Hallucinations, Verbal AuditoryVR-VOICESNCT06013748
Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial
A study testing VR-VOICES and Treatment as usual in people with Hallucinations, Verbal Auditory, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hallucinations, Verbal Auditory
- What is being tested?
- VR-VOICES and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesNetherlands
- Study dates
- 31 Oct 2022to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having a DSM-5 diagnosis of a psychiatric disorder
- Distressing AVH for minimally 3 months.
- Age 16 years or older
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
GGZ Drenthe
Assen
Gerard van Rijsbergen, dr
- Not yet recruiting
Lentis
Groningen, Provincie Groningen
Stynke Castelein, Prof
- Recruiting
University Medical Center Groningen
Groningen, 9712EW
Chris Geraets, dr, +31649231353, c.n.w.geraets@umcg.nl
Chris Geraets, dr
About this study
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.
Read the 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.
- Conditions
- Hallucinations, Verbal Auditory
- Being tested
- VR-VOICES, Treatment as usual
- Keywords
- Virtual reality, Auditory hallucination, Voice-hearing, Psychological intervention
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-VOICESBehavioural
7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU.
Treatment as usualOther
Treatment as usual as provided by the mental health centers
| Study group | Role | What they receive |
|---|---|---|
| VR-VOICES | Experimental | 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. Receives: Behavioral: VR-VOICES |
| Treatment as usual | Other | 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. This will vary per individual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between baseline and posttreatment after 3 months
Secondary outcomes (14)
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.
Measured: 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)
The BAVQ-R has 54 items, measured on a four-point scale: "disagree" (0), "unsure" (1), "slightly agree" (2), "strongly agree"(3).
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
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.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
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).
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Voices acceptance (Voices Acceptance and Action scale, VAAS)
Section A of the VAAS has 12 items and section B 27. Items are rated on a 5-point scale: strongly disagree, disagree, unsure or neutral, or strongly agree.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Depressive symptoms (Inventory of Depressive Symptomatology, IDS)
The IDS-SR is a 30-item questionnaire. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS)
The R-GPTS part A consists of 8 items, and B of 10 items. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (totally).
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Self-esteem (Self Esteem Rating Scale, SERS)
The SERS has 20 items which are rated on a 7-point likert scale from 1 (strongly disagree) -7 (strongly agree).
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Health care costs (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P)
The TiC-P is a self-report questionnaire that consists of two parts. The first part includes 38 structured questions, starting with yes/no questions and followed by a question on the volume of medical consumption.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Costs production losses (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P)
The TiC-P is a self-report questionnaire that consists of two parts. The second part deals with 12 questions about work to collect data on productivity losses due to health problems.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Quality of life (Sheehan Disability Scale, SDS)
The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life on a scale from 0-10, and assess how many days someone missed work/school/responsibilities and how many days someone was unproductive.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Quality of life (EuroQol, EQ-5D-5L)
The first 25 items of this questionnaires are based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The patient is asked to indicate their health status by choosing the most appropriate level: no problems, slight problems, moderate problems, severe problems, and extreme problems. The last question indicates their current health status on a scale from 0 to 100.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Empowerment/self-efficacy (Mental Health Confidence Scale, MHCS)
The MHCS has 16 items that are measured on a 6-point likert scale ranging from totally not confidant
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Experience sampling method (ESM) of auditory hallucinations and mental states
ESM of auditory verbal hallucinations and mental states measured in the flow of daily life. ESM is a structured diary method for reporting momentary experiences 18. Individuals complete short questionnaires on their mobile device, by pressing a link in a text message. Participants will complete ESM 5x daily for 7 days, completion takes ±1 minute. Participants have to complete the questionnaire within 30 minutes after the text message notification, the interval between measurements is 3 hours.
Measured: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start31 Oct 2022
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallucinations, Verbal AuditoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013748
- Sponsor's protocol ID
- NL78885.042.22
- Other IDs
- 60-63600-98-1055 / 636320017
- Acronym
- VR-VOICES
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06013748
- Acronym / sponsor ID
- VR-VOICES / NL78885.042.22
- Conditions
- Hallucinations, Verbal Auditory
- Keywords
- Virtual reality, Auditory hallucination, Voice-hearing, Psychological intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-VOICES | Experimental | Behavioral: VR-VOICES7-10 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. |
| Treatment as usual | Other | Other: Treatment as usualTAU 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. This will vary per individual. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Having a DSM-5 diagnosis of a psychiatric disorder
- Distressing AVH for minimally 3 months.
- Age 16 years or older
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-VOICES7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU. | Behavioural | VR-VOICES |
| Treatment as usualTreatment as usual as provided by the mental health centers | Other | Treatment as usual |
Primary outcome
Voices severity
Time frame: Between baseline and posttreatment after 3 months
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.
14 secondary outcomes
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)
Empowerment/self-efficacy (Mental Health Confidence Scale, MHCS)
Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Experience sampling method (ESM) of auditory hallucinations and mental states
Time frame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hallucinations, Verbal Auditory
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Treatment Resistant Schizophrenia
Recruiting
Impact of EDEN College Courses on the Quality of Life of Voice-Hearers
Hallucinations, Auditory
Not yet recruiting
Testing a Peer-Support Group for Veterans Who Hear Voices
Psychotic Disorders, Hallucinations, Auditory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-VOICES and Treatment as usual in people with Hallucinations, Verbal Auditory, run by University Medical Center Groningen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Geraets, dr (0031649231353, c.n.w.geraets@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voices severity (time frame: Between baseline and posttreatment after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.