The CoSMoS Pilot Trial C BT S oftware for the treatment of depression in people with M ultiple S clerosis

1. Outcomes of the study The outcomes of the study will be (1) indication of the impact of CCBT on depression in multiple sclerosis (2) a well researched protocol for a definitive RCT of the effectiveness of CCBT in treating depression in people with multiple sclerosis and (3) a computerised CBT software product developed in response to the views of people with multiple sclerosis. Quantitative component A pilot trial of the effectiveness of CCBT in multiple sclerosis will be undertaken. Either Beating The Blues or MoodGym, whichever is most acceptable to people with multiple sclerosis, will be compared with standard care for mild or moderate depression. Twenty-four people will be consented into the study and will be randomised to usual care or CCBT. Participants in the usual care arm will be offered CCBT at the end of the study. Those in the CCBT arm will be further randomised to undertake the sessions at home or in a community facility. The CoSMoS Pilot TrialCBT Software for the treatment of depression in people with Multiple Sclerosis • Aims • To explore the acceptability and appropriateness of computerised cognitive behavioural therapy (CCBT) packages for the treatment of depression in people with MS; and, • To test the feasibility of undertaking a randomised controlled trial (RCT) to compare usual care with use of CCBT in depression for people with MS. Qualitative component Twenty people with multiple sclerosis and mild or moderate depression will be consented and allocated to one of two computerised cognitive behavioural therapy packages: Beating The Blues or MoodGym. Views on the acceptability and appropriateness of the treatment will be collected during two semi-structured interviews and from weekly evaluation sheets. The transcribed texts will form the basis for a framework analysis, which is suitable for policy research. Feedback will be provided to the software manufacturers who will be able to make their software more appropriate for people with multiple sclerosis. Background Half of all people with multiple sclerosis experience major depression during the course of their lifetime. Cognitive Behavioural Therapy (CBT) is a talking therapy which has been shown to be effective for treatment of depression, generally and in multiple sclerosis.[1] However, access to CBT is very limited, as there are too few therapists and many patients are reluctant to enter face-to-face therapy.[2,3] RCT evidence demonstrates that a particular computerised CBT (CCBT) package – Beating The Blues - is more effective for the treatment of depression than standard (drug) treatment,[4,5] and is recommended for use in the NHS.[6] However CCBT has not been designed specifically for use by, or evaluated in people with multiple sclerosis and may not be appropriate or effective for use by people with physical disabilities and cognitive symptoms. The Team The study is led by researchers from the University of Sheffield and the team includes people with personal experience of MS, a consultant neurologist and clinical psychologists. Contact: Principal Investigator: Cindy Cooper (c.l.cooper@sheffield.ac.uk) Study Manager: Daniel Hind (d.hind@sheffield.ac.uk)  0114 222 0707 Administrator: Karen Beck (karen.beck@sheffield.ac.uk)  0114 222 0795 Trial Management Group: Alicia O’Cathain, Anita Rose, Claire Isaac. Patient Representatives: Leonie Martin, Ray Stonehill. References 1. Siegert RJ, 2005. Depression in multiple sclerosis: a review. Journal of Neurology Neurosurgery and Psychiatry,76:469-79. 2. House of Commons Select Committee on Health, 2000. Fourth Report on the Provision of Mental Health Services. HM Stationary Office: London. 3. Shapiro DA, 2003. Geographical Inequity in the Availability of Cognitive Behavioural Therapy in England and Wales. Behavioural & Cognitive Psychotherapy, 31:185-92. 4. Proudfoot, J. 2004. Clinical efficacy of computerised cognitive behavioural therapy for anxiety and depression in primary care: randomised control trial. British Journal of Psychiatry, 185:46-54. 5. Kaltenthaler E, Brazier J, De Nigris E, Tumur I, Ferriter M, Beverley C, Parry G, Rooney G, Sutcliffe P, 2006. Computerised cognitive behaviour therapy for depression and anxiety update: a systematic review and economic evaluation. Health Technology Assessment, 10(33):1-168. 6. National Institute for Health and Clinical Excellence, 2006. Computerised cognitive behaviour therapy for depression and anxiety Review of Technology Appraisal 51. NICE: London.