COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR P… (NCT07532070) | Clinical Trial Compass
RecruitingNot Applicable
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
United States, Australia384 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Pain severity
Timeframe: Baseline and 2, 6 (primary time-point) and 12 months