Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: EAP Treatment as Usual (TAU)Behavioral: Prolonged Exposure for Primary Care (PE-PC)
- Registration Number
- NCT05751473
- Lead Sponsor
- University of Michigan
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 410
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EAP Treatment as Usual (TAU) EAP Treatment as Usual (TAU) Employee Assistance Programs standard treatment. Prolonged Exposure for Primary Care Prolonged Exposure for Primary Care (PE-PC) -
- Primary Outcome Measures
Name Time Method Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score 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 Outcome Measures
Name Time Method Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8) baseline to 6 months This is an 8-item questionnaire that participants complete. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH) baseline to 6 months The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 visual analog scale (VAS).
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9) baseline to 6 months This is a 9-item questionnaire that participants select responses from not at all (0) to nearly every day (3), the minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Change in Burnout based on the Oldenburg Burnout Inventory baseline to 6 months This is a 16-question inventory that assesses burnout. The self-report rating scale is 1-4 for each symptom.The minimum and maximum values are 16 and 64, with higher scores indicating worse outcome.
Trial Locations
- Locations (8)
Michigan State University
🇺🇸East Lansing, Michigan, United States
Cope NewYork-Presbyterian
🇺🇸New York, New York, United States
Tanner Health System
🇺🇸Carrollton, Georgia, United States
ProMedica
🇺🇸Fremont, Ohio, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Cincinati Health
🇺🇸Cincinnati, Ohio, United States
Sharp Healthcare
🇺🇸San Diego, California, United States