Clinical trial NCT00826475: Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Official title: Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Headache
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: number of days suffering from migraine-type headache per month to be determined by a headache diary
timeFrame: one month
Secondary outcomes:
measure: pain sensation scale (Schmerzempfindungsskala)
timeFrame: at post intervention
measure: Brief Symptom Inventory (BSI)
timeFrame: post intervention
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: post intervention
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
Study officials:
References: