RELATE - A randomized controlled trial of a cognitive behavioural module for distressing auditory verbal hallucinations

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Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH using experiential role-plays. A small pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but an independent multicentre study is required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone in reducing AH distress. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities. A total of 75 patients diagnosed with a schizophrenia spectrum disorder (ICD-10, F2) and persistent distressing AH will be recruited across 3 sites and receive either 16 50-minute sessions of RM plus TAU or TAU alone within a 4-months period. Assessments will take place at baseline, at 4 months (post-intervention) and at 9 months (primary endpoint).