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Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
This study is currently recruiting participants.
Study NCT00826475   Information provided by University Hospital Freiburg
First Received: January 20, 2009   No Changes Posted
This Tabular View shows the required WHO registration data elements as marked by

January 20, 2009
January 20, 2009
January 2009
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 ]
Same as current
No Changes Posted
  • pain sensation scale (Schmerzempfindungsskala) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory (BSI) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
  • Profile of Quality of Life for the Chronically Ill (Profil der Lebensqualität chronischer Kranker, Siegrist et al., 1996) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
  • Questionnaire for pain regulation (Fragebogen zur Schmerzregulation Schermelleh-Engel, 1995) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
  • Chronic Pain Acceptance Questionnaire (McCracken et al., 2004) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
  • Freiburg Mindfulness Inventory (FMI) [ Time Frame: at baseline, at post intervention and after 12 months ] [ Designated as safety issue: No ]
Same as current
 
Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
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.

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. We 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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Migraine
  • Behavioral: Mindfulness Based Stress Reduction MBSR
  • Behavioral: Psychoeducation
  • Experimental: Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
  • Active Comparator: Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Stefan M Schmidt, PhD +49-761-270-8305 stefan.schmidt@uniklinik-freiburg.de
Contact: Holger Kaube, Prof., MD +49-761-270-5020 holger.kaube@uniklinik-freiburg.de
Germany
 
 
NCT00826475
Dr. Stefan Schmidt, Institute of Environmental Health Sciences, University Medical Center Freiburg
 
University Hospital Freiburg
 
 
University Hospital Freiburg
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.