Effects of iCBT and Exercise for Chronic Knee Patients

University of Bahrain

Status: Not yet enrolling

Conditions: Chronic Knee Pain

Treatments: Other: Educational Materials; Other: Standardized Exercise Program; Other: Internet based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06133738

iCBTExCKP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Standardized Exercise Program

Other: Internet based Cognitive Behavioral Therapy

Other: Educational Materials

Control Group

Active Comparator group

Description:

Participants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions.

Treatment:

Other: Standardized Exercise Program

Other: Educational Materials