Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations

NCT06628323 | Active Not Recruiting

• 1 other identifier: H-24010871
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback. The main questions it aims to answer are:

1. 1.Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?
2. 2.Will VR-NF show indications of being more effective than Virtual Reality-based therapy alone in reducing the severity of auditory hallucinations, improving daily functioning, and enhancing quality of life?

Conditions

Auditory Hallucinations; Schizophrenia

Keywords

Virtual Reality-based therapy; Schizophrenia; Auditory Hallucinations; Neurofeedback; EEG

Outcome Measures

Primary Outcomes (3)

• Feasibility and acceptability as assessed by recruitment rate

  Percentage of target sample (30 participants) recruited after 12 months from study start.

  Recruitment rate is monitored throughout the study period (1 year)

• Feasibility and acceptability to the VR-NF intervention as assessed by retention rate

  Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).

  Retention rates are monitored throughout the study period (1 year)

• Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group

  Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a Likert scale ranging from 1-10 with higher scoring indicating a higher level of satisfaction with therapy.

  At 12 weeks follow up

Secondary Outcomes (8)

• Severity of positive symptoms (hallucinations, delusions, bizarre behavior and positive formal thought disorder) as assessed by the Scale for the Assessment of Positive Symptoms (SAPS)

  Baseline and at 12 weeks follow up

• Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)

  Baseline and at 12 weeks follow up

• Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)

  Baseline and at 12 weeks follow up

• Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)

  Baseline and at 12 weeks follow up

• Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)

  Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up

Other Outcomes (21)

• Level of negative symptoms as assessed by the Brief Negative Symptoms Scale (BNSS)

  Baseline and at 12 weeks follow up

• Level of negative symptoms as assessed by the Self Evaluation of Negative Symptoms (SNS)

  Baseline and at 12 weeks follow up

• Ability to use emotion regulation strategies as assessed by the Emotion Regulation Questionnaire (ERQ)

  Baseline and at 12 weeks follow up

Study Arms (2)

Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF)

EXPERIMENTAL

Participants in the experimental group undergo 8 sessions of a manualized virtual reality-based intervention added real-time EEG neurofeedback aiming to enhance the control and sense of power in relation to the dominant hallucinated voice. Together with the therapist, the participants create a digital representation (avatar) in virtual reality corresponding to the visual perception and sound of the voice. During therapy, the participants will be encouraged to engage in a dialogue with the avatar. While immersed in virtual reality, EEG recordings will be conducted by electrodes connected to a cap on the participants' head. Processed EEG-data will provide real-time information on the participants' brain activity associated with the emotional distress when confronted with the avatar and will be visible both to the participant and therapist. The feedback will be used to continuously adjust the intervention to the brain activity and aims to help the participant practice emotion regulation.

Behavioral: Virtual Reality-based Intervention employing Neurofeedback

Virtual Reality - based therapy

ACTIVE COMPARATOR

Participants in the control group will be offered 8 sessions of a manualized virtual reality - based therapy that follows the same principles as described in the experimental arm. Together with the therapist, the participants create a digital representation (avatar) in virtual reality that corresponds to their visual perception of and sounds like their hallucinated voice. Thoughout the therapy sessions, the participants will be encouraged to engage in a dialogue with the 'avatar', voiced by the therapist who will alternate between talking as the 'avatar' and as a supportive therapist. The therapy aims at enhancing the participants' control and feeling of power in relation to the dominant hallucinated voice. Furthermore, the therapy focuses on regulating the emotional distress associated with the hallucinated voice.

Behavioral: Virtual Reality-based Intervention

Interventions

Virtual Reality-based Intervention BEHAVIORAL

Virtual Reality-based intervention targeting auditory hallucinations in schizophrenia

Virtual Reality - based therapy

Virtual Reality-based Intervention employing Neurofeedback BEHAVIORAL

Virtual Reality-based intervention augmented with real-time EEG-based neurofeedback targeting auditory hallucinations in schizophrenia

Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF)

Eligibility Criteria

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

You may qualify if:

• Ability to give informed consent
• Age of 18-65 years
• Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)
• Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)
• Identification of at least one dominant voice
• A command of Danish or English sufficient to engage in therapy

You may not qualify if:

• Rejecting informed consent
• A diagnosis of organic brain disease
• Intellectual disability (IQ ˂ 70)
• A primary diagnosis of substance dependence hindering engaging in therapy
• Hear voices in a language the therapist does not speak
• Inability to tolerate the therapy

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (1)

• Habla AF, Soleim SB, Due AS, Tinglef TH, Eskelund K, Diaz-I-Calvete J, Larsen KM, Kristensen TD, Ebdrup BH, Nordentoft M, Lyngholm D, Miskowiak KW, Ambrosen KS, Birkedal Glenthoj L. Study protocol for a randomized clinical pilot trial investigating feasibility and efficacy of augmenting a virtual reality-assisted intervention targeting auditory verbal hallucinations with biofeedback: The Neuro-VR study. PLoS One. 2026 Feb 26;21(2):e0333716. doi: 10.1371/journal.pone.0333716. eCollection 2026.

  PMID: 41746906 DERIVED

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Louise B. Glenthøj, DMSc, PhD

  Copenhagen Research Center for Mental Health - CORE

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist / Research Assistant

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: October 4, 2024
• Study Start: November 12, 2024
• Primary Completion: April 22, 2026
• Study Completion: May 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DK (1)