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临床试验/NCT03585127
NCT03585127已完成不适用

A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.

Ciusss de L'Est de l'Île de Montréal2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年3月1日最近更新:
适应症

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

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

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Dumais

Psychiatrist, Clinical Associate Professor, Principal Investigator

Ciusss de L'Est de l'Île de Montréal

研究点 (2)

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