Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
Part of paid clinical trials in San Diego, California.
- Sponsor
- University of Michigan
- Study ID
- NCT05751473
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Prolonged Exposure for Primary Care (PE-PC) — BEHAVIORALTreatment will be given by telehealth or in person, depending on the participant preference. Content is drawn from the Full Prolonged Exposure model and condensed so as to deliver the most efficacious components in a brief format. There will be 4-6 weekly 30-minute sessions. Treatment follows the standardized PE-PC manual and workbook. At the end of the final session, the counselor and participant will review treatment progress and either conclude treatment or refer the participant to outside mental healthcare for more intensive treatment. Participants will complete surveys and complete homework during and following the study.
- EAP Treatment as Usual (TAU) — BEHAVIORALTreatment will be given by telehealth or in person, depending on the participant preference and current EAP practices (4-6 weeks). This will be the standard of care practice at each EAP site. Usually, this includes up to six sessions of solution focused therapy, and referrals to an established network of community providers who specialize in PTSD treatment. All PTSD care received during the study will be collected and monitored as TAU. The type of TAU used will reflect the current practice in EAPs and will not be constrained in the study design. EAP staff will monitor and record all EAP care received, including tracking no shows and cancellations. Study team members will document care received outside of the EAP (including psychiatric medications) by self-report. Participants will complete surveys and complete homework during and following the study.
Study Details
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).
Key Dates
- Start date
- May 16, 2023
- Status verified
- Jun 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 410 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Prolonged Exposure for Primary Care
- Active Comparator: EAP Treatment as Usual (TAU)Employee Assistance Programs standard treatment.
Primary Outcome Measure
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 ]
Central Contacts
- James Garlick734-232-2663
- Naomi Hemphill
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sharp Healthcare | San Diego | California | 92129 | - |
| Tanner Health System | Carrollton | Georgia | 30117 | |
| University of Michigan | Ann Arbor | Michigan | 48109 | James Garlick Naomi Hemphill Rebecca Sripada, PhD (PRINCIPAL_INVESTIGATOR) |
| Detroit Fire Department | Detroit | Michigan | 48226 | |
| Health Management Systems of America | Detroit | Michigan | 48226 | |
| Henry Ford Health System | Detroit | Michigan | 48202 | - |
| Michigan State University | East Lansing | Michigan | 48824-1037 | Jon Novello, LMSW,ACSW (PRINCIPAL_INVESTIGATOR) |
| West Bloomfield Fire Department | West Bloomfield | Michigan | 48322 | - |
| Cope NewYork-Presbyterian | New York | New York | 10017 | Randy Martin, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinati Health | Cincinnati | Ohio | 45229 | Lisa Melink, MA,LPCC (PRINCIPAL_INVESTIGATOR) |
| ProMedica | Fremont | Ohio | 43420 | Chris Tafelski, LPCC,CEAP (PRINCIPAL_INVESTIGATOR) |
| Houston Fire Department | Houston | Texas | 77002 |
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