Digital CBTI for Comorbid Insomnia in Chronic Migraine

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

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Strathclyde

  lead OTHER

Principal Investigators

• Louise McKean · University of Strathclyde

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-31

Primary Completion

2024-07-30

Completion

2025-03-31

Countries

• United Kingdom

Study Locations