroit
  • Michigan State University — East Lansing
  • West Bloomfield Fire Department — West Bloomfield
  • … and 6 more centers

Publications

  • 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

Identifiers

NCT: NCT05751473 · HUM00219260 · 1R01MH126693-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