Digital Treatment for Migraines - a Feasibility Study

NCT ID: NCT05018572

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-14

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?

Conditions

Migraine With Aura; Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalised internet-based treatment "I am"

Personalised internet-based treatment "I am".

Group Type: EXPERIMENTAL

I AM

Intervention Type: BEHAVIORAL

"I am" has a biopsychosocial perspective with a focus on pain management in migraines. The cognitive behavioural interventions being tested are Mindfulness, Acceptance and Commitment Therapy (ACT), Compassion Focused Therapy and Physiotherapist-led cardiotherapy. The treatment program consists of ten modules of texts, animated films with a fictional person to identify with, recorded audio exercises adapted for patients with migraines and filmed physiotherapeutic exercises with physiotherapists.The interventions in "I am" are personalised in that the first three modules and module 10 are for those who are being helped by a shorter treatment. The other modules, four to ten, are a more in-depth treatment for those who have frequent or chronic migraines. The participants are in contact with processors via message function as well as via phone at startup, at the middle of treatment and termination. The duration of treatment is 4-10 weeks.

Treatment As Usual

Treatment in primary care / Treatment As Usual (TAU), which is medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

I AM

"I am" has a biopsychosocial perspective with a focus on pain management in migraines. The cognitive behavioural interventions being tested are Mindfulness, Acceptance and Commitment Therapy (ACT), Compassion Focused Therapy and Physiotherapist-led cardiotherapy. The treatment program consists of ten modules of texts, animated films with a fictional person to identify with, recorded audio exercises adapted for patients with migraines and filmed physiotherapeutic exercises with physiotherapists.The interventions in "I am" are personalised in that the first three modules and module 10 are for those who are being helped by a shorter treatment. The other modules, four to ten, are a more in-depth treatment for those who have frequent or chronic migraines. The participants are in contact with processors via message function as well as via phone at startup, at the middle of treatment and termination. The duration of treatment is 4-10 weeks.

Intervention Type: BEHAVIORAL

Other Intervention Names

Learn to live with migraines

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

FoU primary care Södra Älvsborg

Borås, Sven Eriksonsplatsen 4, Sweden

Countries

Sweden

Other Identifiers

VGFOUSA-963615

Identifier Type: -

Identifier Source: org_study_id