Table 2.
Per Protocol | Intent-To-Treat | |||||
---|---|---|---|---|---|---|
Condition | Immediate | 3 Month | 6 Month | Immediate | 3 Month | 6 Month |
Patient-Report CGI | ||||||
MC-CBT | 68.1% ± 8.1 | 64.0% ± 8.8 | 63.9% ± 8.8 | 61.0% ± 8.0 | 57.0% ± 8.4 | 56.6% ± 8.4 |
S-CBT | 64.6% ± 8.9 | 64.6% ± 9.3 | 58.1% ± 9.4 | 54.5% ± 8.4 | 53.3% ± 8.6 | 48.1% ± 8.6 |
EDU | 46.7% ± 8.8 | 49.5% ± 9.3 | 51.0% ± 9.6 | 43.5% ± 8.4 | 45.8% ± 9.0 | 47.0% ± 9.2 |
MC-CBT – S-CBT | 3.5% ± 12.0 | <1% ± 12.7 | 5.9% ± 12.9 | 6.5% ± 11.6 | 3.7% ± 12.0 | 8.5% ± 12.0 |
MC-CBT – EDU | 21.5% ± 12.0** | 14.5% ± 12.8* | 12.9% ± 13.0a,b | 17.6% ± 11.6** | 11.2% ± 12.3a,b | 9.6% ± 12.5 |
S-CBT – EDU | 18.1% ± 12.5** | 15.0% ± 13.1* | 7.1% ± 13.4 | 11.1% ± 11.9a,b | 7.5% ± 12.2 | 1.1% ± 12.6 |
MC-CBT – S-CBT CI | −8.5% to 15.5% | −13.2% to 12.5% | −7.0% to 18.7% | −5.1% to 18.0% | −8.3% to 15.8% | −3.6% to 20.5% |
Physician-Rated CGI | ||||||
MC-CBT | 63.0% ± 9.0 | - | 66.4% ± 9.1 | 55.7% ± 8.6 | - | 58.4% ± 8.9 |
S-CBT | 61.0% ± 9.4 | - | 64.0% ± 9.9 | 50.6% ± 8.7 | - | 51.6% ± 9.2 |
EDU | 43.6% ± 9.2 | - | 49.6% ± 10.5 | 40.4% ± 8.8 | - | 44.8% ± 10.0 |
MC-CBT – S-CBT | 2.0% ± 13.0 | - | 2.4% ± 13.5 | 5.1% ± 12.2 | - | 6.8% ± 12.8 |
MC-CBT – EDU | 19.4% ± 12.9** | - | 16.8% ± 13.9* | 15.2% ± 12.3** | - | 13.7% ± 13.4* |
S-CBT – EDU | 17.4% ± 13.1* | - | 14.4% ± 14.5a,b | 10.1% ± 12.4 | - | 6.8% ± 13.6 |
MC-CBT – S-CBT CI | −10.0% to 15.0% | - | −11.1% to 15.9% | −7.1% to 17.3% | - | −5.9% to 19.6 % |
notes:
p < 0.05,
p < 0.01,
p < 0.08;
trend p value using listwise deletion is p < 0.05 for chained equation missing data algorithm; MC-CBT - S-CBT CI = 95% CI for difference; numbers after ± are margins of error (half widths of 95% CIs); IBSOS was not designed to collect blind ratings at 3 month follow up