Randomized Trial to Evaluate the Effectiveness of a Mindf... | NCT00826475

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

NCT00826475

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Aug 15, 2011Estimated

Enrollment

62Actual

Phase

Not Applicable

Conditions

Migraine

Interventions

Mindfulness Based Stress Reduction MBSR
Psychoeducation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jan 20, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2011

Last Update Posted Date

Aug 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Based Stress Reduction MBSR	Behavioral	Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills	Mindfulness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of days suffering from migraine-type headache per month to be determined by a headache diary		one month

Secondary Outcomes

Measure	Description	Time Frame
pain sensation scale (Schmerzempfindungsskala)		at post intervention
Brief Symptom Inventory (BSI)		post intervention
Freiburg Mindfulness Inventory (FMI)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Freiburg		Freiburg im Breisgau		79106	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D006261	Headache

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000099024	Mindfulness-Based Stress Reduction

Ancestor Terms

ID	Term
D064866	Mindfulness
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided