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NCT00423631 · ClinicalTrials.gov registry record · NA
Web-based Education to Enhance Fibromyalgia Management
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
NCT00423631: Completed NA study, sponsored by University of Michigan.
NCT00423631 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 118 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423631, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
Study Summary
Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period. Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website. Secondary Hypotheses 1. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website 2. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain wi
Interventions
- BEHAVIORAL Standard Care
- BEHAVIORAL Standard care and web
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-04 |
| Phase | NA |
What the finished NCT00423631 record still lists
NCT00423631 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT00423631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423631 about?
NCT00423631 is a clinical study titled "Web-based Education to Enhance Fibromyalgia Management". Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard car...
What is the current status of trial NCT00423631?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2006-09. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00423631?
The interventions under investigation include: Standard Care (BEHAVIORAL), Standard care and web (BEHAVIORAL).
Who is sponsoring clinical trial NCT00423631?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423631's enrollment target sits among peer trials
118 803rd of 2000 higher than 1,194 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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