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

Last updated: July 1, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Prolonged Exposure for Primary Care (PE-PC)

EAP Treatment as Usual (TAU)

Clinical Study ID

NCT05751473
HUM00219260
1R01MH126693-01
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are employees at an orginization served by a participating EAP

  • Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and StatisticalManual 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 atreatment non-responder

Exclusion

Exclusion Criteria:

  • Severe cognitive impairment that in the judgment of the investigators makes itunlikely that the participant can adhere to the study regimen (as evidenced byconfusion, inability to track discussion or answer questions, or other clear andsignificant indicators of cognitive impairment)

  • High risk of suicide (defined as meeting criteria for Action Step 3 on theParticipant Suicide Risk Screening form: found in protocol)

  • Need for detoxification

  • Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 ofthe cross cutting assessment

  • Currently engagement in a trauma-focused behavioral treatment (such as ProlongedExposure or Cognitive Processing Therapy).

  • Patients who do not speak English will be excluded for logistical reasons.

Study Design

Total Participants: 410
Treatment Group(s): 2
Primary Treatment: Prolonged Exposure for Primary Care (PE-PC)
Phase:
Study Start date:
May 16, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Sharp Healthcare

    San Diego, California 92129
    United States

    Site Not Available

  • Tanner Health System

    Carrollton, Georgia 30117
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Michigan State University

    East Lansing, Michigan 48824-1037
    United States

    Active - Recruiting

  • Cope NewYork-Presbyterian

    New York, New York 10017
    United States

    Active - Recruiting

  • University of Cincinati Health

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • ProMedica

    Fremont, Ohio 43420
    United States

    Active - Recruiting

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