Digital CBTI for Comorbid Insomnia in Chronic Migraine

NAActive, not recruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

January 31, 2022

Primary Completion Date

July 30, 2024

Study Completion Date

March 31, 2025

Conditions
Insomnia ChronicMigraine Disorders
Interventions
BEHAVIORAL

Digital CBT-I

"The digital CBT-I intervention (www.sleepio.com) consists of six weekly sessions of CBT-I delivered over the internet by an animated virtual therapist known as The Prof. The content includes behavioral (e.g. sleep restriction, stimulus control), cognitive (e.g. putting the day to rest, thought re-structuring, mindfulness) strategies, relaxation strategies (e.g., progressive muscle relaxation) and advice on lifestyle and bedroom factors (sleep hygiene). Although the sessions can be completed at the persons own pace, the shortest interval between individual sessions is 7 days, thus participants can complete the course in 6 weeks, or take as long as 12 weeks. As part of the SLEEPIO program, participants will be required to enter their sleep/wake patterns using electronic sleep diaries. There is no face-to-face contact throughout the intervention and all treatment sessions, support and reminders are provided through the online platform."

BEHAVIORAL

Sleep Hygiene Education

Sleep Hygiene Education (SHE) has successfully been used as a control condition in other trials evaluating dCBT-I42. SHE does not have any therapeutic benefits for individuals with insomnia alone, but is often part of usual care. Consequently it is a credible alternative to dCBT-I. The sleep hygiene education will be provided on a website with access to information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). As with the dCBT-I group, participants will not be required to make any changes to their usual care.

Trial Locations (2)

Unknown

Glasgow, Glasgow

Walton Centre, Liverpool, Liverpool

All Listed Sponsors
lead

University of Strathclyde

OTHER