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Tailored Digital Treatment for Migraine

Primary Purpose

Migraine With Aura, Migraine Without Aura

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
I am (internet approach to migraine)
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura focused on measuring migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FoU primary care Södra Älvsborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personalised internet-based treatment "I am".

Treatment As Usual

Arm Description

Need-based internet-based treatment

Control group, Treatment in primary care which is medical treatment

Outcomes

Primary Outcome Measures

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?
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?
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?
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?
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?

Secondary Outcome Measures

Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Mental Health Continuum Short Form (MHC-SF).
Mental health and quality of life
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Swedish version of CORE-10
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Self-Efficacy for Exercise Scale
Their ability to conduct physical exercise
Five Facet Mindfulness Questionnaire
Conscious
Five Facet Mindfulness Questionnaire
Conscious
Five Facet Mindfulness Questionnaire
Conscious
Five Facet Mindfulness Questionnaire
Conscious
Five Facet Mindfulness Questionnaire
Conscious
Self-Compassion Scale
Self compassion
Self-Compassion Scale
Self compassion
Self-Compassion Scale
Self compassion
Self-Compassion Scale
Self compassion
Self-Compassion Scale
Self compassion
Two questions to Haskell 2007 -
Physical activity Physical activity
Two questions to Haskell 2007 -
Physical activity Physical activity
Two questions to Haskell 2007 -
Physical activity Physical activity
Two questions to Haskell 2007 -
Physical activity Physical activity
Two questions to Haskell 2007 -
Physical activity Physical activity
Two questions to Haskell 2007 -
Physical activity Physical activity
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
Central Sensitization Inventory (CSI)
Key symptoms associated with central sensitization
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?
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?
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?
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?
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).

Full Information

First Posted
October 17, 2022
Last Updated
November 7, 2022
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT05617339
Brief Title
Tailored Digital Treatment for Migraine
Official Title
Tailored Digital Treatment for Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura
Keywords
migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The groups are predetermined based on the tool randomizer.org and blinded to the researcher assigning the participants to groups.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalised internet-based treatment "I am".
Arm Type
Experimental
Arm Description
Need-based internet-based treatment
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Control group, Treatment in primary care which is medical treatment
Intervention Type
Behavioral
Intervention Name(s)
I am (internet approach to migraine)
Other Intervention Name(s)
Learn to live with migraine (Lär dig leva med migrän)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache Impact Test-6 (HIT-6)
Description
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?
Time Frame
Week 1
Title
Headache Impact Test-6 (HIT-6)
Description
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?
Time Frame
post (week 8 or 20)
Title
Headache Impact Test-6 (HIT-6)
Description
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?
Time Frame
6 months follow up
Title
Headache Impact Test-6 (HIT-6)
Description
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?
Time Frame
12 months follow up
Title
Headache Impact Test-6 (HIT-6)
Description
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?
Time Frame
24 months follow up
Secondary Outcome Measure Information:
Title
Mental Health Continuum Short Form (MHC-SF).
Description
Mental health and quality of life
Time Frame
Week 1
Title
Mental Health Continuum Short Form (MHC-SF).
Description
Mental health and quality of life
Time Frame
post (week 8 or 20)
Title
Mental Health Continuum Short Form (MHC-SF).
Description
Mental health and quality of life
Time Frame
6 months follow up
Title
Mental Health Continuum Short Form (MHC-SF).
Description
Mental health and quality of life
Time Frame
12 months follow up
Title
Mental Health Continuum Short Form (MHC-SF).
Description
Mental health and quality of life
Time Frame
24 months follow up
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
Week 1
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
up to week 4 or 10.
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
post (week 8 or 20)
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
6 months follow up
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
12 months follow up
Title
Swedish version of CORE-10
Description
A broader measure of mental health in terms of well-being, symptoms, function and risk.
Time Frame
24 months follow up
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
Week 1
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
up to week 4 or 10.
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
post (week 8 or 20)
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
6 months follow up
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
12 months follow up
Title
Self-Efficacy for Exercise Scale
Description
Their ability to conduct physical exercise
Time Frame
24 months follow up
Title
Five Facet Mindfulness Questionnaire
Description
Conscious
Time Frame
Week 1
Title
Five Facet Mindfulness Questionnaire
Description
Conscious
Time Frame
post (week 8 or 20)
Title
Five Facet Mindfulness Questionnaire
Description
Conscious
Time Frame
6 months follow up
Title
Five Facet Mindfulness Questionnaire
Description
Conscious
Time Frame
12 months follow up
Title
Five Facet Mindfulness Questionnaire
Description
Conscious
Time Frame
24 months follow up
Title
Self-Compassion Scale
Description
Self compassion
Time Frame
Week 1
Title
Self-Compassion Scale
Description
Self compassion
Time Frame
post (week 8 or 20)
Title
Self-Compassion Scale
Description
Self compassion
Time Frame
6 months follow up
Title
Self-Compassion Scale
Description
Self compassion
Time Frame
12 months follow up
Title
Self-Compassion Scale
Description
Self compassion
Time Frame
24 months follow up
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
Week 1
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
up to week 20
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
post (week 8 or 20)
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
6 months follow up
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
12 months follow up
Title
Two questions to Haskell 2007 -
Description
Physical activity Physical activity
Time Frame
24 months follow up
Title
Central Sensitization Inventory (CSI)
Description
Key symptoms associated with central sensitization
Time Frame
Week 1
Title
Central Sensitization Inventory (CSI)
Description
Key symptoms associated with central sensitization
Time Frame
post (week 8 or 20)
Title
Central Sensitization Inventory (CSI)
Description
Key symptoms associated with central sensitization
Time Frame
6 months follow up
Title
Central Sensitization Inventory (CSI)
Description
Key symptoms associated with central sensitization
Time Frame
12 months follow up
Title
Central Sensitization Inventory (CSI)
Description
Key symptoms associated with central sensitization
Time Frame
24 months follow up
Title
Acceptance of the treatment
Description
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?
Time Frame
Post (week 8 or 20)
Title
Acceptance of the treatment
Description
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?
Time Frame
6 months follow up
Title
Acceptance of the treatment
Description
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?
Time Frame
12 months follow up
Title
Acceptance of the treatment
Description
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?
Time Frame
24 months follow up
Title
Other treatment
Description
"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.
Time Frame
post (week 8 or 20)
Title
Other treatment
Description
"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.
Time Frame
6 months follow up
Title
Other treatment
Description
"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.
Time Frame
12 months follow up
Title
Other treatment
Description
"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.
Time Frame
24 months follow up
Title
Bulls eye
Description
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).
Time Frame
Week 1
Title
Bulls eye
Description
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).
Time Frame
up to week 20
Title
Bulls eye
Description
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).
Time Frame
post (week 8 or 20)
Title
Bulls eye
Description
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).
Time Frame
6 months follow up
Title
Bulls eye
Description
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).
Time Frame
12 months follow up
Title
Bulls eye
Description
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).
Time Frame
24 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie S Persson, Phd-student
Phone
+46733167183
Email
marie.s.persson@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Weineland, Docent
Phone
+46700825088
Email
sandra.weineland@vgregion.se
Facility Information:
Facility Name
FoU primary care Södra Älvsborg
City
Borås
State/Province
Sven Eriksonsplatsen 4
ZIP/Postal Code
503 38
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Tailored Digital Treatment for Migraine

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