PTSD Therapy for Healthcare Workers' Stress
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Severe cognitive impairment, High suicide risk, Need detox, Active psychosis, Unmanaged bipolar, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
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.
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.
12345Is 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.
12467How 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.
12345Eligibility 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.
+1 more
Exclusion Criteria
High risk of suicide
Need for detoxification
Active psychosis or unmanaged bipolar disorder
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Tanner Health SystemCarrollton, GA
Cope NewYork-PresbyterianNew York, NY
University of Cincinati HealthCincinnati, OH
University of MichiganAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]Prolonged exposure therapy (PE) is an evidence-based treatment for posttraumatic stress disorder (PTSD) that is underutilized in the military health system. Standard workshop training in PE may not be sufficient to alter provider behavior, but post-workshop consultation requires significant resources. Therefore, it is important to determine the incremental utility of post-workshop consultation.
Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. [2020]Posttraumatic stress disorder (PTSD) is a costly mental health issue in the United States and throughout the world. Effective treatments are available; however, most people with PTSD never access these treatments. 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, each lasting 90 minutes. Most people with PTSD do not enter specialty mental health to access this service. Over the past 15 years, provision of mental health care in primary care has increased due to patient preference for care in this setting and the ability to overcome many access barriers (stigma, longer sessions, insurance coverage, etc.). While medications for PTSD are available in primary care, effective brief psychotherapeutic PTSD treatment options have only recently been established. PE-PC (prolonged exposure for primary care) is a brief version of PE therapy for PTSD with efficacy in a primary care (PC) setting in reducing PTSD, depression, and related mental disorder symptoms. PE-PC has four 30-minute sessions and focuses on imaginal exposure to the trauma memory, in vivo exposure to trauma-related avoidance, and emotional processing of the memory. Dissemination efforts are currently underway to expand availability.
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]Prolonged exposure (PE) therapy is an evidence-based psychological treatment of post-traumatic stress disorder (PTSD), yet uptake amongst practitioners is less than desirable. The aim of this study was to evaluate the efficacy of a PE training workshop plus intensive consultation programme to improve practitioners' self-efficacy and outcome expectations as well as uptake of PE for emergency service patients with PTSD.
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]Prolonged exposure (PE) is a first-line treatment for posttraumatic stress disorder (PTSD) available in specialty mental health. PE for primary care (PE-PC) is a brief version of PE adapted for primary care mental health integration, composed of four-eight, 30-min sessions. Using retrospective data of PE-PC training cases from 155 Veterans Health Administration (VHA) providers in 99 VHA clinics who participated in a 4- to 6-month PE-PC training and consultation program, we examined patients' PTSD and depression severity across sessions via mixed effects multilevel linear modeling. Additionally, hierarchical logistic regression analysis was conducted to assess predictors of treatment dropout. Among 737 veterans, medium-to-large reductions in PTSD (intent-to-treat, Cohen's d = 0.63; completers, Cohen's d = 0.79) and small-to-medium reductions in depression (intent-to-treat, Cohen's d = 0.40; completers, Cohen's d = 0.51) were observed. The modal number of PE-PC sessions was five (SD = 1.98). Providers previously trained in both PE and cognitive processing therapy (CPT) were more likely than providers who were not trained in either PE or CPT to have veterans complete PE-PC (OR = 1.54). Veterans with military sexual trauma were less likely to complete PE-PC than veterans with combat trauma (OR = 0.42). Asian American and Pacific Islander veterans were more likely than White veterans to complete treatment (OR = 2.93). Older veterans were more likely than younger veterans to complete treatment (OR = 1.11). (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. [2023]Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that affects 6% of U.S. adults, yet is treated in only 30% of affected individuals and even fewer low-income individuals. One third of the nation's low-income individuals are treated in Federally Qualified Health Centers (FQHCs). Most of these facilities lack capacity to provide their patients with first-line, evidence-based treatments for PTSD such as Prolonged Exposure (PE). To address this problem, PE has been adapted for use in a primary care setting and demonstrated efficacy in a brief model for military service members (PE in Primary Care: PE-PC). The effectiveness of this treatment in civilian, low-resource settings such as FQHCs is unknown. This pilot study tested the feasibility and acceptability of PE-PC in 30 Michigan FQHC patients. High rates of therapy participation suggest that the intervention was feasible and acceptable. Semi-structured interview data from 10 patients and 5 FQHC providers indicated that the intervention was helpful and filled a critical need for effective PTSD treatment in the FQHC setting. Interviews also elucidated barriers such as transportation, provider training, and time commitment for patients and providers. These findings set the stage for a full-scale randomized controlled trial to test the effectiveness of PE-PC on PTSD symptoms in this low-resource, high-need setting.Trial registry ClinicalTrials.gov Identifier: NCT03711266. October 18, 2018.
The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]Prolonged exposure (PE) therapy is a first-line posttraumatic stress disorder (PTSD) treatment, but the manualized 90-min session format constitutes a barrier to adopting PE in most settings because they use 60-min sessions for scheduling and billing. We examined whether 60-min PE sessions were as effective and efficient as 90-min PE sessions.
Review of exposure therapy: a gold standard for PTSD treatment. [2021]Prolonged exposure (PE) is an effective first-line treatment for posttraumatic stress disorder (PTSD), regardless of the type of trauma, for Veterans and military personnel. Extensive research and clinical practice guidelines from various organizations support this conclusion. PE is effective in reducing PTSD symptoms and has also demonstrated efficacy in reducing comorbid issues such as anger, guilt, negative health perceptions, and depression. PE has demonstrated efficacy in diagnostically complex populations and survivors of single- and multiple-incident traumas. The PE protocol includes four main therapeutic components (i.e., psychoeducation, in vivo exposure, imaginal exposure, and emotional processing). In light of PE's efficacy, the Veterans Health Administration designed and supported a PE training program for mental health professionals that has trained over 1,300 providers. Research examining the mechanisms involved in PE and working to improve its acceptability, efficacy, and efficiency is underway with promising results.