RELATE-a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol.

Abstract

Auditory verbal hallucinations (AVHs) are associated with distress and reduced functioning. Research suggests that distress is associated with the voice hearer's responding to AVH in a passive and subordinate manner. A novel approach focuses on relating to AVH and teaches assertive responses to AVH using experiential role-plays. A small pilot study found a large effect of this approach on AVH distress but an independent multicentre study is required to ascertain effectiveness across different settings. We aim to estimate the expected effect for a subsequent trial to demonstrate that adding a module of Relating Therapy (RT) to treatment as usual (TAU) is superior to TAU alone in reducing AVH distress. We also test the feasibility of patient recruitment, therapist training, and therapy monitoring in different psychological and psychiatric outpatient facilities in Germany. We will recruit 75 patients diagnosed with a schizophrenia spectrum disorder and persistent distressing AVH across four sites. Patients will be randomised to receive either 16 sessions of RT plus TAU or TAU alone within a 5-month period. Randomisation will be stratified by sites. Single-blind assessments will take place at baseline, at 5 months (T1) and at 9 months (T2). The primary outcome is the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scale at T2 adjusted for the baseline value. Secondary outcomes are change in depressive symptoms, quality of life, time spent in structured activities as well as negative relating to voices and to other people. The trial has received ethical approval from the German Psychological Society Ethics Committee. The trial results will be disseminated through conference presentations, peer-reviewed publications and social media. ClinicalTrials.gov Registry (NCT04578314).