Digital Treatment for Migraines - a Feasibility Study

Vastra Gotaland Region

Status: Completed

Conditions: Migraine With Aura; Migraine Without Aura

Treatments: Behavioral: I AM

Study type: Interventional

Funder types: Other

Identifiers

NCT05018572

VGFOUSA-963615

Details and patient eligibility

About

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.

Full 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?

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

29 participants in 2 patient groups

Personalised internet-based treatment "I am"

Experimental group

Description:

Personalised internet-based treatment "I am".

Treatment:

Behavioral: I AM

Treatment As Usual

No Intervention group

Description:

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