Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Introvision for Migraine and Headaches (IntroMig)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507400
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
University of Hamburg
Introvision e.V
Information provided by (Responsible Party):
Dr. Monika Empl, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE September 20, 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2018)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 14, 2018)
  • 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.
  • 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?
  • 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?
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Introvision for Migraine and Headaches
Official Title  ICMJE Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
waiting list control study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Migraine
  • Chronic Migraine
Intervention  ICMJE Behavioral: Introvision: mental and emotional self-regulation
Participants learn Introvision
Study Arms  ICMJE
  • Experimental: non-waiting list group
    Intervention: Introvision: mental and emotional self-regulation
    Intervention: Behavioral: Introvision: mental and emotional self-regulation
  • 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

    Intervention: Behavioral: Introvision: mental and emotional self-regulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monika Empl, MD +49 89 4400 ext 73906 monika.empl@med.uni-muenchen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507400
Other Study ID Numbers  ICMJE IntroMig 632-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Monika Empl, Ludwig-Maximilians - University of Munich
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE
  • University of Hamburg
  • Introvision e.V
Investigators  ICMJE
Principal Investigator: Monika Empl, MD Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
PRS Account Ludwig-Maximilians - University of Munich
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP