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

Autor: Lisa Charlotte Smith, Lise Mariegaard, Ditte Lammers Vernal, Annette Gosvig Christensen, Nikolai Albert, Neil Thomas, Carsten Hjorthøj, Louise Birkedal Glenthøj, Merete Nordentoft
Rok vydání: 2022
DOI: 10.21203/rs.3.rs-1368643/v1
Popis: Background: Many patients suffering from schizophrenia spectrum disorders continue having distressing auditory hallucinations in spite of treatment with antipsychotic medication. The aim of this trial is to examine the effect of a targeted virtual reality therapy for persistent auditory hallucinations in individuals with psychosis. The trial explores whether this type of therapy can decrease the severity, frequency, and distress of auditory hallucinations and additionally, whether it can reduce clinical symptoms and enhance daily functioning in individuals with psychosis. Methods: The study is a randomised, assessor-blinded parallel-groups superiority clinical trial, allocating a total of 266 patients to either the experimental intervention or supportive counselling. The participants will be randomised to either 1) seven sessions of virtual reality therapy or 2) seven sessions of supportive counselling to be delivered within the first 12 weeks after inclusion in the study. All participants will be assessed at baseline and 12- and 24 weeks post baseline. Independent assessors blinded to treatment allocation will evaluate outcome. The primary outcome is the level of auditory hallucinations measured with The Psychotic Symptoms Rating Scales (PSYRATS-AH) total score at cessation of treatment at 12-weeks. Secondary outcomes are frequency of auditory hallucinations, the distress caused by auditory hallucinations, perceived voice power, patient acceptance of voices, patients’ ability to respond to voices in an assertive way and social and daily function. Discussion: Promising evidence exist of the efficacy of this immersive virtual reality-based therapy for auditory hallucinations, but evidence needs to be established in a large, methodological rigorous trial. If the therapy proves to be beneficial in reducing the severity of refractory auditory hallucinations, a large group of patients with schizophrenia and related disorders could be the target group of this short-term psychotherapeutic intervention.
Databáze: OpenAIRE