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

NCT01213056 | Completed Phase 1

• 1 other identifier: 09-0378
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Pain

Keywords

Mindfulness Based Cognitive Therapy; Chronic Headache Pain; Randomized Controlled Trial.

Outcome Measures

Primary Outcomes (1)

• Headache diary

  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.

  6 months

Secondary Outcomes (1)

• General Health Survey

  6 month follow-up

Study Arms (2)

Mindfulness Based Cognitive Therapy * (MBCT)

ACTIVE COMPARATOR

Mindfulness based cognitive therapy aimed to improve coping with, and managing chronic headache pain.

Behavioral: Mindfulness Based Cognitive Therapy

Delayed Treatment Control * (DT)

NO INTERVENTION

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

Cognitive Behavioral (Active treatment condition)

Mindfulness Based Cognitive Therapy * (MBCT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Study Sites (1)

UATuscaloosa

Tuscaloosa, Alabama, 35487, United States

Location

MeSH Terms

Conditions

Headache; Pain

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Beverly E Thorn, Ph.D.

  University of Alabama, Tuscaloosa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: October 1, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)