Clinical trial NCT03507400: Introvision for Migraine and Headaches
Official title: Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Chronic Migraine
Keywords: Introvision: mental and emotional self-regulation technique
Mindfulness, perception technique
Migraine
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
name: Introvision e.V
First posted: 2018-04-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: waiting list control study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Headache Days Per Month
timeFrame: 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:
measure: Headache Intensity
timeFrame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
measure: Acute Medication Per Month
timeFrame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
measure: Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision
timeFrame: approximately 5-6 months
measure: Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)
timeFrame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
measure: Headache-Impact Test 6, HIT-6
timeFrame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
measure: Overall Satisfaction of Patients
timeFrame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Other outcomes:
measure: Influence of Frequency of Exercises as Exploratory Outcome Measure
timeFrame: approximately 5-6 months
measure: Patients' Mastery of Introvision as Exploratory Outcome Measure
timeFrame: approximately 5-6 months
measure: Influence of Side of Headache on Outcome as Exploratory Outcome Measure
timeFrame: approximately 5-6 months
Locations:
city: Munich
country: Germany
facility: Hospital of the Ludwig-Maximilians-University
state: Bavaria
Study officials:
affiliation: Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
name: Monika Empl, MD
role: PRINCIPAL_INVESTIGATOR
References: