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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction MBSR
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills | Behavioral: Mindfulness Based Stress Reduction MBSR<br>* Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills<br>|
| Active Comparator: Psychoeducation<br>Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work | Behavioral: Psychoeducation<br>* Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days suffering from migraine-type headache per month to be determined by a headache diary |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain sensation scale (Schmerzempfindungsskala) |  | at post intervention | 
| Brief Symptom Inventory (BSI) |  | post intervention | 
| Freiburg Mindfulness Inventory (FMI) |  | post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Headache