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A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from Jul 15, 2026 to Nov 1, 2026 Enrollment target: 302 to 304v11 Show 1 more changeShow less
    • Enrollment target: 302 to 304
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 300 to confirmed 302 · Site details revised at 7 of 7 sitesv10 Show 2 more changesShow less
    • Enrollment target: estimated 300 to confirmed 302
    • Site details revised at 7 of 7 sites
  3. Site details revised at 2 of 7 sitesv9
  4. Study sites: 6 to 7 Primary and study completion dates: Feb 15, 2026 to Jul 15, 2026 · Collaborators: 7 to 8v8 Show 2 more changesShow less
    • Primary and study completion dates: Feb 15, 2026 to Jul 15, 2026
    • Collaborators: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 450 to 300 Primary and study completion dates: Feb 15, 2025 to Feb 15, 2026 · Study description revised · Site details revised at 2 of 6 sitesv7 Show 3 more changesShow less
    • Primary and study completion dates: Feb 15, 2025 to Feb 15, 2026
    • Study description revised
    • Site details revised at 2 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 4 of 6 sitesv6
  2. Start date changed from estimate of Apr 15, 2022 to May 25, 2022v5
  3. Start date: Mar 15, 2022 to Apr 15, 2022v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 2022 to Mar 15, 2022 · Study sites: 5 to 6 · Eligibility criteria revisedv3 Show 3 more changesShow less
    • Start date: Jan 2022 to Mar 15, 2022
    • Study sites: 5 to 6
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Nov 1, 2021 to Jan 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 (representing an individual's "predicted advantage" of one treatment over the others).
Trial Details
NCT Number NCT04961190
Lead Sponsor University of Pennsylvania
Collaborators: Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Coatesville VA Medical Center, Milwaukee VA Medical Center, North Texas Veterans Healthcare System, San Diego Veterans Healthcare System, VA Palo Alto Health Care System, Birmingham VA Health Care System
Conditions Posttraumatic Stress Disorder
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov