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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 20, 2009
Last Updated Date	August 12, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00826475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 12, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 20, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Official Title ^ICMJE	Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Behavioral: Mindfulness Based Stress Reduction MBSR Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills Behavioral: Psychoeducation Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Study Arm (s)	Experimental: Mindfulness Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills Intervention: Behavioral: Mindfulness Based Stress Reduction MBSR Active Comparator: Psychoeducation Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work Intervention: Behavioral: Psychoeducation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	62
Completion Date	July 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00826475
Other Study ID Numbers ^ICMJE	423/08
Has Data Monitoring Committee	No
Responsible Party	Dr. Stefan Schmidt, Institute of Environmental Health Sciences, University Medical Center Freiburg
Study Sponsor ^ICMJE	University Hospital Freiburg
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital Freiburg
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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