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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Nevada
Madigan Army Medical Centre 9040A Jackson Ave Joint Base
NOT_YET_RECRUITING
San Antonio
Texas
Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
NOT_YET_RECRUITING
San Antonio
Other Locations
Australia
The University of Queensland Therapies Building (84A)
NOT_YET_RECRUITING
Brisbane
Susan Wakil Health Building
RECRUITING
Camperdown
Contact Information
Primary
Alan A Nguyen, BSc/B.A
sleepfit.trial@sydney.edu.au
+610433014884
Backup
Michelle Hall, PhD, MSc, BSc (Hons)
michelle.hall@sydney.edu.au
+61 432128223
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2029-04
Participants
Target number of participants: 384
Treatments
Experimental: Aerobic physical activity
Experimental: CBT-I
Cognitive behaviour therapy for insomnia
Experimental: combined aerobic physical activity and CBT-I
combined aerobic physical activity and cognitive behaviour therapy for insomnia
Related Therapeutic Areas
Sponsors
Collaborators: The University of Queensland, Uniformed Services University of the Health Sciences
Leads: University of Sydney

This content was sourced from clinicaltrials.gov