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

University of Michigan

Status: Enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: EAP Treatment as Usual (TAU); Behavioral: Prolonged Exposure for Primary Care (PE-PC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05751473

HUM00219260

1R01MH126693-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 410 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

Prolonged Exposure for Primary Care

Experimental group

Treatment:

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

EAP Treatment as Usual (TAU)

Active Comparator group

Description:

Employee Assistance Programs standard treatment.

Treatment:

Behavioral: EAP Treatment as Usual (TAU)