Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction MBSR
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache
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
Sites / Locations
- University Medical Center Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness
Psychoeducation
Arm Description
Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Outcomes
Primary Outcome Measures
number of days suffering from migraine-type headache per month to be determined by a headache diary
Secondary Outcome Measures
pain sensation scale (Schmerzempfindungsskala)
Brief Symptom Inventory (BSI)
Freiburg Mindfulness Inventory (FMI)
Full Information
NCT ID
NCT00826475
First Posted
January 20, 2009
Last Updated
August 12, 2011
Sponsor
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT00826475
Brief Title
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
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction MBSR
Intervention Description
Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Primary Outcome Measure Information:
Title
number of days suffering from migraine-type headache per month to be determined by a headache diary
Time Frame
one month
Secondary Outcome Measure Information:
Title
pain sensation scale (Schmerzempfindungsskala)
Time Frame
at post intervention
Title
Brief Symptom Inventory (BSI)
Time Frame
post intervention
Title
Freiburg Mindfulness Inventory (FMI)
Time Frame
post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Medical Center Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
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