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NCT04961190 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
A Phase 4 study of Post Traumatic Stress Disorder, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 4
- Development phase
- 302
- Enrollment target
- 7
- Study locations
NCT04961190: Active Phase 4 study of Post Traumatic Stress Disorder, sponsored by University of Pennsylvania.
NCT04961190 is a Phase 4 study of Post Traumatic Stress Disorder that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 302 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04961190, a Phase 4 study of Post Traumatic Stress Disorder, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 302 participants
- Enrollment target
- 7
- Study locations
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
Primary Outcome
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Twenty items are rated on a 5-point scale from 0 (absent) to 4 (extremely/incapacitating). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity
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 |
What the registry record for NCT04961190 still lists
NCT04961190 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Prolonged Exposure Therapy is the first listed.
NCT04961190 lists 7 locations in 5 states (California, Pennsylvania, Alabama).
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: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04961190?
The interventions under investigation include: Prolonged Exposure Therapy (BEHAVIORAL), Pharmacotherapy with paroxetine or venlafaxine XR (DRUG).
Who is sponsoring clinical trial NCT04961190?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04961190's enrollment target sits among peer trials
302 26th of 262 higher than 236 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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