NCT03507400|CompletedResults
Introvision for Migraine and Headaches
IntroMig
Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
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Sponsor study identifier
interventional
72
1 country
1
Study Start
September 20, 2017
Actual (reported)Primary Completion
September 11, 2019
Actual (reported)Study Completion
July 19, 2020
Actual (reported)To evaluate the effect of Introvision, a mental and emotional self-regulation-technique developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 19, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2017
Actual (reported)March 5, 2018
Actual (reported)April 25, 2018
Actual (reported)September 11, 2019
Actual (reported)July 19, 2020
Actual (reported)April 18, 2025
Actual (reported)Number of Headache Days Per Month
The number of headache days per month 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.
approximately 4 months, as the course to learn Introvision and the three individual sessions will take nearly 2 months to be completed, and headaches per month will be assessed in the month 3 months after the last session of Introvision.
Headache Intensity
approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Acute Medication Per Month
approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision
approximately 5-6 months
Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)
approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Headache-Impact Test 6, HIT-6
approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Influence of Frequency of Exercises as Exploratory Outcome Measure
approximately 5-6 months
Patients' Mastery of Introvision as Exploratory Outcome Measure
approximately 5-6 months
Influence of Side of Headache on Outcome as Exploratory Outcome Measure
approximately 5-6 months
Intervention: Introvision: mental and emotional self-regulation
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
Participants learn Introvision
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital of the Ludwig-Maximilians-University
Munich, Bavaria, 81377, Germany
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.
Monika Empl, MD
Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
72 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2018
First Posted
April 25, 2018
Study Start
September 20, 2017
Actual (reported)Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Contact the study team to confirm eligibility.
Primary Completion
September 11, 2019
Actual (reported)Study Completion
July 19, 2020
Actual (reported)Last Updated
April 18, 2025
Results First Posted
April 18, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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