The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- 40-m Fast-Paced Walk Test (40-m FPWT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Eligible patients will be randomly allocated to either the study group or the control group (1:1). Participants will be blinded to their group assignment.
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
40-m Fast-Paced Walk Test (40-m FPWT)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Patient Health Questionnaire (PHQ-2)(8 weeks)
- Health-Related Quality of Life-Short Form-12 (SF-12)(8 weeks)
- Psychological Distress (Kessler 6)(8 weeks)
- Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS- PS)(8 weeks)
- Maximum Isometric Muscle Strength(8 weeks)
研究者
Amal Alaradi
Senior Physiotherapist
University of Bahrain