Depression, Multiple Sclerosis
Conditions
Keywords
CBT-software, Computerised Cognitive Behavioural Therapy, CCBT, Cognitive Therapy, Therapy, Computer-Assisted, Depression, Multiple Sclerosis
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.
Interventions
OTHERCBT Software
Beating the Blues is a CBT-based software package for patients with anxiety and/or depression. The CBT strategies used include: identifying thinking errors, challenging automatic negative thoughts, modifying attributional style and identifying core beliefs. The behavioural techniques used include graded exposure, sleep management, problem solving, task breakdown and activity scheduling. The programme consists of a 15 minute Introduction to Therapy video plus eight computer-interactive sessions of approximately 50 minutes each in duration. Each session consists of a mix of cognitive and behavioural strategies, which are customised to the patient's individual problems. The eight computer sessions are designed to be taken weekly, or thereabouts, and each session builds on the previous one.
OTHERTreatment as usual
Participants in the usual care arm are asked to refrain from accessing psychological services during their participation in the study, but may be prescribed anti-depressants or referred to a counsellor by their general practitioner.
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Walton Centre NHS Foundation Trust
University of Sheffield
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 5extremely. 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. |
Countries
United Kingdom
Participant flow
Recruitment details
We reached our recruitment target on 30 July 2009 (in 281 days; 2.6 participants/month) after adding a second centre (The Walton Centre National Health Service (NHS) Foundation Trust, Liverpool).
Pre-assignment details
Participants were invited to take part via clinic mailouts. Responders were excluded if their Beck Depression Inventory score was too high, too low, if they were under the care of a psychiatrist, or were not resident within the boundaries of participating primary care trusts (UK NHS commissioning bodies 2001-2013), or if they refused consent.
Participants by arm
| Arm | Count |
|---|---|
| CBT Software CBT using 'Beating the Blues'® software (Ultrasis Ltd). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly. Each session consists of a mix of cognitive and behavioural strategies, which the user customises to their individual problems. | 12 |
| Treatment as Usual Treatment as usual. The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | CBT Software | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 7.7 | 42 years STANDARD_DEVIATION 7 | 45 years STANDARD_DEVIATION 7.9 |
| BDI total score (0 weeks) | 21 units on a scale STANDARD_DEVIATION 4 | 23 units on a scale STANDARD_DEVIATION 5.2 | 22 units on a scale STANDARD_DEVIATION 4.7 |
| Expanded Disability Status Scale (EDSS) score | 4.8 units on a scale STANDARD_DEVIATION 1.7 | 3.6 units on a scale STANDARD_DEVIATION 1.8 | 4.2 units on a scale STANDARD_DEVIATION 1.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 1 / 8 | 0 / 10 |
Outcome results
Primary
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score
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.
Time frame: 21 weeks
Population: There may be different numbers of patients analysed at 8 weeks and 21 weeks, as patients may have dropped out, or there may have been missing information at 8 weeks meaning that the score could not be calculated, but the patient was still followed up at 21 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CCBT | Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score | 8 weeks | -5.33 units on a scale | Standard Deviation 4.7 |
| CCBT | Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score | 21 weeks | -2.00 units on a scale | Standard Deviation 5.1 |
| Treatment as Usual | Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score | 8 weeks | -1.17 units on a scale | Standard Deviation 8.1 |
| Treatment as Usual | Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score | 21 weeks | 0.25 units on a scale | Standard Deviation 8.8 |
Secondary
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29)
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 5extremely. 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.
Time frame: Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.
Population: There may be different numbers of patients analysed at 8 weeks and 21 weeks, as patients may have dropped out, or there may have been missing information at 8 weeks meaning that the score could not be calculated, but the patient was still followed up at 21 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CCBT | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Psychological - 8 weeks | -5.88 units on a scale | Standard Deviation 9.5 |
| CCBT | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Psychological - 21 weeks | -4.33 units on a scale | Standard Deviation 8 |
| CCBT | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Physical - 8 weeks | -7.00 units on a scale | Standard Deviation 12.9 |
| CCBT | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Physical - 21 weeks | -7.89 units on a scale | Standard Deviation 12.3 |
| Treatment as Usual | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Physical - 21 weeks | -2.20 units on a scale | Standard Deviation 11 |
| Treatment as Usual | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Psychological - 8 weeks | 0.18 units on a scale | Standard Deviation 5.1 |
| Treatment as Usual | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Physical - 8 weeks | -1.82 units on a scale | Standard Deviation 7.8 |
| Treatment as Usual | Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29) | Psychological - 21 weeks | -2.60 units on a scale | Standard Deviation 5.6 |