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

Tania M Lincoln, Matthias Pillny, Björn Schlier, Mark Hayward, Tania M Lincoln, Matthias Pillny, Björn Schlier, Mark Hayward

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: ClinicalTrials.gov Registry (NCT04578314).

Keywords: clinical trials; psychiatry; schizophrenia & psychotic disorders.

Conflict of interest statement

Competing interests: There is a potential conflict of interest for one member of the research team. MH is an author on a self-help book on distressing voices that informs the RT approach. Therefore, the research team commits themselves to publishing the results of this feasibility trial irrespective of the findings.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Illustration of the participant flow through the study. RT, Relating Therapy; TAU, treatment as usual.

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Source: PubMed

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