Title: Assessing surgical outcomes for osteoarthritis of the knee following short-term psychological therapy: A single blind feasibility randomised controlled trial
Funder: Department of Health (England)

Abstract: Background: Mood difficulties have been documented in patients with osteoarthritis (OA; Theis et al., 2007). There is also an association between mood and pain (Dekker et al., 1992) and surgical outcomes (Mavros et al., 2011). The use of cognitive behavioural therapy (CBT) in improving mood outcomes is established (NICE, 2009). However, a recent systematic review (Yohannes & Caton, 2010) found only two studies which investigated the effectiveness of CBT in people with OA. The results from these studies were equivocal, the interventions mainly focussed on coping rather than mood, and the impact on outcomes of joint replacement was not addressed. The proposed feasibility study will help develop a protocol to assess the effectiveness of CBT-based intervention in improving outcomes after knee replacement surgery for people with OA, from patient and provider perspectives. The aims are to determine: 1. The acceptability of the intervention based on Cognitive Behavioural Therapy (CBT), inclusion/exclusion criteria, baseline and outcome measures, audio recording of sessions, and randomisation protocol from a patients’ perspective. 2. Rates of recruitment and retaining participants through the trial. 3. Sample-size needed for a fully powered randomised trial. 4. What the ‘treatment as usual’ (TAU) control group received, in order to operationally define this term. 5. How the intervention was delivered to inform the development of a treatment manual, by time-sampling the content of therapy. 6. Utility of patient-partner led interview data collection and analysis, and the support required for this. 7. Feasibility of collecting data for an economic evaluation using a service-use questionnaire. 8. Feasibility of conducting the interventions within existing patient pathways, without affecting usual care, by recording attendance rates. Plan of investigation The study will recruit participants with knee OA with psychological distress (n=50), and randomly allocate them to one of two groups: CBT-based intervention, or a TAU control. Baseline questionnaires assessing mood, pain, quality of life, and functional ability, will be conducted by a Research Associate (RA). For those in the CBT group, up to ten sessions will be offered individually by a clinical psychologist. These sessions will be audio-recorded to determine the content and delivery of the therapy. The control group will receive usual care (no psychological interventions, based on our awareness of local services). The RA, blind to group allocation, will assess the outcomes at 4 and 6 months after randomisation, with the same measures used at baseline. Audio-recorded feedback interviews will be conducted by patient-partners (PPs) and the RA with a selected sample from each group. The PPs will receive training and support to do this. Data will be transcribed and thematically analysed. The PPs will also be interviewed to assess the success and challenges in conducting the feedback interviews. These interviews will also be thematically analysed. The data obtained will enable sample size calculation for a definitive study and indicate the feasibility of conducting a definitive study using the methods proposed. Potential benefits to patients and NHS: The feasibility study will enable us to plan for a Phase III RCT to evaluate the effectiveness of a CBT-based pre-surgical intervention to improve post-surgical outcomes, including reducing inpatient stays and readmissions. If the intervention is effective, patients may experience reduced distress, more confidence in carrying out daily activities and improved quality of life. Patients with more control over their pain will place less reliance on health services and this will reduce the burden on the NHS. Furthermore, if patients can manage their pain using psychological methods, there may be less reliance on pain medication, less exposure to risk from medications, and better engagement with rehabilitation. This has beneficial cost-implications for both patients and the NHS.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.4 SURGERY
Health categories: MUSCULOSKELETAL