Clinical trial NCT05018572: Digital Treatment for Migraines - a Feasibility Study
Official title: Personalised Internet-based Treatment From a Biopsychosocial Perspective for Migraine Patients and Its Feasibility in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine With Aura
Migraine Without Aura
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-08-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An individualised internet-based treatment from a biopsychosocial perspective for patients with migraines in primary care has been developed within the Vastra Gotaland region in 2019. The treatment program is called Learning to live with migraines, and goes by the acronym "I am" (Internet Approach to Migraine). In a pilot study, the treatment programme and its feasibility in primary care will be evaluated. It is hoped that the intervention "I am" can educate patients about their illness and help the patient manage migraine attacks so that the likelihood of difficulty and frequency of migraine attacks does not increase, as well as provide an increased function and quality of life.

Detailed description: Purpose The overall purpose of the study is to evaluate in a pilot study the practical feasibility of a future randomized study to evaluate personalized digital biopsychosocial treatment method, "I am"- Learning to live with migraines in primary care.

Issues

Will a large or small percentage of individuals who are asked to participate in the study accept participation? Will the random advantage to the different groups make potential participants hesitant? Will measuring the effect be practicable? What investigative instruments are appropriate in this situation? Is a new investigative instrument to be built? Are the interventions reasonable to apply given the resources we can expect to have in a larger study? Will a large or small proportion of patients discontinue participation in the study for various reasons? How common are unforeseen problems (which may justify the exclusion of a patient or the negative/harmful effects of the intervention)? What change in endpoints is seen in the different groups?

Eligibility criteria: Inclusion Criteria:

* Women and men
* Age18 to 65
* Diagnosis migraine with (G43.0) or without aura (G43.1)
* 3-15 migraine days a month
* Access to computer/tablet or smartphone with bankid and internet connection

Exclusion Criteria:

* Ongoing malignant disease
* Other migraine diseases
* Moderate to severe psychiatric problems such as depression or anxiety disorder
* Neuropsychiatric conditions
* Psychosis disorders
* Addiction
* Personality disorders
* People who cannot read, speak or understand the Swedish language
* Ongoing psychological/psychotherapeutic treatment

Primary outcomes:
measure: Migraine Diary - change through week 2-10, and to 3 months follow up
timeFrame: Week 2-10 through the study and by 3 months follow up. The participant fills in a new form of the diary for each new attack.
measure: Employment rate - change through week 1, week 10, and by 3 months follow up
timeFrame: Week 1, week 10 and by 3 months follow up
measure: Bulls eye - activation in valued direction -change through week 1 and week 10, and to 3 months follow up
timeFrame: Week 1-10 through the study and by 3 months follow up
Secondary outcomes:
measure: Mental Health Continuum Short Form - Mental health and quality of life
timeFrame: Week 1 and week 10 and by 3 months follow up
measure: CORE-10 - A broader measure of mental health in terms of well-being, symptoms, function and risks
timeFrame: Week 1 and week 10 and by 3 months follow up
measure: Self-Efficacy for Exercise Scale - in their ability to conduct physical exercise
timeFrame: Week 1, week 5, week 10 and by 3 months follow up
measure: Five Facet Mindfulness Questionnaire - conscious
timeFrame: Week 1, week 5, week 10 and by 3 months follow up
measure: Self-Compassion Scale - Self compassion
timeFrame: Week 1, week 5, week 10 and by 3 months follow up
measure: Exercise diary, condition
timeFrame: Week 1-10 through the study and by 3 months follow up
measure: Two questions to Haskell 2007 - Physical activity
timeFrame: Week 1-10 through the study and by 3 months follow up
measure: Acceptance of the treatment
timeFrame: Week 10 and by 3 months follow up
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: FoU primary care Södra Älvsborg
state: Sven Eriksonsplatsen 4
Study officials:
References: