Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
NCT ID: NCT05751473
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
410 participants
INTERVENTIONAL
2023-05-16
2026-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prolonged Exposure for Primary Care
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.
EAP Treatment as Usual (TAU)
Employee Assistance Programs standard treatment.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
\- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Michigan
OTHER
Responsible Party
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Rebecca Sripada
Associate Professor of Psychiatry
Principal Investigators
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Rebecca Sripada, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Sharp Healthcare
San Diego, California, United States
Tanner Health System
Carrollton, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Detroit Fire Department
Detroit, Michigan, United States
Health Management Systems of America
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
West Bloomfield Fire Department
West Bloomfield, Michigan, United States
Cope NewYork-Presbyterian
New York, New York, United States
University of Cincinati Health
Cincinnati, Ohio, United States
ProMedica
Fremont, Ohio, United States
Houston Fire Department
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00219260
Identifier Type: -
Identifier Source: org_study_id
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