Clinical trial NCT05751473: Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
Official title: Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Employee Assistance Programs
Frontline Healthcare Workers
Prolonged Exposure for Primary Care
First Responders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-03-02
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in Burnout based on the Oldenburg Burnout Inventory
timeFrame: baseline to 6 months
measure: Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)
timeFrame: baseline to 6 months
measure: Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline to 6 months
measure: Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Carrollton
country: United States
facility: Tanner Health System
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: New York
country: United States
facility: Cope NewYork-Presbyterian
state: New York
city: Cincinnati
country: United States
facility: University of Cincinati Health
state: Ohio
city: Fremont
country: United States
facility: ProMedica
state: Ohio
Study officials:
affiliation: University of Michigan
name: Rebecca Sripada, PhD
role: PRINCIPAL_INVESTIGATOR
References: