Introvision for Migraine and Headaches (IntroMig)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Chronic Migraine; Migraine

Treatments: Behavioral: Introvision: mental and emotional self-regulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03507400

IntroMig 632-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

non-waiting list group

Experimental group

Description:

Intervention: Introvision: mental and emotional self-regulation

Treatment:

Behavioral: Introvision: mental and emotional self-regulation

waiting list group

Experimental group

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

Treatment:

Behavioral: Introvision: mental and emotional self-regulation