Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in Migraine Days
研究概览
简要总结
The overall aims of the study are:
Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines.
Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms.
Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.
详细描述
Chronic migraine (CM) is a debilitating condition that places a direct burden worth £150 million on the NHS per year. Previous research has shown that insomnia is a risk factor for migraines. The investigators hypothesise that two modifiable behaviours explain this relationship between insomnia and migraines: daytime napping and nocturnal light exposure. To cope with the migraines, individuals will nap during the day, reducing the homeostatic drive for sleep at night and delaying sleep onset. This inability to fall asleep potentially increases exposure to evening bright light, delaying the release of the hormone melatonin and reducing sleep quality. Poor sleep in turn is a trigger for migraines, which creates a vicious cycle of migraines and poor sleep. The investigators believe that these behavioural mechanisms are valid targets for treatment and are explicitly addressed in Cognitive Behaviour Therapy for insomnia (CBT-I). Digital versions of CBT-I (dCBT-I) offer a scalable solution to the problem of limited access to CBT-I. This research group has demonstrated the feasibility, acceptability and preliminary efficacy of dCBT-I in an uncontrolled proof-of concept study. Utilising randomised control trial (RCT) methodology, the investigator's aim now is to evaluate the effectiveness of dCBT-I for improving insomnia and migraines in patients with chronic migraines. The second aim is to probe mechanism of change and to test the hypotheses that behavioural markers such as daytime napping and evening light exposure can reduce insomnia symptoms leading to an improvement in migraines. Prior to progressing to a full-scale RCT, the investigators require a feasibility RCT, to refine the methodology. The investigators propose to recruit individuals who meet criteria for CM and insomnia, directly referred from two neurology clinics, who will act as clinical recruiters. Eighty-eight participants will be randomised either to a dCBT-I group or to sleep hygiene education (SHE) control group. The main outcomes are insomnia and migraine days and will be collected at post-treatment, and long-term effects will be assessed at month 6.
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
- Single (Outcomes Assessor)
盲法说明
While the study will be single-blinded (researchers analysing data will be blind to allocation), randomisation will be concealed to the RA and participant until the individual's eligibility has been established.
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 age 18 and above
- •Insomnia, satisfied by a total score ≥ 11 on the insomnia severity index (ISI)
- •Headache ≥ 15 days per month, ≥ 12 months and meet criteria for migraine with/without aura on ≥ 8 days per month, ≥ 12 months
排除标准
- •Medical condition that is unstable, requires immediate treatment, or is judged to interfere with the protocol, including other pain conditions such as chronic low back pain and fibromyalgia and also sleep disorders such as untreated sleep apnoea or parasomnias.
- •Psychiatric condition that is judged to interfere with the study protocol including substance abuse, psychotic disorder, cognitive disorder, current suicidal ideation, or any uncontrolled psychiatric conditions that require immediate treatment
- •Regular use of illegal substances
- •Women who are pregnant or breastfeeding
- •Shiftworkers
研究组 & 干预措施
Digital CBT-I
After assignment to dCBT-I, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session dCBT-I programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of dCBT-I. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.
干预措施: Digital CBT-I (Behavioral)
Sleep Hygiene Education (SHE)
After assignment to SHE, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session SHE programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of SHE. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
Change in Migraine Days
时间窗: Posttreatment (3 months after intervention starts).
The change in migraine days (measured with the headache diary) from baseline to posttreatment
Light exposure
时间窗: Mid treatment (Month 1-2 of study)
Light exposure measured through an actigraphy device
Recruitment rate
时间窗: Monthly throughout study completion
How many participants have been recruited per month
Barriers and Facilitators to Engagement with the protocol
时间窗: Post-treatment (3 months after the intervention started)
Measured through qualitative interviews/focus groups
Change in Insomnia Severity
时间窗: Posttreatment (3 months after intervention starts).
The change in insomnia (measured with the Insomnia Severity Index - ISI) from baseline to posttreatment. The ISI is scored from 0 to 28, where a higher score indicates more severe insomnia severity.
Retention rate
时间窗: Through study completion, up to 3 years
How many participants have dropped out
Naps
时间窗: Mid treatment (Month 1-2 of study)
Number (N) of naps
次要结局
- Adverse Events(Through study completion, up to 3 years)
- Medication use(Post-treatment (3 months after the intervention started))
- Sleepiness(Post-treatment (3 months after the intervention started))
- Fatigue(Post-treatment (3 months after the intervention started))
- Treatment Satisfaction(Post-treatment (3 months after the intervention started))
- Migraine Disability(Post-treatment (3 months after the intervention started))
- Cost-utility(Post-treatment (3 months after the intervention started))
- Depression and Anxiety(Post-treatment (3 months after the intervention started))
研究者
Megan Crawford
Principal Investigator
University of Strathclyde