Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Neuro-VR Augmenting a Virtual Reality-based Therapy with Neurofeedback for Auditory Hallucinations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neuro-VR
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 7 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
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 7 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None