Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Hamburg-Eppendorf | OTHER |
| Introvision e.V | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-waiting list group | Experimental | Intervention: Introvision: mental and emotional self-regulation |
|
| waiting list group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Introvision: mental and emotional self-regulation | Behavioral | Participants learn Introvision |
|
| 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. |
| 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 values before Introvison. | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of Frequency of Exercises as Exploratory Outcome Measure | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monika Empl, MD | Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the Ludwig-Maximilians-University | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37924063 | Derived | Empl M, Loser S, Spille P, Rozwadowska A, Ruscheweyh R, Straube A. Effects of Introvision, a self-regulation method with a mindfulness-based perception technique in migraine prevention: a monocentric randomized waiting-list controlled study (IntroMig Study). J Headache Pain. 2023 Nov 3;24(1):146. doi: 10.1186/s10194-023-01684-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Non-waiting List Group | Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision |
| FG001 | 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 Introvision: mental and emotional self-regulation: Participants learn Introvision |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-waiting List Group | Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision |
| BG001 | Waiting List Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | days per month | 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. |
|
Start of group sessions till forth month after last introvision session, when collecting the data after the last Introvision session (diaries, questionnaires, question for recommendations) participants were asked whether they experienced any adverse events.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Introvision Group | Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia self-limiting during a SAP (stating attentive perception) exercise | Cardiac disorders | Systematic Assessment | after Introvision training |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monika Empl | Practice for Neurology and Ludwigs-Maximilians-Universitiy Munich | +4989500598710 | dr.empl@dr-empl-neurologie.de |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Cover letter EC | Oct 22, 2015 | Mar 23, 2018 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: EC application | Oct 22, 2015 | Mar 23, 2018 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: EC Form | Oct 22, 2015 | Mar 23, 2018 | Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol without Cover letter wo Application wo Form | Mar 30, 2025 | Mar 30, 2025 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2015 | Mar 5, 2018 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2025 | Mar 30, 2025 | ICF_007.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
waiting list control study
Not provided
Not provided
Not provided
Not provided
| 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 before Introvision. | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
| 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, baseline before introvision training and 3 three months after the last introvision session |
| 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 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 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
| Overall Satisfaction of Patients | 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. | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
| approximately 5-6 months |
| Patients' Mastery of Introvision as Exploratory Outcome Measure | 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? | approximately 5-6 months |
| Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 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? | approximately 5-6 months |
| Protocol Violation |
|
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
Introvision: mental and emotional self-regulation: Participants learn Introvision
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 Introvision: mental and emotional self-regulation: Participants learn Introvision |
|
|
|
| Secondary | 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 values before Introvison. | Posted | Mean | Standard Deviation | units on a scale | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
|
|
|
| Secondary | 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 before Introvision. | Posted | Mean | Standard Deviation | days per month | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | days per month | approximately 5-6 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
|
|
|
|
| Secondary | 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 before introvision. The total score may range from 6 to 78 points, a higher score indicates a higher impact of headaches on daily activities. | Posted | Mean | Standard Deviation | score on a scale | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
|
|
|
|
| Secondary | Overall Satisfaction of Patients | 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. | 97% of participants recommended Introvision for migraine patients. | Posted | Count of Participants | Participants | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session |
|
|
|
| Other Pre-specified | Influence of Frequency of Exercises as Exploratory Outcome Measure | 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. | Not Posted | approximately 5-6 months | Participants |
| Other Pre-specified | Patients' Mastery of Introvision as Exploratory Outcome Measure | 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? | Not Posted | approximately 5-6 months | Participants |
| Other Pre-specified | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 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? | Headache days before and after Introvision in patients with a) predominantly left-sided headache, b) predominantly right-sided headache, c) bilateral or equally alterating headache | Posted | Mean | Standard Deviation | days per month | approximately 5-6 months |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 1 |
| 51 |
| EG001 | Waiting List Group Before Introvision | 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 Introvision: mental and emotional self-regulation: Participants learn Introvision | 0 | 37 | 0 | 37 | 0 | 37 |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.02 | Superiority |