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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00826475
Enrollment
62
Registered
2009-01-22
Start date
2009-01-31
Completion date
2010-07-31
Last updated
2011-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Headache

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.

Interventions

BEHAVIORALMindfulness Based Stress Reduction MBSR

Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills

BEHAVIORALPsychoeducation

Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Sponsors

University Hospital Freiburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of days suffering from migraine-type headache per month to be determined by a headache diaryone month

Secondary

MeasureTime frame
pain sensation scale (Schmerzempfindungsskala)at post intervention
Brief Symptom Inventory (BSI)post intervention
Freiburg Mindfulness Inventory (FMI)post intervention

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026