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NCT03304613 · ClinicalTrials.gov registry record · NA
Resilience Skills Self-Management for Chronic Pain.
A NA study of Fibromyalgia and Chronic Spine Pain, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT03304613: Completed NA study of Fibromyalgia and Chronic Spine Pain, sponsored by University of Michigan.
NCT03304613 is a NA study of Fibromyalgia and Chronic Spine Pain that has completed, run by University of Michigan. The registered enrollment target is 300 participants, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (71% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03304613, a NA study of Fibromyalgia and Chronic Spine Pain, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4
Primary Outcome
The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.
Conditions Studied
Interventions
- BEHAVIORAL Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management
- BEHAVIORAL Promoting Resilience through Innovative Self-Management
Study Locations (1)
Michigan
- Back & Pain Center, University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2023-03-21 |
| Phase | NA |
What the finished NCT03304613 record still lists
NCT03304613 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (71% higher).
The record links to 2 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management is the first listed.
NCT03304613 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03304613 about?
NCT03304613 is a clinical study titled "Resilience Skills Self-Management for Chronic Pain.". The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will underg...
What is the current status of trial NCT03304613?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2017-11-16. Estimated completion is 2023-03-21.
What conditions does trial NCT03304613 study?
This clinical trial studies the following conditions: Fibromyalgia, Chronic Spine Pain.
What interventions are being tested in trial NCT03304613?
The interventions under investigation include: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management (BEHAVIORAL), Promoting Resilience through Innovative Self-Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT03304613?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03304613 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03304613's enrollment target sits among peer trials
300 13th of 76 higher than 62 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.
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