Comparing therapies and medications for PTSD in veterans
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best, and for Whom
This study is testing whether a combination of therapy and medication, or either one alone, can help veterans with PTSD feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT04961190 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Prolonged Exposure (PE) therapy, pharmacotherapy with paroxetine or venlafaxine, and their combination for treating Posttraumatic Stress Disorder (PTSD) in military veterans. A randomized trial will involve 300 veterans recruited from six Veterans Affairs Medical Centers across the United States. Participants will undergo baseline assessments followed by up to 14 treatment sessions, which can be conducted in person or via telehealth to enhance accessibility. The study seeks to fill the gap in comparative effectiveness data for PTSD treatments, providing valuable insights for clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates for this study are military veterans diagnosed with PTSD who are fluent in English and willing to participate in the treatment options provided.
Not a fit: Patients with recent suicidal ideation, active psychosis, or a history of failed trials with the treatments being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the most effective treatment options for PTSD, improving outcomes for veterans.
How similar studies have performed: Other studies have shown success in comparing PTSD treatments, but this study aims to provide more comprehensive data on the effectiveness of specific therapies and medications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * DSM-5 diagnosis of Posttraumatic Stress Disorder * military veteran * fluent in English * willing to participate in PE, pharmacotherapy, or both * capable of providing informed consent Exclusion Criteria: * suicidal ideation with intent and/or plan, or suicidal behavior in the past month * active psychosis * history of manic episode(s) * a failed trial of Prolonged Exposure therapy or paroxetine and venlafaxine XR * ongoing medical conditions or treatments that would contraindicate initiating these treatments (e.g., medications that have potential interactions with paroxetine and venlafaxine such as MAO inhibitors)
Where this trial is running
Birmingham, Alabama and 6 other locations
- Birmingham VA Healthcare System — Birmingham, Alabama, United States (Recruiting)
- VA Palo Alto Healthcare System — Menlo Park, California, United States (Active_not_recruiting)
- VA San Diego Healthcare System — San Diego, California, United States (Recruiting)
- Coatesville VA Medicial Center — Coatesville, Pennsylvania, United States (Recruiting)
- Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- VA North Texas Healthcare System — Dallas, Texas, United States (Recruiting)
- Milwaukee VA Medical Center — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Keith E Bredemeier, PhD
- Email: kbredem@udel.edu
- Phone: 215-746-3327
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.