Personalised Internet-based Treatment From a Biopsychosocial Perspective for Migraine Patients and Its Feasibility in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Employment rate - change through week 1, week 10, and by 3 months follow up
研究概览
简要总结
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.
详细描述
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?
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Employment rate - change through week 1, week 10, and by 3 months follow up
时间窗: Week 1, week 10 and by 3 months follow up
Employment rate: measured in percent by questions put to the participant.
Bulls eye - activation in valued direction -change through week 1 and week 10, and to 3 months follow up
时间窗: Week 1-10 through the study and by 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)
Migraine Diary - change through week 2-10, and to 3 months follow up
时间窗: 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.
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?
次要结局
- Self-Compassion Scale - Self compassion(Week 1, week 5, week 10 and by 3 months follow up)
- Exercise diary, condition(Week 1-10 through the study and by 3 months follow up)
- 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)
- Five Facet Mindfulness Questionnaire - conscious(Week 1, week 5, 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)
- Two questions to Haskell 2007 - Physical activity(Week 1-10 through the study and by 3 months follow up)
- Acceptance of the treatment(Week 10 and by 3 months follow up)