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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03304613
The ClinicalTrials.gov registry entry for NCT03304613 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (71% higher). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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