HeadachePhase 1/2NCT01213056
Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain
A Phase 1/2 study testing Mindfulness Based Cognitive Therapy in people with Headache and Pain, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Mindfulness Based Cognitive Therapy, Chronic Headache Pain, Randomized Controlled Trial.
- Medical subject headings
- Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Cognitive Behavioral (Active treatment condition)
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy * (MBCT) | Active comparator | Mindfulness based cognitive therapy aimed to improve coping with, and managing chronic headache pain. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Delayed Treatment Control * (DT) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
General Health Survey
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).
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly E Thorn, Ph.D., Principal investigator, University of Alabama, Tuscaloosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213056
- Sponsor's protocol ID
- 09-0378
- Status last verified
- Nov 2015
- First submitted
- 5 Apr 2010
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy for the Treatment of Chronic Headache Pain
- ClinicalTrials.gov ID
- NCT01213056
- Acronym / sponsor ID
- 09-0378
- Keywords
- Mindfulness Based Cognitive Therapy, Chronic Headache Pain, Randomized Controlled Trial.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy * (MBCT) | Active comparator | Behavioral: Mindfulness Based Cognitive TherapyMindfulness based cognitive therapy aimed to improve coping with, and managing chronic headache pain. |
| Delayed Treatment Control * (DT) | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyCognitive Behavioral (Active treatment condition) | Behavioural | Mindfulness Based Cognitive Therapy * (MBCT) |
Primary outcome
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.
1 secondary outcome
General Health Survey
Time frame: 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly E Thorn, Ph.D. principal investigator
University of Alabama, Tuscaloosa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mindfulness Based Cognitive Therapy in people with Headache and Pain, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache diary (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.