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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00475241
The ClinicalTrials.gov registry entry for NCT00475241 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure therapy for PTSD is the first listed.
NCT00475241 reports 0 study locations.
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.
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