Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in Frontline Health Care Workers

Study Overview
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Brief Summary
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This study is being completed to address PTSD symptoms in Health System workers after the COVID-19 pandemic. Specifically, the study team is testing whether an adapted PTSD treatment (talk therapy) effectively treats PTSD when provided in Employee Assistance Programs (EAPs). The central hypothesis is that Prolonged Exposure for Primary Care (PE-PC) will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).

Official Title
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Reducing PTSD Symptoms in Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: EAP Treatment as Usual (TAU)
* Behavioral: Prolonged Exposure for Primary Care (PE-PC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are employees at a healthcare system served by a participating EAP Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33 Have had psychotropic medication stability for at least 4 weeks Inclusion criteria for the qualitative portion of the study: - Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder Exclusion Criteria: Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment) High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol) Need for detoxification Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy). Patients who do not speak English will be excluded for logistical reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure for Primary Care<br> | Behavioral: Prolonged Exposure for Primary Care (PE-PC)<br>* 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.<br>|
| Active Comparator: EAP Treatment as Usual (TAU)<br>Employee Assistance Programs standard treatment. | Behavioral: EAP Treatment as Usual (TAU)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score | The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Burnout based on the Oldenburg Burnout Inventory | This is a 16-question inventory that assesses burnout. The self-report rating scale is 1-4 for each symptom.The minimum and maximum values are 16 and 64, with higher scores indicating worse outcome. | baseline to 6 months | 
| Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH) | The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 visual analog scale (VAS). | baseline to 6 months | 
| Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9) | This is a 9-item questionnaire that participants select responses from not at all (0) to nearly every day (3), the minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome. | baseline to 6 months | 
| Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8) | This is an 8-item questionnaire that participants complete. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Employee Assistance Programs, Frontline Healthcare Workers, Prolonged Exposure for Primary Care