CClinicalTrials.gg
CompletedNCT00826475Updated Aug 15, 2011

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

An interventional study of Mindfulness Based Stress Reduction MBSR and Psychoeducation in Migraine, sponsored by University Hospital Freiburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-15.

Sponsored by University Hospital Freiburg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Migraine

Browse trials for

Keywords

  • Migraine
  • Headache
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 62 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

University Hospital Freiburg is the lead sponsor of 91 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Mindfulness

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

    Behavioral: Mindfulness Based Stress Reduction MBSR

  • Active comparator
    Psychoeducation

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

    Behavioral: Psychoeducation

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

06

What researchers measure

Primary outcomes

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

    Time frame: one month

Secondary outcomes

  1. pain sensation scale (Schmerzempfindungsskala)

    Time frame: at post intervention

  2. Brief Symptom Inventory (BSI)

    Time frame: post intervention

  3. Freiburg Mindfulness Inventory (FMI)

    Time frame: post intervention

07

Study locations

1 site
  • University Medical Center Freiburg
    Freiburg, 79106, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00826475
Lead sponsor
University Hospital Freiburg
First posted
Jan 22, 2009
Start date
Jan 2009
Primary completion
Apr 2010
Completion
Jul 2010
Last update
Aug 15, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion