Clinical trial NCT06628323: Neuro-VR: Augmenting a Virtual Reality-based Therapy With Neurofeedback for Auditory Hallucinations
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Auditory Hallucinations
Schizophrenia
Keywords: Virtual Reality-based therapy
Schizophrenia
Auditory Hallucinations
Neurofeedback
EEG
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility and acceptability as assessed by recruitment rate
timeFrame: Recruitment rate is monitored throughout the study period (1 year)
measure: Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
timeFrame: Retention rates are monitored throughout the study period (1 year)
measure: Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
timeFrame: At 12 weeks follow up
Secondary outcomes:
measure: 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)
timeFrame: Baseline and at 12 weeks follow up
measure: Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)
timeFrame: Baseline and at 12 weeks follow up
measure: Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)
timeFrame: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
measure: Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire
timeFrame: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
measure: Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)
timeFrame: Baseline and at 12 weeks follow up
measure: Social functioning as assessed by the Social Functioning Scale (SFS)
timeFrame: Baseline and at 12 weeks follow up
Other outcomes:
measure: Level of negative symptoms as assessed by the Brief Negative Symptoms Scale (BNSS)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of negative symptoms as assessed by the Self Evaluation of Negative Symptoms (SNS)
timeFrame: Baseline and at 12 weeks follow up
measure: Ability to use emotion regulation strategies as assessed by the Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline and at 12 weeks follow up
measure: Difficulties in emotion regulation as assessed by the Difficulties in Emotion Regulation Scale, short version (DERS-16)
timeFrame: Baseline and at 12 weeks follow up
measure: Beliefs about self and others as assessed by The Brief Core Schema Scales: Beliefs about self and others (BCSS)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of client satisfaction with intervention as assessed by the Client Satisfaction Questionnaire (CSQ)
timeFrame: At 12 weeks follow up
measure: Level of simulator sickness elicited by virtual reality as assessed by the Simulator Sickness Questionnaire (SSQ)
timeFrame: 2, 4 and 8 weeks post baseline
measure: Level of depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Baseline and at 12 weeks follow up
measure: Severity of suicidal ideation and risk for suicidal behavior as assessed by the Suicidal Ideation Attributes Scale (SIDAS)
timeFrame: Baseline and at 12 weeks follow up
measure: Experience with childhood traumas as assessed by the Childhood Trauma Questionnaire(CTQ)
timeFrame: Baseline
measure: Psychological well-being as assessed by The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: Baseline and at 12 weeks follow up
measure: Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of self-efficacy as assessed by the General Self-Efficacy Scale (GSE)
timeFrame: Baseline and at 12 weeks follow up
measure: Level of insight into illness as assessed by the Birchwood Insight Scale (BIS)
timeFrame: Baseline and at 12 weeks follow up
measure: Readiness for therapy as assessed by the Readiness for Therapy Questionnaire (RTQ)
timeFrame: Baseline
measure: Change in EEG (Electroencephalography) activity - P50 suppression
timeFrame: Baseline and at 12 weeks follow up
measure: Change in EEG (Electroencephalography) activity - Mismatch Negativity (MMN)
timeFrame: Baseline and at 12 weeks follow up
measure: Change in EEG (Electroencephalography) activity - Auditory Steady State Response (ASSR)
timeFrame: Baseline and at 12 weeks follow up
measure: Change in EEG (Electroencephalography) activity - Selective Attention (SA)
timeFrame: Baseline and at 12 weeks follow up
measure: Change in EEG (Electroencephalography) activity - Resting State
timeFrame: Baseline and at 12 weeks follow up
measure: A qualitative measure of feasibility and acceptability to the VR-NF intervention
timeFrame: Semi-structured interviews will be conducted throughout the study period (up to 18 months)
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Research Center for Mental Health - CORE
state: Hellerup
Study officials:
affiliation: Copenhagen Research Center for Mental Health - CORE
name: Louise B. Glenthøj, DMSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: