Introvision for Migraine and Headaches

Migraine Clinical Trial

— IntroMig  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507400
• Other study ID #: IntroMig 632-15
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: May 2020

Study information

• Verified date: August 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: Monika Empl, MD
• Phone: +49 89 4400
• Email: monika.empl[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Introvision: mental and emotional self-regulation
Participants learn Introvision

Locations

Country	Name	City	State
Germany	Hospital of the Ludwig-Maximilians-University	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Introvision e.V, University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	influence of side of headache on outcome as exploratory outcome measure	Do patients with a predominantely 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
Primary	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	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 waiting list group before Introvison.	approximately 4 months
Secondary	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 of the waiting list group in the month before the course to learn Introvision.	approximately 4 months, experimental group compared to the waiting list group
Secondary	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
Secondary	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
Secondary	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 the waiting list group 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 4 months
Secondary	overall satisfaction of patients	Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no".	approximately 5-6 months