Migraine With AuraNCT05617339
Tailored Digital Treatment for Migraine
A study testing I am (internet approach to migraine) in people with Migraine With Aura and Migraine Without Aura, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- I am (internet approach to migraine)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
FoU primary care Södra Älvsborg
Borås, Sven Eriksonsplatsen 4, 503 38
About this study
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.
Read the 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.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- I am (internet approach to migraine)
- Keywords
- migraine
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I am (internet approach to migraine)Behavioural
Also called Learn to live with migraine (Lär dig leva med migrän)
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised internet-based treatment "I am". | Experimental | Need-based internet-based treatment Receives: Behavioral: I am (internet approach to migraine) |
| Treatment As Usual | No intervention | Control group, Treatment in primary care which is medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 24 months follow up
Secondary outcomes (52)
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Measured: Week 1
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Measured: post (week 8 or 20)
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Measured: 6 months follow up
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Measured: 12 months follow up
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Measured: 24 months follow up
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Measured: Week 1
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Measured: 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.
Measured: 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.
Measured: 6 months follow up
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Measured: 12 months follow up
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Measured: 24 months follow up
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: Week 1
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: up to week 4 or 10.
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: post (week 8 or 20)
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: 6 months follow up
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: 12 months follow up
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Measured: 24 months follow up
Five Facet Mindfulness Questionnaire
Conscious
Measured: Week 1
Five Facet Mindfulness Questionnaire
Conscious
Measured: post (week 8 or 20)
Five Facet Mindfulness Questionnaire
Conscious
Measured: 6 months follow up
Five Facet Mindfulness Questionnaire
Conscious
Measured: 12 months follow up
Five Facet Mindfulness Questionnaire
Conscious
Measured: 24 months follow up
Self-Compassion Scale
Self compassion
Measured: Week 1
Self-Compassion Scale
Self compassion
Measured: post (week 8 or 20)
Self-Compassion Scale
Self compassion
Measured: 6 months follow up
Self-Compassion Scale
Self compassion
Measured: 12 months follow up
Self-Compassion Scale
Self compassion
Measured: 24 months follow up
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: Week 1
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: up to week 20
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: post (week 8 or 20)
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: 6 months follow up
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: 12 months follow up
Two questions to Haskell 2007 -
Physical activity Physical activity
Measured: 24 months follow up
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Measured: Week 1
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Measured: post (week 8 or 20)
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Measured: 6 months follow up
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Measured: 12 months follow up
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617339
- Sponsor's protocol ID
- VGFOUREG-979683
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Digital Treatment for Migraine
- ClinicalTrials.gov ID
- NCT05617339
- Acronym / sponsor ID
- VGFOUREG-979683
- Conditions
- Migraine With Aura, Migraine Without Aura
- Keywords
- migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised internet-based treatment "I am". | Experimental | Behavioral: I am (internet approach to migraine)Need-based internet-based treatment |
| Treatment As Usual | No intervention | –Control group, Treatment in primary care which is medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I am (internet approach to migraine)Also: Learn to live with migraine (Lär dig leva med migrän)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. | Behavioural | Personalised internet-based treatment "I am". |
Primary outcome
Headache Impact Test-6 (HIT-6)
Time frame: Week 1
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?
Headache Impact Test-6 (HIT-6)
Time frame: post (week 8 or 20)
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?
Headache Impact Test-6 (HIT-6)
Time frame: 6 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?
Headache Impact Test-6 (HIT-6)
Time frame: 12 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?
Headache Impact Test-6 (HIT-6)
Time frame: 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?
52 secondary outcomes
Mental Health Continuum Short Form (MHC-SF).
Time frame: Week 1
Mental Health Continuum Short Form (MHC-SF).
Time frame: post (week 8 or 20)
Mental Health Continuum Short Form (MHC-SF).
Time frame: 6 months follow up
Mental Health Continuum Short Form (MHC-SF).
Time frame: 12 months follow up
Mental Health Continuum Short Form (MHC-SF).
Time frame: 24 months follow up
Swedish version of CORE-10
Time frame: Week 1
Swedish version of CORE-10
Time frame: up to week 4 or 10.
Swedish version of CORE-10
Time frame: post (week 8 or 20)
Swedish version of CORE-10
Time frame: 6 months follow up
Swedish version of CORE-10
Time frame: 12 months follow up
Swedish version of CORE-10
Time frame: 24 months follow up
Self-Efficacy for Exercise Scale
Time frame: Week 1
Self-Efficacy for Exercise Scale
Time frame: up to week 4 or 10.
Self-Efficacy for Exercise Scale
Time frame: post (week 8 or 20)
Self-Efficacy for Exercise Scale
Time frame: 6 months follow up
Self-Efficacy for Exercise Scale
Time frame: 12 months follow up
Self-Efficacy for Exercise Scale
Time frame: 24 months follow up
Five Facet Mindfulness Questionnaire
Time frame: Week 1
Five Facet Mindfulness Questionnaire
Time frame: post (week 8 or 20)
Five Facet Mindfulness Questionnaire
Time frame: 6 months follow up
Five Facet Mindfulness Questionnaire
Time frame: 12 months follow up
Five Facet Mindfulness Questionnaire
Time frame: 24 months follow up
Self-Compassion Scale
Time frame: Week 1
Self-Compassion Scale
Time frame: post (week 8 or 20)
Self-Compassion Scale
Time frame: 6 months follow up
Self-Compassion Scale
Time frame: 12 months follow up
Self-Compassion Scale
Time frame: 24 months follow up
Two questions to Haskell 2007 -
Time frame: Week 1
Two questions to Haskell 2007 -
Time frame: up to week 20
Two questions to Haskell 2007 -
Time frame: post (week 8 or 20)
Two questions to Haskell 2007 -
Time frame: 6 months follow up
Two questions to Haskell 2007 -
Time frame: 12 months follow up
Two questions to Haskell 2007 -
Time frame: 24 months follow up
Central Sensitization Inventory (CSI)
Time frame: Week 1
Central Sensitization Inventory (CSI)
Time frame: post (week 8 or 20)
Central Sensitization Inventory (CSI)
Time frame: 6 months follow up
Central Sensitization Inventory (CSI)
Time frame: 12 months follow up
Central Sensitization Inventory (CSI)
Time frame: 24 months follow up
Acceptance of the treatment
Time frame: Post (week 8 or 20)
Acceptance of the treatment
Time frame: 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Pediatric Migraine
RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Migraine, Migraine Disease
RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I am (internet approach to migraine) in people with Migraine With Aura and Migraine Without Aura, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie S Persson, Phd-student (+46733167183, marie.s.persson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test-6 (HIT-6) (time frame: Week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.