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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

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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