Increasing access to CBT for psychosis patients: a randomized controlled trial evaluating a brief, targeted CBT-informed intervention for distressing voices delivered by Assistant Psychologists (the GiVE3 study).

Background Cognitive Behaviour Therapy for psychosis (CBTp) is recommended for treating psychosis. However, access to CBTp is extremely poor for patients internationally due to its intensive nature and delivery by highly trained therapists. This study evaluated the clinical and cost effectiveness of the GiVE intervention (Guided self-help CBT for distressing voices) delivered by briefly trained therapists (Assistant Psychologists). Methods This study was a pragmatic, two-arm, parallel group, superiority randomised controlled trial, comparing the GiVE intervention (delivered by Assistant Psychologists) in addition to treatment-as-usual (TAU) to TAU alone, recruiting patients with psychosis across three National Health Service sites in the UK, using 1:1 allocation and blinded post-treatment and follow-up assessments. Clinical and health economic outcomes were assessed at baseline, 16 weeks, and 28 weeks. The primary outcome was the Psychotic Symptom Rating Scale - Auditory Hallucinations Distress Scale (PSYRATS-AH Distress). Results In total, 135 participants were randomised: 68 to GiVE plus TAU, 67 to TAU alone. Participant's mean age was 43.8 years (SD=12.1; range 18-69), 44 (33%) were women, 88 (65%) men, and 2 (1%) non-binary. For the intention-to-treat analysis, adjusted between-group differences in mean PSYRATS-AH Distress were -0·73 (95% CI -2·34 to 0·88; p=0·376; Cohen's d=-0·35) at 16-weeks and -0·61 (95% CI -2·23 to 1·01; p=0·460; Cohen's d=-0·30) at 28-weeks in favour of GiVE plus TAU but were not statistically significant. Conclusion Our study found that the GiVE intervention was not clinically effective in treating distressing voice hearing experiences when delivered by briefly trained Assistant Psychologists to psychosis patients.