Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
2022年4月9日 更新者：Mei-Chi Hsu、I-Shou University
Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence Through Regulation of Serum Lipid Profile in Schizophrenia: A Randomized Controlled Trial
Total cholesterol levels and other lipids are associated with violence in psychiatric patients.
There is a paucity of studies on preventive interventions.
In this study, an integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence in schizophrenia is proposed.
A controlled clinical trial was carried out to evaluate the effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC in particular, to the recommended levels in schizophrenia.
The investigators examined whether the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning.
研究概览
详细说明
Total cholesterol levels and other lipids are associated with violence in psychiatric patients.
There is a paucity of studies on preventive interventions.
In this study, an integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence in schizophrenia is proposed.
A controlled clinical trial was carried out to evaluate the effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC in particular, to the recommended levels in schizophrenia.
The investigators examined whether the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning.
The multimodal lifestyle intervention included psychoeducation, lifestyle modification and health promotion and exercise.
Outcome measures comprised lipid profiles, body mass index and violence-related parameters.
研究类型
介入性
注册 (实际的)
62
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
-
-
-
Kaohsiung City、台湾
- I-Shou University
-
-
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
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of schizophrenia for more than 2 years
- Psychiatrically hospitalized
- Repetitive violence within one year
- Ambulatory
- Having basic literacy
- More than 20 years old
- Less than 65 years old
Exclusion Criteria:
- Clinical psychiatric diagnosis other than schizophrenia
- Physical co-morbidity or life-threatening illnesses that may impact on lipid homeostasis
- dietary restrictions for physical condition
- pregnancy
- reported disabilities
- impairments or health illness/problems that significantly limited their ability to perform the intervention such as severe arthritis, uncorrected visual or hearing impairments, developmental disability, or signs of intellectual disability.
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：支持治疗
- 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 |
|---|---|
|
实验性的：Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)
The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
|
The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
|
|
无干预：Control group
The control group is the Treatment as Usual (TAU).
|
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 |
|---|---|---|
|
Weight in kilograms
大体时间：Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: weight.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Height in meters
大体时间：Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: height.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Body Mass Index (BMI)
大体时间：Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: Body Mass Index; Weight and height will be combined to report BMI in kg/m^2.
The World Health Organisation defines an adult who has a BMI between 25 and 29.9 as overweight - an adult who has a BMI of 30 or higher is considered obese - a BMI below 18.5 is considered underweight, and between 18.5 to 24.9 a healthy weight.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
大体时间：Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
|
Lipid profiles.
Assessment of serum metabolites.
|
Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
|
|
Violence Risk Screening (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence.
A higher score indicates a higher violence risk.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Attribution Questionnaire (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence attributions.
The Attribution Questionnair was applied to measure the participant's internal/external attributions about the causality and likelihood of violence and responsibility for changing the behavior.
The measure was rated on a continuum scale from 1 (e.g., not at all likely; not at all able, etc.) to 7 (e.g., totally due to me; totally likely; totally able, etc.).
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Modified Overt Aggression Scale (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of aggression frequency.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Buss-Perry Aggression Questionnaire (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence/aggression.
The higher the score is, the higher the participant has the violent behavior.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Barratt Impulsiveness Scale (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of impulsivity.
The score ranged from 1 (rarely/never) to 4 (almost always/always).
The higher the scores indicates the greater the impulsivity.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Mini-Mental State Examination (Change is being assessed)
大体时间：Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of cognitive functioning.
The MMSE ranged from 0 to 30, where higher scores indicate better cognitive functioning.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
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。
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)
2016年8月15日
初级完成 (实际的)
2018年8月14日
研究完成 (实际的)
2018年8月14日
研究注册日期
首次提交
2022年1月6日
首先提交符合 QC 标准的
2022年1月27日
首次发布 (实际的)
2022年2月8日
研究记录更新
最后更新发布 (实际的)
2022年4月15日
上次提交的符合 QC 标准的更新
2022年4月9日
最后验证
2022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
- IShouU-cholesterol I
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.