Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-VOICES, Treatment as usual.
- Who it may be relevant to
- Registry conditions: Hallucinations, Verbal Auditory. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Study design: Single-blind randomized controlled intervention trial (RCT) with two arms: VR-VOICES as intervention and treatment as usual (TAU) as a control condition.
Study population: Patients with a DSM-5 diagnosis who have experienced distressing AVH for at least 3 months, who are 16 years or older (N=112).
Intervention:
* VR-VOICES intervention: 7-10 sessions of 45-60 minutes of individual VR assisted therapy and two booster sessions, in addition to TAU. Participants allocated to VR-VOICES create together with their therapist a VR digital representation (avatar with face, body and voice) of the voice that bothers them most. Patients have dialogues with the avatar, voiced by the therapist. As indicated in the treatment protocol, over the sessions the avatar will become less hostile and the participant will gain more power and resilience over the avatar. * Control: TAU as described in the current Dutch treatment guidelines, which generally exists of pharmacological treatment, supportive counseling, and psychological interventions such as CBT and coping strategies.
Main study parameters/endpoints: Assessments will be obtained at baseline, within some VR-VOICES sessions, posttreatment (12 weeks after baseline), and at 6-month follow-up. Primary outcome: severity of AVH (total score on the auditory hallucinations scale of the PSYRATS) at post-treatment. Secondary outcomes: in-depth characteristics of AVH such as the frequency, voice impact, beliefs about voices, power relative to voices, levels of anxiety, distress and impact on daily life as measured with questionnaires and diary assessments in the flow of daily life. Other secondary outcomes include clinical symptoms, cost-effectiveness and quality of life.
Interventions
- Behavioral VR-VOICES
7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU. - Other Treatment as usual
Treatment as usual as provided by the mental health centers
Primary outcome measures
- Voices severity [Time frame: Between baseline and posttreatment after 3 months]
Secondary outcome measures (12)
- Voice severity (frequency and distress) and delusions [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Impact of voice-hearing (Voice Impact Scale, VIS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Voices acceptance (Voices Acceptance and Action scale, VAAS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Depressive symptoms (Inventory of Depressive Symptomatology, IDS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Self-esteem (Self Esteem Rating Scale, SERS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Health care costs (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Costs production losses (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Quality of life (Sheehan Disability Scale, SDS) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
- Quality of life (EuroQol, EQ-5D-5L) [Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
Eligibility criteria
Inclusion criteria
- Having a DSM-5 diagnosis of a psychiatric disorder
- Distressing AVH for minimally 3 months.
- Age 16 years or older
Exclusion criteria
- 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
- Auditory verbal hallucinations in a language not spoken by therapists
- Patients cannot receive CBT specifically focused at gaining empowerment over voices during the study period or 6 months prior to enrolment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 3 centers
- Lentis — Groningen
- GGZ Drenthe — Assen
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT06013748 · NL78885.042.22 · 60-63600-98-1055 / 636320017