Actively Recruiting
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Led by University of Sydney · Updated on 2026-05-05
384
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
T
The University of Queensland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older for low back pain; age 45 or older for hip or knee osteoarthritis
- Persistent low back pain, or hip/knee osteoarthritis with activity-related joint pain and limited morning stiffness
- Average pain score of 4 or higher on an 11-point scale over the past week
- Insomnia Severity Index score of 11 or higher
- Access to a computer, laptop, or tablet with internet for videoconferencing
- Willing and able to participate in video consultations
- US participants must be beneficiaries of the Military Health System
You will not qualify if you...
- Engaged in more than 120 minutes per week of moderate intensity physical activity in the past 6 months
- Received cognitive behavioral therapy for insomnia in the past 6 months
- Cognitive impairment based on Short Orientation Memory Concentration Test score of 7 or higher
- Received an injection into the study pain site in the past 3 months
- Waiting or planning to receive an injection in the study pain site in the next 12 months
- Had surgery in the past 12 months or planning surgery in the next 12 months
- Neurological or systemic conditions affecting physical function (e.g., Parkinson's, active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)
- Failed the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance
- Unable to give informed consent or participate in the intervention and assessments
- Unable to speak or read English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Madigan Army Medical Centre 9040A Jackson Ave Joint Base
San Antonio, Nevada, United States, 78234
Not Yet Recruiting
2
Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
San Antonio, Texas, United States, 78234
Not Yet Recruiting
3
Susan Wakil Health Building
Camperdown, New South Wales, Australia, 2200
Actively Recruiting
4
The University of Queensland Therapies Building (84A)
Brisbane, Saint Lucia, Australia, 4072
Not Yet Recruiting
Research Team
A
Alan A Nguyen, BSc/B.A
CONTACT
M
Michelle Hall, PhD, MSc, BSc (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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