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

NCT00826475 | Completed

• 1 other identifier: 423/08
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Headache

Outcome Measures

Primary Outcomes (1)

• number of days suffering from migraine-type headache per month to be determined by a headache diary

  one month

Secondary Outcomes (3)

• pain sensation scale (Schmerzempfindungsskala)

  at post intervention

• Brief Symptom Inventory (BSI)

  post intervention

• Freiburg Mindfulness Inventory (FMI)

  post intervention

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness Based Stress Reduction MBSR

Psychoeducation

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation

Interventions

Mindfulness Based Stress Reduction MBSR BEHAVIORAL

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

Mindfulness

Psychoeducation BEHAVIORAL

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

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• migraine for at least 6 months
• commandment of German language
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 15, 2011

Record last verified: 2009-01

Locations

DE (1)