Digital CBTI for Comorbid Insomnia in Chronic Migraine

Migraine Disorders Clinical Trial

Official title:

Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244889
• Other study ID #: BRUK 202021-29
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: September 21, 2024

Study information

• Verified date: December 2022
• Source: University of Strathclyde
• Contact: Megan R Crawford, PhD
• Phone: 01415482669
• Email: hass-research-missionstudy[@]strath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Chronic
• Migraine Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital CBT-I
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 Education
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.

Locations

Country	Name	City	State
United Kingdom	Glasgow	Glasgow
United Kingdom	Walton Centre, Liverpool	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment (3 months after intervention starts).
Primary	Change in Migraine Days	The change in migraine days (measured with the headache diary) from baseline to posttreatment	Posttreatment (3 months after intervention starts).
Primary	Recruitment rate	How many participants have been recruited per month	Monthly throughout study completion
Primary	Retention rate	How many participants have dropped out	Through study completion, up to 3 years
Primary	Naps	Number (N) of naps	Mid treatment (Month 1-2 of study)
Primary	Light exposure	Light exposure measured through an actigraphy device	Mid treatment (Month 1-2 of study)
Primary	Barriers and Facilitators to Engagement with the protocol	Measured through qualitative interviews/focus groups	Post-treatment (3 months after the intervention started)
Secondary	Adverse Events	Adverse Events	Through study completion, up to 3 years
Secondary	Treatment Satisfaction	Measured through in house post-treatment satisfaction questionnaire	Post-treatment (3 months after the intervention started)
Secondary	Migraine Disability	Measured with Migraine Disability Assessment (MIDAS) questionnaire	Post-treatment (3 months after the intervention started)
Secondary	Medication use	Captured through headache diaries	Post-treatment (3 months after the intervention started)
Secondary	Depression and Anxiety	Captured with the Four-Item Patient Health Questionnaire (PHQ-4) for Anxiety and Depression	Post-treatment (3 months after the intervention started)
Secondary	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.	Post-treatment (3 months after the intervention started)
Secondary	Sleepiness	Measured with Epworth Sleepiness Scale	Post-treatment (3 months after the intervention started)
Secondary	Fatigue	Measured with Flinders Fatigue Scale (FFS)	Post-treatment (3 months after the intervention started)