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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: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.

NCT00855816 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment. Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms. Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms. Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (ak

Interventions

  • BEHAVIORAL Breathing training

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2010-02
Est. Completion 2013-07
Phase Phase 2
US Department of Veterans Affairs

632 total trials

What the finished NCT00855816 record still lists

NCT00855816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which Breathing training is the first listed.

NCT00855816 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00855816's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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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Source: ClinicalTrials.gov NCT00855816, the US trial registry maintained by the National Library of Medicine. NCT00855816 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.