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Completed

NCT Number: NCT00826475

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction MBSR

Behavioral

Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills

Psychoeducation

Behavioral

Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Primary outcomes

  1. number of days suffering from migraine-type headache per month to be determined by a headache diary

    Time frame: one month

Secondary outcomes

  1. pain sensation scale (Schmerzempfindungsskala)

    Time frame: at post intervention

  2. Brief Symptom Inventory (BSI)

    Time frame: post intervention

  3. Freiburg Mindfulness Inventory (FMI)

    Time frame: post intervention

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2009
Registry last updated
Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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