Insomnia ChronicNCT05244889
Digital CBTI for Comorbid Insomnia in Chronic Migraine
A study testing Digital CBT-I and Sleep Hygiene Education in people with Insomnia Chronic and Migraine Disorders, run by University of Strathclyde at 2 sites in United Kingdom.
Trial summary
The overall aims of the study are: Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Chronic, Migraine Disorders
- What is being tested?
- Digital CBT-I and Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 31 Jan 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Glasgow
Glasgow
Walton Centre, Liverpool
Liverpool
About this study
Official title: Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial
The overall aims of the study are:
Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines.
Read more
Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms.
Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.
Read the detailed description
Chronic migraine (CM) is a debilitating condition that places a direct burden worth £150 million on the NHS per year. Previous research has shown that insomnia is a risk factor for migraines. The investigators hypothesise that two modifiable behaviours explain this relationship between insomnia and migraines: daytime napping and nocturnal light exposure. To cope with the migraines, individuals will nap during the day, reducing the homeostatic drive for sleep at night and delaying sleep onset. This inability to fall asleep potentially increases exposure to evening bright light, delaying the release of the hormone melatonin and reducing sleep quality. Poor sleep in turn is a trigger for migraines, which creates a vicious cycle of migraines and poor sleep. The investigators believe that these behavioural mechanisms are valid targets for treatment and are explicitly addressed in Cognitive Behaviour Therapy for insomnia (CBT-I). Digital versions of CBT-I (dCBT-I) offer a scalable solution to the problem of limited access to CBT-I. This research group has demonstrated the feasibility, acceptability and preliminary efficacy of dCBT-I in an uncontrolled proof-of concept study. Utilising randomised control trial (RCT) methodology, the investigator's aim now is to evaluate the effectiveness of dCBT-I for improving insomnia and migraines in patients with chronic migraines. The second aim is to probe mechanism of change and to test the hypotheses that behavioural markers such as daytime napping and evening light exposure can reduce insomnia symptoms leading to an improvement in migraines. Prior to progressing to a full-scale RCT, the investigators require a feasibility RCT, to refine the methodology. The investigators propose to recruit individuals who meet criteria for CM and insomnia, directly referred from two neurology clinics, who will act as clinical recruiters. Eighty-eight participants will be randomised either to a dCBT-I group or to sleep hygiene education (SHE) control group. The main outcomes are insomnia and migraine days and will be collected at post-treatment, and long-term effects will be assessed at month 6.
- Conditions
- Insomnia Chronic, Migraine Disorders
- Being tested
- Digital CBT-I, Sleep Hygiene Education
- Keywords
- Cognitive Behaviour Therapy, Digital Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital CBT-IBehavioural
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.
Sleep Hygiene EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT-I | Experimental | 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. Receives: Behavioral: Digital CBT-I |
| Sleep Hygiene Education (SHE) | Active comparator | 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. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity
The change in insomnia (measured with the Insomnia Severity Index - ISI) from baseline to posttreatment. The ISI is scored from 0 to 28, where a higher score indicates more severe insomnia severity.
Measured: Posttreatment (3 months after intervention starts).
Change in Migraine Days
The change in migraine days (measured with the headache diary) from baseline to posttreatment
Measured: Posttreatment (3 months after intervention starts).
Recruitment rate
How many participants have been recruited per month
Measured: Monthly throughout study completion
Retention rate
How many participants have dropped out
Measured: Through study completion, up to 3 years
Naps
Number (N) of naps
Measured: Mid treatment (Month 1-2 of study)
Light exposure
Light exposure measured through an actigraphy device
Measured: Mid treatment (Month 1-2 of study)
Barriers and Facilitators to Engagement with the protocol
Measured through qualitative interviews/focus groups
Measured: Post-treatment (3 months after the intervention started)
Secondary outcomes (8)
Adverse Events
Adverse Events
Measured: Through study completion, up to 3 years
Treatment Satisfaction
Measured through in house post-treatment satisfaction questionnaire
Measured: Post-treatment (3 months after the intervention started)
Migraine Disability
Measured with Migraine Disability Assessment (MIDAS) questionnaire
Measured: Post-treatment (3 months after the intervention started)
Medication use
Captured through headache diaries
Measured: Post-treatment (3 months after the intervention started)
Depression and Anxiety
Captured with the Four-Item Patient Health Questionnaire (PHQ-4) for Anxiety and Depression
Measured: Post-treatment (3 months after the intervention started)
Cost-utility
Measured with the EQ-5D, health-related quality of life, from which quality adjusted life years (QUALY) can be obtained. This will allow us to calculate cost-utility.
