Introvision for Migraine and Headaches

NCT03507400 | Completed Results

• 1 other identifier: IntroMig 632-15
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Chronic Migraine

Keywords

Introvision: mental and emotional self-regulation technique; Mindfulness, perception technique; Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

non-waiting list group

EXPERIMENTAL

Intervention: Introvision: mental and emotional self-regulation

Behavioral: Introvision: mental and emotional self-regulation

waiting list group

EXPERIMENTAL

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

Behavioral: Introvision: mental and emotional self-regulation

Interventions

Introvision: mental and emotional self-regulation BEHAVIORAL

Participants learn Introvision

non-waiting list group; waiting list group

Eligibility Criteria

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

You may qualify if:

• Episodic migraine with at least 5 headache days per month, episodic migraine and tension type headache with at least 5 migraine headache days per month, chronic migraine
• Stable prophylactic headache medication
• Stable non-medication headache prophylaxis (sports, relaxation techniques, …)
• Informed consent

You may not qualify if:

• Other causes of headache, symptomatic headaches
• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• University of Hamburg-Eppendorf: collaborator
• Introvision e.V: collaborator

Study Sites (1)

Hospital of the Ludwig-Maximilians-University

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

• 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.

  PMID: 37924063 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Monika Empl
• Organization: Practice for Neurology and Ludwigs-Maximilians-Universitiy Munich

dr.empl@dr-empl-neurologie.de

+4989500598710

Study Officials

• Monika Empl, MD

  Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: waiting list control study

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 25, 2018
• Study Start: September 20, 2017
• Primary Completion: September 11, 2019
• Study Completion: July 19, 2020
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Locations

DE (1)