Trial and Follow-up of the Efficacy of Two-stage Integrated Treatment for Chinese Schizophrenia Inpatients
2016年7月29日 更新者：Shenglin She、Guangzhou Psychiatric Hospital
Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
Regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia.
However, it's expensive, time-consuming, and sometimes inconvenient for patients and their family members in developing areas where the number of well-trained therapist remains limited in local psychiatric settings.
The investigators aimed to establish an efficient model of integrated treatment (IT) for patients with schizophrenia.
The procedure contains two stages: a centralized treatment during hospitalization and the following consolidation treatments with long intervals.
研究概览
地位
未知
条件
研究类型
介入性
注册 (预期的)
170
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510370
- 招聘中
- Guangzhou psychitric hosptial
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接触：
- Yingjun Zheng, Phd,Md
- 电话号码：+8618998303126
- 邮箱：brainzheng@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosed with the Structured Clinical Interview for DSM-IV (SCID-DSM-IV) (First et al., 1996), were recruited from inpatient psychiatric ward. Patients with diagnoses of schizoaffective or other psychotic disorders were not included.
- Additional inclusion criteria for participants were aged between 18 and 50 years with education of more than 9 years, and
- PANSS (Positive and Negative Syndrome Scale) total scores of more than 60.
Exclusion Criteria:
- Diagnosed with a serious and unstable medical condition including abuse and/or dependence of alcohol and/or drugs;
- Pregnant or breastfeeding;
- Under a treatment of clozapine with a dose of more than 200 mg/day,
- Had a treatment of the electroconvulsive therapy (ECT) or modified electroconvulsive therapy within 6 months(MECT) within the past six months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：综合治疗
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All patients with schizophrenia were under medication treatment at the baseline.
Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation.
Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.
Rehabilitation treatment include three modules: medication management, symptom management, and social kill training.
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Rehabilitation treatment therapy.
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.
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有源比较器：antipsychotic medication alone treatment
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All patients with schizophrenia were under medication treatment at the baseline.
Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation.
Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Medication nonadherence was assessed in two groups after 12-month follow-up.
大体时间：One year follow-up
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Medication non-adherence was defined as a failure to take medication for one week or longer
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One year follow-up
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Rehospitalization rate was assessed in two groups after 12-month follow-up.
大体时间：One year follow-up
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One year follow-up
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Rate of Relapse was assessed in two groups after 12-month follow-up.
大体时间：One year follow-up
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One year follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.
大体时间：One year follow-up
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Time course and treatment differences for changes in the PANSS( Positive and Negative Syndrome Scale) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
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One year follow-up
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Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.
大体时间：One year follow-up
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Time course and treatment differences for changes in the CGI( Clinical Global Impressions) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
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One year follow-up
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Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.
大体时间：One year follow-up
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Time course and treatment differences for changes in the PSP(Personal and Social Performance) were analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
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One year follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2016年7月14日
首先提交符合 QC 标准的
2016年7月29日
首次发布 (估计)
2016年8月1日
研究记录更新
最后更新发布 (估计)
2016年8月1日
上次提交的符合 QC 标准的更新
2016年7月29日
最后验证
2016年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.