title: Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Knee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients' moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural therapy (CBT), a psychological therapy, is recommended by the National Institute for Health and Care Excellence for improving mood. However, evidence for the effectiveness of CBT before knee surgery in improving pain, mood, and quality of life following this surgery for people with knee OA is lacking.
  
  
  METHODS
  This is a multi-centre, mixed-methods feasibility randomised controlled trial to compare treatment as usual (TAU) plus a brief CBT-based intervention with a TAU-only control, for people with knee OA. We will recruit 50 patients with knee OA, listed for knee replacement surgery, with high levels of distress (assessed using a mood questionnaire), and who consent to take part. Participants will be randomly allocated to receive TAU plus intervention or TAU. Up to 10 sessions of CBT will be offered on an individual basis by a psychologist. The assessments and interventions will be completed before surgery. Repeat assessments at 4 and 6 months after randomisation will be sent and received by post. Two patient-partners will conduct feedback interviews with some participants to assess what aspects of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. Interviews will be audio-recorded, transcribed, and analysed using the framework approach. We will examine the feasibility and acceptability of patient-partners conducting the interviews by also interviewing the patient-partners.
  
  
  CONCLUSIONS
  Findings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT intervention in improving patient outcomes following knee surgery.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN80222865; Date: 19 June 2014.
authors.affiliation: Division of Rehabilitation & Ageing, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK. Roshan.dasNair@nottingham.ac.uk.|Department of Clinical Psychology & Neuropsychology, Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, UK. Roshan.dasNair@nottingham.ac.uk.
authors.forename: Roshan
authors.initials: R
authors.lastname: das Nair
authors.affiliation: Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Singleton Park, Swansea, SA2 8PP, UK. P.Anderson@swansea.ac.uk.
authors.forename: Pippa
authors.initials: P
authors.lastname: Anderson
authors.affiliation: Division of Rehabilitation & Ageing, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK. S.Clarke@nottingham.ac.uk.|Arthritis Research UK Pain Centre, Clinical Sciences Building, City Hospital, Nottingham, NG5 1 PB, UK. S.Clarke@nottingham.ac.uk.|Physical Health Clinical Psychology Services, Nottinghamshire Healthcare NHS Trust, Pain Management Suite, Clinic 9, King's Mill Hospital, Mansfield, NG17 4JL, UK. S.Clarke@nottingham.ac.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Clarke
authors.affiliation: School of Medicine, University of Nottingham, Room 2104, C Floor South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK. Paul.Leighton@nottingham.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Leighton
authors.affiliation: Division of Rehabilitation & Ageing, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK. Nadina.Lincoln@nottingham.ac.uk.|Arthritis Research UK Pain Centre, Clinical Sciences Building, City Hospital, Nottingham, NG5 1 PB, UK. Nadina.Lincoln@nottingham.ac.uk.
authors.forename: Nadina B
authors.initials: NB
authors.lastname: Lincoln
authors.affiliation: Division of Rehabilitation & Ageing, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK. Jacqueline.Mhizha-Murira@nottingham.ac.uk.
authors.forename: Jacqueline R
authors.initials: JR
authors.lastname: Mhizha-Murira
authors.affiliation: Arthritis Research UK Pain Centre, Clinical Sciences Building, City Hospital, Nottingham, NG5 1 PB, UK. B.Scammell@nottingham.ac.uk.
authors.forename: Brigitte E
authors.initials: BE
authors.lastname: Scammell
authors.affiliation: Arthritis Research UK Pain Centre, Clinical Sciences Building, City Hospital, Nottingham, NG5 1 PB, UK. David.Walsh@nottingham.ac.uk.|Academic Rheumatology, University of Nottingham, Clinical Sciences Building, City Hospital, Nottingham, NG5 1 PB, UK. David.Walsh@nottingham.ac.uk.
authors.forename: David A
authors.initials: DA
authors.lastname: Walsh
mesh_terms: D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003627:Data Interpretation, Statistical; D006801:Humans; D007258:Informed Consent; D020370:Osteoarthritis, Knee / Q000628:therapy*; D010358:Patient Participation; D036301:Qualitative Research
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