RecruitingNot ApplicableNCT07532070

COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL

Sponsor

University of Sydney

Enrollment

384 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Low Back Pain Osteo Arthritis Knee and Hip

Summary

This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

An average pain of ≥4 on an 11-point numerical rating scale (NRS); 0 equals no pain, 10 equals worst pain possible over the last week
≥11 on the Insomnia Severity Index
Access to a computer/laptop/tablet with internet availability for videoconferencing consultations
Willing and able to participate in video consultations
Verification that participants recruited in the US are beneficiaries of the Military Health System.

Exclusion Criteria10

Self-report engagement in >120 minute per week of at least moderate intensity physical activity within the past 6 months
Current or previous engagement in CBT-I in the past 6 months
Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test
Received an injection of any substance into the study pain site in the previous 3 months
Waiting or planning to receive an injection in the study pain site in the next 12 months
Had within the past 12 months, or waiting or planning surgery in the next 12 months
Neurological or systemic conditions that may affect physical function (e.g. Parkinson's, Active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)
Failing the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance to participate
Unable to give informed consent and/or participate in the intervention and assessment procedures.
Unable to speak or read English.

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Interventions

BEHAVIORALAerobic physical activity

This intervention consists of a structured, individualised aerobic physical activity program delivered via videoconferencing by a physiotherapist. The program focuses exclusively on aerobic-based activities and does not include any sleep-specific or cognitive behavioural components. Exercise prescription will be tailored and progressively adjusted based on participant tolerance, goals, and clinical guidelines.

BEHAVIORALCBT-I

This intervention consists of cognitive behavioural therapy for insomnia (CBT-I) delivered via videoconferencing by a physiotherapist trained in CBT-I principles. The program targets sleep-related behaviours and cognitions using evidence-based CBT-I strategies, including sleep restriction, stimulus control, cognitive restructuring, and sleep hygiene education. No structured physical activity or exercise prescription is included.

BEHAVIORALCombined aerobic physical activity and CBT-I

This intervention integrates both a structured aerobic physical activity program and cognitive behavioural therapy for insomnia (CBT-I) within the same physiotherapist-delivered videoconferencing consultations. Participants receive both aerobic physical activity alongside CBT-I strategies targeting sleep behaviours and cognitions. The combined intervention delivers both components concurrently and differs from the single-component interventions by addressing physical aerobic activity and sleep within an integrated treatment framework.