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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826475
• Other study ID #: 423/08
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: August 12, 2011
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2009
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days suffering from migraine-type headache per month to be determined by a headache diary		one month	No
Secondary	pain sensation scale (Schmerzempfindungsskala)		at post intervention	No
Secondary	Brief Symptom Inventory (BSI)		post intervention	No
Secondary	Freiburg Mindfulness Inventory (FMI)		post intervention	No