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NCT00475241 · ClinicalTrials.gov registry record · Phase 2
Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00475241: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT00475241 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00475241, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The goals of the proposed research are to produce preliminary evidence of PE with OEF/OIF veterans with PTSD and to examine cognitive, psychophysiological, and neuroendocrine mechanisms of change in PTSD treatment. In brief, 36 OEF/OIF veterans with chronic PTSD or PTSS of at least 3 months duration will be randomly assigned to 15 sessions of either PE or TAU (see below for descriptions of the interventions). All veterans will receive psychobiological assessments at pre treatment, mid treatment, post treatment, 3 months, and 6 months follow-up. Each of these assessments will cover in 2 sessions on separate days and will include interview and self-report of symptoms (i.e., PTSD, depression, and general anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., heart rate, skin conductance, respiration, and end-tidal CO2) assessment during neutral and trauma scripts, and assessment of salivary cortisol during neutral and trauma scripts. Also, on the morning prior to each laboratory assessment, patients will collect salivary cortisol at the moment of waking and 30 and 45 minutes post-walking. In addition to these assessments, patients assigned to PE will collect salivary cortisol during three imaginal exposure sessions (sessions 3, 9, and 15).
Primary Outcome
Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.
Interventions
- BEHAVIORAL Prolonged Exposure therapy for PTSD
- BEHAVIORAL Present centered therapy for PTSD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00475241 record still lists
NCT00475241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure therapy for PTSD is the first listed.
NCT00475241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00475241 about?
NCT00475241 is a clinical study titled "Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms". The goals of the proposed research are to produce preliminary evidence of PE with OEF/OIF veterans with PTSD and to examine cognitive, psychophysiological, and neuroendocrine mechanisms of change in PTSD treatment. In brief, 36 OEF/OIF veterans with chronic PTSD or PTSS of at least 3 months duration...
What is the current status of trial NCT00475241?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2008-01. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00475241?
The interventions under investigation include: Prolonged Exposure therapy for PTSD (BEHAVIORAL), Present centered therapy for PTSD (BEHAVIORAL).
Who is sponsoring clinical trial NCT00475241?
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 NCT00475241's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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