Clinical trial NCT06133738: Effects of iCBT and Exercise for Chronic Knee Patients
Official title: The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Knee Pain
Keywords: Internet Based Cognitive Behavioural Therapy
Psychological Distress
Exercise
Lead sponsor: University of Bahrain
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Single-Item Numerical Rating Scale (NRS)
timeFrame: 8 weeks
measure: 40-m Fast-Paced Walk Test (40-m FPWT)
timeFrame: 8 weeks
measure: Step Test (ST)
timeFrame: 8 weeks
measure: 30 seconds Chair Stand Test (30s CTS test)
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: 8 weeks
measure: Psychological Distress (Kessler 6)
timeFrame: 8 weeks
measure: Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS- PS)
timeFrame: 8 weeks
measure: Health-Related Quality of Life-Short Form-12 (SF-12)
timeFrame: 8 weeks
measure: Maximum Isometric Muscle Strength
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Primary Healthcare Centers- Kingdom of Bahrain
name: Amal Alaradi
role: PRINCIPAL_INVESTIGATOR
References: