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NCT05617339
Tailored Digital Treatment for Migraine
Conditions: Migraine With Aura, Migraine Without Aura
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Vastra Gotaland Region
Location: Sweden
Summary
Background: An individualized internet-based treatment program from a biopsychosocial perspective has been developed within the Västra Götaland region (VGR) with funds from the Innovation Fund.
The treatment program is called Learn to live with migraine and goes by the abbreviation I AM (Internet Approach to Migraine).
I AM is a complement to the medical treatment and focuses on pain management and learning to live as good a life as possible with the disease migraine.
During the spring of 2022, I AM has been tested regarding the feasibility of primary care on 29 research subjects in a pilot RCT (DNR 2020-02359).
A weighted preliminary assessment shows moderate effect size on mental health, that the participants accept the intervention, and that I AM with recruitment and care process can be carried out in a primary care context.
Purpose: An overall purpose of the study is to evaluate the effect of the addition of the internet-based biopsychosocial treatment I AM compared to usual treatment (TREATMENT as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate with a randomized controlled trial design (RCT).
An additional aim is to evaluate whether it is possible to prevent episodic migraine from developing into chronic migraine among those who have episodic migraine at the start of the study via the supplement treatment program I AM.
Expected results: The greatest expected benefit of I AM is to reduce the burden and suffering of migraines for all the people affected.
AM is also expected to increase the availability of treatment with a biopsychosocial perspective, have a quality-enhancing effect in terms of method and increase the patient's participation in their treatment.
An environmental aspect is that neither patient nor therapist need to travel, accessibility also increases for individuals living in smaller communities who receive equal treatment.
Eligibility Criteria
Inclusion Criteria:Women and men18 years and updiagnosed episodic or chronic migraine with or without aura 3 or more migraine days a month.Access to computer / tablet or smartphone with Bankid and internet connection.Exclusion Criteria:ongoing malignant diseaseother rarer migraine diseases such as cluster headache, basilar migraine, hemiplegis migraine, vestibular migraine and eye migraineongoing moderate to more severe psychiatric problems such as depression, anxiety disorders, neuropsychiatric conditions, psychotic disorders, substance abuse and personality disordersOngoing psychological/physiotherapeutic treatmentPeople who cannot read, speak or understand the Swedish language
Source: ClinicalTrials.gov (NCT05617339). StuddyBuddy aggregates publicly available trial information.