NCT06133738

Effects of iCBT and Exercise for Chronic Knee Patients

The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Bahrain · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Knee Pain

Interventions

Type	Name	Description
OTHER	Standardized Exercise Program	Participants will be asked to attend to the department for 8 supervised physiotherapy sessions designed to strengthen lower limb muscles. Eight sessions were chosen as this number should be able to achieve improvements in pain and function. Standardized exercises sessions will be held once weekly in the health center and will be supervised by the researcher. In addition, participants will be requested to perform the prescribed exercises 3 times per week at home, with 1-2 days rest interval between the exercise's sessions. The program is comprised of a minimum of 4 and a maximum of 6 individualized lower limb exercises to be performed 4 times per week (once in the health center and 3 times at home). All exercise programs will include at least 2 knee extensor strengthening exercises, 1 hip abductor strengthening exercise, 1 hamstring strengthening exercise, 1 calf strengthening exercise, and 1 other exercise will be chosen based on assessment findings.
OTHER	Internet based Cognitive Behavioral Therapy	This intervention will be given to participants in intervention group. This is a link to access pre-recorded online sessions of CBT. The iCBT link contained eight 35- to 45-minute sessions, designed to be completed weekly, each provided an explanation of a cognitive or behavioural pain coping skill. Session 1 provided an overview, including a therapeutic rationale of CBT, followed by training in progressive muscle relaxation. Sessions 2 through 7 taught brief relaxation skills, activity-rest cycling, pleasant activity scheduling, cognitive restructuring, pleasant imagery, and problem-solving. Session 8 consolidated the learnt and taught strategies for long-term skill use. Each session has to be completed within the same week where the physiotherapy session is given. The researcher has developed a website that contained all the CBT materials.
OTHER	Educational Materials	All participants will receive a link to access online educational material about chronic knee pain. This is a YouTube link that consists of 5 sessions, with each lasting for 5-7 minutes, and is comprised of general information about the following: healthy eating, osteoarthritis and X-Ray, physical activity, the full pain experience, and proper footwear. Participants will be encouraged to access the educational material at their own leisure and pace.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-11-15
• Last updated: 2023-11-15