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Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis (CoSMoS)
This study is currently recruiting participants.
Verified by University of Sheffield, October 2008
Sponsors and Collaborators: University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
Walton Centre for Neurology & Neurosurgery NHS Trust
Information provided by: University of Sheffield
ClinicalTrials.gov Identifier: NCT00678496
  Purpose

Guidance issued by the 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.


Condition Intervention Phase
Depression
Multiple Sclerosis
 Other: CBT Software
Other: Treatment as usual
 Phase II

MedlinePlus related topics: Anxiety Depression Multiple Sclerosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study

Further study details as provided by University of Sheffield:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9) [ Time Frame: Baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter. ] [ Designated as safety issue: No ]
  • Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7) [ Time Frame: Baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter. ] [ Designated as safety issue: No ]
  • Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29) [ Time Frame: Baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter. ] [ Designated as safety issue: No ]
  • Generic health-related quality of life, measured on the Short Form-36 item (SF-36) [ Time Frame: Baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
CBT software delivered in a primary care facility (n=6)
Other: CBT 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.
2: Experimental
CBT delivered at home (n=6)
Other: CBT 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.
3
Treatment as usual (n=12)
Other: Treatment 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678496

Contacts
Contact: Daniel Hind, PhD +44 (0) 114 222 0707 d.hind@sheffield.ac.uk
Contact: Karen Beck, BSc +44 (0) 114 222 0795 karen.beck@sheffield.ac.uk

Locations
United Kingdom, South Yorkshire
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 3TG
Contact: Basil Sharrack, MD, PhD     +44 (0) 114 271 3608     basil.sharrack@sth.nhs.uk    
Contact: Vicki Gill     +44 (0) 114 271 3608     Vicki.Gill@sth.nhs.uk    
Principal Investigator: Basil Sharrack, MD, PhD            
Sponsors and Collaborators
University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
Walton Centre for Neurology & Neurosurgery NHS Trust
Investigators
Principal Investigator: Cindy L Cooper, PhD University of Sheffield
Study Chair: Glenys D Parry, PhD University of Sheffield
  More Information

Responsible Party: The University of Sheffield ( Dr Cindy Cooper )
Study ID Numbers: 112276, EudraCT number: 2008-001039-37, MS Society: 845/06
Study First Received: May 14, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00678496  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Sheffield:
CBT-software
Computerised Cognitive Behavioural Therapy
CCBT
Cognitive Therapy
 Therapy, Computer-Assisted
Depression
Multiple Sclerosis

Study placed in the following topic categories:
Autoimmune Diseases
Depression
Multiple Sclerosis
Demyelinating Diseases
Mental Disorders
Mood Disorders
 Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Depressive Disorder
Autoimmune Diseases of the Nervous System
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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