NCT03507400: IntroMig

Introvision for Migraine and Headaches

Completed NA Results posted Last updated 18 April 2025

What this trial tests

NA trial testing Introvision: mental and emotional self-regulation in Migraine in 72 participants. Completed in 19 July 2020.

Timeline

20 September 2017

Primary endpoint
11 September 2019

19 July 2020

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	72
Start date	20 September 2017
Primary completion	11 September 2019
Estimated completion	19 July 2020
Sites	1 location across Germany

Drugs / interventions tested

• Introvision: mental and emotional self-regulation

Conditions studied

• Migraine — all drugs for Migraine →
• Chronic Migraine — all drugs for Chronic Migraine →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Migraine or Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Headache Days Per Month Primary · 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.

Group	Value	95% CI
Non-waiting List Group	10.6	± 7.7
Waiting List Group	10.9	± 6.3

Headache Intensity Secondary · approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

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.

Group	Value	95% CI
Before Introvision	2.0	± 0.5
After Introvision	2.0	± 0.5

Acute Medication Per Month Secondary · approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

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.

Group	Value	95% CI
Before Introvision	6.3	± 3.6
After Introvision	5.0	± 3.7

Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision Secondary · 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

Group	Value	95% CI
Before Introvision	11.7	± 6.5
After Introvision	9.8	± 7.0

Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF) Secondary · approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

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

Group	Value	95% CI
Before Introvision	21.7	± 7.7
After Introvision	26.2	± 6.0

Headache-Impact Test 6, HIT-6 Secondary · approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

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.

Group	Value	95% CI
Before Introvision	64.3	± 4.2
After Introvision	61.4	± 5.9

Overall Satisfaction of Patients Secondary · approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session

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.

Group	Value	95% CI
After Introvision	45

Influence of Side of Headache on Outcome as Exploratory Outcome Measure Secondary · approximately 5-6 months

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?

Group	Value	95% CI
Patients With Predominantly Left-sided Headache Before Introvision	13.9	± 5.7
Patients With Predominantly Left-sided Headache After Introvision	10.1	± 3.6
Patients With Predominantly Right-sided Headache Before Introvision	9.9	± 4.5
Patients With Predominantly Right-sided Headache After Introvision	9.1	± 4.9
Patients With Bilateral or Alternating Headache Before Introvision	11.7	± 7.3
Patients With Bilateral or Alternating Headaches After Introvision	10.4	± 9.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Introvision Group

Serious: 0/51 (0%)

Deaths: 0/51

Waiting List Group Before Introvision

Serious: 0/37 (0%)

Deaths: 0/37

Other adverse events (1 terms — click to expand)

Reaction	System	Introvision Group	Waiting List Group Before …
Tachycardia self-limiting during a SAP (stating attentive perception) exercise	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03507400 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Empl M, Löser S, Spille P, Rozwadowska A, et al · · 2023 · cited 2× · PMID 37924063 · DOI 10.1186/s10194-023-01684-0
2. 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)
   Empl M, Löser S, Spille P, Rozwadowska A, et al · · 2023 · DOI 10.21203/rs.3.rs-3325442/v1