Clinical trial NCT05617339: Tailored Digital Treatment for Migraine
Official title: Tailored Digital Treatment for Migraine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine With Aura
Migraine Without Aura
Keywords: migraine
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Headache Impact Test-6 (HIT-6)
timeFrame: Week 1
measure: Headache Impact Test-6 (HIT-6)
timeFrame: post (week 8 or 20)
measure: Headache Impact Test-6 (HIT-6)
timeFrame: 6 months follow up
measure: Headache Impact Test-6 (HIT-6)
timeFrame: 12 months follow up
measure: Headache Impact Test-6 (HIT-6)
timeFrame: 24 months follow up
Secondary outcomes:
measure: Mental Health Continuum Short Form (MHC-SF).
timeFrame: Week 1
measure: Mental Health Continuum Short Form (MHC-SF).
timeFrame: post (week 8 or 20)
measure: Mental Health Continuum Short Form (MHC-SF).
timeFrame: 6 months follow up
measure: Mental Health Continuum Short Form (MHC-SF).
timeFrame: 12 months follow up
measure: Mental Health Continuum Short Form (MHC-SF).
timeFrame: 24 months follow up
measure: Swedish version of CORE-10
timeFrame: Week 1
measure: Swedish version of CORE-10
timeFrame: up to week 4 or 10.
measure: Swedish version of CORE-10
timeFrame: post (week 8 or 20)
measure: Swedish version of CORE-10
timeFrame: 6 months follow up
measure: Swedish version of CORE-10
timeFrame: 12 months follow up
measure: Swedish version of CORE-10
timeFrame: 24 months follow up
measure: Self-Efficacy for Exercise Scale
timeFrame: Week 1
measure: Self-Efficacy for Exercise Scale
timeFrame: up to week 4 or 10.
measure: Self-Efficacy for Exercise Scale
timeFrame: post (week 8 or 20)
measure: Self-Efficacy for Exercise Scale
timeFrame: 6 months follow up
measure: Self-Efficacy for Exercise Scale
timeFrame: 12 months follow up
measure: Self-Efficacy for Exercise Scale
timeFrame: 24 months follow up
measure: Five Facet Mindfulness Questionnaire
timeFrame: Week 1
measure: Five Facet Mindfulness Questionnaire
timeFrame: post (week 8 or 20)
measure: Five Facet Mindfulness Questionnaire
timeFrame: 6 months follow up
measure: Five Facet Mindfulness Questionnaire
timeFrame: 12 months follow up
measure: Five Facet Mindfulness Questionnaire
timeFrame: 24 months follow up
measure: Self-Compassion Scale
timeFrame: Week 1
measure: Self-Compassion Scale
timeFrame: post (week 8 or 20)
measure: Self-Compassion Scale
timeFrame: 6 months follow up
measure: Self-Compassion Scale
timeFrame: 12 months follow up
measure: Self-Compassion Scale
timeFrame: 24 months follow up
measure: Two questions to Haskell 2007 -
timeFrame: Week 1
measure: Two questions to Haskell 2007 -
timeFrame: up to week 20
measure: Two questions to Haskell 2007 -
timeFrame: post (week 8 or 20)
measure: Two questions to Haskell 2007 -
timeFrame: 6 months follow up
measure: Two questions to Haskell 2007 -
timeFrame: 12 months follow up
measure: Two questions to Haskell 2007 -
timeFrame: 24 months follow up
measure: Central Sensitization Inventory (CSI)
timeFrame: Week 1
measure: Central Sensitization Inventory (CSI)
timeFrame: post (week 8 or 20)
measure: Central Sensitization Inventory (CSI)
timeFrame: 6 months follow up
measure: Central Sensitization Inventory (CSI)
timeFrame: 12 months follow up
measure: Central Sensitization Inventory (CSI)
timeFrame: 24 months follow up
measure: Acceptance of the treatment
timeFrame: Post (week 8 or 20)
measure: Acceptance of the treatment
timeFrame: 6 months follow up
measure: Acceptance of the treatment
timeFrame: 12 months follow up
measure: Acceptance of the treatment
timeFrame: 24 months follow up
measure: Other treatment
timeFrame: post (week 8 or 20)
measure: Other treatment
timeFrame: 6 months follow up
measure: Other treatment
timeFrame: 12 months follow up
measure: Other treatment
timeFrame: 24 months follow up
measure: Bulls eye
timeFrame: Week 1
measure: Bulls eye
timeFrame: up to week 20
measure: Bulls eye
timeFrame: post (week 8 or 20)
measure: Bulls eye
timeFrame: 6 months follow up
measure: Bulls eye
timeFrame: 12 months follow up
measure: Bulls eye
timeFrame: 24 months follow up
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: FoU primary care Södra Älvsborg
state: Sven Eriksonsplatsen 4
Study officials:
References: