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

NCT ID: NCT00678496

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

CBT Software

Intervention Type: 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.

2

Treatment as usual (n=12)

Group Type: OTHER

Treatment as usual

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Ultrasis Beating the Blues; Beating the Blues; Waiting list; Usual care; Treatment As Usual (TAU)

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Walton Centre NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Sheffield

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy L Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Glenys D Parry, PhD

Role: STUDY_CHAIR

University of Sheffield

Locations

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

EudraCT number: 2008-001039-37

Identifier Type: -

Identifier Source: secondary_id

MS Society: 845/06

Identifier Type: -

Identifier Source: secondary_id

112276

Identifier Type: -

Identifier Source: org_study_id