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Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study
NCT00734799 · View on ClinicalTrials.gov ↗
Study Summary
A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD) following deployment in recent military conflicts, and sleep disturbance is a primary complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more self-reported and physician-rated health problems, and health status is associated with PTSD symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep disturbance. Even after receiving treatment for PTSD, Veterans continue to experience residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission. There are currently no PTSD-specific sleep interventions available, excepting an intervention that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number of post-deployment Veterans with trauma-related sleep difficulties, such interventions are desperately needed. In this study, we will test the effectiveness of a multi-component cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The secondary objective is to examine the relative impact of the intervention on PTSD symptoms. The project is a prospective, randomized, clinical intervention trial. Participants will be randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD + Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep intervention plus usual care will produce greater improvements (reduced total wake time, increased sleep eff
Conditions Studied
Interventions
- BEHAVIORAL Sleep Intervention for PTSD (SIP).
Study Locations (1)
North Carolina
- Durham VA Medical Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734799
The ClinicalTrials.gov registry entry for NCT00734799 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durham VA Medical Center, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention — of which Sleep Intervention for PTSD (SIP). is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00734799 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00734799 about?
NCT00734799 is a clinical study titled "Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study". A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD) following deployment in recent military conflicts, and sleep disturbance is a primary complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more self-reported and physician-rated healt...
What is the current status of trial NCT00734799?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2008-01. Estimated completion is 2009-12.
What conditions does trial NCT00734799 study?
This clinical trial studies the following conditions: Insomnia, Posttraumatic Stress Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00734799?
The interventions under investigation include: Sleep Intervention for PTSD (SIP). (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00734799?
This trial is sponsored by Durham VA Medical Center, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00734799 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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