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NCT00321451 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
A Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT00321451: Completed Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders, sponsored by Duke University.
NCT00321451 is a Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders that has completed, run by Duke University. The registered enrollment target is 111 participants, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321451, a Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
Study Summary
Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving other FM-related symptoms.
Conditions Studied
Interventions
- OTHER Usual care
- BEHAVIORAL Cognitive behavioral therapy for insomnia
- BEHAVIORAL Pseudo-desensitization procedure
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT00321451 record still lists
NCT00321451 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (38% lower).
The record links to 2 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 3 interventions - of which Usual care is the first listed.
NCT00321451 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00321451 about?
NCT00321451 is a clinical study titled "Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia". Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may wors...
What is the current status of trial NCT00321451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2006-05. Estimated completion is 2011-02.
What conditions does trial NCT00321451 study?
This clinical trial studies the following conditions: Fibromyalgia, Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00321451?
The interventions under investigation include: Usual care (OTHER), Cognitive behavioral therapy for insomnia (BEHAVIORAL), Pseudo-desensitization procedure (BEHAVIORAL).
Who is sponsoring clinical trial NCT00321451?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00321451 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
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 NCT00321451's enrollment target sits among peer trials
111 28th of 76 higher than 49 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia 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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