Tailored Digital Treatment for Migraine

NCT05617339 | Unknown DMC

• 1 other identifier: VGFOUREG-979683
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine With Aura; Migraine Without Aura

Keywords

migraine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (52)

• Mental Health Continuum Short Form (MHC-SF).

  Week 1

• Mental Health Continuum Short Form (MHC-SF).

  post (week 8 or 20)

• Mental Health Continuum Short Form (MHC-SF).

  6 months follow up

• Mental Health Continuum Short Form (MHC-SF).

  12 months follow up

• Mental Health Continuum Short Form (MHC-SF).

  24 months follow up

Study Arms (2)

Personalised internet-based treatment "I am".

EXPERIMENTAL

Need-based internet-based treatment

Behavioral: I am (internet approach to migraine)

Treatment As Usual

NO INTERVENTION

Control group, Treatment in primary care which is medical treatment

Interventions

I am (internet approach to migraine) BEHAVIORAL

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.

Also known as: Learn to live with migraine (Lär dig leva med migrän)

Personalised internet-based treatment "I am".

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

FoU primary care Södra Älvsborg

Borås, Sven Eriksonsplatsen 4, 503 38, Sweden

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura; Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Marie S Persson, Phd-student

CONTACT

+46733167183; marie.s.persson@vgregion.se

Sandra Weineland, Docent

CONTACT

+46700825088; sandra.weineland@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The groups are predetermined based on the tool randomizer.org and blinded to the researcher assigning the participants to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 15, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-10

Locations

SE (1)