None listed
Conditions
Brief summary
Musculoskeletal conditions such as chronic low back pain and osteoarthritis are leading causes of pain and disability worldwide, and many people also experience poor sleep. This study will investigate whether adding cognitive behavioural therapy for insomnia (CBT-I) to usual physiotherapy care improves pain and sleep outcomes compared with usual physiotherapy care alone. The SLEEP-MSK trial is a two-stage adaptive basket randomised controlled trial involving people with chronic low back pain, hip osteoarthritis or knee osteoarthritis and insomnia. Participants will be randomly allocated to receive either usual physiotherapy care alone or usual physiotherapy care plus CBT-I delivered by trained physiotherapists. Outcomes including pain, insomnia severity, physical function, fatigue and quality of life will be assessed over 12 months.
Interventions
Participants allocated to the cognitive behavioural therapy for insomnia (CBT-I) and usual care group will receive usual care as described above in addition to a structured physiotherapist-delivered CBT-I intervention. Usual care is led by a physiotherapist and may include education, self-management advice, exercise therapy and physical activity recommendations.
This is a basket trial involving participants with knee osteoarthritis, hip osteoarthritis and low back pain. Participants across all
Participants allocated to the cognitive behavioural therapy for insomnia (CBT-I) and usual care group will receive usual care as described above in addition to a structured physiotherapist-delivered CBT-I intervention. Usual care is led by a physiotherapist and may include education, self-management advice, exercise therapy and physical activity recommendations. This is a basket trial involving participants with knee osteoarthritis, hip osteoarthritis and low back pain. Participants across all musculoskeletal conditions will receive the same CBT-I intervention. The same primary and secondary outcomes will be assessed across all conditions. Participants commence the trial on the day of their first usual care appointment with their physiotherapist. They will be randomised by the study team and if randomised to the CBT-I group, they will have a CBT-I appointment scheduled. Participants will receive 6 CBT-I appointments (~30 mins each session) over a period of 8 weeks. The CBT-I appointments do not need to be scheduled at the same time as their usual care appointments. Most CBT-I appointments will be delivered over the phone or online, but can be delivered in-person if needed due to convenience. Physiotherapists will receive up to 4 hours of training in CBT-I delivered online via a bespoke eLearning program based on recordings slides and educational materials developed previously for in-person training delivered by Prof Sue McCurry (University of Washington, Clinical Psychologist). The eLearning modules will be supplemented by voice-to-voice AI patient avatars developed on case studies from real study participants developed with the support of the University of Sydney Faculty of Medicine and Health Media Lab. The AI avatars will provide physiotherapists with an opportunity for real-time practice in delivering the six sessions of CBT-I using their new knowledge and skills, and increase their familiarity with using the physiotherapist treatment notes to structure the sessions. The intervention includes behavioural, cognitive, circadian rhythm, and educational strategies for insomnia management. Behavioural strategies: (1) Stimulus control: Strengthens bed and bedroom as sleep stimuli. Interventions may include adjusting sleep timing, managing light exposure, and reinforcing consistent wake times to support optimal sleep regulation. (2) Sleep (Bed) restriction: Restricts time in bed to improve sleep depth and consolidation. Participants are prescribed a personalised sleep plan using a daily electronic sleep diary. Their time in bed is adjusted as their sleep efficiency (% time spent asleep/total time in bed) changes over time. The aim is to achieve sleep efficiency of 85% or better. (3) Sleep hygiene: Promotes habits and environments that help sleep. Cognitive strategies: (1) Cognitive therapy: Addresses unhelpful beliefs, worries, and expectations that interfere with sleep. Interventions may include cognitive restructuring, constructive worry, and mindfulness practices. (2) Relaxation/mindfulness training: Reduces arousal and decrease anxiety. (3) Acceptance based: Decrease struggle to control sleep at cost of living your life. The circadian component targets the timing of sleep and wake cycles, helping align sleep patterns with natural biological rhythms. Interventions may include adjusting sleep timing, managing light exposure, and reinforcing consistent wake times to support optimal sleep regulation. Education: Core education about insomnia – understanding what insomnia is, how it develops, and why it often persists over time. Participants are educated about the 3P (+1) model of insomnia – understanding Predisposing, Precipitating, and Perpetuating factors, plus Protective factors, that influence sleep difficulties. CBT-I equips people with tools to manage their sleep independently, promoting long-term success and resilience. It empowers people to track their own progress and adapt strategies that enhance their confidence and engagement in the recovery process. Participants will complete daily sleep diaries, and this information will be used to tailor behavioural prescriptions and sleep scheduling recommendations. Examples, include recommendations regarding bedtime, wake time, and avoidance of daytime napping. Minor modifications to CBT-I delivery will be permitted to enhance feasibility and participant-centred care, including adjustments to session length, mode of delivery and pacing of behavioural prescriptions. Intervention fidelity will be assessed using structured clinician checklists and audit of audio-recorded sessions (with participant consent). Attendance at intervention sessions will be recorded by physiotherapists in REDCap.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Referred to a participating hospital-based outpatient physiotherapy service for management of chronic low back pain and/or osteoarthritis of the hip or knee. 2. Aged 18 years or older and low back pain defined as moderate pain-related interference with normal work or daily activity by item 8 of the 36-item Short Form Health Survey and/or osteoarthritis of the hip or knee according to the National Institute for Health and Care Excellence clinical criteria (aged 45 years or older, activity-related hip and/or knee pain, and morning stiffness lasting 30 minutes or less). 3. Low back, hip or knee pain on most days for at least 3 months. 4. Average low back, hip or knee pain over the last week of 4 or greater on an 11-point numerical rating scale where 0 = “No pain” and 10 = “Worst pain possible”. 5. Insomnia Severity Index score of 11 or greater. 6. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder. 7. Has access to a smartphone or device with internet access.
Exclusion criteria
1. Current or previous participation in cognitive behavioural therapy for insomnia (CBT-I) within the past 6 months. 2. Regular overnight shift workers (i.e. shifts occurring between 12am and 6am). 3. Cognitive impairment defined as a score of 7 or greater on the Short Orientation Memory Concentration Test. 4. Women who are pregnant, lactating, or of childbearing potential who are unwilling to avoid pregnancy during the study. 5. Sciatica, spinal stenosis, spinal fracture, systemic inflammatory disease or cancer. 6. Received an injection (e.g. cortisone, platelet-rich plasma or viscosupplementation) into the primary affected area (lower back, hip or knee) within the previous 3 months. 7. Waiting for or planning to receive an injection into the primary affected area within the next 12 months. 8. Surgery for low back, hip or knee pain within the previous 12 months, or planned surgery within the next 12 months. 9. History of a psychological illness or condition likely to interfere with the participant’s ability to understand study requirements. 10. History of a clinically relevant medical, behavioural or psychiatric disorder, other than obstructive sleep apnoea, associated with insomnia or excessive sleepiness. 11. Unable to provide informed consent or participate in the intervention or assessment procedures. 12. Unable to speak or read English.
Outcome results
None listed