Digital Treatment for Migraines - a Feasibility Study

NCT05018572 | Completed

• 1 other identifier: VGFOUSA-963615
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (3)

• Migraine Diary - change through week 2-10, and to 3 months follow up

  Frequency and severity of migraine attacks monthly: will take place via a Migraine Diary. Questions to answer; Migraine pain signal? When, day and time? Where does it hurt? Tick: Right temple, Left temple, Neck Inside the head, Area around the eye , other How's the pain? (Pulsating, burning, stinging, idling, stabbing) Strength, pain? (0-10) discomfort? (0-10) How do I try to deal with the pain? What emergency medication did you take at the beginning of the migraine attack? How long did the migraine attack last? Pain peak (throughout migraine attack) 0-10 In total, how much emergency medicine have you taken throughout the migraine attack? Pre symptoms or other symptoms?

  Week 2-10 through the study and by 3 months follow up. The participant fills in a new form of the diary for each new attack.

• Employment rate - change through week 1, week 10, and by 3 months follow up

  Employment rate: measured in percent by questions put to the participant.

  Week 1, week 10 and by 3 months follow up

• Bulls eye - activation in valued direction -change through week 1 and week 10, and to 3 months follow up

  Measured with a Swedish version of Bulls eye (Lundgren, Louma, Dahl, Strohsal \& Melin, 2012). ) The self-assessment scale is divided into four value areas in people's lives: work/education, leisure, relationships and self-care/health. The instrument has demonstrated a test-retest reliability of 0.86 and good criterion validity (Lundgren, Dahl \& Hayes, 2008)

  Week 1-10 through the study and by 3 months follow up

Secondary Outcomes (8)

• Mental Health Continuum Short Form - Mental health and quality of life

  Week 1 and week 10 and by 3 months follow up

• CORE-10 - A broader measure of mental health in terms of well-being, symptoms, function and risks

  Week 1 and week 10 and by 3 months follow up

• Self-Efficacy for Exercise Scale - in their ability to conduct physical exercise

  Week 1, week 5, week 10 and by 3 months follow up

• Five Facet Mindfulness Questionnaire - conscious

  Week 1, week 5, week 10 and by 3 months follow up

• Self-Compassion Scale - Self compassion

  Week 1, week 5, week 10 and by 3 months follow up

Study Arms (2)

Personalised internet-based treatment "I am"

EXPERIMENTAL

Personalised internet-based treatment "I am".

Behavioral: I AM

Treatment As Usual

NO INTERVENTION

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

Interventions

I AM 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.

Also known as: Learn to live with migraines

Personalised internet-based treatment "I am"

Eligibility Criteria

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

You may qualify if:

• Women and men
• Age18 to 65
• Diagnosis migraine with (G43.0) or without aura (G43.1)
• migraine days a month
• Access to computer/tablet or smartphone with bankid and internet connection

You may not qualify if:

• 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

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

Condition Hierarchy (Ancestors)

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

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: July 28, 2021
• First Posted: August 24, 2021
• Study Start: July 1, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: June 22, 2023

Record last verified: 2022-10

Locations

SE (1)