AVATAR2 Outcome Data

New effective treatments for distressing voices are needed. AVATAR therapy is a novel approach in which voice-hearers engage in a series of facilitated dialogues with a digital embodiment of the distressing voice.  We report a late phase2/3 trial to assess the efficacy of two forms of AVATAR therapy.  We recruited 345 participants with psychosis and randomly assigned them to AVATAR-Brief (AV-BRF), AVATAR-Extended (AV-EXT) or Treatment as Usual, and conducted an intention-to-treat analysis. Data were available on 300 participants (86.9%) at 16 weeks and 298 (86.4%) at 28 weeks. The primary outcome was Voice-related Distress (PSYRATS-AH Distress) at both timepoints. Distress improved, compared with TAU, in both forms at 16 weeks but not 28 weeks. Distress at 16 weeks: AV-BRF, effect -1.05 points, 96.5% CI, -2.110 to 0.000, P= 0.035, Cohen’s d=0.38 (CI, 0.000 to 0.767); AV-EXT -1.60 points, 96.5% CI -3.133 to -0.058, P=0.029, Cohen’s d= 0.58 (CI, 0.021 to 1.139). Distress at 28 weeks: AV-BRF, -0.62 points, 96.5% CI, -1.912 to 0.679, P= 0.316, Cohen’s d= 0.22 (CI, -0.247 to 0.695); AV-EXT -1.06 points, 96.5% CI, -2.700 to 0.586, P=0.175, Cohen’s d= 0.38 (CI, -0.213 to 0.981). Voice Severity (PSYRATS-AH Total) and Voice Frequency (PSYRATS-AH Frequency) were key secondary outcomes. Severity improved in both forms, compared with TAU, at 16 weeks but not 28 weeks whereas Frequency reduced in AV-EXT but not in AV-BRF at both timepoints. There were no related Serious Adverse Events. These findings provide partial support of our primary hypotheses. AV-EXT met our threshold for clinically significant change suggesting future work is primarily guided by this protocol. ISRCTN Registry: ISRCTN55682735.