A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
研究概览
简要总结
Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 Behavioral Therapy for psychosis within the last 12 months
结局指标
主要结局
Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
时间窗: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
11-item structured interview assessing the severity of auditory hallucinations; Range 0-44, Higher values indicate a worse outcome
次要结局
- Change in Beck Depression Inventory - II (BDI-II)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in Empowerment scale (Making Decisions) - Revised Short Form(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in Positive And Negative Syndrome Scale (PANSS)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
研究者
Alexandre Dumais
Psychiatrist, Clinical Associate Professor, Principal Investigator
Ciusss de L'Est de l'Île de Montréal
