Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Gaia AG
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Number of days with migraine headache
研究概览
简要总结
This trial was designed to evaluate the effectiveness of a dialogue-based online intervention (ceprica) that provides information regarding cognitive behavioural therapy (CBT) in patients with migraine.
The study aims to test the hypothesis that ceprica has a greater positive impact on migraine symptoms than an active control intervention providing psychoeducational content. Patients fulfilling ICHD-criteria for migraine will be randomized and allocated to either an intervention group, receiving ceprica in addition to treatment as usual, or a control group, which receives access to an active control intervention in addition to treatment as usual. The primary endpoint is the number of migraine days per month.
详细描述
Migraine is common in the German population and leads to a decreased quality of life as well as high economic consequences. Cognitive behavioural therapy has shown to be effective in the treatment of migraine. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective.
In this study, the treatment effects of a novel dialogue-based online intervention compared to a psychoeducational control intervention will be investigated. The interventional online program ceprica contains elements of cognitive behavioural therapy that address specific approaches in the management of pain, integrated in an individually tailored dialogue that is based on the responses given in the program. The intervention ceprica, as well as the psychoeducational control intervention, aer both delivered via the internet and protected by individually assigned passwords.
This randomised controlled trial will include 306 patients with migraine. Participants will be recruited via a website containing relevant information about the study. Participants will be randomly assigned in a 1:1 ratio to either a control group, in which they continue their usual treatment and receive access to a psychoeducational control intervention, or an intervention group who may also use treatment as usual and in addition receives the online intervention ceprica. Data are collected at baseline (T0) and three months after allocation (T1).
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, Outcomes Assessor)
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
- •age 18-65 at the time of screening
- •fulfill diagnostic criteria of migraine (ICD-10: G43.0 or G43.1, confirmed either by upload of a medical document issued by a medical specialist or by a diagnostic phone/video call with a study physician who is experienced in headache diagnostics)
- •age at onset of migraine <50y
- •Migraine is present for at least 12 months at the time of study entry
- •4-14 migraine headache days per 28 days
- •able and willing to give signed informed consent
- •sufficient language skills in German
排除标准
- •currently receiving preventive migraine medication within 60 days of T0, or planning to start another preventive treatment during the course of the study
- •routinely taking, or planning to take, gepant-type acute migraine medication (e.g., rimegepant)
- •Botulinum toxin A and B administered in the head or neck area within 4 months prior to T0
- •patients with a history of failure to respond to 3 or more classes of migraine preventive treatments with good scientific evidence
- •patients with regular intake of analgesics for other reasons than headache (e.g., chronic back pain, (rheumatoid) arthritis, cancer, injuries/accidents)
- •patients with incomplete headache diaries at baseline (>6 non-consecutive days within 28 days missing)
- •patients with substance use disorder
结局指标
主要结局
Number of days with migraine headache
时间窗: 3 months
Change since baseline in migraine headache days per 28 days; assessed via diary
次要结局
- Anxiety symptoms(3 months)
- Use of acute migraine medication(3 months)
- Migraine-related disability(3 months)
- Number of moderate/severe headache days(3 months)
- Migraine days responder rate(3 months)
- Functional impairment due to migraine(3 months)
- Headache-related pain intensity(3 months)
- Depressive symptoms(3 months)
- Migraine attacks(3 months)