"This is a trial about doing a trial; this is why progress is may be slower than you expect. It reinforces a recent article I read in the Economist about the state of the world economy; in the past innovation use to create jobs. The current wave of innovation is about automation. The fact that you can administer CBT via a computer interface is taking this to the limit. I am interested to see if this will work."
BACKGROUND: MS'ers are at high risk of depression. This pilot study of computerised cognitive behavioural therapy (CCBT) for the treatment of depression in MS'ers was 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: 24 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.
"Are you depressed? Would you be up for some computerised CBT?"
P.S. The Mousedoctor is going to be upset with this post. I am meant to be on holiday."