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

NCT06013748 | Recruiting

• 2 other identifiers: NL78885.042.2260-63600-98-1055 / 636320017
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Hallucinations, Verbal Auditory

Keywords

Virtual reality; Auditory hallucination; Voice-hearing; Psychological intervention

Outcome Measures

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.

  Between baseline and posttreatment after 3 months

Secondary Outcomes (14)

• Voice severity (frequency and distress) and delusions

  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)

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

• Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS)

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

• Impact of voice-hearing (Voice Impact Scale, VIS)

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

• Voices acceptance (Voices Acceptance and Action scale, VAAS)

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

Other Outcomes (10)

• Trauma (Trauma and Life Events TALE)

  Assessment at baseline

• Trauma impact (Trauma screening questionnaire (TSQ)

  Assessment at baseline

• Medication use

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

Study Arms (2)

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.

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.

Other: Treatment as usual

Interventions

VR-VOICES BEHAVIORAL

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

VR-VOICES

Treatment as usual OTHER

Treatment as usual as provided by the mental health centers

Treatment as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a DSM-5 diagnosis of a psychiatric disorder
• Distressing AVH for minimally 3 months.
• Age 16 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (3)

Lentis

Groningen, Provincie Groningen, Netherlands

NOT YET RECRUITING

GGZ Drenthe

Assen, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9712EW, Netherlands

RECRUITING

MeSH Terms

Conditions

Hallucinations

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chris Geraets, dr

CONTACT

0031649231353; c.n.w.geraets@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 28, 2023
• Study Start: October 31, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)