Digital CBT-I for Patients With Chronic Pain and Insomnia
Active, not recruitingNot applicableNCT06361914
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints. The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia. Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on: 1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients). 2. Self-reported sleep quality. 3. Quality of life. 4. Physical and mental health. 5. Thoughts and beliefs about sleep and pain.
Study details
- Official title
- Digital CBT-I for Patients With Chronic Pain and Insomnia (The Back2Sleep Trial). A Randomized Controlled Trial
- Conditions
- Interventions
- Behavioral: Digital CBT-I
- Behavioral: Digital Sleep hygiene education
- Sponsor
- Odense University Hospital
- Collaborators
- Aarhus University Hospital; University of Southern Denmark; University of Aarhus; Odense Patient Data Explorative Network; T&W Engineering A/S
- Start date
- 2024-04-12
- Primary completion
- 2026-02-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: For a participant to be eligible, all inclusion criteria must be answered "yes": * Age ≥ 18 years. * Understand and write Danish. * Have smartphone access. * Pain for 3 months or longer. * Pain must be present on 'most days' or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did you have pain? - response options: 'never'; 'some days'; 'most days'; 'every day'). * Pain must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did your pain limit your life or work activities - response options: never, some days, most days, every day * Average pain intensity equal to or higher than 4 on a 0-10 Numeric Rating Scale \[NRS\] in the past 7 days (ranging from 'no pain' to 'worst imaginable pain'). Insomnia symptoms (Insomnia Severity Index (ISI) score \> 10; moderate insomnia). Exclusion Criteria: For a participant to be eligible, all exclusion criteria must be answered "no": * Pregnancy or lactation (Pregnancy is screened for through self-reporting as no risks regarding pregnancy have been identified for the described study procedures). * Does not have daily assess to smartphone/tablet * Night shift during the time of the CBT-I treatment. * Currently receiving pharmacological treatment for insomnia (e.g. benzodiazepines, hypnotics etc.). * Severe psychiatric/somatic illnesses of relevance of their sleep (reported by participant). * Diagnosed sleep disorders (e.g., OSA, narcolepsy). * Does not have E-boks. * Known abuse of alcohol or other substances. * Suicide and self-harm thoughts (reported by participant). * People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation. For the EEG subgroup only (60 patients): * Age ≥ 65 years * Anatomy of the outer ear making it impossible to do ear EEG monitoring. * Ear piercings that are not compatible with ear EEG. * Previous stroke or cerebral haemorrhage and any other structural cerebral disease. * Teeth grinding (bruxism). * Allergic contact dermatitis caused by metals or generally prone to skin irritation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06361914