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NCT01131611 · ClinicalTrials.gov registry record · Phase 1
Cognitive-Behavioral Physical Therapy
A Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT01131611 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 86 participants.
The verdict
NCT01131611, a Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve surgical outcomes, through reductions in fear of movement and pain catastrophizing. We have established the feasibility of training therapists in the CBPT intervention, recruiting and retaining patients, and the procedures for data collection and study management. The long-term goal is to broaden the availability of well-accepted and effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with musculoskeletal pain populations.
Interventions
- BEHAVIORAL CBPT
- OTHER Control-Attention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01131611
The ClinicalTrials.gov registry entry for NCT01131611 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CBPT is the first listed.
NCT01131611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01131611 about?
NCT01131611 is a clinical study titled "Cognitive-Behavioral Physical Therapy". The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative cond...
What is the current status of trial NCT01131611?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2012-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01131611?
The interventions under investigation include: CBPT (BEHAVIORAL), Control-Attention (OTHER).
Who is sponsoring clinical trial NCT01131611?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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