Digital CBT-I for Patients With Chronic Pain and Insomnia
NCT ID: NCT06361914
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
160 participants
INTERVENTIONAL
2024-04-12
2026-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Insomnia Secondary to Chronic Pain
NCT00127790
Sleep Well Despite Persistent Pain Symptoms
NCT06351839
Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
NCT02688569
Sleep, Pain and Quality of Life in Chronic Pain Patients
NCT04265586
App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints
NCT05572697
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After inclusion, participants will receive an unique randomization key to impute in the Hvil® app according to the abovementioned procedure to receive either digital CBT-I or sleep hygiene education for 9 weeks. This Hvil® App platform is used for both treatments to ensure that only the contents is different, but the form of delivery is the same. All patient reported data will be filled in directly to the eCRF via an online questionnaire using REDCap. Statistical analyses will be blinded to treatment allocation.
Sample size estimation:
Minimal clinical important difference for insomnia severity is 5 point. With an estimated SD for change of 2 times the minimal clinical important difference (SD=10) for patients with chronic pain and insomnia, power of 80%, an alpha value of 0.05, a minimum of 63 participants in each group is required.
Minimal clinical important difference for pain intensity is 15% corresponding to a change of 1.0 points in this population. With a SD for change of 2.0 for patients with chronic pain and insomnia, power of 80%, an alpha value of 0.05, a minimum of 63 participants in each group is required.
With an expected drop-out of 30% the investigators plan to recruit 160 participants (80 for each group).
Stopping rules: This trial has two stopping rules. Inclusion will stop December 31st 2025. In the event that 130 patients have completed the 9 weeks follow-up before 160 patients have been recruited the investigators will stop recruitment of further participants.
All participants that are withdrawn from the study will be encouraged to complete all visits as scheduled. Participants that are withdrawn from the treatment will not be replaced and will be included in the intention-to-treat population. According to the sample size calculation, the investigators will include participants enough to tolerate a drop-out rate of up to 30%. Both intention-to-treat and per protocol analysis will be performed and compared to assess the robustness of the primary analysis.
Statistical methods:
Difference in change from baseline to 9 weeks in the two primary outcomes (ISI score or mean NRS pain in last 7 days, both being continuous variables) between the digital CBT-I group and the sleep hygiene education group will be estimated using a mixed linear model approach with ISI and NRS pain as outcomes, time, treatment arm (digital CBT-I or sleep hygiene education), and the interaction between time and treatment arm as fixed effects. Both participant specific intercept and slope will be considered as random effects. The model will be adjusted for ISI score or NRS pain at baseline, respectively. The error variance will be allowed to vary over time and across the two arms. Interactions will be parametrized as time dependent treatment effects such that the treatment effect at week 9 corresponds directly with the efficacy parameter of interest. The treatment effect will be expressed as the gain in reduction observed in the digital CBT-I arm, i.e. a positive number expresses a favoring of the intervention. The pre-specified effectiveness analyses will be based on the intention-to-treat (ITT) principle, which includes all participants that are assessed and randomized at baseline. In the case of missing data during the 9-week trial, repeated measures linear mixed models will take this into account automatically, under the assumption that data is missing at random.
For the statistical assessment of the two primary outcomes (ISI and pain intensity), the investigators will apply a sequential test procedure to compare the effect of the two treatments (CBT-I vs. sleep hygiene education) on ISI severity in the first step and the effect on pain intensity in the second step. This means that statistical significance in the second step will only be assessed if statistical significance has been reached in the first step . The investigators use this approach as it seems unlikely that these interventions has direct effect on pain, but rather work through improved sleep. The significance level is set to 5%.
In responder analysis, a responder is defined as a patient who report a more than 30% and 50% decrease in insomnia or pain after 9 weeks. Proportion of responders between treatment groups will be expressed by adjusted odds ratios. These will be based on a logistic regression model with treatment, baseline value of pain intensity and insomnia severity, and sex as covariates.
A detailed statistical analysis plan (SAP) will be made publicly available before the statistical analysis is initiated.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Digital Sleep hygiene education
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 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.
Digital CBT-I
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
University of Southern Denmark
OTHER
University of Aarhus
OTHER
Odense Patient Data Explorative Network
OTHER
T&W Engineering A/S
INDUSTRY
Odense University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henrik B Vægter, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Odense
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Olsen MLS, Thorlund JB, Zachariae R, Vach W, Bendix L, Jespersen J, Kidmose P, Parsons C, Kidholm K, Vaegter HB. Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial. Trials. 2025 Aug 15;26(1):292. doi: 10.1186/s13063-025-09013-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2314393
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.