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Clinical Trial Summary

The goal of this clinical trial is to study the effects of using an internet-based cognitive behavioural therapy (iCBT) program and exercise in chronic knee patients with psychological distress. The main question[s] it aims to answer are: - What are the effects of a combined iCBT and standardized exercise program on pain and function in chronic knee pain patients with psychological distress - What are the effects of a combined iCBT and standardized exercise program on depression, psychological distress, physical function, quality of life, and quadriceps muscle strength in chronic knee pain patients with psychological distress - Do a combined iCBT and standardized exercise program significantly improve pain and function in chronic knee pain patients with psychological distress compared to a control group? - Do a combined iCBT and standardized exercise program significantly improve depression, psychological distress, physical function, QoL, and quadriceps muscles strength in chronic knee pain patients with psychological distress compared to a control group? Participants will be allocated randomly to either intervention group or control group. Intervention group will be given iCBT, exercise and educational program, while the control group will be given exercise and educational program only. Researchers will compare both groups to see if the intervention group improves much better in terms of pain, function and other outcome measures compared to the study group.


Clinical Trial Description

This will be a 2-arm quasi-randomized controlled trial of eight weeks of intervention involving eight sessions of standardized exercise program and either concomitant iCBT and educational sessions or educational sessions only. Measurements will be taken at baseline and eight weeks immediately following the intervention. Primary outcome measures are a numerical pain rating scale, 40-m Fast-Paced Walk Test, Step Test, and 30 seconds Chair Stand Test. Secondary outcome measures are Patient Health Questionnaire, Psychological Distress, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Health-Related Quality of Life-Short Form-12, and Quadriceps Maximum Isometric Muscle Strength. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06133738
Study type Interventional
Source University of Bahrain
Contact Amal Alaradi, MSc
Phone +97336366300
Email to.alaradi@gmail.com
Status Not yet recruiting
Phase N/A
Start date December 1, 2023
Completion date March 1, 2024

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