Table 2.
Endpoint analyses of outcome variables (following 15 sessions)1
| Outcome variable | mean (standard error)4 | PGroup effect | Estimated effect size (95% CI) | |
|---|---|---|---|---|
| Sham N=28 | Active N=55 | |||
| HCS2 (primary) | 7.78 (0.67) | 6.38 (0.47) | 0.09 | 0.40 |
| Hallucination frequency difference3 | −0.26 (0.31) | −1.32 (0.22) | 0.005 | 0.65 (0.19 – 1.11) |
| Total AHRS Difference3 | −2.78 (1.2) | −4.58 (0.85) | 0.22 | 0.28 |
| CGI2 | 3.31 (0.25) | 2.70 (0.17) | 0.045 | 0.47 (0.01 – 0.93) |
1
Model includes group and site (W versus rW, corresponding to optimal response); based on data collected after the third 5-session block, with multiple imputations used for missing data
2
Lower scores correspond to greater improvement; all HCS were 10 at baseline; no baseline for CGI, scores range from 1 to 7, with 4 = no change.
3
Difference = baseline − endpoint; lower scores correspond to greater improvement
4
Model-based least-square means and standard errors