Digital CBTI for Comorbid Insomnia in Chronic Migraine

University of Strathclyde

Status: Active, not recruiting

Conditions: Migraine Disorders; Insomnia Chronic

Treatments: Behavioral: Sleep Hygiene Education; Behavioral: Digital CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT05244889

BRUK 202021-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women age 18 and above
2. Insomnia, satisfied by a total score ≥ 11 on the insomnia severity index (ISI)
3. Headache ≥ 15 days per month, ≥ 12 months and meet criteria for migraine with/without aura on ≥ 8 days per month, ≥ 12 months

Exclusion criteria

1. 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.
2. 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
3. Regular use of illegal substances
4. Women who are pregnant or breastfeeding
5. Shiftworkers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Digital CBT-I

Experimental group

Description:

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.

Treatment:

Behavioral: Digital CBT-I

Sleep Hygiene Education (SHE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Hygiene Education