Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00826475
First received: January 20, 2009
Last updated: August 12, 2011
Last verified: January 2009
  Purpose

Patients suffering from migraine will be randomly allocated to one of two different behavioral interventions:

  • mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation & yoga techniques and teaching information regarding the relationship between stress and health.
  • into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigators will measure the frequency and intensity of migraine attacks before during and after the intervention as well as secondary variables on quality of life and psychological functioning. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

Condition Intervention
Migraine
Behavioral: Mindfulness Based Stress Reduction MBSR
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • number of days suffering from migraine-type headache per month to be determined by a headache diary [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain sensation scale (Schmerzempfindungsskala) [ Time Frame: at post intervention ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory (BSI) [ Time Frame: post intervention ] [ Designated as safety issue: No ]
  • Freiburg Mindfulness Inventory (FMI) [ Time Frame: post intervention ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness
Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Behavioral: Mindfulness Based Stress Reduction MBSR
Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Active Comparator: Psychoeducation
Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Behavioral: Psychoeducation
Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Detailed Description:

Sixty patients suffering from migraine will be randomly allocated to one of two different behavioral interventions: (i) mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation & yoga techniques and teaching information regarding the relationship between stress and health. or (ii) into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigator will measure the frequency and intensity of migraine attacks before during and after the intervention by headache diaries as well as secondary variables on pain sensation, psychological well being, generic quality of life, pain regulation, pain acceptance, mindfulness, compliance and satisfaction with the intervention. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • migraine for at least 6 months
  • commandment of German language
  • 3-8 migraine attacks per month
  • willingness to participate in a behavioral intervention and to conduct the daily homework
  • if patients take a drug as prophylaxis for migraine no change of drug for at least three months and no change of dose for at least one month prior to enrollment

Exclusion Criteria:

  • psychiatric disorders at the time of enrollment
  • addiction
  • participation in other trials
  • prior experience with mbsr
  • migraine related to the ovary cycle
  • abuse of acute medication for migraine
  • other psychological disorders which impair the communication and interaction with the patient
  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: NCT00826475

Locations
Germany
University Medical Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
  More Information

No publications provided

Responsible Party: Dr. Stefan Schmidt, Institute of Environmental Health Sciences, University Medical Center Freiburg
ClinicalTrials.gov Identifier: NCT00826475     History of Changes
Other Study ID Numbers: 423/08
Study First Received: January 20, 2009
Last Updated: August 12, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
Migraine
Headache

Additional relevant MeSH terms:
Migraine Disorders
Stress, Psychological
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 27, 2014