Cognitive behavioural therapy software for the treatment of depression in people with multiple sclerosis
| ISRCTN | ISRCTN81846800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81846800 |
| ClinicalTrials.gov number | NCT00678496 |
| Secondary identifying numbers | 112276 |
- Submission date
- 09/05/2008
- Registration date
- 06/10/2008
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing problems with movement, attention, concentration and memory. It has been found that depression (extreme low mood) is very common amongst MS sufferers, and can greatly reduce quality of life. Cognitive behavioural therapy (CBT) is a type of talking therapy which helps people to change the way they think and behave. In recent years, an online version of CBT has been developed (computerized cognitive behavioural therapy, cCBT) which allows more people to get access to the treatment that they could not have received otherwise. It is not known whether cCBT would be an effective treatment for depressed MS patients as it is not specifically designed for these patients. The aim of this study is to test the effectiveness of cCBT in treating depression in patients with MS.
Who can participate?
Adults with MS who are showing signs of depression.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive their usual treatment, with no access to the cCBT programme. Those in the second group are given access to the cCBT programme “Beating the Blues”, a computer-interactive programme for the treatment of anxiety and depression. The programme uses a series of eight interactive sessions which help patients to understand the causes and symptoms of anxiety and depression and to work on their specific problems (“thinking” and “doing” strategies). The eight sessions are designed to be taken weekly, and each session builds on the previous one. At the start of the study and then again after 8 weeks and 3 months, participants in both groups complete a number of questionnaires in order to find out if there have been any changes to their mood and quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Clinical Trials Research Unit, University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
September 2009 to January 2010
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Dr Cindy Cooper
c.l.cooper@sheffield.ac.uk
Contact information
Scientific
Clinical Trials Research Unit
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 5454 |
|---|---|
| c.l.cooper@sheffield.ac.uk |
Study information
| Study design | Parallel group randomised pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information sheet can be found at: http://www.shef.ac.uk/content/1/c6/07/73/06/Participant%20Information%20Sheet%20v1.pdf |
| Scientific title | Computerised cognitive behavioural therapy for treatment of depression in multiple sclerosis (MS) (CoSMoS): Clinical trial pilot study |
| Study acronym | CoSMoS |
| Study hypothesis | 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. |
| Ethics approval(s) | Northern and Yorkshire NHS Research Ethics Committee, 05/09/2008, ref: 08/H0903/41 |
| Condition | Depression in people with multiple sclerosis (MS) |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: CBT software (Ultrasis - Beating the Blues®) Control group: Treatment as usual Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems. The programme consists of two interwoven strands: the cognitive (or "thinking") strategies and the behavioural (or "doing") strategies. Patients are helped to understand the causes and symptoms of anxiety and depression and to work on their specific problems. 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. Patients can repeat sessions if they wish. The computer keeps track of which session they have reached. Total duration of interventions: 8 weeks Total duration of follow-up: 3 months |
| Intervention type | Other |
| Primary outcome measure | Change 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. |
| Secondary outcome measures | 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-related quality of life, measured on the 36-item Short Form health survey (SF-36) |
| Overall study start date | 01/09/2008 |
| Overall study end date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Participant inclusion criteria | 1. Aged 18+, both males and females 2. Diagnosis of MS confirmed by neurologist 3. Beck Depression Inventory-II score of at least 14 on two consecutive occasions 4. Not currently or within past three months receiving any treatment from a psychologist, psychotherapist or psychiatrist 5. Willingness to be randomised to CCBT, at home or primary care facility or treatment as usual |
| Participant exclusion criteria | 1. Unable to read or write English 2. Beck Depression Inventory score of at least 29 on two consecutive occasions 3. Active suicidal ideas 4. Current or life-time diagnosis of any of the following: 4.1. Psychosis 4.2. Organic mental disorder 4.3. Alcohol or drug dependency 5. Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above 6. Unable to use the CCBT package due to physical disability 7. 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) |
| Recruitment start date | 01/09/2008 |
| Recruitment end date | 31/01/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
Sponsor information
University/education
Research Office
New Spring House
231 Glossop Road
S10 2GW
England
United Kingdom
| Phone | +44 (0)114 222 1469 |
|---|---|
| r.j.hudson@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk/researchservices/ro.html |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2010 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/12/2011 | Yes | No |
Editorial Notes
16/03/2020: Internal review.
10/09/2019: ClinicalTrials.gov number added.
02/02/2016: Plain English summary added.
