Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis (CoSMoS)

University of Sheffield

Status

Completed

Conditions

Multiple Sclerosis

Depression

Treatments

Other: Treatment as usual

Other: CBT Software

Study type

Interventional

Funder types

Other

Identifiers

NCT00678496

EudraCT number: 2008-001039-37

112276

MS Society: 845/06

Details and patient eligibility

About

Guidance issued by the United Kingdom (UK) National Institute for Health and Clinical Excellence (NICE) recommends the use of computerised cognitive behavioural therapy (CCBT) 'Beating the Blues' (BtB) in treatment of depression. However CCBT has not been designed specifically for use by people with Multiple Sclerosis (MS) and may not be effective or appropriate for use by people with physical disabilities or cognitive symptoms. There would therefore be value in conducting a trial of the effectiveness of CCBT for depression in people with MS. The aim of this pilot study is to test the feasibility of a randomised control trial (RCT) of CCBT for depression in people with MS. The objective is to undertake a pilot RCT of comparison of CCBT with usual care including 3 month follow up to identify a realistic patient recruitment rate and provide reliable estimates of other parameters needed for designing a definitive RCT including the sample size. Other outcomes to be measured include estimates of the effect on depression and quality of life. Participants will be assessed as experiencing clinical levels of depression and be recruited from two participating MS Centres. The outcomes of the study will be (1) preliminary indication of the impact of CCBT on depression in MS; and, (2) a well researched protocol for a definitive RCT of the effectiveness of CCBT in treating depression in people with MS.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18+
Diagnosis of MS confirmed by neurologist
Beck Depression Inventory-II score of at least 14 on two consecutive occasions
Not currently or within past three months receiving any treatment from a psychologist, psychotherapist or psychiatrist.
Willingness to be randomised to CCBT, at home or primary care facility or treatment as usual.

Exclusion criteria

Unable to read or write English
Beck Depression Inventory score of at least 29 on two consecutive occasions
Active suicidal ideas
Current or life-time diagnosis of any of the following:
- psychosis
- organic mental disorder;
- alcohol or drug dependency
Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above
Unable to use the CCBT package due to physical disability
Unable to use the CCBT package due to cognitive symptoms (mini-mental state of 20 below or if, in the opinion of the study psychologist, the individual would be unlikely to benefit from CCBT)