Digital CBT-I for Patients With Chronic Pain and Insomnia
Key facts
- Who runs it
- Odense University Hospital
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 140 people enrolled
- Started
- 12 Apr 2024
- Expected to end
- 5 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Digital CBT-I
- Digital Sleep hygiene education
- Record updated
- 15 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Currently receiving pharmacological treatment for insomnia (e.g. benzodiazepines, hypnotics etc.)
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- Severe psychiatric/somatic illnesses of relevance of their sleep (reported by participant)
- Diagnosed sleep disorders (e.g., OSA, narcolepsy)
- Allergic contact dermatitis caused by metals or generally prone to skin irritation
- Age ≥ 65 years
- 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
- 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):
- Anatomy of the outer ear making it impossible to do ear EEG monitoring
- Ear piercings that are not compatible with ear EEG
- Teeth grinding (bruxism)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Digital Sleep hygiene educationExisting treatment, for comparison
Sleep hygiene education is the commonly delivered treatment for insomnia in patients with chronic pain. The digital sleep hygiene education treatment in the Hvil® app includes the sleep hygiene education element that 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. Parallel to engaging with this element, participants are asked to fill in a sleep diary during the intervention's entire course.
- Digital CBT-ITreatment being tested
The digital CBT-I intervention in the Hvil® app is designed to be completed over a period of nine weeks (5 weeks with the components described below and 4 weeks with maintenance of new habits), and is based on the current consensus concerning non-pharmacological treatment of insomnia including five treatment components (sleep restriction, stimulus control, deactivation/relaxation training, cognitive therapy, sleep hygiene education). Each treatment component consists of an information module (i.e., content and purpose of the specific component), assessment module (i.e., assessment of the severity of the "problem" addressed by the component), application module (i.e., specific information on different types of exercises the participant should engage in), and evaluation module (i.e., assessment of the treatment gain). Participants are encouraged to complete the information and assessment module in one streak, estimated to last 30-60 minutes.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Digital CBT-I for Patients With Chronic Pain and Insomnia (The Back2Sleep Trial). A Randomized Controlled Trial
- Record updated
- 15 April 2026