Introvision for Migraine and Headaches

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Migraine, Chronic Migraine

Intervention / Treatment
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* Behavioral: Introvision: mental and emotional self-regulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: waiting list control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-waiting list group<br>Intervention: Introvision: mental and emotional self-regulation | Behavioral: Introvision: mental and emotional self-regulation<br>* Participants learn Introvision<br>|
| Experimental: waiting list group<br>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<br>* Participants learn Introvision<br>|

What is the study measuring?
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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 waiting list group before Introvison. | approximately 4 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine