Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Psychotic Symptom Rating Scale - auditory hallucinations
研究概览
简要总结
Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. For the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. To help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.The hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •distressing auditory verbal hallucinations
- •medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder
排除标准
- •any change in medication within the past 2 months;
- •substance use disorder within the last 12 months
- •neurological disorder or unstable and serious physical illness
- •ongoing psychotic episode
- •cognitive behavioural therapy for psychosis within the last 12 months
研究组 & 干预措施
Avatar therapy
Immediate Avatar therapy.
干预措施: Avatar therapy (Behavioral)
Treatment-as-usual
Treatment-as-usual then delayed Avatar therapy.
干预措施: Avatar therapy (Behavioral)
Treatment-as-usual
Treatment-as-usual then delayed Avatar therapy.
干预措施: Treatment-as-usual (Other)
结局指标
主要结局
Change in Psychotic Symptom Rating Scale - auditory hallucinations
时间窗: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
11-item structured interview assessing the severity of auditory hallucinations
次要结局
- Change in Beck Depression Inventory - II(Within 1 week before treatment, within 1 week after treatment, follow-up 3 months)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From(Within 1 week before treatment, within 1 week after treatment, follow-up 3 months)
- Change in Beliefs About Voices Questionnaire - Revised(Within 1 week before treatment, within 1 week after treatment, follow-up 3 months)
- Change in Positive And Negative Syndrome Scale(Within 1 week before treatment, within 1 week after treatment, follow-up 3 months)
研究者
Alexandre Dumais
Psychiatrist, researcher
Ciusss de L'Est de l'Île de Montréal