Status:
ACTIVE_NOT_RECRUITING
Digital CBTI for Comorbid Insomnia in Chronic Migraine
Lead Sponsor:
University of Strathclyde
Conditions:
Insomnia Chronic
Migraine Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 relation...
Detailed Description
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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05244889
Start Date
January 31 2022
End Date
March 31 2025
Last Update
January 9 2025
Active Locations (2)
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1
Glasgow
Glasgow, United Kingdom
2
Walton Centre, Liverpool
Liverpool, United Kingdom