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

U

University Hospital Freiburg

Status

Completed

Conditions

Migraine

Treatments

Behavioral: Mindfulness Based Stress Reduction MBSR
Behavioral: Psychoeducation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

62 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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