Effects of iCBT and Exercise for Chronic Knee Patients
Unknown statusNot applicableNCT06133738
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol
- Conditions
- Interventions
- Other: Standardized Exercise Program
- Other: Internet based Cognitive Behavioral Therapy
- Other: Educational Materials
- Sponsor
- University of Bahrain
- Start date
- 2023-12-01
- Primary completion
- 2024-03-01
- Sex
- All
- Age range
- from 45 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06133738