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Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213056
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa

Brief 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.

Condition or disease Intervention/treatment Phase
Headache Pain Behavioral: Mindfulness Based Cognitive Therapy Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 3 pain days per month (for the past 3 months or more) due to migraine and/or tension-type headaches;
  • Recent evaluation (within 6 months) of headaches by a physician, participants will also need to receive permission from their physician to take part in the study;
  • Age of 19 years or older;
  • Reading ability sufficient to comprehend self-monitoring forms;
  • If currently using psychotropic or headache medications, use of these medications must have begun at least 4-weeks before treatment; and
  • Agree to be videotaped during the group treatment sessions, although the video camera will be directed at the group leader, and not directed at the participant.

Exclusion Criteria:

  • History of seizure or facial neuralgia, as these conditions might preclude the accurate diagnosis of headache;
  • Significant cognitive impairment;
  • History of schizophrenia, bipolar affective disorder or substance abuse as these conditions could result in a psychiatric emergency during treatment

Information from the National Library of Medicine

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 identifier (NCT number): NCT01213056

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United States, Alabama
Tuscaloosa, Alabama, United States, 35487
Sponsors and Collaborators
University of Alabama, Tuscaloosa
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Principal Investigator: Beverly E Thorn, Ph.D. University of Alabama, Tuscaloosa

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Responsible Party: University of Alabama, Tuscaloosa Identifier: NCT01213056     History of Changes
Other Study ID Numbers: 09-0378
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by University of Alabama, Tuscaloosa:
Mindfulness Based Cognitive Therapy
Chronic Headache Pain
Randomized Controlled Trial.

Additional relevant MeSH terms:
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Headache Disorders
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases