N/A
Completed N=24
Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00678496 ↗Enrolled (actual)
24
Serious AEs
5.6%
Results posted
Mar 2021
Primary outcomePrimary: Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score — -5.33; -1.17; -2.00; 0.25 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score |
-5.33; -1.17; -2.00; 0.25 | — |
| SECONDARY Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) |
-5.88; 0.18; -4.33; -2.60; -7.00; -1.82 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00678496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.