NCT05244889Active, not recruiting
Digital CBTI for Comorbid Insomnia in Chronic Migraine
Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 7 Jul 2021
- Start date
- 31 Jan 2022
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- University of Strathclyde
- Diseases
- Migraine
- NCT number
- NCT05244889
What you commit to
- Study type: Interventional
- Planned participants: 88
- From 31 Jan 2022 to the primary completion date, 30 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Regular use of illegal substances
- Women who are pregnant or breastfeeding
- Shiftworkers
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Walton Centre, Liverpool Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.