Digital therapy for chronic pain and insomnia

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

This study is trying out a digital therapy program to see if it can help people with chronic pain and insomnia sleep better and feel less pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Odense University Hospital (Academic / other)
• Locations: 1 site (Odense)
• Trial ID: NCT06361914 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a digital cognitive behavioral therapy for insomnia (CBT-I) program in patients suffering from chronic pain and insomnia. Participants will be randomly assigned to either the digital CBT-I group or a sleep hygiene education group, both utilizing the Hvil® app for a duration of 9 weeks. The aim is to assess improvements in sleep quality and reductions in pain intensity through a randomized controlled trial design. Data will be collected via online questionnaires, ensuring a comprehensive evaluation of treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who experience chronic pain for at least three months and have comorbid insomnia.

Not a fit: Patients who do not have chronic pain or insomnia, or those who cannot access a smartphone, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide an accessible and effective non-pharmacological treatment option for patients with chronic pain and insomnia.

How similar studies have performed: Previous studies have shown that digital CBT-I can be effective, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Odense

• Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense — Odense, Denmark (Recruiting)

Study contacts

• Principal investigator: Henrik B Vægter, PhD — University Hospital Odense
• Study coordinator: Henrik B Vaegter, PhD

Conditions Chronic Pain; Insomnia