Tailored Digital Treatment for Migraine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Behavioral: I am (internet approach to migraine)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Sven Eriksonsplatsen 4
    • Borås, Sven Eriksonsplatsen 4, Sweden, 503 38
      • FoU primary care Södra Älvsborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalised internet-based treatment "I am".; Need-based internet-based treatment	Behavioral: 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 Names: Learn to live with migraine (Lär dig leva med migrän)
No Intervention: Treatment As Usual; Control group, Treatment in primary care which is medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test-6 (HIT-6)	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?	Week 1
Headache Impact Test-6 (HIT-6)	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?	post (week 8 or 20)
Headache Impact Test-6 (HIT-6)	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?	6 months follow up
Headache Impact Test-6 (HIT-6)	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?	12 months follow up
Headache Impact Test-6 (HIT-6)	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?	24 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Continuum Short Form (MHC-SF).	Mental health and quality of life	Week 1
Mental Health Continuum Short Form (MHC-SF).	Mental health and quality of life	post (week 8 or 20)
Mental Health Continuum Short Form (MHC-SF).	Mental health and quality of life	6 months follow up
Mental Health Continuum Short Form (MHC-SF).	Mental health and quality of life	12 months follow up
Mental Health Continuum Short Form (MHC-SF).	Mental health and quality of life	24 months follow up
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	Week 1
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	up to week 4 or 10.
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	post (week 8 or 20)
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	6 months follow up
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	12 months follow up
Swedish version of CORE-10	A broader measure of mental health in terms of well-being, symptoms, function and risk.	24 months follow up
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	Week 1
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	up to week 4 or 10.
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	post (week 8 or 20)
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	6 months follow up
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	12 months follow up
Self-Efficacy for Exercise Scale	Their ability to conduct physical exercise	24 months follow up
Five Facet Mindfulness Questionnaire	Conscious	Week 1
Five Facet Mindfulness Questionnaire	Conscious	post (week 8 or 20)
Five Facet Mindfulness Questionnaire	Conscious	6 months follow up
Five Facet Mindfulness Questionnaire	Conscious	12 months follow up
Five Facet Mindfulness Questionnaire	Conscious	24 months follow up
Self-Compassion Scale	Self compassion	Week 1
Self-Compassion Scale	Self compassion	post (week 8 or 20)
Self-Compassion Scale	Self compassion	6 months follow up
Self-Compassion Scale	Self compassion	12 months follow up
Self-Compassion Scale	Self compassion	24 months follow up
Two questions to Haskell 2007 -	Physical activity Physical activity	Week 1
Two questions to Haskell 2007 -	Physical activity Physical activity	up to week 20
Two questions to Haskell 2007 -	Physical activity Physical activity	post (week 8 or 20)
Two questions to Haskell 2007 -	Physical activity Physical activity	6 months follow up
Two questions to Haskell 2007 -	Physical activity Physical activity	12 months follow up
Two questions to Haskell 2007 -	Physical activity Physical activity	24 months follow up
Central Sensitization Inventory (CSI)	Key symptoms associated with central sensitization	Week 1
Central Sensitization Inventory (CSI)	Key symptoms associated with central sensitization	post (week 8 or 20)
Central Sensitization Inventory (CSI)	Key symptoms associated with central sensitization	6 months follow up
Central Sensitization Inventory (CSI)	Key symptoms associated with central sensitization	12 months follow up
Central Sensitization Inventory (CSI)	Key symptoms associated with central sensitization	24 months follow up
Acceptance of the treatment	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?	Post (week 8 or 20)
Acceptance of the treatment	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?	6 months follow up
Acceptance of the treatment	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?	12 months follow up
Acceptance of the treatment	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?	24 months follow up
Other treatment	"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.	post (week 8 or 20)
Other treatment	"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.	6 months follow up
Other treatment	"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.	12 months follow up
Other treatment	"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.	24 months follow up
Bulls eye	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).	Week 1
Bulls eye	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).	up to week 20
Bulls eye	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).	post (week 8 or 20)
Bulls eye	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).	6 months follow up
Bulls eye	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).	12 months follow up
Bulls eye	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).	24 months follow up

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura; Migraine with Aura
• Other Study ID Numbers: VGFOUREG-979683

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No