Cognitive Behavioural Therapy Software for the Treatment of Depression
Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- CBT Software
- Treatment as usual
Results by group
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score
21 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| CCBT | -5.33 units on a scale | 4.7 (Standard Deviation) | 10 |
| Treatment as Usual | -1.17 units on a scale | 8.1 (Standard Deviation) | 12 |
| CCBT | -2.00 units on a scale | 5.1 (Standard Deviation) | 10 |
| Treatment as Usual | 0.25 units on a scale | 8.8 (Standard Deviation) | 12 |
CCBT
Treatment as Usual
CCBT
Treatment as Usual
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| CCBT Using 'Beating the Blues'® (Ultrasis Ltd) | 8 | 1 (12.5%) | 0 |
| Treatment as Usual | 10 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score
21 weeks
Mood and sleepChange in self-reported symptoms of depression: the difference between mean change scores of CCBT and standard care, as measured on the Beck Depression Inventory - Second Edition (BDI-II) 21-item self report instrument. Recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter.
Mood and sleep
Other measures (2)
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.
Quality of life (reported by participants)The following will be recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter: 1. Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9) 2. Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7) 3. Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29) 4. Generic health
Mood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Oct 2008
Main results due
Jan 2010
Finished
Jan 2010
Results posted
Mar 2021