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

Abstract

IntroductionAuditory 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 analysisWe 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 disseminationThe 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 numberClinicalTrials.gov Registry (NCT04578314).

Distress factors of voice‐hearing in young people and social relating: Exploring a cognitive‐interpersonal voice‐hearing model

“…The subscales used in this study have demonstrated good reliability (intra‐class correlation coefficient > .93 for distress and > .87 for frequency) (Woodward et al, 2014 ), and they have been used in adult (e.g. Badcock et al, 2020 ; Craig et al, 2018 ; du Sert et al, 2018 ; Hayward et al, 2017 , 2018 ; Jongeneel et al, 2018 ; Lincoln et al, 2021 ; Paulik et al, 2019 , 2018 ) and youth research (Cavelti et al, 2019 ). In this study, internal consistency of PSYRATS‐AH subscales was acceptable (α > .66).…”

Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial

“…Reducing the level of psychological distress due to voice-hearing (instead of reducing hearing voices per se) is the main therapy aim of CBTv and the PSYRATS-AH has been widely used in clinical trials investigating the efficacy of CBTv in the past [ 17 , 35 , 36 ]. Additionally, distress is the prioritized outcome by patients with voices and is related to dysfunction [ 37 ].…”

“…The VAY has good internal consistency and acceptable test-retest reliability [ 80 ]. The psychometric properties of the German version are currently under examination by Lincoln et al [ 37 ].…”

“…Items are scored on a 10-point Likert scale, ranging from 0 (disagree completely) to 10 (agree completely). The Approve questionnaires have been found to be reliable and valid in both their English [ 40 ] and German versions, with the German validation study being currently in preparation for publication [ 37 ].…”

The CHALLENGE-trial: the effects of a virtual reality-assisted exposure therapy for persistent auditory hallucinations versus supportive counselling in people with psychosis: study protocol for a randomised clinical trial.

“…There is some emerging evidence that using experiential exercises to recreate hallucinatory episodes within a session may facilitate therapy. For example, in-session role plays [12,13] or audio recordings of things the voice often says [14,15] may be utilised to practise alternative responses. Using in-session exercises may be valuable in helping the person to apply what is discussed in therapy whilst the therapist can support them, aiding transfer to the selfmanagement of hallucinations when encountered in daily life.…”