Measured: Post-treatment (3 months after the intervention started)
Sleepiness
Measured with Epworth Sleepiness Scale
Measured: Post-treatment (3 months after the intervention started)
Fatigue
Measured with Flinders Fatigue Scale (FFS)
Measured: Post-treatment (3 months after the intervention started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start31 Jan 2022
- Primary completion30 Jul 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomly assigned to a dCBT-I or the sleep hygiene education control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Crawford, University of Strathclyde
- Investigators
- Louise McKean, Study chair, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244889
- Sponsor's protocol ID
- BRUK 202021-29
- Status last verified
- Jan 2025
- First submitted
- 7 Jul 2021
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05244889
- Acronym / sponsor ID
- BRUK 202021-29
- Conditions
- Insomnia Chronic, Migraine Disorders
- Keywords
- Cognitive Behaviour Therapy, Digital Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aims of the study are:
Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines.
Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms.
Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.
Detailed description
Chronic migraine (CM) is a debilitating condition that places a direct burden worth £150 million on the NHS per year. Previous research has shown that insomnia is a risk factor for migraines. The investigators hypothesise that two modifiable behaviours explain this relationship between insomnia and migraines: daytime napping and nocturnal light exposure. To cope with the migraines, individuals will nap during the day, reducing the homeostatic drive for sleep at night and delaying sleep onset. This inability to fall asleep potentially increases exposure to evening bright light, delaying the release of the hormone melatonin and reducing sleep quality. Poor sleep in turn is a trigger for migraines, which creates a vicious cycle of migraines and poor sleep. The investigators believe that these behavioural mechanisms are valid targets for treatment and are explicitly addressed in Cognitive Behaviour Therapy for insomnia (CBT-I). Digital versions of CBT-I (dCBT-I) offer a scalable solution to the problem of limited access to CBT-I. This research group has demonstrated the feasibility, acceptability and preliminary efficacy of dCBT-I in an uncontrolled proof-of concept study. Utilising randomised control trial (RCT) methodology, the investigator's aim now is to evaluate the effectiveness of dCBT-I for improving insomnia and migraines in patients with chronic migraines. The second aim is to probe mechanism of change and to test the hypotheses that behavioural markers such as daytime napping and evening light exposure can reduce insomnia symptoms leading to an improvement in migraines. Prior to progressing to a full-scale RCT, the investigators require a feasibility RCT, to refine the methodology. The investigators propose to recruit individuals who meet criteria for CM and insomnia, directly referred from two neurology clinics, who will act as clinical recruiters. Eighty-eight participants will be randomised either to a dCBT-I group or to sleep hygiene education (SHE) control group. The main outcomes are insomnia and migraine days and will be collected at post-treatment, and long-term effects will be assessed at month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to a dCBT-I or the sleep hygiene education control group.
| Arm | Type | Receives |
|---|---|---|
| Digital CBT-I | Experimental | Behavioral: Digital CBT-IAfter 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. |
| Sleep Hygiene Education (SHE) | Active comparator | Behavioral: Sleep Hygiene EducationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital CBT-IThe 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. | Behavioural | Digital CBT-I |
| Sleep Hygiene EducationSleep 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. | Behavioural | Sleep Hygiene Education (SHE) |
Primary outcome
Change in Insomnia Severity
Time frame: Posttreatment (3 months after intervention starts).
The change in insomnia (measured with the Insomnia Severity Index - ISI) from baseline to posttreatment. The ISI is scored from 0 to 28, where a higher score indicates more severe insomnia severity.
Change in Migraine Days
Time frame: Posttreatment (3 months after intervention starts).
The change in migraine days (measured with the headache diary) from baseline to posttreatment
Recruitment rate
Time frame: Monthly throughout study completion
How many participants have been recruited per month
Retention rate
Time frame: Through study completion, up to 3 years
How many participants have dropped out
Naps
Time frame: Mid treatment (Month 1-2 of study)
Number (N) of naps
Light exposure
Time frame: Mid treatment (Month 1-2 of study)
Light exposure measured through an actigraphy device
Barriers and Facilitators to Engagement with the protocol
Time frame: Post-treatment (3 months after the intervention started)
Measured through qualitative interviews/focus groups
8 secondary outcomes
Adverse Events
Time frame: Through study completion, up to 3 years
Treatment Satisfaction
Time frame: Post-treatment (3 months after the intervention started)
Migraine Disability
Time frame: Post-treatment (3 months after the intervention started)
Medication use
Time frame: Post-treatment (3 months after the intervention started)
Depression and Anxiety
Time frame: Post-treatment (3 months after the intervention started)
Cost-utility
Time frame: Post-treatment (3 months after the intervention started)
Sleepiness
Time frame: Post-treatment (3 months after the intervention started)
Fatigue
Time frame: Post-treatment (3 months after the intervention started)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise McKean study chair
University of Strathclyde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital CBT-I and Sleep Hygiene Education in people with Insomnia Chronic and Migraine Disorders, run by University of Strathclyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity (time frame: Posttreatment (3 months after intervention starts).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.