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NCT01213056 · ClinicalTrials.gov registry record · Phase 1
Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain
A Phase 1 study, sponsored by University of Alabama, Tuscaloosa.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01213056: Completed Phase 1 study, sponsored by University of Alabama, Tuscaloosa.
NCT01213056 is a Phase 1 study that has completed, run by University of Alabama, Tuscaloosa. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01213056, a Phase 1 study, has completed, sponsored by University of Alabama, Tuscaloosa.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The literature on the efficacy of Cognitive Behavioral Therapy (CBT) for the treatment of chronic pain is well established. Support for the efficacy of Mindfulness Based Stress Reduction (MBSR) and other mindfulness based treatments for chronic pain is building. Recently, research has demonstrated the efficacy of Mindfulness Based Cognitive Therapy (MBCT) in simultaneously addressing the outcome variables targeted by both CBT and mindfulness based treatment modalities. Although the efficacy of MBCT depression and for other populations has been investigated, there is no extant literature reporting on MBCT for chronic pain. The current application proposes to investigate the feasibility and efficacy of an MBCT protocoll adapted for chronic pain in a series of pilot groups with headache pain patients. We selected headache pain patients for this trial because headache pain is a common complaint in the general population, is the most frequently reported cause of pain in medical practice, and is one of the most disabling conditions for both genders combined. To examine the feasibility of the adapted protocol, the investigators will investigate a number of treatment related outcomes such as recruitment, completion, and drop out rates. Both primary and secondary outcome variables will be investigated to determine treatment efficacy. This study will provide a research base examining the feasibility and efficacy of MBCT for pain. Results from this study will lay the foundation for future randomized controlled trials comparing MBCT to attention control, and future comparative effectiveness studies of MBCT and CBT.
Primary Outcome
Headache diary recordings of Headache Index, headache duration, headache frequency, and headache related disability. Pre-treatment, daily for two weeks prior to commencement of condition, daily during condition (i.e. both treatment and control condition participants complete the diary), post-treatment, 6-months follow-up.
Interventions
- BEHAVIORAL Mindfulness Based Cognitive Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01213056 record still lists
NCT01213056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Based Cognitive Therapy is the first listed.
NCT01213056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01213056 about?
NCT01213056 is a clinical study titled "Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain". The literature on the efficacy of Cognitive Behavioral Therapy (CBT) for the treatment of chronic pain is well established. Support for the efficacy of Mindfulness Based Stress Reduction (MBSR) and other mindfulness based treatments for chronic pain is building. Recently, research has demonstrated t...
What is the current status of trial NCT01213056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2010-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01213056?
The interventions under investigation include: Mindfulness Based Cognitive Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01213056?
This trial is sponsored by University of Alabama, Tuscaloosa, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01213056's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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