Recruiting

PTSD

Sponsor:

University of Michigan

Code:

NCT05751473

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Exposure for Primary Care (PE-PC)

EAP Treatment as Usual (TAU)

Study Details

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).

Conditions

Post Traumatic Stress Disorder

Study ID

NCT05751473

Start date

May 16, 2023

Status verified date

Jun, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prolonged Exposure for Primary Care

active comparator: EAP Treatment as Usual (TAU)

Employee Assistance Programs standard treatment.

Interventions

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.

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 and Locations

Central contacts

James Garlick

734-232-2663jgarlick@med.umich.edu

Locations

Tanner Health System

Recruiting

Carrollton, Georgia, United States, 30117

Contacts

Emily Norris, PhD, LPC, CPCS, CEAP

770-834-8327enorris@tanner.org

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

James Garlick

jgarlick@umich.edu

Principal Investigator:

Rebecca Sripada, PhD

Detroit Fire Department

Recruiting

Detroit, Michigan, United States, 48226

Contacts

Lennette Wood

313-530-2912Woodl4116@detroitmi.gov

Health Management Systems of America

Recruiting

Detroit, Michigan, United States, 48226

Contacts

Monique Jones, LMSW, CEAP

800-847-7240monique.jones@hmsanet.com

Michigan State University

Recruiting

East Lansing, Michigan, United States, 48824-1037

Contacts

Jon Novello, LMSW,ACSW

517-355-4509novelloj@msu.edu

Principal Investigator:

Jon Novello, LMSW,ACSW

Rutgers Health

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Susan Weinstein

732-235-4365sww42@ubhc.rutgers.edu

Cope NewYork-Presbyterian

Recruiting

New York, New York, United States, 10017

Contacts

Randy Martin, PhD

646-988-1763rdm4002@med.cornell.edu

Principal Investigator:

Randy Martin, PhD

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Laurie Kovens

919-416-1727Laurie.kovens@duke.edu

ProMedica

Recruiting

Fremont, Ohio, United States, 43420

Contacts

Chris Tafelski, LPCC,CEAP

419-291-1219Christopher.tafelski@promedica.org

Principal Investigator:

Chris Tafelski, LPCC,CEAP

Houston Fire Department

Recruiting

Houston, Texas, United States, 77002

Contacts

Leah Belsches, PsyD

832-405-6865leah.belsches@houstontx.gov

More Information

Sponsor

University of Michigan

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Employee Assistance Programs
  • Frontline Healthcare Workers
  • Prolonged Exposure for Primary Care
  • First Responders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-01.