ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06361914 (Digital CBT-I for Patients With Chronic Pain and Insomnia), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Digital CBT-I for Patients With Chronic Pain and Insomnia (The Back2Sleep Trial). A Randomized Controlled Trial
Who cites it
1 citing paper in PubMed.
- Myofascial pain in older adults: a geroscience-informed framework integrating precision geriatrics and digital therapeutics.Frontiers in aging neuroscience · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundMore than half of individuals with chronic pain also experience insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to widespread implementation. This study aims to evaluate the effectiveness of a 9-week app-delivered CBT-I intervention, compared to an app-delivered sleep hygiene education program (active control), in reducing insomnia and pain severity in patients with disabling chronic pain and comorbid insomnia.
methodsThe trial is a 1:1 randomized, single-blind, superiority trial randomizing 160 patients with disabling chronic pain and comorbid insomnia to either app-delivered CBT-I for 9 weeks or app-delivered sleep hygiene education for 9 weeks. Primary outcomes are the between-group differences in change in Insomnia Severity Index (ISI) and average pain intensity assessed using a 0-10 numeric rating scale (NRS) from baseline to post-interventions. Short-term secondary outcomes post-intervention include perceived effects on sleep and pain (Global Perceived Effect scales), sleep quality, thoughts and beliefs about sleep and pain, physical and mental health, and EQ5D-5L. Medium-term and long-term secondary outcomes (ISI, pain intensity, EQ5D-5L, health care costs, and use of sleep and pain medication) will be collected after 24 and 52 weeks. Exploratory physiological sleep metrics from at-home ear-electroencephalography (EEG) will be collected for five nights at baseline and for five nights during week 8. DISCUSSION: This planned study addresses a critical need for identifying effective, safe, and easily accessible alternatives to the current treatments for patients with chronic pain and insomnia.
trial registrationClinicalTrials.gov NCT06361914. Registered on April 17, 2024.
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