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

Part of paid clinical trials in San Antonio, Nevada.

Sponsor
University of Sydney
Study ID
NCT07532070
Status
Recruiting
Apply to this trial

Conditions

  • Insomnia
  • Low Back Pain
  • Osteo Arthritis Knee and Hip

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aerobic physical activity — BEHAVIORAL
    This intervention consists of a structured, individualised aerobic physical activity program delivered via videoconferencing by a physiotherapist. The program focuses exclusively on aerobic-based activities and does not include any sleep-specific or cognitive behavioural components. Exercise prescription will be tailored and progressively adjusted based on participant tolerance, goals, and clinical guidelines.
  • CBT-I — BEHAVIORAL
    This intervention consists of cognitive behavioural therapy for insomnia (CBT-I) delivered via videoconferencing by a physiotherapist trained in CBT-I principles. The program targets sleep-related behaviours and cognitions using evidence-based CBT-I strategies, including sleep restriction, stimulus control, cognitive restructuring, and sleep hygiene education. No structured physical activity or exercise prescription is included.
  • Combined aerobic physical activity and CBT-I — BEHAVIORAL
    This intervention integrates both a structured aerobic physical activity program and cognitive behavioural therapy for insomnia (CBT-I) within the same physiotherapist-delivered videoconferencing consultations. Participants receive both aerobic physical activity alongside CBT-I strategies targeting sleep behaviours and cognitions. The combined intervention delivers both components concurrently and differs from the single-component interventions by addressing physical aerobic activity and sleep within an integrated treatment framework.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
384 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Average Pain severity [ Time Frame: Baseline and 2, 6 (primary time-point) and 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Madigan Army Medical Centre 9040A Jackson Ave Joint BaseSan AntonioNevada78234
Rachel Mayhew
[email protected]
Daniel Rhon (PRINCIPAL_INVESTIGATOR)
Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam HoustonSan AntonioTexas78234
Rachel Mayhew
[email protected]
Daniel Rhon (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Antonio, NV

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Madigan Army Medical Centre 9040A Jackson Ave Joint Base· San Antonio, NVBrooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston· San Antonio, TX

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