MigraineIntroMigNCT03507400
Introvision for Migraine and Headaches
A study testing Introvision: mental and emotional self-regulation in people with Migraine and Chronic Migraine, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Chronic Migraine
- What is being tested?
- Introvision: mental and emotional self-regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 20 Sep 2017to 19 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hospital of the Ludwig-Maximilians-University
Munich, Bavaria, 81377
About this study
Official title: Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
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.
Read the 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.
- Conditions
- Migraine, Chronic Migraine
- Being tested
- Introvision: mental and emotional self-regulation
- Keywords
- Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introvision: mental and emotional self-regulationBehavioural
Participants learn Introvision
| Study group | Role | What they receive |
|---|---|---|
| non-waiting list group | Experimental | Intervention: Introvision: mental and emotional self-regulation Receives: Behavioral: 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 Receives: Behavioral: Introvision: mental and emotional self-regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (6)
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.
Measured: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start20 Sep 2017
- Primary completion11 Sep 2019
- Study completion19 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- waiting list control study
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Introvision e.V
- Responsible party
- Principal investigator, Dr. Monika Empl, Ludwig-Maximilians - University of Munich
- Investigators
- Monika Empl, MD, Principal investigator, Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507400
- Sponsor's protocol ID
- IntroMig 632-15
- Acronym
- IntroMig
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2018
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37924063
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
- ClinicalTrials.gov ID
- NCT03507400
- Acronym / sponsor ID
- IntroMig / IntroMig 632-15
- Conditions
- Migraine, Chronic Migraine
- Keywords
- Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Introvision e.V
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 19 Jul 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- waiting list control study
| Arm | Type | Receives |
|---|---|---|
| non-waiting list group | Experimental | Behavioral: Introvision: mental and emotional self-regulationIntervention: Introvision: mental and emotional self-regulation |
| waiting list group | Experimental | Behavioral: Introvision: mental and emotional self-regulationIntervention: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introvision: mental and emotional self-regulationParticipants learn Introvision | Behavioural | non-waiting list group, waiting list group |
Primary outcome
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.
6 secondary outcomes
Headache Intensity
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Acute Medication Per Month
Time frame: 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
Time frame: approximately 5-6 months
Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Headache-Impact Test 6, HIT-6
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Overall Satisfaction of Patients
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37924063Empl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Empl, MD principal investigator
Department of Neurology, Marchioninistr. 15, 81377 Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introvision: mental and emotional self-regulation in people with Migraine and Chronic Migraine, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.