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Trial record 11 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Migraine Disorders"

Introvision for Migraine and Headaches (IntroMig)

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ClinicalTrials.gov Identifier: NCT03507400
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Collaborators:
University of Hamburg
Introvision e.V
Information provided by (Responsible Party):
Dr. Monika Empl, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Migraine Chronic Migraine Behavioral: Introvision: mental and emotional self-regulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: waiting list control study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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




Primary Outcome Measures :
  1. Number of headache days per month [ 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.


Secondary Outcome Measures :
  1. Headache intensity [ Time Frame: approximately 4 months ]
    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.

  2. acute medication per month [ Time Frame: approximately 4 months, experimental group compared to the waiting list group ]
    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.

  3. number of headache days per month in pooled groups analysis before and 3 months after Introvision as parameter for the efficacy of 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

  4. Headache Management Self-efficacy Scale-German-short form (HMSE-G-SF) [ Time Frame: approximately 5-6 months ]
    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.

  5. Headache-Impact Test 6, HIT-6 [ Time Frame: approximately 4 months ]
    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.

  6. overall satisfaction of patients [ Time Frame: approximately 5-6 months ]
    Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no".


Other Outcome Measures:
  1. Influence of frequency of exercises as exploratory outcome measure [ 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.


  2. patients' mastery of introvision as exploratory outcome measure [ 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?


  3. influence of side of headache on outcome as exploratory outcome measure [ Time Frame: approximately 5-6 months ]
    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?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507400


Contacts
Contact: Monika Empl, MD +49 89 4400 ext 73906 monika.empl@med.uni-muenchen.de

Locations
Germany
Hospital of the Ludwig-Maximilians-University Recruiting
Munich, Bavaria, Germany, 81377
Contact: Monika Empl, MD    +49 89 4400 ext 73690    monika.empl@med.uni-muenchen.de   
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
University of Hamburg
Introvision e.V
Investigators
Principal Investigator: Monika Empl, MD Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
  Study Documents (Full-Text)

Documents provided by Dr. Monika Empl, Ludwig-Maximilians - University of Munich:
Informed Consent Form  [PDF] October 22, 2015
Statistical Analysis Plan  [PDF] October 13, 2015
Study Protocol: Cover letter EC  [PDF] October 22, 2015
Study Protocol: EC application  [PDF] October 22, 2015
Study Protocol: EC Form  [PDF] October 22, 2015


Responsible Party: Dr. Monika Empl, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03507400     History of Changes
Other Study ID Numbers: IntroMig 632-15
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Monika Empl, Ludwig-Maximilians - University of Munich:
Introvision: mental and emotional self-regulation technique
Mindfulness, perception technique
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases