TY - JOUR
T1 - Integration of Cognitive Behavioral Therapy for Insomnia in Best-Practice Care for Patients with Knee Osteoarthritis and Insomnia
T2 - A Randomized Controlled Trial Protocol
AU - Labie, Céline
AU - Runge, Nils
AU - Mairesse, Olivier
AU - Nijs, Jo
AU - Malfliet, Anneleen
AU - Verschueren, Sabine
AU - Van Assche, Dieter
AU - de Vlam, Kurt
AU - Luyten, Frank
AU - Bilterys, Thomas
AU - Stat, Wilfried Cools
AU - De Pourcq, Veerle
AU - Delwiche, Bérénice
AU - Huysmans, Eva
AU - De Baets, Liesbet
N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: [email protected].
PY - 2024/4/1
Y1 - 2024/4/1
N2 - OBJECTIVE: Knee osteoarthritis (KOA) is a common musculoskeletal problem worldwide and its key symptom is pain. Guidelines recommend incorporating comorbidity-specific therapies into patient-centered care. Patients diagnosed with KOA frequently have insomnia, which is associated with higher pain severity. For this reason, this study protocol outlines the methodology of a randomized controlled trial (RCT) investigating the effectiveness of cognitive behavioral therapy for insomnia (CBTi) combined with best-practice KOA care (BPC) compared to best-practice KOA care and lifestyle education.METHODS: A 2-arm RCT in patients with KOA and insomnia is conducted, in which a total of 128 patients are randomly allocated to intervention or control group. The experimental intervention consists of 12 sessions of physical therapist-led BPC with an additional 6 sessions of CBTi. The control intervention also receives BPC, which is supplemented with 6 general lifestyle information sessions. The primary outcome is the between-group difference in change in pain severity at 6 months after intervention. Secondary outcomes are pain-related outcomes, sleep-related outcomes, symptoms of anxiety and depression, level of physical activity and function, perceived global improvement, biomarkers of inflammation and health-related quality of life. Assessments are conducted at baseline, immediately after intervention, and 3, 6, and 12 months after intervention. Furthermore, a cost-utility analysis for the proposed intervention will be performed alongside the RCT.IMPACT: This is the first RCT investigating the clinical and cost-effectiveness of a physical therapist-led intervention integrating CBTi into BPC in patients with KOA and insomnia. The results of this trial will add to the growing body of evidence on the effectiveness of individualized and comorbidity-specific KOA care, can inform clinical decision-making, and assist policymakers and other relevant stakeholders in optimizing the care pathway for patients with KOA.
AB - OBJECTIVE: Knee osteoarthritis (KOA) is a common musculoskeletal problem worldwide and its key symptom is pain. Guidelines recommend incorporating comorbidity-specific therapies into patient-centered care. Patients diagnosed with KOA frequently have insomnia, which is associated with higher pain severity. For this reason, this study protocol outlines the methodology of a randomized controlled trial (RCT) investigating the effectiveness of cognitive behavioral therapy for insomnia (CBTi) combined with best-practice KOA care (BPC) compared to best-practice KOA care and lifestyle education.METHODS: A 2-arm RCT in patients with KOA and insomnia is conducted, in which a total of 128 patients are randomly allocated to intervention or control group. The experimental intervention consists of 12 sessions of physical therapist-led BPC with an additional 6 sessions of CBTi. The control intervention also receives BPC, which is supplemented with 6 general lifestyle information sessions. The primary outcome is the between-group difference in change in pain severity at 6 months after intervention. Secondary outcomes are pain-related outcomes, sleep-related outcomes, symptoms of anxiety and depression, level of physical activity and function, perceived global improvement, biomarkers of inflammation and health-related quality of life. Assessments are conducted at baseline, immediately after intervention, and 3, 6, and 12 months after intervention. Furthermore, a cost-utility analysis for the proposed intervention will be performed alongside the RCT.IMPACT: This is the first RCT investigating the clinical and cost-effectiveness of a physical therapist-led intervention integrating CBTi into BPC in patients with KOA and insomnia. The results of this trial will add to the growing body of evidence on the effectiveness of individualized and comorbidity-specific KOA care, can inform clinical decision-making, and assist policymakers and other relevant stakeholders in optimizing the care pathway for patients with KOA.
UR - http://www.scopus.com/inward/record.url?scp=85187254826&partnerID=8YFLogxK
U2 - 10.1093/ptj/pzad181
DO - 10.1093/ptj/pzad181
M3 - Article
C2 - 38157312
VL - 104
JO - Physical Therapy
JF - Physical Therapy
SN - 0031-9023
IS - 4
M1 - pzad181
ER -