What side effects are associated with this type of intervention?

Common treatments for PTSD, such as exposure therapy and pharmacotherapy with SSRIs and SNRIs, have known side effects. Exposure therapy, including Prolonged Exposure for Primary Care (PE-PC), may cause temporary increases in anxiety or distress as patients confront traumatic memories. SSRIs and SNRIs can cause side effects like nausea, headache, sexual dysfunction, and insomnia. In some cases, they may also increase the risk of suicidal thoughts, particularly in younger patients.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms but are not directly related to exposure therapy mechanisms like Prolonged Exposure for Primary Care (PE-PC). Exposure therapy, including Prolonged Exposure (PE), is a well-established, non-pharmacological treatment for PTSD that involves patients confronting trauma-related memories and stimuli in a controlled manner to reduce their distress over time. While the FDA does not approve specific psychotherapies, exposure therapy is widely recognized and recommended in clinical guidelines for PTSD treatment.

What other types of research exist?

Promising, novel alternatives to Prolonged Exposure for Primary Care (PE-PC) for PTSD patients include MDMA-assisted psychotherapy, which has shown potential in reducing PTSD symptoms and improving overall functioning. Additionally, psilocybin-assisted psychotherapy has demonstrated efficacy in treating psychiatric and existential distress, which may be applicable to PTSD. Both therapies are emerging as innovative treatments with supportive clinical evidence.

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PTSD Therapy for Healthcare Workers' Stress

N/A

Recruiting

Led By Rebecca Sripada, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

Study Summary

This trial is testing a PTSD therapy to help health system workers cope with stress caused by the pandemic. The therapy will be offered through Employee Assistance Programs to see if it can reduce PTSD symptoms.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the document doesn't list specific side effects of the interventions being studied, talk therapies like PE-PC may sometimes cause temporary increases in distress due to discussing traumatic events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in Burnout based on the Oldenburg Burnout Inventory

Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)

Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)

+1 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prolonged Exposure for Primary Care (PE-PC)

2019

N/A

~120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exposure therapy, including Prolonged Exposure (PE), works by gradually and systematically exposing patients to trauma-related memories, feelings, and situations in a controlled environment. This process helps patients confront and process their traumatic experiences, reducing the power these memories have over their emotional and physiological responses. Over time, this can lead to a decrease in PTSD symptoms such as flashbacks, avoidance, and hyperarousal. Selective serotonin reuptake inhibitors (SSRIs) are another common treatment, which work by increasing serotonin levels in the brain to help regulate mood and anxiety. These treatments are crucial for PTSD patients as they address both the psychological and biological aspects of the disorder, providing a comprehensive approach to symptom management and improving overall functioning.

Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,811 Previous Clinical Trials

6,384,378 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,799 Previous Clinical Trials

2,660,754 Total Patients Enrolled

Rebecca Sripada, PhDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Prolonged Exposure for Primary Care (PE-PC) Clinical Trial Eligibility Overview. Trial Name: NCT05751473 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Prolonged Exposure for Primary Care, EAP Treatment as Usual (TAU)

Post-Traumatic Stress Disorder Clinical Trial 2023: Prolonged Exposure for Primary Care (PE-PC) Highlights & Side Effects. Trial Name: NCT05751473 — N/A

Prolonged Exposure for Primary Care (PE-PC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751473 — N/A

~258 spots leftby Apr 2026

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