Hospital of the Ludwig-Maximilians-University
Munich, Bavaria, 81377, Germany
NCT Number: NCT03507400
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Munich, Bavaria, 81377, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants learn Introvision
Time frame: 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.
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.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Time frame: approximately 5-6 months
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
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Time frame: approximately 5-6 months
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.
Time frame: approximately 5-6 months
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?
Time frame: approximately 5-6 months
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?
Ludwig-Maximilians - University of Munich
Other
Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
Acronym: IntroMig
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