Clinical trial NCT00678496: Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis
Official title: Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Multiple Sclerosis
Keywords: CBT-software
Computerised Cognitive Behavioural Therapy
CCBT
Cognitive Therapy
Therapy, Computer-Assisted
Depression
Multiple Sclerosis
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Walton Centre NHS Foundation Trust
First posted: 2008-05-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Self-reported Symptoms of Depression, as Measured by Total BDI-II Score
timeFrame: 21 weeks
Secondary outcomes:
measure: Change in Disease-specific Quality of Life, Measured on the Multiple Sclerosis Impact Scale-29 Item (MSIS-29)
timeFrame: Eight weeks or on completion of CCBT (whichever is later), and three months thereafter.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Cindy L Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sheffield
name: Glenys D Parry, PhD
role: STUDY_CHAIR
References: