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Migraine With AuraNCT05018572

Digital Treatment for Migraines - a Feasibility Study

A study testing I AM in people with Migraine With Aura and Migraine Without Aura, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine With Aura, Migraine Without Aura
What is being tested?
I AM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteSweden
Study dates
1 Jul 2021to 14 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Ongoing malignant disease
  • Other migraine diseases
  • Moderate to severe psychiatric problems such as depression or anxiety disorder
  • Neuropsychiatric conditions
  • Psychosis disorders
  • Addiction
Show all 9Show fewer
  • Personality disorders
  • People who cannot read, speak or understand the Swedish language
  • Ongoing psychological/psychotherapeutic treatment

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • FoU primary care Södra Älvsborg

    Borås, Sven Eriksonsplatsen 4, 503 38

Other trials in Sweden

About this study

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

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.

Read the 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?

Being tested
I AM
Medical subject headings
Migraine with Aura, Migraine without Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I AMBehavioural

    Also called Learn to live with migraines

    "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.

Study groups in NCT05018572
Study groupRoleWhat they receive
Personalised internet-based treatment "I am"ExperimentalPersonalised internet-based treatment "I am".
Receives: Behavioral: I AM
Treatment As UsualNo interventionTreatment in primary care / Treatment As Usual (TAU), which is medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?

    Measured: 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.

  2. 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.

    Measured: Week 1, week 10 and by 3 months follow up

  3. 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)

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

Secondary outcomes (8)

  1. Mental Health Continuum Short Form - Mental health and quality of life

    Measured with Mental Health Continuum Short Form (MHC-SF). The self-assessment form consists of 14 questions that focus on emotional, psychological and social well-being and are considered to have good psychometric properties (Keyes, 2005).

    Measured: Week 1 and week 10 and by 3 months follow up

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

    Measured with the Swedish version CORE-10. The self-assessment form consists of 10 questions, one of which measures suicidality (Elfström, M. L., Evans, C., Lundgren, J., Johansson, B., Hakeberg, M., \& Carlsson, S. G. (2012).

    Validation of the Swedish version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE). Clinical Psychology and Psychotherapy. Epub ahead of print. doi:10.1002/cpp.1788)

    Measured: Week 1 and week 10 and by 3 months follow up

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

    Measured by the Swedish version of the Self-Efficacy for Exercise Scale (SEE-EN). The form contains nine questions about the patient's faith in broad physical activity under different circumstances. A sum is calculated between 0 and 90, where higher number means higher confidence.Resnick B, Jenkins L 2000 Testing the reliability and validity of the Self-efficacy for Exercise Scale. Nursing Research 49: 149-159).The form has been translated into Swedish and tested for validity and reliability for patients with heart disease (Cavrak A 2010 Test of the psychometric properties of the Swedish version of the Self-Efficacy for Exercise scale for patients in cardiac rehabilitation.

    Masters Thesis, Uni-versity of Gothenberg.) And patients with long-term pain (Dahlbäck A, Andréll P, Varkey E. Reliability and Validity of the Swedish Version of the Self-Efficacy for Exercise Scale (SEE-SV) for Patients with Chronic Pain .2020 Unpublished manuscript).

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

  4. Five Facet Mindfulness Questionnaire - conscious

    Measured using the Swedish version of the Five Facet Mindfulness Questionnaire (FFMQ_SWE). FFMQ originally created by Baer et al. (2006) is a self-assessment form that aims to measure the ability to conscious presence. FFMQ_SWE consists of 29 claims and can be estimated between 1-5 points. The higher the score, the higher the self-rated ability to conscious presence. The internal validity and reliability of FFMQ_SWE is good (Lilja et al., 2011).

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

  5. Self-Compassion Scale - Self compassion

    Measured with Self-Compassion Scale - Short Form (SCS-SF). SCS-SF consists of 12 statements and is an abbreviated version of Self compassion scale (Neff, KD (2003b). The development and validation of a scale to measure self-compassion. Self \& Identity, 2 (3), 223-250. doi: 10.1080 / 15298860309027. Self-compassion is measured with a corpse scale between 1 (almost never) and 5 (almost always) and has 6 subscales. SCS-SF has been shown to have good internal consistency (α ≥ .86) and constructivevalidity as it correlates positively with SCS (r ≥ 0.97). However, the subscale score has been shown to have poorer internal consistency and SCS-SF is therefore only suitable for measuring general self-compassion (Raes et al., 2011). Swedish translation of SCS-SF has been shown to have moderate internal consistency (α ≥ .68) (Almqvist \& Johansson, 2016).

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

  6. Exercise diary, condition

    Cardio training is measured with exercise diary Exercise diary contains filling in; activity, date, set

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

  7. Two questions to Haskell 2007 - Physical activity

    Physical activity issues according to Haskell 2007. Two questions. Five total points or more means that the physical activity level is considered regular and corresponds to the public health recommendation. Below 5 total points means that the physical activity level needs to be increased.

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

  8. Acceptance of the treatment

    Measured with its own constructed form developed for the study. The form consists of four questions: Would you recommend the processing to someone else? How meaningful have you experienced the treatment scale 1-7, as well as two open questions answered in writing: what have you got out of the treatment? What has been less good about the treatment?

    Measured: Week 10 and by 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start1 Jul 2021
  3. Primary completion14 Oct 2022
  4. Study completion14 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018572
Sponsor's protocol ID
VGFOUSA-963615
Status last verified
Oct 2022
First submitted
28 Jul 2021
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing I AM in people with Migraine With Aura and Migraine Without Aura, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Migraine Diary - change through week 2-10, and to 3 months follow up (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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