Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity Medical Center Groningen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • VR-VOICES

    Behavioral

    7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU.

  • Treatment as usual

    Other intervention

    Treatment as usual as provided by the mental health centers

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: VR-VOICESExperimental treatment 1 intervention
Group B: Treatment as usualOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Between baseline and posttreatment after 3 months

Secondary outcomes

1

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.

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
2

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).

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
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.

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
4

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).

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)

Other outcomes

1

Trauma (Trauma and Life Events TALE)

21 items on traumatic events, whether they happened, more than once and at which age.

Time frame
Assessment at baseline
2

Trauma impact (Trauma screening questionnaire (TSQ)

10 items to screen trauma which can be answered with yes or no.

Time frame
Assessment at baseline
3

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)

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
4

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.

Time frame
Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator