Comparing exercise, cognitive behavioral therapy for insomnia, and both for chronic musculoskeletal pain with poor sleep
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
This project will test whether a 12-month home-based exercise program, CBT for insomnia, or their combination helps reduce pain and improve sleep in adults with chronic low back pain or hip/knee osteoarthritis who have poor sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sydney Academic / other |
| Locations | 4 sites (San Antonio, Nevada and 3 other locations) |
| Trial ID | NCT07532070 on ClinicalTrials.gov |
What this trial studies
Adults with chronic low back pain or hip/knee osteoarthritis and coexisting insomnia are randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combined program. Each program includes up to 10 online consultations with a physiotherapist and tailored guidance on pain, sleep, and physical activity. Outcomes are measured at baseline, 2, 6, and 12 months using questionnaires, wearable activity and sleep monitors, sensory testing, blood samples, and sleep EEG at baseline and 6 months. The aim is to determine which non-drug lifestyle approach produces the greatest improvement in pain, sleep, physical function, and related biological markers.
Who should consider this trial
Good fit: Adults with chronic low back pain or hip/knee osteoarthritis lasting at least 6 months, average pain of ≥4/10, an Insomnia Severity Index ≥11, access to a computer or tablet for video visits, and willingness to complete wearable and in-person assessments.
Not a fit: People with short-term pain, inability to use video technology, or those requiring immediate surgical intervention or urgent medical management may not receive benefit from these behavioral programs.
Why it matters
Potential benefit: If successful, this work could offer accessible non-drug options that reduce pain and improve sleep, leading to better function and quality of life.
How similar studies have performed: Previous research shows exercise and CBT-I can each improve pain and sleep outcomes separately, but direct comparisons and combined interventions for patients with both chronic pain and insomnia are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA Participants will be included if they have persistent LBP defined as i) age ≥18 years; ii) sought or seriously considered care from a primary care clinician or specialist for their LBP within the past 6 weeks; iii) have at least moderate LBP-related interference with normal work or daily activity (including both work outside the home and housework), as assessed by item 8 of the 36-item Short Form Health Survey OR hip or knee OA defined by the National Institute for Health and Care Excellence as: i) age ≥45 years; ii) activity-related hip or knee joint pain; and iii) no morning hip or knee stiffness, or morning stiffness ≤30 minutes) * 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 CRITERIA * 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.
Where this trial is running
San Antonio, Nevada and 3 other locations
- Madigan Army Medical Centre 9040A Jackson Ave Joint Base — San Antonio, Nevada, United States (Not_yet_recruiting)
- Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston — San Antonio, Texas, United States (Not_yet_recruiting)
- Susan Wakil Health Building — Camperdown, New South Wales, Australia (Recruiting)
- The University of Queensland Therapies Building (84A) — Brisbane, Saint Lucia, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Alan A Nguyen, BSc/B.A
- Email: sleepfit.trial@sydney.edu.au
- Phone: +610433014884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.