A Stepped-Care Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain – Protocol of a Randomized Clinical Trial (the StepUp Study)

Abstract Chronic spinal pain (CSP) and insomnia frequently co-occur in a mutually reinforcing relationship that amplifies symptom severity and reduces treatment efficacy. Despite the robust evidence supporting cognitive behavioral therapy for insomnia (CBT-i) as the first-line treatment, accessibility remains critically low due to workforce limitations, insufficient training in primary care, and the high burden of traditional treatment formats. This paper is the protocol of the StepUp study which aims to evaluate a stepped-care approach to CBT-i designed to improve access, efficiency, and clinical outcomes for individuals with CSP and chronic insomnia. In this three-arm randomized controlled trial, participants with CSP will be allocated to stepped-care CBT-i, standard CBT-i, or usual care. The primary outcome is remission of chronic insomnia at six months post-treatment. Secondary outcomes include cost-effectiveness, medication use, treatment adherence, sleep quality, pain intensity, and physical functioning assessed up to 12 months follow-up. By integrating precision medicine principles and resource optimization, this study addresses a critical gap in the management of comorbid insomnia and pain. Findings are expected to inform scalable, evidence-based care pathways and enhance the delivery of effective behavioral sleep interventions within real-world healthcare systems.