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Integrating cognitive behavioral therapy for insomnia into best-practice care reduces pain severity in patients with knee osteoarthritis and insomnia

This protocol describes a randomized controlled trial testing whether adding 6 sessions of CBTi to 12 sessions of physical therapist-led best-practice care (BPC) reduces pain severity more than BPC plus 6 general lifestyle education sessions in 128 patients with knee osteoarthritis and insomnia. The primary outcome is between-group difference in pain severity change at 6 months post-intervention. Secondary outcomes include sleep, mood, function, inflammation biomarkers, and cost-effectiveness.

Last updated: Jul 11, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score42/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Integration of Cognitive Behavioral Therapy for Insomnia in Best-Practice Care for Patients With Knee Osteoarthritis and Insomnia: A Randomized Controlled Trial Protocol.

observational

Labie C, Runge N, Mairesse O, Nijs J, Malfliet A, Verschueren S, Van Assche D, de Vlam K, Luyten F, Bilterys T, Cools W, De Pourcq V, Delwiche B, Huysmans E, De Baets L · Physical therapy (2024)

Participants: N/A
Duration: 12 months follow-up
Intervention: 12 sessions of physical therapist-led best-practice knee osteoarthritis care plus 6 sessions of cognitive behavioral therapy for insomnia
Outcome: Pain severity (primary), pain-related outcomes, sleep-related outcomes, anxiety and depression symptoms, physical activity and function, perceived global improvement, biomarkers of inflammation, health-related quality of life
Effect Size: N/A
Population: Patients with knee osteoarthritis and comorbid insomnia

Result:

PubMed: 38157312DOI: 10.1093/ptj/pzad181

Mechanism Graph

CBTi targets insomnia-related hyperarousal and maladaptive sleep behaviors
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Improved sleep reduces pain sensitivity and inflammation
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Combined with BPC (exercise, education, weight management) enhances physical function
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Result: Greater reduction in pain severity and improved overall outcomes

Limitations

  • ⚠Results are not yet available as this is a protocol paper
  • ⚠No blinding of participants or therapists due to the nature of behavioral interventions
  • ⚠Generalizability may be limited to physical therapist-led settings

Frequently Asked Questions

What is the primary outcome of this trial?▼

The between-group difference in change in pain severity at 6 months after intervention.

How many participants are enrolled?▼

128 patients with knee osteoarthritis and insomnia are randomly allocated to intervention or control groups.

What does the control group receive?▼

The control group receives 12 sessions of best-practice knee osteoarthritis care plus 6 sessions of general lifestyle education.

Is this study completed?▼

No, this is a protocol paper outlining the methodology; results are not yet available.

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References

  1. 1.Labie C, Runge N, Mairesse O, Nijs J, Malfliet A, Verschueren S, Van Assche D, de Vlam K, Luyten F, Bilterys T, Cools W, De Pourcq V, Delwiche B, Huysmans E, De Baets L. "Integration of Cognitive Behavioral Therapy for Insomnia in Best-Practice Care for Patients With Knee Osteoarthritis and Insomnia: A Randomized Controlled Trial Protocol.." Physical therapy, 2024. PMID: 38157312 DOI: 10.1093/ptj/pzad181
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.