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NCT01928732 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness Research in Veterans With PTSD
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 916
- Enrollment target
NCT01928732: Completed NA study, sponsored by VA Office of Research and Development.
NCT01928732 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 916 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928732, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 916 participants
- Enrollment target
Study Summary
VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), for treating posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about the effectiveness of these treatments compared with one another. The sample will include 900 male and female Veterans with PTSD due to any traumatic military event. Veterans who are eligible and agree to participate in the study will be randomly assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The standard "dose" of treatment is 12 weekly sessions but Veterans who improve more rapidly may finish in fewer sessions and Veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be measured at regular follow-up visits that will occur at the middle and at the end of treatment and then 3 and 6 months later. The investigators will measure other outcomes, including additional mental health problems, functioning, quality of life, and use of treatments for mental and physical problems. The investigators also will measure Veterans' treatment preference and examine whether Veterans who get the treatment they prefer do better than Veterans who get the less-preferred treatment. As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive information about whether one treatment is better than the other, overall and for different types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients will have more information to help them make an informed decisions about which treatment to choose and VA will have stronger evidence to help make care Veteran-c
Primary Outcome
The primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE an
Interventions
- BEHAVIORAL Prolonged Exposure (PE)
- BEHAVIORAL Cognitive Processing Therapy (CPT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 916 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2019-04-18 |
| Phase | NA |
What the finished NCT01928732 record still lists
NCT01928732 is an interventional study that assigns participants to a tested intervention. The registered 916 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure (PE) is the first listed.
NCT01928732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928732 about?
NCT01928732 is a clinical study titled "Comparative Effectiveness Research in Veterans With PTSD". VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), for treating posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that both treatments are effecti...
What is the current status of trial NCT01928732?
This trial is currently completed. It is a NA study. The enrollment target is 916 participants. The study started on 2014-10-31. Estimated completion is 2019-04-18.
What interventions are being tested in trial NCT01928732?
The interventions under investigation include: Prolonged Exposure (PE) (BEHAVIORAL), Cognitive Processing Therapy (CPT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01928732?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928732's enrollment target sits among peer trials
916 124th of 2000 higher than 1,877 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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