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NCT00855816 · ClinicalTrials.gov registry record · Phase 2
Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00855816 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 80 participants.
The verdict
NCT00855816, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation training in reducing this hyperarousal. Measurements will be both physiological, using 24 hour ambulatory monitoring of skin conductance, heart rate, and physical activity during waking and sleeping, and psychological, using self-reports and clinician interviews. Specific aims include initially evaluating 100 or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at least moderate hyperarousal who either have participated in a trauma-focused therapy or have declined to participate in such a therapy will be recruited for a therapy trial. Volunteers will be randomized to treatment consisting of 5 sessions of individual physiological relaxation training with biofeedback over a 4-week period or to a 2-month waiting period after which they also may receive this therapy. Physiological evaluations of the patients' ability to relax will be measured at three times -before treatment, immediately after treatment, and 6 months after treatment. Clinical evaluations by interviews and questionnaires on measures of symptoms and disability will be measured at four times - before treatment, immediately after treatment, 1 month after treatment, and 6 months after treatment. The waiting-list group and a nonanxious control group will be tested psychophysiologically twice at the same interval as the patients before and immediately after treatment. A control group will allow us to calibrate our measures in the setting in which they are being applied. We hypothesize that this therapy will relieve both self-reported and objective, physiological symptoms of hyperarousal. Relevance to health and the VA mission: Many of our clients at the VA Palo
Interventions
- BEHAVIORAL Breathing training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00855816
The ClinicalTrials.gov registry entry for NCT00855816 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Breathing training is the first listed.
NCT00855816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00855816 about?
NCT00855816 is a clinical study titled "Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management". Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physio...
What is the current status of trial NCT00855816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2010-02. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00855816?
The interventions under investigation include: Breathing training (BEHAVIORAL).
Who is sponsoring clinical trial NCT00855816?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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