NCT05018572

Digital Treatment for Migraines - a Feasibility Study

Personalised Internet-based Treatment From a Biopsychosocial Perspective for Migraine Patients and Its Feasibility in Primary Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2021-08-24
• Last updated: 2023-06-22

Locations

1 site across 1 country: Sweden