410 Participants Needed

PTSD Therapy for Healthcare Workers' Stress

Recruiting at 6 trial locations
JG
NH
ML
Overseen ByMichael Levy, LCSW, CEAP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication has been stable for at least 4 weeks before joining. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment EAP Treatment as Usual (TAU), Employee Assistance Program Treatment as Usual, Standard EAP Care, Prolonged Exposure for Primary Care (PE-PC), Prolonged Exposure Therapy, Prolonged Exposure for Primary Care for PTSD?

Prolonged Exposure for Primary Care (PE-PC) has been shown to effectively reduce PTSD and depression symptoms in veterans, with medium-to-large reductions in PTSD symptoms and small-to-medium reductions in depression symptoms. It is a brief version of Prolonged Exposure therapy, adapted for primary care settings, and has been found feasible and acceptable in low-resource settings, indicating its potential effectiveness for healthcare workers' stress.12345

Is prolonged exposure therapy safe for humans?

Prolonged exposure therapy has been extensively researched and is considered a safe and effective treatment for PTSD, with clinical guidelines supporting its use. It has been shown to reduce symptoms of PTSD and related issues like depression and anger in various populations, including veterans and military personnel.12467

How is the treatment Prolonged Exposure for Primary Care (PE-PC) different from other PTSD treatments?

Prolonged Exposure for Primary Care (PE-PC) is a unique treatment for PTSD because it is a brief version of the standard Prolonged Exposure therapy, designed specifically for primary care settings. It involves four 30-minute sessions focusing on confronting trauma memories and related avoidance, making it more accessible and feasible for healthcare workers who may not have time for longer therapy sessions.12345

What is the purpose of this trial?

This trial tests a talk therapy called Prolonged Exposure for Primary Care (PE-PC) to help First Responders and Healthcare workers with PTSD. The therapy involves discussing traumatic experiences to reduce symptoms. The goal is to see if this method is more effective than usual treatments provided by Employee Assistance Programs. Prolonged Exposure (PE) therapy has been extensively researched and is widely regarded as an effective treatment for PTSD across various populations and trauma types.

Research Team

RS

Rebecca Sripada, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for healthcare workers with PTSD symptoms post-COVID-19, who have a PCL-5 score ≥33 and stable psychotropic medication use. Participants must work in a healthcare system with an EAP. Those with active psychosis, high suicide risk, current trauma-focused treatment, non-English speakers, severe cognitive impairment or needing detoxification cannot join.

Inclusion Criteria

Employees at a healthcare system served by a participating EAP
Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
My mental health medication has been stable for over a month.
See 1 more

Exclusion Criteria

High risk of suicide
Need for detoxification
Active psychosis or unmanaged bipolar disorder
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Prolonged Exposure for Primary Care (PE-PC) or EAP Treatment as Usual (TAU) to address PTSD symptoms

6 months

Follow-up

Participants are monitored for changes in PTSD symptoms, burnout, job performance, depressive symptoms, and patient satisfaction

6 months

Treatment Details

Interventions

  • EAP Treatment as Usual (TAU)
  • Prolonged Exposure for Primary Care (PE-PC)
Trial Overview The study compares two treatments for PTSD: standard support from Employee Assistance Programs (EAP Treatment as Usual) versus specialized talk therapy called Prolonged Exposure for Primary Care (PE-PC). The goal is to see if PE-PC can better reduce PTSD symptoms and improve overall functioning.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Exposure for Primary CareExperimental Treatment1 Intervention
Group II: EAP Treatment as Usual (TAU)Active Control1 Intervention
Employee Assistance Programs standard treatment.

Prolonged Exposure for Primary Care (PE-PC) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Prolonged Exposure Therapy for:
  • Posttraumatic Stress Disorder (PTSD)
🇪🇺
Approved in European Union as Prolonged Exposure Therapy for:
  • Posttraumatic Stress Disorder (PTSD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.
Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.
The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial.Foa, EB., McLean, CP., Brown, LA., et al.[2022]
Prolonged exposure therapy (PE) is a highly effective treatment for PTSD, but many individuals do not access it due to barriers in specialty mental health settings.
PE-PC, a brief version of PE therapy consisting of four 30-minute sessions, has been shown to effectively reduce PTSD and related symptoms in primary care, making it more accessible for patients.
Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care.Rauch, SAM., Cigrang, J., Austern, D., et al.[2020]
A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.
The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.
Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder.Wade, D., Terhaag, S., Putica, A., et al.[2021]

References

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]
Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. [2020]
Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. [2021]
Treatment of posttraumatic stress disorder with prolonged exposure for primary care (PE-PC): Effectiveness and patient and therapist factors related to symptom change and retention. [2023]
Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. [2023]
The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]
Review of exposure therapy: a gold standard for PTSD treatment. [2021]
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