Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial

BACKGROUND Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes, but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing. An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective. This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists. METHODS/DESIGN An external pilot randomized controlled trial (RCT) comparing outcomes for 15 patients receiving 16 hours (weekly sessions of one hour) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment. Participants will be assessed using questionnaires at baseline, 16 weeks (post-intervention), and 36 weeks (follow-up). DISCUSSION Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT. If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices. TRIAL REGISTRATION Current Controlled Trials ISRCTN registration number 44114663. Registered on 13 June 2013.