Cognitive behavioural therapy software for the treatment of depression in people with multiple sclerosis

Not Applicable

Completed

• Conditions: Mental and Behavioural Disorders; Depression in people with multiple sclerosis (MS); Depressive episodes in MS sufferers

• Registration Number: ISRCTN81846800
• Lead Sponsor: niversity of Sheffield (UK)

Brief Summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22168507

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-06
• Study Completion: 2010-01-31
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Aged 18+, both males and females
2. Diagnosis of MS confirmed by neurologist
3. Beck Depression Inventory-II score of at least 14 on two consecutive occasions
4. Not currently or within past three months receiving any treatment from a psychologist, psychotherapist or psychiatrist
5. Willingness to be randomised to CCBT, at home or primary care facility or treatment as usual

Exclusion Criteria

1. Unable to read or write English
2. Beck Depression Inventory score of at least 29 on two consecutive occasions
3. Active suicidal ideas
4. Current or life-time diagnosis of any of the following:
4.1. Psychosis
4.2. Organic mental disorder
4.3. Alcohol or drug dependency
5. Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above
6. Unable to use the CCBT package due to physical disability
7. 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. Recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter.

Secondary Outcome Measures

Name	Time	Method
<br> The following will be recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter:<br> 1. Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9)<br> 2. Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7)<br> 3. Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29)<br> 4. Generic health-related quality of life, measured on the 36-item Short Form health survey (SF-36)<br>