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

NCT00678496 | Completed Results

• 3 other identifiers: 112276EudraCT number: 2008-001039-37MS Society: 845/06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Multiple Sclerosis

Keywords

CBT-software; Computerised Cognitive Behavioural Therapy; CCBT; Cognitive Therapy; Therapy, Computer-Assisted; Depression; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

CBT software delivered at home or in a primary care facility (n=12)

Other: CBT Software

2

OTHER

Treatment as usual (n=12)

Other: Treatment as usual

Interventions

CBT Software OTHER

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.

Also known as: Ultrasis Beating the Blues, Beating the Blues

1

Treatment as usual OTHER

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.

Also known as: Waiting list, Usual care, Treatment As Usual (TAU)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sheffield: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Walton Centre NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 3TG, United Kingdom

Location

MeSH Terms

Conditions

Depression; Multiple Sclerosis

Interventions

Therapeutics; Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Daniel Hind, Assistant Director, Sheffield CTRU
• Organization: University of Sheffield

d.hind@sheffield.ac.uk

+441142220707

Study Officials

• Cindy L Cooper, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Glenys D Parry, PhD

  University of Sheffield

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 15, 2008
• Study Start: October 1, 2008
• Primary Completion: January 31, 2010
• Study Completion: January 31, 2010
• Last Updated: March 17, 2021
• Results First Posted: March 17, 2021

Record last verified: 2020-09

Locations

GB (1)