NCT05751473 Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
| NCT ID | NCT05751473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2023-05-16 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2023-05-16 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Rebecca Sripada, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05751473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05751473 currently recruiting?
Yes, NCT05751473 is actively recruiting participants. Contact the research team at jgarlick@med.umich.edu for enrollment information.
Where is the NCT05751473 trial being conducted?
This trial is being conducted at San Diego, United States, Carrollton, United States, Ann Arbor, United States, Detroit, United States and 10 additional locations.
Who is sponsoring the NCT05751473 clinical trial?
NCT05751473 is sponsored by University of Michigan. The principal investigator is Rebecca Sripada, PhD at University of Michigan. The trial plans to enroll 410 participants.