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 new PTSD treatment called Prolonged Exposure for Primary Care (PE-PC) to determine if it reduces PTSD symptoms more effectively than the usual counseling offered by Employee Assistance Programs (EAPs). It targets First Responders and Healthcare workers who may face work-related stress and trauma. The researchers aim to assess whether this talk therapy can enhance daily functioning and mental health. Those employed by organizations with an EAP and experiencing PTSD symptoms might find this trial suitable. As an unphased trial, it provides a unique opportunity to explore new therapeutic options for improving mental health and daily functioning.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Prolonged Exposure for Primary Care (PE-PC) safely treats PTSD. Studies have found it effective and easy for patients to handle. For example, one study found that PE-PC can be safely used in regular healthcare settings, helping patients manage PTSD symptoms without major problems.

Additionally, many people choose to participate in this therapy, indicating they find it acceptable and manageable. This often results in fewer side effects. Overall, PE-PC has been successfully used in various settings, making it a safe choice for those dealing with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prolonged Exposure for Primary Care (PE-PC) is unique because it offers a focused approach tailored specifically for healthcare workers dealing with PTSD. Unlike traditional PTSD treatments that might require long sessions and multiple appointments, PE-PC is designed to be more efficient and practical for busy healthcare professionals. It emphasizes real-world exposure exercises that can be easily integrated into daily life, potentially leading to quicker relief from stress symptoms. Researchers are excited about this treatment because it could provide a more accessible and time-effective option for healthcare workers who are often under significant stress.

What evidence suggests that Prolonged Exposure for Primary Care is effective for treating PTSD in healthcare workers?

Studies have shown that Prolonged Exposure for Primary Care (PE-PC), one of the treatments in this trial, helps reduce PTSD symptoms. Research with veterans found that PE-PC led to significant decreases in these symptoms. Another review highlighted that exposure therapy, like PE-PC, has strong evidence supporting its effectiveness. Additionally, PE-PC has been linked to moderate reductions in depression symptoms. Overall, PE-PC is considered a strong treatment option for PTSD, especially in settings like Employee Assistance Programs. Participants in this trial may receive either PE-PC or EAP Treatment as Usual (TAU), which serves as the active comparator. ^{1 6 7 8 9}

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

Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33

Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder (for the qualitative portion of the study)

Employees at a healthcare system served by a participating EAP

Exclusion Criteria

Active psychosis or unmanaged bipolar disorder

High risk of suicide

Need for detoxification

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

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]

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]

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 (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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721715/

Treatment of Posttraumatic Stress Disorder with Prolonged ... The current analyses of training case data from 737 veterans demonstrates as expected that PE-PC produced clinically significant reductions in PTSD in four to ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - PTSD: National Center for ... The review concluded that there is high strength of evidence to support the efficacy of exposure therapy such as PE for reduction of PTSD symptoms and ...

3. apa.org apa.org/pubs/highlights/spotlight/issue-285

Bringing effective posttraumatic stress disorder treatment to ... PE-PC showed significant and large reductions in PTSD and moderate reductions in depression. In addition, these significant reductions in PTSD ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6519517/

Expanding the Reach of Effective PTSD Treatment Into ... Prolonged exposure (PE) therapy has emerged as an effective, first-line treatment for PTSD and is provided in specialty mental health in eight to 15 sessions, ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Conclusions and Relevance In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160482/

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most effective treatments for PTSD, with response rates ranging from 65 to 80% [[9], [10], [11]].

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020756/

Feasibility and Acceptability of Prolonged Exposure in ... High rates of therapy participation suggest that the intervention was feasible and acceptable. Semi-structured interview data from 10 patients ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107772292030105X

Pilot Program of PE for Primary Care in VA PE-PC can be effectively implemented in behavioral health primary care. ... PE-PC provides an effective and safe treatment option for patients with PTSD in PC.