Body-Mind-Spirit Intervention for Women With Early Psychosis
2021年4月10日 更新者：Professor Eric Y.H. Chen、The University of Hong Kong
Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial
This is an open-labelled randomised controlled trial (RCT) that aims to examine the effectiveness of exercise coaching approach in improving the physical activity engagement in patients with psychosis.
研究概览
详细说明
Patients with psychosis will be recruited from the out-patient department (OPD) of the Kwai Chung Hospital (KCH).
The patient with informed consent will be randomly assigned to exercise coaching or psychoeducation group to prevent decline in cognitive and functional outcomes known to be common in this group.
This comprises locally-tested evidence-based intervention strategies such as exercise and Yoga intervention, combined with exercise coaching to consolidate the exercise habit.
Each of the intervention includes 28 sessions spanning for16-week.
研究类型
介入性
注册 (预期的)
57
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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Hong Kong、香港、0000
- University of Hong Kong
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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 64年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Female
- Age from 18-64
- Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders
- Have the ability to understand Chinese
- Able to give informed consent
- Physically fit for participating in our study assessed by using the Physical Activity Readiness Questionnaire (PAR-Q)
Exclusion Criteria:
- Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders.
- Comorbid substance dependence
- Unstable psychotic symptoms
- Any history of brain trauma or organic brain disease
- Known history of intellectual disability or special school attendance
- Other mental conditions that requires other treatment priorities, e.g., suicidal risk.
- Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Exercise coaching group
This intervention is an integration of aerobic exercise, yoga, mindfulness and exercise coaching.
Exercise class and coaching will be provided weekly in the first 8 weeks.
In the next 8 week, exercise class will be provided weekly while exercise coaching will be provided bi-weekly.
The exercise class includes aerobic exercise coached by a well-trained intervention officer, and the yoga and mindfulness coached by a certified yoga instructor.
The exercise coaching session followed by some stretching and aerobic exercise session.
Both motivational coaching and aerobic exercise will be coached by a well-trained intervention officer.
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28 classes in 16 weeks
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有源比较器：Psychoeducation group
This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.
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28 classes in 16 weeks
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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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Physical Activity Engagement
大体时间：Change from baseline to 6-month post-intervention
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Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)
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Change from baseline to 6-month post-intervention
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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：Eric Yu Hai Chen, MD、The University of Hong Kong
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 (实际的)
2018年11月15日
初级完成 (预期的)
2021年6月30日
研究完成 (预期的)
2021年9月30日
研究注册日期
首次提交
2018年6月14日
首先提交符合 QC 标准的
2018年11月21日
首次发布 (实际的)
2018年11月23日
研究记录更新
最后更新发布 (实际的)
2021年4月14日
上次提交的符合 QC 标准的更新
2021年4月10日
最后验证
2021年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- JCWowExercise
- 124-01 (KWC IRB / REC No.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
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