Tailored Digital Treatment for Migraine
- Conditions
- Migraine With AuraMigraine Without Aura
- Interventions
- Behavioral: I am (internet approach to migraine)
- Registration Number
- NCT05617339
- Lead Sponsor
- Vastra Gotaland Region
- Brief 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.
- Detailed Description
An overall purpose of the study is to evaluate in a randomized controlled trial (RCT) the effect of the addition of the internet-based treatment Internet Approach to Migraine (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. An additional aim is to evaluate whether it is possible to prevent episodic migraine, among those who have episodic migraine at the start of the study, from developing into chronic migraine in primary care via the addition of the I AM treatment program for migraine, compared to TAU.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Women and men
- 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.
- ongoing malignant disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Personalised internet-based treatment "I am". I am (internet approach to migraine) Need-based internet-based treatment
- Primary Outcome Measures
Name Time Method Headache Impact Test-6 (HIT-6) 24 months follow up Frequency and severity of migraine attacks.Two questions are added in the present study: How many migraine days per month have you had on average in the last 3 months? Estimated on a scale of 1-10 how painful the headache was. 0= no pain and 10= worst imaginable pain. What percentage have you been employed in the last 3 months?
- Secondary Outcome Measures
Name Time Method Swedish version of CORE-10 24 months follow up A broader measure of mental health in terms of well-being, symptoms, function and risk.
Self-Efficacy for Exercise Scale 24 months follow up Their ability to conduct physical exercise
Five Facet Mindfulness Questionnaire 24 months follow up Conscious
Self-Compassion Scale 24 months follow up Self compassion
Bulls eye 24 months follow up Behavioral activation in a valued direction was measured with a Swedish version of Bulls eye (Lundgren, Louma, Dahl, Strohsal \&melin, 2012). The self-assessment scale is divided into four areas of values in people's lives: work/education, leisure, relationships and self-care/health. The instrument has demonstrated a test-retest reliability of 0.86 and good kriterieva deaths (Lundgren, Dahl \&hayes, 2008).
Mental Health Continuum Short Form (MHC-SF). 24 months follow up Mental health and quality of life
Two questions to Haskell 2007 - 24 months follow up Physical activity Physical activity
Central Sensitization Inventory (CSI) 24 months follow up Key symptoms associated with central sensitization
Acceptance of the treatment 24 months follow up Acceptance of the treatment Measured with its own constructed form developed for the study. The form consists of four questions: Would you recommend the processing to someone else? How meaningful have you experienced the treatment scale 1-7, as well as two open questions answered in writing: what have you got out of the treatment? What has been less good about the treatment?
Other treatment 24 months follow up "Other treatment" is measured with the question: Have you since you finished the treatment I AM, Learn to live with migraine or since the last self-assessment received other treatment for migraine? If yes, please describe which one.
Trial Locations
- Locations (1)
FoU primary care Södra Älvsborg
🇸🇪Borås, Sven Eriksonsplatsen 4, Sweden