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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: Completed Phase 1 study, sponsored by Vanderbilt University.
NCT01131611 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ODI measures disability
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 |
What the finished NCT01131611 record still lists
NCT01131611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which CBPT is the first listed.
NCT01131611 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131611's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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