Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Migraine Headaches |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | December 2013 |
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.
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.
Cognitive Behavioral Therapy (CBT) is well established as an efficacious treatment for a
wide variety of chronic pain conditions, including headache pain. A promising trend within
the behavioral medicine field in recent years has been the integration of mindfulness into
traditional treatment modalities and the development of innovative treatments based upon
these principles. Mindfulness Based Stress Reduction (MBSR) maintains a patient-centered
approach that focuses upon mindfulness meditation as the key mechanism to teach people how
to cope with their pain, take better care of themselves, and to improve their overall
quality of life. MBSR has successfully been utilized in a number of disorders including
chronic pain 1,2,3 and in general medical populations 4 Mindfulness-Based Cognitive Therapy
(MBCT),5 originally developed to target relapse prevention in major depression, is
essentially a modification of MBSR to incorporate more traditional cognitive-behavioral
interventions into the extant MBSR framework. Studies of MBCT support its efficacy in
eliciting cognitive changes similar to those demonstrated in CBT, while still incorporating
the more general salutary effects seen in MBSR,6,7,8,9,10While MBCT has been applied to
other populations, there has been no published work to date adapting it to chronic pain
patients. This is a surprising gap in the literature given the effectiveness of both CBT and
mindfulness independently for chronic pain. Therefore, the present proposal seeks to begin
to fill these gaps by testing the feasibility and efficacy of MBCT for chronic pain in a
series of pilot groups.
Primary Specific Aims The proposed project is a feasibility study designed to test the MBCT
protocol for chronic pain treatment and to provide pilot data to support subsequent research
proposals to be submitted to the National Institutes of Health. In this initial trial the
investigators will use patients with primary complaints of headache pain and treat them at a
collaborating headache clinic. We selected this target population because headache pain is
highly disabling and is the most common pain related complaint treated in medical practice.
Furthermore, given the time frame of the study, it is more feasible to recruit patients
where the PI has an established and ongoing collaborative relationship. The proposed project
emphasizes the research area of health, medicine, and behavior.
Aim 1: To examine feasibility of the treatment, data will be collected regarding participant
flow across each stage of the study design, including recruitment, participation, and
drop-out rates, and percentage of sessions attended. Furthermore, pre-treatment
expectations, post-treatment satisfaction, and global ratings of self-perceived improvement
will be assessed.
Hypotheses: It is expected that the feasibility of MBCT, as measured by the above
indicators, will be comparable to similar data for other psychosocial treatments for pain,
such as CBT.
Aim 2: As an initial test of the efficacy of MBCT for chronic pain, the investigators will
compare an immediate treatment condition to a delayed treatment (OT) control on pre- and
post-intervention measures. Time constraints of the current project will necessitate
follow-up assessment to be part of future proposals.
Hypotheses: Participants in the immediate treatment condition will obtain significantly
greater pre-post treatment gains compared to OT on primary outcome measures of pain
acceptance, pain catastrophizing, and pain interference; and secondary outcome measures of
mindfulness, pain intensity, perceived disability, selfefficacy, quality of life, and
depression.
Long-term objectives: Future projects will include a randomized controlled trial (RCT)
comparing MBCT to an attention control condition (education support group), and eventually a
comparative effectiveness stUdy of CBT vs. MBCT.
Innovative aspects of the proposed study: This is the first examination of MBCT for chronic
pain, which incorporates specific components of mindfulness and cognitive behavioral therapy
to form a comprehensive treatment approach.
wide variety of chronic pain conditions, including headache pain. A promising trend within
the behavioral medicine field in recent years has been the integration of mindfulness into
traditional treatment modalities and the development of innovative treatments based upon
these principles. Mindfulness Based Stress Reduction (MBSR) maintains a patient-centered
approach that focuses upon mindfulness meditation as the key mechanism to teach people how
to cope with their pain, take better care of themselves, and to improve their overall
quality of life. MBSR has successfully been utilized in a number of disorders including
chronic pain 1,2,3 and in general medical populations 4 Mindfulness-Based Cognitive Therapy
(MBCT),5 originally developed to target relapse prevention in major depression, is
essentially a modification of MBSR to incorporate more traditional cognitive-behavioral
interventions into the extant MBSR framework. Studies of MBCT support its efficacy in
eliciting cognitive changes similar to those demonstrated in CBT, while still incorporating
the more general salutary effects seen in MBSR,6,7,8,9,10While MBCT has been applied to
other populations, there has been no published work to date adapting it to chronic pain
patients. This is a surprising gap in the literature given the effectiveness of both CBT and
mindfulness independently for chronic pain. Therefore, the present proposal seeks to begin
to fill these gaps by testing the feasibility and efficacy of MBCT for chronic pain in a
series of pilot groups.
Primary Specific Aims The proposed project is a feasibility study designed to test the MBCT
protocol for chronic pain treatment and to provide pilot data to support subsequent research
proposals to be submitted to the National Institutes of Health. In this initial trial the
investigators will use patients with primary complaints of headache pain and treat them at a
collaborating headache clinic. We selected this target population because headache pain is
highly disabling and is the most common pain related complaint treated in medical practice.
Furthermore, given the time frame of the study, it is more feasible to recruit patients
where the PI has an established and ongoing collaborative relationship. The proposed project
emphasizes the research area of health, medicine, and behavior.
Aim 1: To examine feasibility of the treatment, data will be collected regarding participant
flow across each stage of the study design, including recruitment, participation, and
drop-out rates, and percentage of sessions attended. Furthermore, pre-treatment
expectations, post-treatment satisfaction, and global ratings of self-perceived improvement
will be assessed.
Hypotheses: It is expected that the feasibility of MBCT, as measured by the above
indicators, will be comparable to similar data for other psychosocial treatments for pain,
such as CBT.
Aim 2: As an initial test of the efficacy of MBCT for chronic pain, the investigators will
compare an immediate treatment condition to a delayed treatment (OT) control on pre- and
post-intervention measures. Time constraints of the current project will necessitate
follow-up assessment to be part of future proposals.
Hypotheses: Participants in the immediate treatment condition will obtain significantly
greater pre-post treatment gains compared to OT on primary outcome measures of pain
acceptance, pain catastrophizing, and pain interference; and secondary outcome measures of
mindfulness, pain intensity, perceived disability, selfefficacy, quality of life, and
depression.
Long-term objectives: Future projects will include a randomized controlled trial (RCT)
comparing MBCT to an attention control condition (education support group), and eventually a
comparative effectiveness stUdy of CBT vs. MBCT.
Innovative aspects of the proposed study: This is the first examination of MBCT for chronic
pain, which incorporates specific components of mindfulness and cognitive behavioral therapy
to form a comprehensive treatment approach.
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
We found this trial at
1
site
Click here to add this to my saved trials
