title: Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial.
abstract: BACKGROUND
  People with multiple sclerosis (MS) are at high risk of depression. We undertook a pilot trial of computerised cognitive behavioural therapy (CCBT) for the treatment of depression in people with MS to test the feasibility of undertaking a full trial.
  
  
  METHODS
  Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening questionnaires at two UK centres and randomised to CCBT or usual care. Clinical outcomes included the Beck Depression Inventory (BDI-II) and Multiple Sclerosis Impact Scale (MSIS-29) at baseline, 8 and 21 weeks. Feasibility outcomes included: recruitment rate; reasons for refusal, withdrawal and dropout; feasibility and acceptability of the proposed outcome measures; sample size estimation and variation in and preferences for service delivery.
  
  
  RESULTS
  Twenty-four participants were recruited. The recruitment rate, calculated as the proportion of those invited to fill in a screening questionnaire who were consented into the trial, was 4.1%. Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar. Of the 12 patients in the CCBT arm, 9 (75%) completed at least four, and 6 completed all 8 CCBT sessions. For completers, the median time (IQR) to complete all eight CCBT sessions was 15 (13 to 20) weeks. Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS. The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns. The estimated sample size for a full trial is between 180 and 390 participants. NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home, with no one expressing a preference for use of CCBT in an alternative location.
  
  
  CONCLUSIONS
  A definitive trial, with a recruitment window of one year, would require the participation of around 13 MS centres. This number of centres could be reduced by expanding the eligibility criteria to include either other neurological conditions or people with more severe depression. The MSIS-29 should be used as a patient-important outcome measurement.
  
  
  BACKGROUND
  ISRCTN: ISRCTN81846800.
authors.affiliation: Clinical Trials Research Unit, ScHARR, University of Sheffield, Regent Court, Sheffield, UK. c.l.cooper@sheffield.ac.uk
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Cooper
authors.forename: Daniel
authors.initials: D
authors.lastname: Hind
authors.forename: Glenys D
authors.initials: GD
authors.lastname: Parry
authors.forename: Claire L
authors.initials: CL
authors.lastname: Isaac
authors.forename: Munyaradzi
authors.initials: M
authors.lastname: Dimairo
authors.forename: Alicia
authors.initials: A
authors.lastname: O'Cathain
authors.forename: Anita
authors.initials: A
authors.lastname: Rose
authors.forename: Jennifer V
authors.initials: JV
authors.lastname: Freeman
authors.forename: Leonie
authors.initials: L
authors.lastname: Martin
authors.forename: Eva C
authors.initials: EC
authors.lastname: Kaltenthaler
authors.forename: Anna
authors.initials: A
authors.lastname: Thake
authors.forename: Basil
authors.initials: B
authors.lastname: Sharrack
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy; D003625:Data Collection; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications*; D018579:Patient Selection; D010865:Pilot Projects; D018401:Sample Size