N/A
N=72
Introvision for Migraine and Headaches
Migraine · Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03507400 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Headache Days Per Month — 10.6; 10.9 days per month — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Introvision: mental and emotional self-regulation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ludwig-Maximilians - University of Munich
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Headache Days Per Month |
10.6; 10.9 | 0.63 |
| SECONDARY Headache Intensity |
2.0; 2.0 | — |
| SECONDARY Acute Medication Per Month |
6.3; 5.0 | 0.004 sig |
| SECONDARY Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision |
11.7; 9.8 | 0.003 sig |
| SECONDARY Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF) |
21.7; 26.2 | 0.001 sig |
| SECONDARY Headache-Impact Test 6, HIT-6 |
64.3; 61.4 | 0.001 sig |
| SECONDARY Overall Satisfaction of Patients |
45 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03507400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.