Digital CBT-I for Patients With Chronic Pain and Insomnia

NCT06361914 | Active Not Recruiting

• 1 other identifier: 2314393
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 1.Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).
2. 2.Self-reported sleep quality.
3. 3.Quality of life.
4. 4.Physical and mental health.
5. 5.Thoughts and beliefs about sleep and pain.

Conditions

Chronic Pain; Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia severity

  Insomnia will be assessed with the Insomnia Severity Index (ISI), which is a brief 7 item patient-reported instrument with a score ranging from 0-28 (0=best;28=worst)

  Difference in change between groups from baseline to 9 weeks.

• Average pain intensity during the last 7 days

  Average pain intensity during last 7 days will be assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain')

  Difference in change between groups from baseline to 9 weeks

Secondary Outcomes (20)

• The trajectory of ISI severity scores

  Baseline, after 4 weeks, after 9 weeks

• 30% ISI responders

  Change from baseline to 9 weeks

• 50% ISI responders

  Change from baseline to 9 weeks

• Weekly pain intensity score trajectory

  Weekly from baseline to 9 weeks

• 30% pain intensity responders

  Change from baseline to 9 weeks

Other Outcomes (32)

• Age

  Baseline

• Sex

  Baseline

• Chronic pain

  Baseline

Study Arms (2)

Digital Sleep hygiene education

ACTIVE COMPARATOR

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.

Behavioral: Digital Sleep hygiene education

Digital CBT-I

EXPERIMENTAL

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.

Behavioral: Digital CBT-I

Interventions

Digital CBT-I BEHAVIORAL

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 CBT-I

Digital Sleep hygiene education BEHAVIORAL

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 Sleep hygiene education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• University of Southern Denmark: collaborator
• University of Aarhus: collaborator
• Odense Patient Data Explorative Network: collaborator
• T&W Engineering A/S: collaborator

Study Sites (1)

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

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40817235 DERIVED

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Henrik B Vægter, PhD

  University Hospital Odense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 12, 2024
• Study Start: April 12, 2024
• Primary Completion: February 4, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)