Active not recruitingNAINTERVENTIONAL

Digital CBTI for Comorbid Insomnia in Chronic Migraine

This research is investigating whether a digital program, called dCBT-I, can help people who suffer from both chronic migraines (very frequent headaches) and insomnia (trouble sleeping). It aims to see if treating insomnia can lead to fewer migraines. The study is comparing dCBT-I to general advice on how to improve sleep habits. Researchers will also look at how this treatment might work, for example, by checking if changes in daytime napping or evening light exposure play a part. This is an important step to help plan a larger study in the future and improve support for people with these conditions.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Strathclyde

Enrolment target

Start

31 Jan 2022

Estimated completion

31 Mar 2025

Insomnia Chronic Migraine Disorders

What is this study about?

You're probably here because you or someone you care about experiences frequent migraines and also struggles with sleep. This research study is trying to find out if improving sleep can lead to fewer migraines. Doctors know that many people who get chronic migraines – that's when you have headaches 15 or more days a month – also have trouble sleeping, known as insomnia. This can create a difficult cycle: poor sleep can trigger migraines, and migraines can make it harder to sleep well.

This study is looking at a specific type of treatment for insomnia called Cognitive Behavioural Therapy for Insomnia, or CBT-I. It's a proven talking therapy that helps you change thoughts and behaviours that contribute to poor sleep. In this study, they're using a digital version of CBT-I (dCBT-I), which means you can access it through a computer or app. They want to see how effective this digital program is compared to simply getting advice on good sleep habits. The hope is that by improving sleep, we can also reduce the number and severity of migraines.

The researchers are also interested in understanding *why* treating insomnia might help migraines. They suspect that certain behaviours, like napping during the day or being exposed to bright light late in the evening, might be part of the problem. These can throw off your body's natural sleep rhythm. By looking at these specific behaviours, the study hopes to learn more about how sleep and migraines are connected and how treatments can best target these issues. This current study is a smaller 'pilot' study to help them plan a larger, more comprehensive study in the future.

Key takeaways

This study explores a digital sleep therapy (dCBT-I) for people with chronic migraines and insomnia.
It aims to see if better sleep can reduce migraine frequency and severity.
The study compares dCBT-I to standard sleep hygiene advice.
It's a pilot study to help plan larger research in the future.
Participation involves using a digital program or following sleep advice, and sharing updates about your sleep and migraines.

Who may be eligible?

To join this study, women must be aged 18 or older. You would need to have specific types of long-lasting migraines (headaches 15 or more days a month, with migraine features for at least 8 of those days, for 12 months or more) and also suffer from insomnia, which means having significant difficulty sleeping.

There are also some reasons why you wouldn't be able to join. For example, if you have other serious medical problems that need immediate attention, or other pain conditions like chronic back pain, or untreated sleep conditions like sleep apnoea. If you have certain unstable mental health conditions, are pregnant or breastfeeding, use illegal substances regularly, or work shifts, you also wouldn't be able to participate. This is to make sure the study is safe for everyone involved and that the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Do you get headaches on 15 or more days a month, with migraine features on at least 8 of those days, for 12 months or more?
Do you have significant trouble sleeping (insomnia)?
Are you generally healthy, without other serious medical or mental health conditions needing immediate treatment, or untreated sleep disorders like sleep apnoea?
Are you not pregnant or breastfeeding, and you don't regularly work shifts or use illegal substances?

Answer every question to see your result.

What does participation involve?

The study involves a small number of participants who will be randomly assigned to one of two groups: one receiving the digital CBT-I program and the other receiving sleep hygiene education (advice on good sleep habits). Your participation will likely involve using the digital program or following sleep advice over a period of time, and regularly providing information about your sleep and migraines. This will help the researchers understand how well each approach is working. The specific frequency of check-ins or length of the treatment will be explained to you if you are invited to join. The total duration of your involvement in the study will be clearly outlined.

Potential risks and benefits

Participating in this study might offer you the benefit of learning strategies to improve your sleep and potentially reduce your migraines. You would also be contributing valuable information to help others with similar conditions in the future. As with any study, there's always a small chance that the treatments might not work for you, or you might experience some inconvenience from participating in the assessments. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Glasgow
Verified postcode
Glasgow, United Kingdom
Walton Centre, Liverpool
Verified postcode
Liverpool, United Kingdom

Common questions

What is dCBT-I?

dCBT-I stands for digital Cognitive Behavioural Therapy for Insomnia. It's an online or app-based program that teaches you strategies to improve your sleep by changing thoughts and behaviours that keep you awake.

What is 'sleep hygiene education'?

Sleep hygiene education means getting advice and tips on good habits and environmental factors that can help you get a better night's sleep, like keeping a regular sleep schedule or making sure your bedroom is dark.

Will I have to take new medication?

No, this study is looking at digital therapy and sleep education, not new medications. It will not involve any changes to your current migraine medication, unless discussed with your doctor.

How long will the study last for me?

The exact duration of your participation will be fully explained if you are eligible and decide to join. It will involve a period of using the assigned program and providing regular updates.

What if I decide to stop?

You are completely free to leave the study at any point, for any reason, and your decision will not affect your routine medical care.