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

Sponsored by:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00826475

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

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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

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 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 ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mindfulness: Experimental 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
Psychoeducation: Active Comparator 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. 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826475

Contacts

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

Locations

Germany
University Medical Center Freiburg	Recruiting
Freiburg, Germany, 79106
Contact: Schmidt +49-761-270-8305
Principal Investigator: Stefan M Schmidt, PhD
Sub-Investigator: Holger Kaube, Prof

Sponsors and Collaborators

University Hospital Freiburg

More Information

No publications provided

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

Keywords provided by University Hospital Freiburg:

Migraine
Headache

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Migraine Disorders
Nervous System Diseases
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on May 06, 2009