Digital CBTI for Comorbid Insomnia in Chronic Migraine
Insomnia Chronic, Migraine Disorders
About this trial
This is an interventional treatment trial for Insomnia Chronic focused on measuring Cognitive Behaviour Therapy, Digital Therapy
Eligibility Criteria
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
- Regular use of illegal substances
- Women who are pregnant or breastfeeding
- Shiftworkers
Sites / Locations
- GlasgowRecruiting
- Walton Centre, LiverpoolRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Digital CBT-I
Sleep Hygiene Education (SHE)
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.
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.