NCT05751473 · University of Michigan
Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
What this study is about
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).
View original scientific description
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).
Interventions
BEHAVIORAL
Prolonged Exposure for Primary Care (PE-PC)
Treatment 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.
BEHAVIORAL
EAP Treatment as Usual (TAU)
Treatment 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.
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Diego, California
- Carrollton, Georgia
- Ann Arbor, Michigan
- Detroit, Michigan
- East Lansing, Michigan
- West Bloomfield, Michigan
- Piscataway, New Jersey
- New York, New York
- Durham, North Carolina
- Cincinnati, Ohio
- Fremont, Ohio
- Houston, Texas
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations