protocolSection identificationModule nctId: NCT06361914, orgStudyIdInfo id: 2314393, briefTitle: Digital CBT-I for Patients With Chronic Pain and Insomnia, acronym: Back2Sleep, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Aarhus University Hospital, collaborators name: University of Southern Denmark, collaborators name: University of Aarhus, collaborators name: Odense Patient Data Explorative Network, collaborators name: T&W Engineering A/S, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Pain, conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Digital CBT-I, interventions name: Digital Sleep hygiene education, outcomesModule primaryOutcomes measure: Insomnia severity, primaryOutcomes measure: Average pain intensity during the last 7 days, secondaryOutcomes measure: The trajectory of ISI severity scores, secondaryOutcomes measure: 30% ISI responders, secondaryOutcomes measure: 50% ISI responders, secondaryOutcomes measure: Weekly pain intensity score trajectory, secondaryOutcomes measure: 30% pain intensity responders, secondaryOutcomes measure: 50% pain intensity responders, secondaryOutcomes measure: Global Perceived Effect (GPE) for sleep, secondaryOutcomes measure: Global Perceived Effect (GPE) for pain, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Physical and Mental Health, secondaryOutcomes measure: Sleep diary, secondaryOutcomes measure: Thoughts about sleep and pain, secondaryOutcomes measure: Thoughts about sleep, secondaryOutcomes measure: Treatment compliance, secondaryOutcomes measure: Health-related quality of life - mobility, secondaryOutcomes measure: Health-related quality of life - self care, secondaryOutcomes measure: Health-related quality of life - usual activities, secondaryOutcomes measure: Health-related quality of life - pain/discomfort, secondaryOutcomes measure: Health-related quality of life - anxiety/depression, secondaryOutcomes measure: Health-related quality of life - global, otherOutcomes measure: Age, otherOutcomes measure: Sex, otherOutcomes measure: Chronic pain, otherOutcomes measure: Ethnicity, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Marital status, otherOutcomes measure: Level of education, otherOutcomes measure: Pain distribution, otherOutcomes measure: Medical history and concomitant illnesses, otherOutcomes measure: Concomitant medication, otherOutcomes measure: Health-related quality of life - mobility, otherOutcomes measure: Health-related quality of life - self care, otherOutcomes measure: Health-related quality of life - usual activities, otherOutcomes measure: Health-related quality of life - pain/discomfort, otherOutcomes measure: Health-related quality of life - anxiety/depression, otherOutcomes measure: Health-related quality of life - global, otherOutcomes measure: Insomnia Severity, otherOutcomes measure: Average pain intensity during the last 7 days, otherOutcomes measure: Medication use, otherOutcomes measure: Economical evaluation, otherOutcomes measure: Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: REM sleep latency from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG, otherOutcomes measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG, otherOutcomes measure: Number of awakenings within TST from Ear EEG, otherOutcomes measure: Arousal index which is number of arousals per hour from Ear EEG, otherOutcomes measure: Ease-of-use and Comfort with ear EEG, otherOutcomes measure: Ear EEG adverse device effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, contacts name: Henrik B Vaegter, PhD, role: CONTACT, phone: 004565413869, email: hbv@rsyd.dk, contacts name: Louise S Olsen, MSc, role: CONTACT, phone: 004565413869, email: Maria.Louise.Stage.Olsen@rsyd.dk, contacts name: Henrik B Vægter, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Louise S Olsen, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False