Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2017-09-20
2020-07-19
Brief Summary
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Detailed Description
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Randomized, single center, waiting-list group control study to evaluate the effect of Introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. The number of headache days 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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non-waiting list group
Intervention: Introvision: mental and emotional self-regulation
Introvision: mental and emotional self-regulation
Participants learn Introvision
waiting list group
Intervention: Introvision: mental and emotional self-regulation
Introvision is teached to participants of the waiting-list group at least 6 weaks or more after first group
Introvision: mental and emotional self-regulation
Participants learn Introvision
Interventions
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Introvision: mental and emotional self-regulation
Participants learn Introvision
Eligibility Criteria
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Inclusion Criteria
* Stable prophylactic headache medication
* Stable non-medication headache prophylaxis (sports, relaxation techniques, …)
* Informed consent
Exclusion Criteria
* Other primary headaches such as Cluster headache, trigeminal neuralgia, idiopathic facial pain, new daily persistent headache
* Severe depression (more than 13 points in the Beck Depression inventory fast screen (BDI-FS)
* Drug - or alcohol abuse
* Non-compliance, especially significant missing entries in the headache diaries
* Active psychosis
18 Years
ALL
No
Sponsors
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University of Hamburg-Eppendorf
OTHER
Introvision e.V
UNKNOWN
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Dr. Monika Empl
Principal Investigator
Principal Investigators
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Monika Empl, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
Locations
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Hospital of the Ludwig-Maximilians-University
Munich, Bavaria, Germany
Countries
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References
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Empl M, Loser S, Spille P, Rozwadowska A, Ruscheweyh R, Straube A. Effects of Introvision, a self-regulation method with a mindfulness-based perception technique in migraine prevention: a monocentric randomized waiting-list controlled study (IntroMig Study). J Headache Pain. 2023 Nov 3;24(1):146. doi: 10.1186/s10194-023-01684-0.
Provided Documents
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Document Type: Study Protocol: Cover letter EC
Document Type: Study Protocol: EC application
Document Type: Study Protocol: EC Form
Document Type: Study Protocol: Study Protocol without Cover letter wo Application wo Form
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IntroMig 632-15
Identifier Type: -
Identifier Source: org_study_id
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