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.

ABSTRACT:

Background

More 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.

Methods

The 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 a

SUBMITTER: Olsen MLS 

PROVIDER: S-EPMC12357470 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature