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Integrating cognitive behavioral therapy for insomnia (CBTi) into best-practice care (BPC) for knee osteoarthritis (KOA) patients with insomnia may reduce pain severity more than BPC alone with lifestyle education.

This randomized controlled trial protocol aims to test whether adding 6 sessions of CBTi to 12 sessions of physical therapist-led best-practice KOA care reduces pain severity more than best-practice care plus 6 general lifestyle education sessions in 128 patients with KOA and insomnia. The primary outcome is between-group difference in change in pain severity at 6 months post-intervention.

Last updated: Jul 7, 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 improves sleep quality and reduces insomnia severity
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Better sleep may reduce pain sensitivity and inflammation
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Reduced pain enhances physical function and quality of life
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Result: Lower pain severity and improved overall outcomes in KOA patients

Limitations

  • ⚠Results are not yet available; this is a protocol paper only
  • ⚠Sample size of 128 may limit generalizability to broader KOA populations
  • ⚠Blinding of participants and therapists is not possible due to the nature of behavioral interventions

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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.