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Search / Trial NCT05663151

Mechanisms Underlying the Efficacy of Prolonged Exposure

Launched by VA BOSTON HEALTHCARE SYSTEM · Dec 21, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Prolonged Exposure Therapy Ptsd Sleep

ClinConnect Summary

This clinical trial is looking at how Prolonged Exposure (PE) therapy can help people with Posttraumatic Stress Disorder (PTSD). The researchers want to understand what changes in the brain and body happen during and after this type of therapy. They will collect information before, during, and after treatment to see how these changes relate to the effectiveness of PE therapy. The study will involve ten therapy sessions, and participants will be assessed at different points: before starting therapy, halfway through, right after completing it, and one month later.

To be eligible for this trial, you need to have a diagnosis of PTSD and a genuine interest in starting PE therapy. You must also be a veteran. However, there are some conditions that would exclude you from participating, such as having certain serious mental health issues or being currently involved in other types of therapy. If you decide to participate, you can expect a supportive environment where you will receive therapy and have your progress carefully monitored. This study aims to gather important information that could help improve PTSD treatments in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5)
  • 2. interest in starting PE (as indicated during the informed consent process)
  • 3. Veteran
  • Exclusion Criteria:
  • 1. Current or past history of schizophrenic or other psychotic disorders,
  • 2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months,
  • 3. Severe traumatic brain injury,
  • 4. Major neurological problems,
  • 5. Current substance use disorder,
  • 6. Active risk to self or others,
  • 7. Current participation in cognitive-behavioral therapy,
  • 8. Previously received \> 2 sessions of Prolonged Exposure, and
  • 9. Having no memory of their traumatic event.
  • 10. For participants who are currently prescribed psychotropic medication, they will be eligible for the study provided medication use has been stable for 2 months prior to enrollment and remains stable throughout participation

About Va Boston Healthcare System

The VA Boston Healthcare System is a leading medical facility dedicated to providing high-quality care and innovative research for veterans. As a prominent sponsor of clinical trials, it focuses on advancing medical knowledge and developing new treatment options across various health conditions. With a commitment to enhancing the health and well-being of veterans, the VA Boston Healthcare System fosters collaborations with academic institutions and research organizations, ensuring a rigorous approach to clinical research while prioritizing patient safety and ethical standards. Its comprehensive clinical trial programs contribute significantly to the evolving landscape of veteran healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Suzanne Pineles

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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