Effects of iCBT and Exercise for Chronic Knee Patients

Not Applicable

Not yet recruiting

• Conditions: Chronic Knee Pain
• Interventions: Other: Standardized Exercise Program; Other: Internet based Cognitive Behavioral Therapy; Other: Educational Materials

• Registration Number: NCT06133738
• Lead Sponsor: University of Bahrain

Brief 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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15
• Study Start: 2023-12-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age ≥ 45 years
2. Depression level of at least 2 out 6 on the PHQ-2 questionnaire and/or psychological distress level (K-6) of at least 7 out of 24
3. Knee pain for more than 3 months and for most days of the previous month
4. A minimum average knee pain intensity of 4 on an 11-point numeric rating scale in the previous week
5. Mild to moderate difficulty with physical activities on KOOS-PS questionnaire, at least 6 out of 24
6. Has a smartphone with internet access.

Exclusion Criteria

1. Knee surgery including arthroscopy within the past 6 months
2. Awaiting or planning any back or lower limb surgery within the next 12 months
3. Current or past (within 3 months) oral or intra-articular corticosteroid use
4. Current long-term use of analgesics or drugs that cause analgesic effects such as the drugs used for epilepsy and bipolar disorders
5. Systemic arthritic conditions such as rheumatoid arthritis
6. Physiotherapy, chiropractic or acupuncture treatment or exercises specifically for the knee within the past 6 months
7. Walking >30 min continuously daily or participating in a regular (more than twice a week) exercise program
8. Past participation in a CBT program
9. Inability to walk unaided as this is necessary for some of the physical testing
10. Grade IV on Kellgren and Lawrence grading system for Osteoarthritis classification
11. Medical condition precluding safe exercise such as uncontrolled hypertension or heart condition
12. Major joint pain (e.g., back, hip or ankle) to a greater extent than the knee pain that could limit the ability to exercise
13. Self-reported psychiatric history such as schizophrenia, epilepsy, and bipolar disorders
14. Self-reported diagnosis of current clinical depression
15. Neurological condition such as Parkinson's disease, Multiple sclerosis, or stroke
16. Inadequate written and spoken Arabic
17. Unable to comply with the protocol such as the inability to attend therapy sessions or attend assessment appointments at the health center.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Educational Materials	Participants in this group will be given 8 sessions of a standardized exercise program, a link to access online educational sessions, in addition to internet based cognitive behavioural therapy sessions.
Intervention Group	Internet based Cognitive Behavioral Therapy	Participants in this group will be given 8 sessions of a standardized exercise program, a link to access online educational sessions, in addition to internet based cognitive behavioural therapy sessions.
Control Group	Standardized Exercise Program	Participants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions.
Control Group	Educational Materials	Participants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions.
Intervention Group	Standardized Exercise Program	Participants in this group will be given 8 sessions of a standardized exercise program, a link to access online educational sessions, in addition to internet based cognitive behavioural therapy sessions.

Primary Outcome Measures

Name	Time	Method
40-m Fast-Paced Walk Test (40-m FPWT)	8 weeks	A participant will be instructed to walk as quickly but as safely as possible to a mark 10 m away, return, and repeat for a total distance of 40 m. Time of one trial, with turn time excluded, will be recorded and expressed as speed m/s by dividing distance (40 m) by time (s).
Step Test (ST)	8 weeks	This test will be performed while the participant maintains balance on the study limb, then the contralateral foot will be stepped on and off a 15-cm step as many times as possible within 15 seconds. The count of the number of times the participant could step the foot up and return it to the floor over a 15-s interval will be recorded. The test will performed with no hand support allowed. For participants with unilateral knee OA, the test will be performed while standing on the affected side. For participants with bilateral knee OA, the most symptomatic limb will be considered the osteoarthritic limb for the purpose of this study.
The Single-Item Numerical Rating Scale (NRS)	8 weeks	Participants will be asked to rate their average knee pain in the past week on a scale from 0 to 10, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. This will be recorded via online form.
30 seconds Chair Stand Test (30s CTS test)	8 weeks	From the sitting position in the middle of seat with feet shoulder-width apart, flat on the floor, arms crossed at chest, a participant will be asked to stand completely up, then sit completely back down, repeatedly for 30s. The chair will be against a wall. Count the total number of complete chair stands (up and down represents one stand) of one trial. If a full stand is completed at 30s then this is counted in the total. The same chair is used for re-testing.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-2)	8 weeks	This is a 2-item scale for depression screening in primary care. This questionnaire will be administered via online forms. A PHQ-2 score ranges from 0-6, with 0 indicating the lowest level of depression, and 6 indicating the highest level of depression.
Health-Related Quality of Life-Short Form-12 (SF-12)	8 weeks	This is a questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health-related QoL. Scores range from 0 to 50, with higher scores indicating better health status. It will be administered through an online survey.
Psychological Distress (Kessler 6)	8 weeks	This is a 6-item self-report questionnaire that measures psychological distress based on anxiety and depressive symptoms in the patient's most recent 4-week period. The range for summed responses on the K6 Scale is 0 to 24, with 0 suggesting the lowest level of nonspecific psychological distress, and 24 suggesting the highest level of nonspecific psychological distress. This questionnaire will be administered via online forms.
Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS- PS)	8 weeks	This is a 7-item measure of physical function derived from the items of the Function, daily living and Function, sports, and recreational activity subscales of the KOOS. It will be administered through an online survey. The range for summed responses on the KOOS-PS is 0 to 24, where 24 is the worst possible and 0 is the best possible score. This questionnaire will be administered via online forms.
Maximum Isometric Muscle Strength	8 weeks	Maximal voluntary isometric quadriceps muscle strength will be assessed using a hand-held dynamometer. To do the test, a participant is seated on an examination table with their knees flexed to 60° and their feet off the ground. The hand-held dynamometer is positioned on the anterior aspect of the distal tibia, just superior to the malleoli. The participant grasps the examination table with his/her hands for stabilization, and the participant is instructed to extend his/her knee "as hard as possible" into the hand-held dynamometer. The participant continues to exert force into the hand-held dynamometer for 4 s, and the maximum force across the trial is recorded. Three testing trials will be completed, and the average force (Newtons \[N\]) across the three trials will be normalized to body mass (N/kg).