The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Neurofeedback to Increase Tolerability and Therapy Efficacy in Psychosis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

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

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

• A command of Danish or English sufficient to engage in therapy

Locations
Other Locations
Denmark
Copenhagen Research Center for Mental Health - CORE
RECRUITING
Copenhagen
Contact Information
Primary
Sara B. Soleim, MSc (Psych.)
sara.breivik.soleim@regionh.dk
+ 45 20131129
Backup
Louise B. Glenthøj, DMSc, PhD
louise.birkedal.glenthoej@regionh.dk
+ 45 21452889
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2026-01
Participants
Target number of participants: 30
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Mental Health Services in the Capital Region, Denmark

This content was sourced from clinicaltrials.gov