The MISSION Study- Version 1
Research type
Research Study
Full title
The Migraine and Insomnia Study- Systematically evaluating the Impact of an ONline intervention- The MISSION STUDY
IRAS ID
295582
Contact name
Megan R Crawford
Contact email
Sponsor organisation
University of Strathclyde
Clinicaltrials.gov Identifier
202021-29,
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
When people experience migraines, they often try to find a dark, quiet room and try to sleep. However, sleeping in the daytime can disrupt sleep at night. Sleep problems at night can trigger a migraine the next day. That starts a vicious cycle of migraines and insomnia. One way to stop this cycle is to treat the insomnia. One of the best treatments is called cognitive behaviour therapy for insomnia (CBT-I). This treatment teaches people to change their sleep behaviours and thoughts that are unhelpful, as well as lifestyle and bedroom factors that disrupt sleep. CBT-I works well, but there are few trained therapists to deliver it. Digital CBT-I was developed to solve that problem. Digital CBT-I is provided through an app or website. The broad aim of this study is to test dCBT-I for individuals with migraines and sleep problems. To answer our research questions we will include 88 participants with migraine and sleep problems in total. Participants will be randomly allocated to dCBT-I or the control treatment. Participants in the digital CBT-I group will log on to a website called Sleepio. Participants in the control treatment will also log on to a website that will only provide information about lifestyle and bedroom factors. We will measure changes in insomnia and migraines at three time points: mid-treatment, right after treatment, and 6 months after the start of treatment in both groups. We will also track certain behaviours such as daytime napping throughout treatment, to understand how improvements in sleep are related to changes in migraines. Lastly, we will collect information about how many and why individuals want to take part in the study, and how many and why individuals drop out of the study, which will be important information for a future larger trial.
REC name
West of Scotland REC 4
REC reference
21/WS/0100
Date of REC Opinion
25 Oct 2021
REC opinion
Further Information Favourable Opinion