Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
2022년 4월 9일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
62
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kaohsiung City, 대만
- I-Shou University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
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간섭 없음: Control group
The control group is the Treatment as Usual (TAU).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Weight in kilograms
기간: Change of weight from baseline and 6 months (3-month follow-up)
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Clinical Assessment: weight.
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Change of weight from baseline and 6 months (3-month follow-up)
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Height in meters
기간: Change of weight from baseline and 6 months (3-month follow-up)
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Clinical Assessment: height.
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Change of weight from baseline and 6 months (3-month follow-up)
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Body Mass Index (BMI)
기간: Change of weight from baseline and 6 months (3-month follow-up)
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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.
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Change of weight from baseline and 6 months (3-month follow-up)
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Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
기간: Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
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Lipid profiles.
Assessment of serum metabolites.
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Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
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Violence Risk Screening (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Questionnaires of violence.
A higher score indicates a higher violence risk.
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Attribution Questionnaire (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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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.).
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Modified Overt Aggression Scale (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Questionnaires of aggression frequency.
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Buss-Perry Aggression Questionnaire (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Questionnaires of violence/aggression.
The higher the score is, the higher the participant has the violent behavior.
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Barratt Impulsiveness Scale (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Questionnaires of impulsivity.
The score ranged from 1 (rarely/never) to 4 (almost always/always).
The higher the scores indicates the greater the impulsivity.
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Mini-Mental State Examination (Change is being assessed)
기간: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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Questionnaires of cognitive functioning.
The MMSE ranged from 0 to 30, where higher scores indicate better cognitive functioning.
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Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 8월 15일
기본 완료 (실제)
2018년 8월 14일
연구 완료 (실제)
2018년 8월 14일
연구 등록 날짜
최초 제출
2022년 1월 6일
QC 기준을 충족하는 최초 제출
2022년 1월 27일
처음 게시됨 (실제)
2022년 2월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 9일
마지막으로 확인됨
2022년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IShouU-cholesterol I
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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