Digital CBTI for Comorbid Insomnia in Chronic Migraine

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.

NCT Number	NCT05244889
Lead Sponsor	University of Strathclyde
Conditions	Insomnia Chronic, Migraine Disorders
Enrollment	88 participants
Start Date	2022-01-31
Primary Completion	2024-07-30 (estimated)
Study Completion	2025-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-09