Tailored Digital Treatment for Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Headache Impact Test-6 (HIT-6)
研究概览
简要总结
Background: An individualized internet-based treatment program from a biopsychosocial perspective has been developed within the Västra Götaland region (VGR) with funds from the Innovation Fund. The treatment program is called Learn to live with migraine and goes by the abbreviation I AM (Internet Approach to Migraine). I AM is a complement to the medical treatment and focuses on pain management and learning to live as good a life as possible with the disease migraine. During the spring of 2022, I AM has been tested regarding the feasibility of primary care on 29 research subjects in a pilot RCT (DNR 2020-02359). A weighted preliminary assessment shows moderate effect size on mental health, that the participants accept the intervention, and that I AM with recruitment and care process can be carried out in a primary care context. Purpose: An overall purpose of the study is to evaluate the effect of the addition of the internet-based biopsychosocial treatment I AM compared to usual treatment (TREATMENT as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate with a randomized controlled trial design (RCT). An additional aim is to evaluate whether it is possible to prevent episodic migraine from developing into chronic migraine among those who have episodic migraine at the start of the study via the supplement treatment program I AM. Expected results: The greatest expected benefit of I AM is to reduce the burden and suffering of migraines for all the people affected. AM is also expected to increase the availability of treatment with a biopsychosocial perspective, have a quality-enhancing effect in terms of method and increase the patient's participation in their treatment. An environmental aspect is that neither patient nor therapist need to travel, accessibility also increases for individuals living in smaller communities who receive equal treatment.
详细描述
An overall purpose of the study is to evaluate in a randomized controlled trial (RCT) the effect of the addition of the internet-based treatment Internet Approach to Migraine (I AM ) compared to usual treatment (Treatment as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate. An additional aim is to evaluate whether it is possible to prevent episodic migraine, among those who have episodic migraine at the start of the study, from developing into chronic migraine in primary care via the addition of the I AM treatment program for migraine, compared to TAU.
Question / Hypothesis Impact evaluation - primary outcomes1. What effect does I AM have, in comparison with treatment as usual (TAU) regarding the frequency and severity of migraine as well as functional capacity, mental health and quality of life, in follow-up measurement after termination, at 6 months after the end of treatment, and at 1 year and 2 years of follow-up measurement? The hypothesis is that there is an interaction effect and that the participants in I AM at follow-ups have a significantly lower degree of frequency and severity of migraine, as well as better functional ability, mental health and quality of life.2. Is there a significant difference between how many people have developed chronic migraine (measured by cut off of 15 days a month?) in the I AM and TAU groups, respectively? The hypothesis being tested is that the frequency and severity of migraine attacks is not reduced or further developed by the targeted treatment program I AM in comparison with TAU.
Process Evaluation - Secondary outcomes3. What effect does I AM have in comparison to TAU regarding flexibility and acceptance, selfcompassion, mindfulness, degree of pain sensitivitization and confidence in one's ability to engage in physical training? How does the effect of the intervention stand after 6, 12 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The groups are predetermined based on the tool randomizer.org and blinded to the researcher assigning the participants to groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men
- •18 years and up
- •diagnosed episodic or chronic migraine with or without aura 3 or more migraine days a month.
- •Access to computer / tablet or smartphone with Bankid and internet connection.
排除标准
- •ongoing malignant disease
- •other rarer migraine diseases such as cluster headache, basilar migraine, hemiplegis migraine, vestibular migraine and eye migraine
- •ongoing moderate to more severe psychiatric problems such as depression, anxiety disorders, neuropsychiatric conditions, psychotic disorders, substance abuse and personality disorders
- •Ongoing psychological/physiotherapeutic treatment
- •People who cannot read, speak or understand the Swedish language
结局指标
主要结局
Headache Impact Test-6 (HIT-6)
时间窗: 24 months follow up
Frequency and severity of migraine attacks.Two questions are added in the present study: How many migraine days per month have you had on average in the last 3 months? Estimated on a scale of 1-10 how painful the headache was. 0= no pain and 10= worst imaginable pain. What percentage have you been employed in the last 3 months?
次要结局
- Swedish version of CORE-10(24 months follow up)
- Self-Efficacy for Exercise Scale(24 months follow up)
- Five Facet Mindfulness Questionnaire(24 months follow up)
- Self-Compassion Scale(24 months follow up)
- Bulls eye(24 months follow up)
- Central Sensitization Inventory (CSI)(24 months follow up)
- Mental Health Continuum Short Form (MHC-SF).(24 months follow up)
- Two questions to Haskell 2007 -(24 months follow up)
- Acceptance of the treatment(24 months follow up)
- Other treatment(24 months follow up)