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

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: Mindfulness Based Stress Reduction MBSR; Behavioral: Psychoeducation

• Registration Number: NCT00826475
• Lead Sponsor: University Hospital Freiburg

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 Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness Based Stress Reduction MBSR	Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Psychoeducation	Psychoeducation	Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Primary Outcome Measures

Name	Time	Method
number of days suffering from migraine-type headache per month to be determined by a headache diary	one month

Secondary Outcome Measures

Name	Time	Method
Brief Symptom Inventory (BSI)	post intervention
Freiburg Mindfulness Inventory (FMI)	post intervention
pain sensation scale (Schmerzempfindungsskala)	at post intervention

Trial Locations

Locations (1)

University Medical Center Freiburg; 🇩🇪 Freiburg, Germany