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Clinical Trials/NCT05751473
NCT05751473
Recruiting
Not Applicable

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

University of Michigan12 sites in 1 country410 target enrollmentMay 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
University of Michigan
Enrollment
410
Locations
12
Primary Endpoint
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Status
Recruiting
Last Updated
10 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 16, 2023
End Date
August 31, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Sripada

Associate Professor of Psychiatry

University of Michigan

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.

Outcomes

Primary Outcomes

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

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 Outcomes

  • Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)(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 Burnout based on the Oldenburg Burnout Inventory(baseline to 6 months)

Study Sites (12)

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