Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
2016年3月16日 更新者：Danang Psychiatric Hospital
Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation.
Other treatment for schizophrenia and other mental illness are provided as usual.
研究概览
详细说明
Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation.
Other treatment for schizophrenia and other mental illness are provided as usual.
The psychoeducation program focuses on: (a) explaining schizophrenia as a medical, biological illness, (b) the prognosis for schizophrenia (e.g., that it is possible to lead a normal life), and (c) what the family and patient can do to maximize the outcome.
研究类型
介入性
注册 (实际的)
59
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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Danang、越南
- Danang Psychiatric Hospital
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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 30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:
- Diagnosis of schizophrenia, based on ICD-10
- Receive in-patient treatment at hospital
- Length of schizophrenia less than 3 years.
- Treated 3 or less times for schizophrenia.
Exclusion Criteria:
- Mental retardation, or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled.
- Suicidal ideation
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：Psychoeducation
3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled.
Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
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3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled.
Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
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无干预：Control
Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.
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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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Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
大体时间：baseline (pre-treatment). six months post-baseline.
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Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable.
The Quality of Life Enjoyment and Satisfaction Questionnaire with patient-report is used at both timepoints.
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baseline (pre-treatment). six months post-baseline.
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Change from baseline (pre-treatment) at 6 months post-baseline in family-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.
大体时间：baseline (pre-treatment). six months post-baseline.
|
Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable.
The Quality of Life Enjoyment and Satisfaction Questionnaire with family-report is used at both timepoints.
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baseline (pre-treatment). six months post-baseline.
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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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Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
大体时间：baseline (pre-treatment). six months post-baseline.
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Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable.
The Stigma Towards Schizophrenia with patient-report is used at both timepoints.
|
baseline (pre-treatment). six months post-baseline.
|
|
Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.
大体时间：baseline (pre-treatment). six months post-baseline.
|
Change in stigma towards schizophrenia using an Analysis of Covariance with the baseline stigma towards schizophrenia as the covariate, the 6 month stigma towards schizophrenia assessment as the dependent variable, and treatment group as the independent variable.
The Stigma Towards Schizophrenia with family-report is used at both timepoints.
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baseline (pre-treatment). six months post-baseline.
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Patient-report for schizophrenia medication compliance, at 6 months post-baseline
大体时间：6 months post-baseline
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Analysis of Variance on medication compliance as reported by the patient
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6 months post-baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-report satisfaction with hospital services, at 6 months post-baseline
大体时间：6 months post-baseline
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Patient-report satisfaction with services provided by the hospital.
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6 months post-baseline
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Family-report satisfaction with hospital services, at 6 months post-baseline
大体时间：6 months post-baseline
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Family-report satisfaction with services provided by the hospital.
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6 months post-baseline
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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。
调查人员
- 首席研究员：Ngoc Tran, MD、Danang Psychiatric Hospital
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
2014年9月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2016年3月3日
首先提交符合 QC 标准的
2016年3月16日
首次发布 (估计)
2016年3月22日
研究记录更新
最后更新发布 (估计)
2016年3月22日
上次提交的符合 QC 标准的更新
2016年3月16日
最后验证
2016年3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.
Psychoeducation的临床试验
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University of Colorado, DenverNational Cancer Institute (NCI)主动，不招人