Multisite randomised controlled trial of a novel dialogical therapy in comparison to treatment as usual in adults with distressing and persistent auditory hallucinations:study protocol for the Talking With Voices (TWV-II) trial

Background: Hearing voices (“auditory hallucinations”) is associated with numerous negative outcomes, including hospitalisation, suicidality, and impaired functioning. Currently, the main treatment approaches are antipsychotic medication and cognitive behavioural therapy (CBT), yet both have variable effectiveness and are often unavailable to those without a schizophrenia diagnosis. Furthermore, CBT does not consistently address the role of trauma in voice onset and maintenance. In response to these unmet needs, a feasibility/acceptability trial of a new intervention, Talking With Voices (TWV), was conducted. TWV involves a therapist speaking to the voice(s) while the client repeats its response verbatim, with the aim of promoting recovery and reducing voice-related distress. This prior pilot study (N = 50) found excellent feasibility/acceptability data amongst participants with schizophrenia, and signals of positive change in measures of personal recovery and voice relating. The next step is to evaluate treatment mechanisms and clinical efficacy of TWV in a transdiagnostic population. Methods: We aim to establish TWV’s clinical efficacy in a multisite RCT for adults with serious mental health problems (SMHP) who hear persistent, distressing voices, and to assess whether improved measures of personal recovery and negative voice impact are mediated via key psychological mechanisms (improved relating to, and beliefs about, voices; and reductions in dissociation and negative self-beliefs). We aim to recruit 296 participants from psychiatric services across 4 UK sites (Manchester, London, Newcastle, and Oxford) who will be randomised to either treatment (TWV + treatment as usual [TAU]) or control (TAU only). The primary outcome is total score on the Questionnaire About the Process of Recovery. Secondary outcomes include overall voice severity and other relevant dimensions of voices and trauma sequalae, with mediational and outcome variables collected at baseline, 8 months (post-treatment), and 14 months. Discussion: The study will investigate the clinical efficacy of a novel intervention deliverable within healthcare services, including hypothesised mechanisms of change to identify key psychological targets for ameliorating distressing voices in a transdiagnostic population. Potential benefits include improving the effectiveness and accessibility of evidence-based psychosocial interventions for SMHP. Trial registration: ISRCTN, ISRCTN15897915. Registered 13 July 2023.