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A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
NCT04961190 · View on ClinicalTrials.gov ↗
Study Summary
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness data for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. The current study will compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial will be conducted with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 VA Medical Centers throughout the US. Participants will complete baseline assessments, followed by an active treatment phase (involving up to 14 sessions of PE and/or medication management) with mid (7 week) and posttreatment (14 week) assessments, and follow-up assessments at 27 and 40 weeks. Study outcomes will include PTSD severity, depression, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, resilience) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another gap in the PTSD treatment literature. These data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs). Effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (clinician rated PTSD severity at Week 14), followed by jacknife analyses to determine the magnitude of the predicted difference (representin
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Exposure Therapy
- DRUG Pharmacotherapy with paroxetine or venlafaxine XR
Study Locations (7)
California
- VA Palo Alto Healthcare System — Menlo Park
- VA San Diego Healthcare System — San Diego
Pennsylvania
- Coatesville VA Medicial Center — Coatesville
- Corporal Michael J. Crescenz VA Medical Center — Philadelphia
Alabama
- Birmingham VA Healthcare System — Birmingham
Texas
- VA North Texas Healthcare System — Dallas
Wisconsin
- Milwaukee VA Medical Center — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2026-07-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04961190
The ClinicalTrials.gov registry entry for NCT04961190 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions — of which Prolonged Exposure Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04961190 reports 7 study locations spanning 5 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04961190 about?
NCT04961190 is a clinical study titled "A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD". Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness da...
What is the current status of trial NCT04961190?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2022-05-25. Estimated completion is 2026-07-15.
What conditions does trial NCT04961190 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04961190?
The interventions under investigation include: Prolonged Exposure Therapy (BEHAVIORAL), Pharmacotherapy with paroxetine or venlafaxine XR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04961190?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04961190 being conducted?
This trial has 7 study locations across Alabama, California, Pennsylvania, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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