Introvision for Migraine and Headaches (IntroMig)

Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Chronic Migraine
• Intervention / Treatment: Behavioral: Introvision: mental and emotional self-regulation

Detailed Description

Randomized, single-center, waiting-list control group study: Introvision as preventative in Migraine

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Hospital of the Ludwig-Maximilians-University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-waiting list group; Intervention: Introvision: mental and emotional self-regulation	Behavioral: Introvision: mental and emotional self-regulation; Participants learn Introvision
Experimental: 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	Behavioral: Introvision: mental and emotional self-regulation; Participants learn Introvision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Intensity	Headache intensity rated by the patients themselves with a scale in the headache diary: weak (=1) , moderate (=2), severe (=3) headache. Scores may range from 1 to 3. Average headache intensity of the attacks per months will be compared three months after the last session of Introvision compared to the values before Introvison.	approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Acute Medication Per Month	The number of days with acute medication against migraine attacks/headache per month 3 months after completion of the last session of Introvision will be compared with the number of days with acute medication per month before Introvision.	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	number of headache days per months in pooled groups analysis before and 3 months after Introvision, measured with the number of headache days per months as in the primary outcome measure, but both groups together compared before Introvision and three months after the last session	approximately 5-6 months
Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)	The headache specific self-efficacy scale (Headache Management Self-efficacy Scale-German-short form: HMSE-G-SF) consists of 6 items with a 7-point response scale which ranges from 1 (strongly disagree) to 7 (strongly agree).The 6 items measure self-efficacy beliefs, for instance: "There are things I can do to alleviate the headache". The scores for each of the six items are combined to compute the total score, that may range from 6 to 42 points. A higher score indicates a stronger self-efficacy in headache management. It is measured before Introvision and three month after the last session of Introvision.	approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Headache-Impact Test 6, HIT-6	Impact of headache (Headache-Impact Test 6, HIT-6), compared three months after the last session of Introvision to before introvision. The total score may range from 6 to 78 points, a higher score indicates a higher impact of headaches on daily activities.	approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Overall Satisfaction of Patients	Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no". The number of patients responding "yes" is reported.	approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of Frequency of Exercises as Exploratory Outcome Measure	Influence of frequency of self-regulation exercises per week on outcome, measured with reduction of headache days per month before and after Introvision. The frequency of self-regulation exercises is documented by the patients themselves on average in a month in the headache diary, with a three categories scale: 0 exercise per week; 1-3 exercises per week, more than 4 exercises per week.	approximately 5-6 months
Patients' Mastery of Introvision as Exploratory Outcome Measure	investigators' estimation of patients' mastery of introvision,. Evaluated by the investigator after the last session in a three category scale: good mastery, moderate mastery, insufficient mastery. Does the mastery of introvision influence the reduction of headache days per month?	approximately 5-6 months
Influence of Side of Headache on Outcome as Exploratory Outcome Measure	Do patients with a predominantly left-sided headache show a greater reduction of headache days per month 3 months after completion of the last session of Introvision compared to patients with predominantely right-sided headache?	approximately 5-6 months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: University of Hamburg-Eppendorf; Introvision e.V
• Investigators: Principal Investigator: Monika Empl, MD, Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): July 19, 2020

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Migraine; Introvision: mental and emotional self-regulation technique; Mindfulness, perception technique
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: IntroMig 632-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No