The integration of cognitive behavioral therapy for insomnia in best-practice care for patients with knee osteoarthritis and insomnia: randomized controlled trial

Abstract

Knee osteoarthritis (KOA) is one of the most common musculoskeletal problems worldwide and its key symptom is pain. Current evidence-based treatment approaches only show small to moderate effects on pain. Therefore, clinical guidelines recommend integrating comorbidity-specific interventions as a part of patient-centered care. Insomnia is a common sleep disorder in patients with KOA and associated with higher pain severity. It also adversely affects daily function and general health; and it represents a barrier for effective conservative management. However, insomnia is rarely addressed in the often joint-targeted KOA treatment. Objective: Investigate if physiotherapist-led best-practice KOA care (BPC)- cognitive behavioral therapy for insomnia (CBTi) is more effective than best-practice KOA care supplemented with general lifestyle information sessions (BPC-GLI) in reducing pain severity at 6-month post-intervention. Methods: A two-arm randomized controlled trial (RCT) in patients with KOA and insomnia is conducted in a community setting, in which a total of 128 patients are randomly allocated to the intervention or control group. The experimental intervention consists of 6 sessions of CBTi that are integrated in 12 sessions of BPC. The control intervention also consists of 12 sessions of physiotherapist-led BPC and is supplemented with 6 general lifestyle information sessions. The primary outcome is the between-group difference in change in pain severity at 6-month post-intervention follow-up. Assessments are conducted at baseline, post-intervention, and 3-, 6- and 12-months post-intervention. (AU)