Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain
|ClinicalTrials.gov Identifier: NCT01213056|
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : December 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Headache Pain||Behavioral: Mindfulness Based Cognitive Therapy||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Mindfulness Based Cognitive Therapy * (MBCT)
Mindfulness based cognitive therapy aimed to improve coping with, and managing chronic headache pain.
Behavioral: Mindfulness Based Cognitive Therapy
Cognitive Behavioral (Active treatment condition)
|No Intervention: Delayed Treatment Control * (DT)|
- Headache diary [ Time Frame: 6 months ]
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.
- General Health Survey [ Time Frame: 6 month follow-up ]General Health Survey Short-Form 36 (SF-36); The Migraine Disability Assessment (MIDAS); Beck Depression Inventory, Second Edition (BDI-II); Pain Catastrophizing Scale (PCS); Mindful Attention and Awareness Scale (MAAS); Chronic Pain Acceptance Questionnaire (CPAQ); Headache Management Self-Efficacy scale (HMSE); and Pain Appraisal Inventory (PAI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213056
|United States, Alabama|
|Tuscaloosa, Alabama, United States, 35487|
|Principal Investigator:||Beverly E Thorn, Ph.D.||University of Alabama, Tuscaloosa|