The University of Sheffield
Clinical Trials Research Unit

CoSMoS:  CBT Software for the treatment of depression in people with MS

CoSMoS logo

Principal Investigator:  Dr Cindy Cooper

Funding: MS Society Symptom Relief Research Initiative

Collaborators:
Sheffield Teaching Hospitals NHS Trust
The Walton Centre for Neurology & Neurosurgery NHS Trust

The University of Sheffield URMS Number: 112276

ClinicalTrials.gov Identifier: NCT00678496

Status: complete

Publications

  1. Hind D, O'Cathain A, Cooper CL, Parry GD, Isaac CL, Rose A, Martin L, Sharrack B.  The acceptability of computerised cognitive behavioural therapy for the treatment of depression in people with chronic physical disease: a qualitative study of people with multiple sclerosis.  Psychology & Health 2010; 25(6): 699-712.
  2. Cindy L Cooper, Daniel Hind, Glenys D Parry, Claire L Isaac, Munyaradzi Dimairo, Alicia O'Cathain, Anita Rose, Jennifer V Freeman, Leonie Martin, Eva C Kaltenthaler, Anna Thake and Basil Sharrack.  Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial. Trials 2011; 12:259.

Aims

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) software 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.

Lay summary

Depression is a very common symptom in MS and is associated with poorer quality of life. MS-appropriate computerised CBT could significantly improve quality of life and personal effectiveness whilst reducing mental distress for people with MS. However CCBT has not been designed specifically for use by people with MS and may not be effective or appropriate for use by people with physical disabilities or cognitive symptoms.

The aim was to carry out pilot work to study the feasibility of undertaking a randomised control trial (RCT) of the effectiveness of computerised CBT for depression in people with Multiple Sclerosis (MS).

The study objectives were:

  1. to explore the acceptability and appropriateness of the recommended commercially available package, Beating the Blues, and a second freely available product, MoodGym, for people with MS.
  2. for the software companies to develop the products in accordance with the findings and
  3. to test the feasibility of an RCT protocol to compare usual care with use of CCBT in depression for people with MS, looking particularly at those aspects which often cause trials to fail, using one of the two packages above.

The acceptability and appropriateness of CCBT for people with MS was explored through interviewing 20 people with MS, after they had been recruited to the study and given access to one of two CCBT software packages, about their views of the experience. The findings and recommendations for improvements were reported to the producers of the packages. One of these, Ultrasis has agreed to develop its product – Beating the Blues – in accordance with our recommendations.

A detailed protocol for a pilot RCT was developed based on lessons from the first stage and a pilot trial of the effectiveness of CCBT in MS was undertaken. Twenty four participants with mild or moderate clinical depression were recruited to the study from two MS centres and randomised to either usual care or CCBT. The outcomes of the pilot trial included information required to design a full trial including recommendations for: the sample population; sample size; recruitment strategies; outcome measures and options for delivery of CCBT. This study has demonstrated that a full trial of the clinical effectiveness of CCBT for depression in MS may be difficult to undertake because of issues related to recruitment rates and it may be better to widen the target population to include people with other neurological conditions.

The Team

Dr Cindy Cooper, Chief Investigator/Reader/Director of the Clinical Trials Research Unit, The University of Sheffield

Dr Daniel Hind, Study Manager/Research Fellow/Assistant Director of the Clinical Trials Research Unit, The University of Sheffield

Karen Beck, Administrator, The University of Sheffield

Munya Dimairo, Medical Statistician, The University of Sheffield

Dr Jenny Freeman, Senior Lecturer in Medical Statistics, The University of Sheffield

Dr Claire L Isaac, Clinical Psychologist, The University of Sheffield

Dr Eva Kaltenthaler, Reader in Health Technology Assessment/Managing Director of ScHARR-TAG, The University of Sheffield

Leonie Martin, Patient & Public Involvement representative

Professor Alicia O'Cathain, Professor of Health Services Research, The University of Sheffield

Professor Glenys Parry, Professor of Applied Psychological Therapies, The University of Sheffield

Dr Anita Rose, Clinical Psychologist, The Walton Centre

Dr Basil Sharrack, Consultant Neurologist, Sheffield Teaching Hospitals NHS Foundation Trust

Anna Thake, Research Assistant, The University of Sheffield

Contact:

Principal Investigator: Cindy Cooper
Email c.l.cooper@sheffield.ac.uk
Telephone +44 (0) 114 222 0743

Study Manager: Daniel Hind
Email d.hind@sheffield.ac.uk
Telephone +44 (0) 114 222 0707

Administrator: Karen Beck
Email karen.beck@sheffield.ac.uk
Telephone +44 (0) 114 222 0795