The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Biofeedback to Increase Tolerability and Therapy Efficacy in Psychosis
概览
- 阶段
- 不适用
- 干预措施
- Virtual Reality-based Intervention employing Neurofeedback
- 疾病 / 适应症
- Auditory Hallucinations
- 发起方
- University Hospital Bispebjerg and Frederiksberg
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability as assessed by recruitment rate
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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:
- Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?
- 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.
详细描述
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.
研究者
Sara Breivik Soleim
Psychologist / Research Assistant
University Hospital Bispebjerg and Frederiksberg
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Virtual Reality-based Intervention employing Neurofeedback
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.
干预措施: Virtual Reality-based Intervention
结局指标
主要结局
Feasibility and acceptability as assessed by recruitment rate
时间窗: Recruitment rate is monitored throughout the study period (1 year)
Percentage of target sample (30 participants) recruited after 12 months from study start.
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
时间窗: Retention rates are monitored throughout the study period (1 year)
Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
时间窗: At 12 weeks follow up
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.
次要结局
- 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)
- Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire(Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up)
- Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)(Baseline and at 12 weeks follow up)
- Social functioning as assessed by the Social Functioning Scale (SFS)(Baseline and at 12 weeks follow up)