Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Understanding how Prolonged Exposure Therapy works for PTSD

Official title: Mechanisms Underlying the Efficacy of Prolonged Exposure

Run by VA Boston Healthcare System · NCT05663151 · Data updated 2026-11-12

This study is testing how Prolonged Exposure therapy helps people with PTSD by looking at changes in their thoughts, feelings, and body responses during and after treatment.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment50 (estimated)
SponsorVA Boston Healthcare System
Federal
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2027
Registry record updatedApril 8, 2025
Trial IDNCT05663151 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are veterans diagnosed with PTSD who are interested in starting Prolonged Exposure therapy.

Probably not a fit

Patients with a history of psychotic disorders, severe brain injuries, or those currently engaged in other forms of therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to gather pilot data on the neural, psychophysiological, and subjective markers that change during Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD). The study will involve 50 participants, with the goal of having 15 complete ten 60-minute sessions of PE therapy. Assessments will be conducted at various stages: before treatment, mid-treatment, post-treatment, and at a one-month follow-up, using a combination of self-report measures, clinician interviews, and physiological recordings. The findings will help enhance the understanding of how PE therapy affects PTSD symptoms and inform future treatment approaches.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for individuals suffering from PTSD.

How similar studies have gone: Other studies have shown promise in understanding the mechanisms of exposure therapy, but this specific approach is novel in its detailed multimodal assessment.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • VA Boston Healthcare System
    Boston, Massachusetts, United States
    Recruiting

Study contacts

  • Principal investigator: Suzanne Pineles — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • Study coordinator: Suzanne Pineles, PhD
  • Email: suzanne.pineles@va.gov
  • Phone: 857-364-5906

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Combined MDMA and psilocybin treatment for Veterans with PTSD

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.