Exercise + CBT for Chronic Pain

(SLEEPFIT Trial)

Recruiting at 3 trial locations

Overseen By Alan A Nguyen, BSc/B.A

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Sydney

Disqualifiers: Neurological conditions, Active cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 months

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to join video consultations.

I am 18 or older with ongoing back pain and hip or knee osteoarthritis affecting my daily life.

My average pain level has been 4 or higher out of 10 in the past week.

Exclusion Criteria

Self-report engagement in >120 minutes per week of at least moderate intensity physical activity within the past 6 months

I have done CBT-I therapy within the last 6 months.

Cognitive impairment based on ≥7 on the Short Orientation Memory Concentration Test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are 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.

12 months

Up to 10 online sessions

Follow-up

Participants are monitored for changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples.

4 weeks

Assessments at baseline, 2 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: combined aerobic physical activity and CBT-I Experimental Treatment 1 Intervention

combined aerobic physical activity and cognitive behaviour therapy for insomnia

Group II: CBT-I Experimental Treatment 1 Intervention

Cognitive behaviour therapy for insomnia

Group III: Aerobic physical activity Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Sydney

Lead Sponsor

Trials

208

Recruited

417,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

The University of Queensland

Collaborator

Trials

149

Recruited

71,700+