Reducing PTSD symptoms in first responders and healthcare workers
Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
This study tests if a new talk therapy for PTSD can help first responders and healthcare workers feel better than the usual support they get.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 12 sites (San Diego, California and 11 other locations) |
| Trial ID | NCT05751473 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a brief talk therapy treatment called Prolonged Exposure for Primary Care (PE-PC) in reducing PTSD symptoms among first responders and frontline healthcare workers. Participants will receive this treatment through Employee Assistance Programs (EAPs) and will be compared to those receiving standard EAP treatment. The central hypothesis is that PE-PC will lead to greater reductions in PTSD symptoms and improved functioning compared to usual care.
Who should consider this trial
Good fit: Ideal candidates include employees of organizations served by participating EAPs who have a confirmed PTSD diagnosis and stable psychotropic medication for at least four weeks.
Not a fit: Patients with severe cognitive impairment, high suicide risk, or active psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate PTSD symptoms in first responders and healthcare workers, improving their overall mental health and job performance.
How similar studies have performed: Previous studies have shown promise in using similar therapeutic approaches for PTSD, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California and 11 other locations
- Sharp Healthcare — San Diego, California, United States (Withdrawn)
- Tanner Health System — Carrollton, Georgia, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Active_not_recruiting)
- Detroit Fire Department — Detroit, Michigan, United States (Recruiting)
- Health Management Systems of America — Detroit, Michigan, United States (Recruiting)
- Michigan State University — East Lansing, Michigan, United States (Recruiting)
- West Bloomfield Fire Department — West Bloomfield, Michigan, United States (Active_not_recruiting)
- Cope NewYork-Presbyterian — New York, New York, United States (Recruiting)
- University of Cincinati Health — Cincinnati, Ohio, United States (Not_yet_recruiting)
- ProMedica — Fremont, Ohio, United States (Recruiting)
- Houston Fire Department — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Sripada, PhD — University of Michigan
- Study coordinator: James Garlick
- Email: jgarlick@med.umich.edu
- Phone: 734-232-2663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.