VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Change in symptom severity
研究概览
简要总结
The primary aim of this study is to evaluate the safety and efficacy of AVATAR therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. The intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (VR)-assisted intervention developed for this purpose by the Danish company HEKA VR. The study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (Hungary, Spain, Poland).
The study centers around administering therapy based on VR over a 12-week period, comprising a total of 7 sessions. These sessions are conducted individually and last 50 minutes each. The psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers.
During the intervention, VR technology is used to simulate the source of distressing auditory hallucinations. The therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses.
Patients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. The intervention is conducted with constant monitoring for possible adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia spectrum disorder according to DSM-5,
- •Age 18 or older,
- •The fluent use of the spoken language at the site (Hungarian/Spanish/Polish),
- •Informed consent provided by the patient or their caregiver after being informed about the research procedure
- •Stable medication dosage for at least 4 weeks prior to recruitment,
- •Regular psychiatric follow-up,
- •Experience of auditory hallucinations for at least three months (PANSS hallucination score of at least 3 points),
- •Meeting the remission criteria described by Andreasen, except for the score related to auditory hallucinations
排除标准
- •Inability to identify a single dominant voice that is the subject of the intervention,
- •Lack of cooperation,
- •Intellectual disability based on medical history,
- •Regular substance abuse
- •Central nervous system injury or neurological disease that affects cognitive performance,
- •Suicidal risk
- •Aversion to virtual reality,
- •Severe visual impairment
结局指标
主要结局
Change in symptom severity
时间窗: Week 0, Week 12, Week 24
Positive and Negative Syndrome Scale: Assesses overall symptom severity in schizophrenia spectrum disorders, including positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., affective flattening, social withdrawal), and general psychopathology (e.g., anxiety, depression).The scale is administered through a semi-structured interview by trained clinicians. The minimum possible score for positive and negative symptoms is 7 points, and the maximum possible score is 49 points. For general symptomatology, the possible minimum score is 16 points, and the maximum score is 112 points. The overall score can range from 30-210. Higher scores indicate greater symptom severity.
Change in severity of auditory hallucinations
时间窗: Week 0, Week 12, Week 24
Psychotic Symptom Rating Scales: Evaluates the severity of auditory hallucinations and associated delusions, including frequency, duration, loudness, and disruption. The scale is administered through a semi-structured interview by trained clinicians. The scale comprises 17 items of the mentioned specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The total score range for the test is 0 to 68, where lower scores indicate reduced severity of hallucinatory experiences.
Change in beliefs about voices in schizophrenia spectrum disorder
时间窗: Week 0, Week 12, Week 24
Beliefs About Voices Questionnaire-Revised: A self-report questionnaire designed to assess individuals' beliefs about auditory hallucinations (e.g.: how important the voices are to the individual, perceived control, emotional reactions elicited by the voices. The scale comprises 35 items, with each item being rated from 0 to 3. The total score range for the test is 0-105, where lower scores indicate reduced distress and improved coping with hallucinatory experiences.
次要结局
- Change in comorbidity (depression)(Week 0, Week 12, Week 24)
- Change in comorbidity (anxiety)(Week 0, Week 12, Week 24)
- Change in subjective well-being(Week 0, Week 12, Week 24)
- Change in health-related quailty of life(Week 0, Week 12, Week 24)
- Change in emotion regulation(Week 0, Week 12, Week 24)
- Change in self-efficacy(Week 0, Week 12, Week 24)
研究者
Gábor Csukly
Associate professor
Semmelweis University