Introvision for Migraine and Headaches - Clinical Trial for Migraine | NCT03507400

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Introvision: mental and emotional self-regulation

About this trial

This is an interventional prevention trial for Migraine focused on measuring Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital of the Ludwig-Maximilians-UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

non-waiting list group

waiting list group

Arm Description

Intervention: Introvision: mental and emotional self-regulation

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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

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.

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.

overall satisfaction of patients

Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no".

Full Information

NCT ID

NCT03507400

First Posted

March 5, 2018

Last Updated

August 12, 2019

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

University of Hamburg-Eppendorf, Introvision e.V

1. Study Identification

Unique Protocol Identification Number

NCT03507400

Brief Title

Introvision for Migraine and Headaches

Acronym

IntroMig

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 20, 2017 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

University of Hamburg-Eppendorf, Introvision e.V

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Chronic Migraine

Keywords

Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

waiting list control study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

non-waiting list group

Arm Type

Experimental

Arm Description

Intervention: Introvision: mental and emotional self-regulation

Arm Title

waiting list group

Arm Type

Experimental

Arm Description

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 Type

Behavioral

Intervention Name(s)

Introvision: mental and emotional self-regulation

Intervention Description

Participants learn Introvision

Primary Outcome Measure Information:

Title

Number of headache days per month

Description

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 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 Measure Information:

Title

Headache intensity

Description

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.

Time Frame

approximately 4 months

Title

acute medication per month

Description

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.

Time Frame

approximately 4 months, experimental group compared to the waiting list group

Title

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

Description

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

Title

Headache Management Self-efficacy Scale-German-short form (HMSE-G-SF)

Description

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

Title

Headache-Impact Test 6, HIT-6

Description

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.

Time Frame

approximately 4 months

Title

overall satisfaction of patients

Description

Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no".

Time Frame

approximately 5-6 months

Other Pre-specified Outcome Measures:

Title

Influence of frequency of exercises as exploratory outcome measure

Description

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

Title

patients' mastery of introvision as exploratory outcome measure

Description

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

Title

influence of side of headache on outcome as exploratory outcome measure

Description

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?

Time Frame

approximately 5-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Monika Empl, MD

Phone

+49 89 4400

Ext

73906

Email

monika.empl@med.uni-muenchen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monika Empl, MD

Organizational Affiliation

Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the Ludwig-Maximilians-University

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Monika Empl, MD

Phone

+49 89 4400

Ext

73690

Email

monika.empl@med.uni-muenchen.de

Introvision for Migraine and Headaches (IntroMig)

Migraine, Chronic Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial