The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Auditory Hallucinations Rating Scale (AHRS)
研究概览
简要总结
One hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group A and group B. Participants of group A will firstly receive a speech competition training for 2 weeks, and those in group B will firstly receive music intervention as placebo treatment. Specifically, speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. The reaction time, accuracy rate and the number of auditory hallucinations during the task will be recorded. On the other hand, the placebo treatment includes soothing music twice a day for a fixed period of time while patients receiving drug treatment. After 2 weeks, the interventions for group A and group B will be switch.
Clinical symptoms will be evaluated using the auditory hallucinations rating scale, positive and negative syndrome scale, belief about voices questionnaire-revised at baseline, 2-week follow up and 4-week follow up. All the data will be analyzed with the Statistical Product and Service Solutions(SPSS) software.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling the diagnostic criteria for schizophrenia as in the International Classification of Diseases (ICD) - 10;
- •Aged 18-55 years old;
- •Education level over 6 years;
- •The score of P3 item in PANSS ≥ 3 points;
- •Taking antipsychotics at a therapeutic dose for at least 1 month, and the symptoms of auditory hallucinations have not been significantly improved, and the score of Auditory Hallucinations Rating Scale (AHRS) is still greater than 18 points;
- •Capable of understanding and singing a written informed consent form, and be able to cooperate in completing intervention training and assessments.
排除标准
- •Diagnosing other Axis I mental disorders;
- •A history of severe neurological disease, brain trauma, major physical disease or history of drug dependence;
- •Auditory hallucinations caused by organic brain diseases;
- •Patients who cannot cooperate with the completion of training;
- •Patients with serious suicidal or self injurious behavior;
- •Pregnant and lactating women;
- •History of alcohol abuse;
- •Intellectual impairment (IQ<70);
- •Patients with hearing impairment.
结局指标
主要结局
Auditory Hallucinations Rating Scale (AHRS)
时间窗: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
The Hoffman Hallucination Rating Scale (AHRS) is a clinical tool used to assess the severity of auditory hallucinations in patients. In current study, the scale is used to evaluate the severity of auditory hallucinations in patients with schizophrenia, mainly from seven aspects: frequency, authenticity, loudness, number of sounds, duration, attention significance, and pain level.
Belief About Voices Questionnaire-Revised (BAVQ-R)
时间窗: Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
This scale is a self-assessment scale developed by Chadwick et al., used to measure the beliefs, emotions, and behaviors of patients with auditory hallucinations, with a total of 35 items. Straus et al. reconducted factor analysis on its basis and extracted four factors, namely victim belief (authority belief+malicious belief), goodwill belief, participation in auditory hallucinations, and resistance to auditory hallucinations. The scale items are scored using the Likert 4-level scoring method, with a score of 0-3 and independent scores for each dimension.
次要结局
- Negative and Negative Syndrome Scale (PANSS)(Change of PANSS score from baseline at 2 weeks and 4 weeks respectively)
研究者
Jing SHI
Nurse practitioner
Shanghai Mental Health Center