About this trial
Rationale: Auditory verbal hallucinations (AVH) - hearing voices that others cannot hear - are common in mental illnesses. For many people AVH are distressing, disabling and persistent, despite medication. Current psychological interventions show low to medium effects. Preliminary studies suggest that an innovative empowering psychological therapy using computer simulations representing the AVH (avatars) can be effective for reducing AVH distress and frequency. Virtual reality (VR) has the potential to improve this treatment. Therefore, we developed a novel VR treatment for this problem. In this study, the effect of this treatment will be investigated.
Objective: To test the effect of a novel VR treatment for AVH (VR-VOICES) on distress and frequency of AVH in patients with a psychiatric disorder. Furthermore, to investigate the effect of VR-VOICES on clinical symptoms, quality of life, and healthcare costs of the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having a DSM-5 diagnosis of a psychiatric disorder
Distressing AVH for minimally 3 months.
Age 16 years or older
Disqualifiers
Insufficient command of the Dutch language
Unable to provide informed consent
Primary diagnosis of a substance use disorder, or organic brain disease (such as dementia)
A degree of substance abuse that hinders treatment adherence
Trial design
Parallel
Treatments tested in this trial
VR-VOICES
Behavioral7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU.
Treatment as usual
Other interventionTreatment as usual as provided by the mental health centers
Treatment groups
Trial outcomes
Primary outcomes
Voices severity
The Psychotic Symptoms Rating Scales (PSYRATS) is a semi-structured interview to assess characteristics of hallucinations and delusions. The auditory hallucinations subscale (AHS), which is used as the primary outcome, has 11 items.
Secondary outcomes
Voice severity (frequency and distress) and delusions
The Psychotic Symptoms Rating Scales (PSYRATS) is a semi-structured interview to assess characteristics of hallucinations and delusions. The auditory hallucinations subscale (AHS) has 11 items.The delusions subscale (DS) has six items.
Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R)
The BAVQ-R has 54 items, measured on a four-point scale: "disagree" (0), "unsure" (1), "slightly agree" (2), "strongly agree"(3).
Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS)
The SCRS has 11 items measuring characteristics of the participants as compared to their voices on a 10-point likert scale ranging from 1-10.
Impact of voice-hearing (Voice Impact Scale, VIS)
The VIS has 24 items measured on a 10-point likert scale ranging from 1 (totally disagree) to 10 (totally agree).
Other outcomes
Trauma (Trauma and Life Events TALE)
21 items on traumatic events, whether they happened, more than once and at which age.
Trauma impact (Trauma screening questionnaire (TSQ)
10 items to screen trauma which can be answered with yes or no.
Medication use
Use of prescribed medication in the past 3 months, type of medication, were the medication is for, how often it was used and what amount (in milligram)
Substance use
Use of substances, number of glasses of alcohol in the past month. Use of softdrugs and harddrugs in the past 3 months, type of drugs, how often the drugs were used, how much was used each time.
Sponsors and contacts
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University Medical Center Groningen
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator