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

Computerised cognitive behavioural therapy for treatment of depression in multiple sclerosis (MS) (CoSMoS): Clinical trial pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81846800

Enrollment

Registered

2008-10-06

Start date

2008-09-01

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants are randomly allocated to one of two groups. Intervention group: CBT software (Ultrasis - Beating the Blues®) Control group: Treatment as usual

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026