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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Aerobic physical activity
  • CBT-I
  • Combined aerobic physical activity and CBT-I

Treatment groups

384 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Sydney

Lead sponsor

The University of Queensland

Collaborator

Uniformed Services University of the Health Sciences

Collaborator