Digital Treatment for Migraines - a Feasibility Study
Condition: Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional

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?
    

Intervention name(s): I AM
Intervention type(s): Behavioral
Intervention description(s): "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.
Other intervention name(s): Learn to live with migraines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment