Effectiveness of digital Cognitive-Behavioural Therapy for Insomnia in patients with musculoskeletal complaints and insomnia in primary care physiotherapy: study protocol for a randomised controlled trial

Introduction: Insomnia is prevalent among patients visiting physiotherapists due to musculoskeletal complaints and associated with poorer pain prognosis. Cognitive-Behavioural Therapy for Insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but its availability and utility are limited in daily physiotherapy practice. The aim of this randomised controlled trial (RCT) is to evaluate the effectiveness of digital CBT-I in addition to usual treatment in patients with chronic musculoskeletal complaints and insomnia, compared with usual treatment only.

Methods and analysis: In this RCT, eligible and consenting participants will be randomised (1:1 ratio) to one of two interventions: (1) digital CBT-I adjunct to physiotherapy treatment or (2) usual physiotherapy treatment. Patients with musculoskeletal complaints and insomnia visiting a physiotherapist in Norway will be invited to participate in the study. We aim to include 188 participants to detect a difference in the primary outcome. Outcome variables will be assessed at baseline (prior to randomisation) and at 6-week, 3-month, 6-month and 12-month follow-up. The primary outcome is between-group difference in insomnia severity, assessed with the Insomnia Severity Index (0-28 points) at 3 months. Secondary outcomes include between-group differences in pain intensity, physical function, work ability, health-related quality of life, mental distress, and self-reported use of sleep and pain medication. Exploratory analyses will identify patient characteristics influencing the effect of the digital intervention.

Ethics and dissemination: This trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2023/533381). The results of the trial will be published in peer-review journals and disseminated at national and international conferences.

Trial registration number: ISRCTN91221906.