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

NCT ID: NCT06628323

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-01-31

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. Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?

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?

Researchers will compare VR-NF to Virtual Reality-based therapy alone to evaluate therapy effectiveness.

Participants will be allocated to receive 8 sessions of either VR-NF or Virtual Reality-based therapy alone. All participants will undergo a thorough assessment at baseline, and at 12 weeks post-baseline.

Detailed Description

Auditory hallucinations represent some of the most frequent and debilitating symptoms in schizophrenia spectrum disorders (SSD), affecting up to 80 % of individuals with SSD. Despite receiving treatment with antipsychotic medication, nearly one-third of these individuals continue to experience psychotic symptoms.

Virtual Reality-based interventions have emerged to address the essential need for targeted and effective psychotherapeutic interventions for auditory hallucinations. A recent randomized controlled trial (RCT) has developed and tested a fully immersive Virtual Reality-based intervention, with preliminary results indicating that this approach is effective in mitigating the severity of auditory hallucinations.

The Neuro-VR study aims to improve the effectiveness of this Virtual Reality-based intervention by incorporating real-time EEG-based neurofeedback into the intervention. We expect that augmenting the VR-based intervention with EEG-based neurofeedback will improve both its tolerability and effectiveness by using individual neurophysiological responses to guide the intervention.

The primary objective of the pilot study is to evaluate whether the combination of Virtual Reality and EEG-based neurofeedback is a feasible and acceptable therapeutic approach for treating auditory hallucinations in SSD. A secondary objective is to investigate whether Virtual Reality combined with EEG-based neurofeedback provides indications of being superior to Virtual Reality alone in reducing severity of auditory hallucinations, improving daily functioning and enhancing quality of life in individuals with SSD.

If the pilot study is found successful it could pave the way for broader clinical trials to document the effect of augmenting Virtual Reality-based interventions with real-time feedback from neurophysiological responses. In the long run, this combined approach can be implemented in the mental health clinics to complement traditional treatments.

Conditions

Auditory Hallucinations; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Virtual Reality-based Intervention employing Neurofeedback

Intervention Type: BEHAVIORAL

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

Virtual Reality - based therapy

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.

Group Type: ACTIVE_COMPARATOR

Virtual Reality-based Intervention

Intervention Type: BEHAVIORAL

Virtual Reality-based intervention targeting auditory hallucinations in schizophrenia

Interventions

Virtual Reality-based Intervention employing Neurofeedback

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

Intervention Type: BEHAVIORAL

Virtual Reality-based Intervention

Virtual Reality-based intervention targeting auditory hallucinations in schizophrenia

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Ability to give informed consent

2. Age of 18-65 years

3. Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)

4. Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)

5. Identification of at least one dominant voice

6. No changes in antipsychotic medications four weeks prior to inclusion in the project

7. No planned changes in antipsychotic medication in the 12 weeks following inclusion in the project

8. A command of Danish or English sufficient to engage in therapy

Exclusion Criteria

1. Rejecting informed consent

2. A diagnosis of organic brain disease

3. Intellectual disability (IQ ˂ 70)

4. A primary diagnosis of substance dependence hindering engaging in therapy

5. Hear voices in a language the therapist does not speak

6. Inability to tolerate the therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise B. Glenthøj, DMSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Research Center for Mental Health - CORE

Locations

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sara B. Soleim, MSc (Psych.)

Role: CONTACT

sara.breivik.soleim@regionh.dk

+ 45 20131129

Louise B. Glenthøj, DMSc, PhD

Role: CONTACT

louise.birkedal.glenthoej@regionh.dk

+ 45 21452889

Facility Contacts

Sara B Soleim, MSc (Psych.)

Role: primary

sara.breivik.soleim@regionh.dk

20131129 ext. +45

Other Identifiers

H-24010871

Identifier Type: -

Identifier Source: org_study_id