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NCT00734799 · ClinicalTrials.gov registry record · NA

Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

A NA study of Post Traumatic Stress Disorder and Insomnia, sponsored by Durham VA Medical Center.

Completed
Registry status
NA
Development phase
22
Enrollment target
1
Study location

NCT00734799: Completed NA study of Post Traumatic Stress Disorder and Insomnia, sponsored by Durham VA Medical Center.

NCT00734799 is a NA study of Post Traumatic Stress Disorder and Insomnia that has completed, run by Durham VA Medical Center. The registered enrollment target is 22 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00734799, a NA study of Post Traumatic Stress Disorder and Insomnia, has completed, sponsored by Durham VA Medical Center.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target
1
Study location

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

Primary Outcome

Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligib

Interventions

  • BEHAVIORAL Sleep Intervention for PTSD (SIP).

Study Locations (1)

North Carolina

  • Durham VA Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2008-01
Est. Completion 2009-12
Phase NA
Durham VA Medical Center

17 total trials

What the finished NCT00734799 record still lists

NCT00734799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Sleep Intervention for PTSD (SIP). is the first listed.

NCT00734799 reports a single indexed study location in North Carolina.

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: Post Traumatic Stress Disorder, Insomnia.

What interventions are being tested in trial NCT00734799?

The interventions under investigation include: Sleep Intervention for PTSD (SIP). (BEHAVIORAL).

Who is sponsoring clinical trial NCT00734799?

This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00734799's enrollment target sits among peer trials

22 229th of 262 higher than 34 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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 NCT00734799, the US trial registry maintained by the National Library of Medicine. NCT00734799 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.