DepressionCoSMoSNCT00678496
Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis
A study testing CBT Software and Treatment as usual in people with Depression and Multiple Sclerosis, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Multiple Sclerosis
- What is being tested?
- CBT Software and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2008to 31 Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 3TG
About this study
Official title: Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study
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.
- Conditions
- Depression, Multiple Sclerosis
- Being tested
- CBT Software, Treatment as usual
- Keywords
- CBT-software, Computerised Cognitive Behavioural Therapy, CCBT, Cognitive Therapy, Therapy, Computer-Assisted, Depression, Multiple Sclerosis
- Medical subject headings
- Depression, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT SoftwareOther
Also called Ultrasis Beating the Blues, Beating the Blues
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.
Treatment as usualOther
Also called Waiting list, Usual care, Treatment As Usual (TAU)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CBT software delivered at home or in a primary care facility (n=12) Receives: Other: CBT Software |
| 2 | Other | Treatment as usual (n=12) Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 weeks
Secondary outcomes (1)
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 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.
Measured: Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startOct 2008
- Primary completion31 Jan 2010
- Study completion31 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Walton Centre NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Cindy L Cooper, PhD, Principal investigator, University of SheffieldGlenys D Parry, PhD, Study chair, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678496
- Sponsor's protocol ID
- 112276
- Other IDs
- EudraCT number: 2008-001039-37, MS Society: 845/06
- Acronym
- CoSMoS
- Status last verified
- Sep 2020
- First submitted
- 14 May 2008
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study
- ClinicalTrials.gov ID
- NCT00678496
- Acronym / sponsor ID
- CoSMoS / 112276
- Conditions
- Depression, Multiple Sclerosis
- Keywords
- CBT-software, Computerised Cognitive Behavioural Therapy, CCBT, Cognitive Therapy, Therapy, Computer-Assisted, Depression, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Walton Centre NHS Foundation Trust
- Study start
- Oct 2008 (actual)
- Primary completion
- 31 Jan 2010 (actual)
- Study completion
- 31 Jan 2010 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 17 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: CBT SoftwareCBT software delivered at home or in a primary care facility (n=12) |
| 2 | Other | Other: Treatment as usualTreatment as usual (n=12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT SoftwareAlso: Ultrasis Beating the Blues, Beating the BluesBeating 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. | Other | 1 |
| Treatment as usualAlso: Waiting list, Usual care, Treatment As Usual (TAU)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. | Other | 2 |
Primary outcome
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score
Time frame: 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.
1 secondary outcome
Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29)
Time frame: Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L Cooper, PhD principal investigator
University of Sheffield
Glenys D Parry, PhD study chair
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT Software and Treatment as usual in people with Depression and Multiple Sclerosis, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.