Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis (CoSMoS)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Multiple Sclerosis
• Intervention / Treatment: Other: CBT Software; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 3TG
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CBT software delivered at home or in a primary care facility (n=12)	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.; Other Names: Ultrasis Beating the Blues; Beating the Blues
Other: 2; 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.; Other Names: Usual care; Treatment As Usual (TAU); Waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.

Collaborators and Investigators

• Sponsor: University of Sheffield
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; Walton Centre NHS Foundation Trust
• Investigators: Principal Investigator: Cindy L Cooper, PhD, University of Sheffield; Study Chair: Glenys D Parry, PhD, University of Sheffield

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): January 31, 2010
• Study Completion (Actual): January 31, 2010

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Multiple Sclerosis; Cognitive Therapy; CCBT; Therapy, Computer-Assisted; CBT-software; Computerised Cognitive Behavioural Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Depression; Depressive Disorder; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 112276; EudraCT number: 2008-001039-37; MS Society: 845/06