Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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Question / Hypothesis Impact evaluation - primary outcomes1. What effect does I AM have, in comparison with treatment as usual (TAU) regarding the frequency and severity of migraine as well as functional capacity, mental health and quality of life, in follow-up measurement after termination, at 6 months after the end of treatment, and at 1 year and 2 years of follow-up measurement? The hypothesis is that there is an interaction effect and that the participants in I AM at follow-ups have a significantly lower degree of frequency and severity of migraine, as well as better functional ability, mental health and quality of life.2. Is there a significant difference between how many people have developed chronic migraine (measured by cut off of 15 days a month?) in the I AM and TAU groups, respectively? The hypothesis being tested is that the frequency and severity of migraine attacks is not reduced or further developed by the targeted treatment program I AM in comparison with TAU.
Process Evaluation - Secondary outcomes3. What effect does I AM have in comparison to TAU regarding flexibility and acceptance, selfcompassion, mindfulness, degree of pain sensitivitization and confidence in one's ability to engage in physical training? How does the effect of the intervention stand after 6, 12 and 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Personalised internet-based treatment "I am".
Need-based internet-based treatment
I am (internet approach to migraine)
I AM has a biopsychosocial perspective. Modules 1-3 and 10 are mandatory and for those who are in need of shorter support and module 1-10 is for those who have more frequent and severe migraines and want a long time of support and treatment. The rationale of the treatment assumes that we do not know why we get migraines and instead focus on becoming as good as possible at managing the migraine attacks. The focus area of the treatments cognitive-behavioral interventions is, among other things, psychoeducation, what migraine is and what happens in the body during migraines and pain, interpretation of symptoms and information processing, training to stop through mindfulness and becoming aware of assumptions that guide behavior during pain management, management of grief, worry, guilt and feelings of shame based on self-compassion, challenging avoidances in a valued direction through ACT interventions and physiotherapist-led cardio training and exercises.
Treatment As Usual
Control group, Treatment in primary care which is medical treatment
No interventions assigned to this group
Interventions
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I am (internet approach to migraine)
I AM has a biopsychosocial perspective. Modules 1-3 and 10 are mandatory and for those who are in need of shorter support and module 1-10 is for those who have more frequent and severe migraines and want a long time of support and treatment. The rationale of the treatment assumes that we do not know why we get migraines and instead focus on becoming as good as possible at managing the migraine attacks. The focus area of the treatments cognitive-behavioral interventions is, among other things, psychoeducation, what migraine is and what happens in the body during migraines and pain, interpretation of symptoms and information processing, training to stop through mindfulness and becoming aware of assumptions that guide behavior during pain management, management of grief, worry, guilt and feelings of shame based on self-compassion, challenging avoidances in a valued direction through ACT interventions and physiotherapist-led cardio training and exercises.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years and up
* diagnosed 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
* other rarer migraine diseases such as cluster headache, basilar migraine, hemiplegis migraine, vestibular migraine and eye migraine
* ongoing moderate to more severe psychiatric problems such as depression, anxiety disorders, neuropsychiatric conditions, psychotic disorders, substance abuse and personality disorders
* Ongoing psychological/physiotherapeutic treatment
* People who cannot read, speak or understand the Swedish language
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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FoU primary care Södra Älvsborg
Borås, Sven Eriksonsplatsen 4, Sweden
Countries
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Central Contacts
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Other Identifiers
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VGFOUREG-979683
Identifier Type: -
Identifier Source: org_study_id
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