Understanding how Prolonged Exposure Therapy works for PTSD
Mechanisms Underlying the Efficacy of Prolonged Exposure
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | VA Boston Healthcare System Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05663151 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans diagnosed with PTSD who are interested in starting Prolonged Exposure therapy.
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.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals suffering from PTSD.
How similar studies have performed: Other studies have shown promise in understanding the mechanisms of exposure therapy, but this specific approach is novel in its detailed multimodal assessment.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.