Tailored Digital Treatment for Migraine

Migraine Without Aura Clinical Trial

Official title:

Tailored Digital Treatment for Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05617339
• Other study ID #: VGFOUREG-979683
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Vastra Gotaland Region
• Contact: Marie S Persson, Phd-student
• Phone: +46733167183
• Email: marie.s.persson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Intervention

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.

Locations

Country	Name	City	State
Sweden	FoU primary care Södra Älvsborg	Borås	Sven Eriksonsplatsen 4

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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