Status:
UNKNOWN
Effects of iCBT and Exercise for Chronic Knee Patients
Lead Sponsor:
University of Bahrain
Conditions:
Chronic Knee Pain
Eligibility:
All Genders
45-70 years
Phase:
NA
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 m...
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 45 years
- 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
- Knee pain for more than 3 months and for most days of the previous month
- A minimum average knee pain intensity of 4 on an 11-point numeric rating scale in the previous week
- Mild to moderate difficulty with physical activities on KOOS-PS questionnaire, at least 6 out of 24
- Has a smartphone with internet access.
Exclusion
- Knee surgery including arthroscopy within the past 6 months
- Awaiting or planning any back or lower limb surgery within the next 12 months
- Current or past (within 3 months) oral or intra-articular corticosteroid use
- Current long-term use of analgesics or drugs that cause analgesic effects such as the drugs used for epilepsy and bipolar disorders
- Systemic arthritic conditions such as rheumatoid arthritis
- Physiotherapy, chiropractic or acupuncture treatment or exercises specifically for the knee within the past 6 months
- Walking \>30 min continuously daily or participating in a regular (more than twice a week) exercise program
- Past participation in a CBT program
- Inability to walk unaided as this is necessary for some of the physical testing
- Grade IV on Kellgren and Lawrence grading system for Osteoarthritis classification
- Medical condition precluding safe exercise such as uncontrolled hypertension or heart condition
- Major joint pain (e.g., back, hip or ankle) to a greater extent than the knee pain that could limit the ability to exercise
- Self-reported psychiatric history such as schizophrenia, epilepsy, and bipolar disorders
- Self-reported diagnosis of current clinical depression
- Neurological condition such as Parkinson's disease, Multiple sclerosis, or stroke
- Inadequate written and spoken Arabic
- Unable to comply with the protocol such as the inability to attend therapy sessions or attend assessment appointments at the health center.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06133738
Start Date
December 1 2023
End Date
March 1 2024
Last Update
November 15 2023
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