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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
1	CBT Software	CBT software delivered at home or in a primary care facility (n=12)
2	Treatment as usual	Treatment as usual (n=12)

Primary Outcome Measures

Name	Time	Method
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score	21 weeks	Beck Depression Inventory II-21 Item (BDI-II) - a self-report measure of severity of symptoms of depression. This is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63 (severe depression). The study reports change from baseline at 21 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29)	Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.	The Multiple Sclerosis Impact Scale (MSIS-29) is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). This study measured the change from baseline at 8 weeks and 21 weeks.