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
Summary of Research
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.
Summary of Results
Previous research has shown that insomnia is a risk factor for migraines, however insomnia is also a modifiable factor, well treated with Cognitive Behaviour Therapy (CBT-I). CBT-I is a time intensive intervention, that would add to the complex medical appointment schedules experienced by patients with chronic migraine. Digital versions of CBT-I (dCBT-I) would offer a scalable solution to this problem. Our group has demonstrated the feasibility, acceptability and preliminary efficacy of dCBT-I in an uncontrolled proof-of concept study. Following this, we conducted a feasibility randomised controlled trial (RCT), to evaluate dCBT-I in individuals with chronic migraine and insomnia. We recruited 90 individuals who were randomised either to a dCBT-I group or to digital sleep hygiene education (SHE) control group. The main outcomes were 1) insomnia and migraine symptoms at post-treatment, and six months and 2) feasibility of conducting an RCT (e.g., recruitment pace, retention rate and barriers & facilitators collected qualitatively). Insomnia and some migraine symptoms improved significantly at post-treatment and 6m follow-up in both groups, but only the improvement in insomnia symptoms was greater in the dCBT-I group compared to the control group. Recruitment pace increased after modifications to our recruitment strategies. Dropout out rates were significantly above expectations (37.8%). Qualitative interviews highlighted some of the barriers associated with the trial (e.g., burden of completing diaries, challenges of completing an intervention through digital means), that will need to be managed before progressing to a full definitive Randomised Control Trial (RCT).
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