PTSD Therapy for Healthcare Workers' Stress

Recruiting at 10 trial locations

Overseen By Michael Levy, LCSW, CEAP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe cognitive impairment, High suicide risk, Need detox, Active psychosis, Unmanaged bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

410 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 2 5 6 7}

Who Is on the Research Team?

Rebecca Sripada, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

High risk of suicide

Need for detoxification

Active psychosis or unmanaged bipolar disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Prolonged Exposure for Primary Care Experimental Treatment 1 Intervention

Group II: EAP Treatment as Usual (TAU) Active Control 1 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)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Prolonged exposure therapy adapted for primary care (PE-PC) significantly reduced PTSD symptoms in veterans, with medium-to-large effect sizes observed (Cohen's d = 0.63 for intent-to-treat and d = 0.79 for completers) and small-to-medium reductions in depression (Cohen's d = 0.40 for intent-to-treat and d = 0.51 for completers).

Factors influencing treatment completion included prior training of providers in PE or cognitive processing therapy, with trained providers having a higher likelihood of veterans completing PE-PC (OR = 1.54), while veterans with military sexual trauma were less likely to complete treatment (OR = 0.42).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rauch, SAM., Venners, MR., Ragin, C., et al.[2023]

A pilot study involving 30 patients at Federally Qualified Health Centers (FQHCs) in Michigan showed that Prolonged Exposure therapy adapted for primary care (PE-PC) was feasible and acceptable for treating PTSD, indicating a potential solution for low-resource settings.

Feedback from patients and providers highlighted the intervention's helpfulness in addressing PTSD, while also identifying barriers such as transportation and training needs, which will inform future larger-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. Sripada, RK., Walters, HM., Ganoczy, D., et al.[2023]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

Prolonged exposure (PE) therapy is an effective first-line treatment for PTSD in Veterans and military personnel, significantly reducing symptoms and comorbid issues like anger and depression, supported by extensive research and clinical guidelines.

The PE protocol includes key components such as psychoeducation and exposure techniques, and the Veterans Health Administration has trained over 1,300 mental health providers to deliver this therapy, indicating a strong commitment to improving PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exposure therapy: a gold standard for PTSD treatment. Rauch, SA., Eftekhari, A., Ruzek, JI.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Review of exposure therapy: a gold standard for PTSD treatment. [2021]