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ACTIVE NOT RECRUITING

NCT06361914

Digital CBT-I for Patients With Chronic Pain and Insomnia

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Digital CBT-I for Patients With Chronic Pain and Insomnia (The Back2Sleep Trial). A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-04-12

Completion Date

2026-12-05

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Chronic Pain Insomnia

Interventions

BEHAVIORAL

Digital CBT-I

Sleep restriction includes behavioral instructions to limit the time spent in bed to increase sleep drive and further reduce time awake in bed. Stimulus control therapy entails behavioral instructions to strengthen the association between bed and sleep and to eliminate conditioning of non-sleep behavior and bed. Deactivation/relaxation training involves methods to reduce somatic tension and limit intrusive thought processes that interfere with sleep. Cognitive therapy helps to identify, challenge, and modify dysfunctional beliefs about sleep. Sleep hygiene education entails specific information relating to lifestyle and environmental factors that may interfere with or promote sound sleep. Sleep hygiene education also includes specific sleep facilitating recommendations, such as avoiding visual access to a clock in the bedroom, regular sleep scheduling, avoiding long daytime naps, and limiting alcohol, caffeine, and nicotine intake.

BEHAVIORAL

Digital Sleep hygiene education

Sleep hygiene education entails specific information relating to lifestyle (diet, exercise, substance use) and environmental factors (light, noise, temperature) that may interfere with or promote sound sleep. Sleep hygiene education also includes specific sleep facilitating recommendations, such as avoiding visual access to a clock in the bedroom, regular sleep scheduling, avoiding long daytime naps, and limiting alcohol, caffeine, and nicotine intake.

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.

Locations (1)

Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense

Odense, Denmark