Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence Through Regulation of Serum Lipid Profile in Schizophrenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
时间窗: Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
Lipid profiles. Assessment of serum metabolites.
Height in meters
时间窗: Change of weight from baseline and 6 months (3-month follow-up)
Clinical Assessment: height.
Weight in kilograms
时间窗: Change of weight from baseline and 6 months (3-month follow-up)
Clinical Assessment: weight.
Body Mass Index (BMI)
时间窗: 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.
Attribution Questionnaire (Change is being assessed)
时间窗: 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.).
Violence Risk Screening (Change is being assessed)
时间窗: 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.
Modified Overt Aggression Scale (Change is being assessed)
时间窗: 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.
Buss-Perry Aggression Questionnaire (Change is being assessed)
时间窗: 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.
Barratt Impulsiveness Scale (Change is being assessed)
时间窗: 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.
Mini-Mental State Examination (Change is being assessed)
时间窗: 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.
次要结局
未报告次要终点