Digital CBTI for Comorbid Insomnia in Chronic Migraine

NCT05244889 | Active Not Recruiting DMC

• 1 other identifier: BRUK 202021-29
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insomnia Chronic; Migraine Disorders

Keywords

Cognitive Behaviour Therapy; Digital Therapy

Outcome Measures

Primary Outcomes (7)

• 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).

• Change in Migraine Days

  The change in migraine days (measured with the headache diary) from baseline to posttreatment

  Posttreatment (3 months after intervention starts).

• Recruitment rate

  How many participants have been recruited per month

  Monthly throughout study completion

• Retention rate

  How many participants have dropped out

  Through study completion, up to 3 years

• Naps

  Number (N) of naps

  Mid treatment (Month 1-2 of study)

• Light exposure

  Light exposure measured through an actigraphy device

  Mid treatment (Month 1-2 of study)

• Barriers and Facilitators to Engagement with the protocol

  Measured through qualitative interviews/focus groups

  Post-treatment (3 months after the intervention started)

Secondary Outcomes (8)

• Adverse Events

  Through study completion, up to 3 years

• Treatment Satisfaction

  Post-treatment (3 months after the intervention started)

• Migraine Disability

  Post-treatment (3 months after the intervention started)

• Medication use

  Post-treatment (3 months after the intervention started)

• Depression and Anxiety

  Post-treatment (3 months after the intervention started)

Study Arms (2)

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.

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.

Behavioral: Sleep Hygiene Education

Interventions

Digital CBT-I BEHAVIORAL

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.

Digital CBT-I

Sleep Hygiene Education BEHAVIORAL

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.

Sleep Hygiene Education (SHE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Strathclyde: lead

Study Sites (2)

Glasgow

Glasgow, United Kingdom

Location

Walton Centre, Liverpool

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Migraine Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Louise McKean

  University of Strathclyde

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While the study will be single-blinded (researchers analysing data will be blind to allocation), randomisation will be concealed to the RA and participant until the individual's eligibility has been established.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individuals will be randomly assigned to a dCBT-I or the sleep hygiene education control group.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: February 17, 2022
• Study Start: January 31, 2022
• Primary Completion: July 30, 2024
• Study Completion: March 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GB (2)