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) — BEHAVIORAL
    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) — BEHAVIORAL
    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.

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

Locations (12)

FacilityCityStateZIPSite coordinators
Sharp HealthcareSan DiegoCalifornia92129-
Tanner Health SystemCarrolltonGeorgia30117
Rachel M Walker, Ed.S., LPC, CEAP, CCC
770-834-8327
University of MichiganAnn ArborMichigan48109
James Garlick
Naomi Hemphill
Rebecca Sripada, PhD (PRINCIPAL_INVESTIGATOR)
Detroit Fire DepartmentDetroitMichigan48226
Lennette Wood
313-530-2912
Health Management Systems of AmericaDetroitMichigan48226
Monique Jones, LMSW, CEAP
800-847-7240
Henry Ford Health SystemDetroitMichigan48202-
Michigan State UniversityEast LansingMichigan48824-1037
Jon Novello, LMSW,ACSW
517-355-4509
Jon Novello, LMSW,ACSW (PRINCIPAL_INVESTIGATOR)
West Bloomfield Fire DepartmentWest BloomfieldMichigan48322-
Cope NewYork-PresbyterianNew YorkNew York10017
Randy Martin, PhD
646-988-1763
Randy Martin, PhD (PRINCIPAL_INVESTIGATOR)
University of Cincinati HealthCincinnatiOhio45229
Lisa Melink, MA,LPCC
513-585-6094
Lisa Melink, MA,LPCC (PRINCIPAL_INVESTIGATOR)
ProMedicaFremontOhio43420
Chris Tafelski, LPCC,CEAP
419-291-1219
Chris Tafelski, LPCC,CEAP (PRINCIPAL_INVESTIGATOR)
Houston Fire DepartmentHoustonTexas77002
Leah Belsches, PsyD
832-405-6865

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