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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT01213056
First received: April 5, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Headache
Pain
Behavioral: Mindfulness Based Cognitive Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain

Resource links provided by NLM:


Further study details as provided by University of Alabama, Tuscaloosa:

Primary Outcome Measures:
  • Headache diary [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • General Health Survey [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 32
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213056

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

No publications provided

Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT01213056     History of Changes
Other Study ID Numbers: 09-0378
Study First Received: April 5, 2010
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014