Digital CBTI for Comorbid Insomnia in Chronic Migraine (NCT05244889) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital CBTI for Comorbid Insomnia in Chronic Migraine
United Kingdom88 participantsStarted 2022-01-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Insomnia Severity
Timeframe: Posttreatment (3 months after intervention starts).
2
Change in Migraine Days
Timeframe: Posttreatment (3 months after intervention starts).
3
Recruitment rate
Timeframe: Monthly throughout study completion
4
Retention rate
Timeframe: Through study completion, up to 3 years
5
Naps
Timeframe: Mid treatment (Month 1-2 of study)
6
Light exposure
Timeframe: Mid treatment (Month 1-2 of study)
7
Barriers and Facilitators to Engagement with the protocol
Timeframe: Post-treatment (3 months after the intervention started)