Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
9 de abril de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
62
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Kaohsiung City, Taiwan
- I-Shou University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: Control group
The control group is the Treatment as Usual (TAU).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Weight in kilograms
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
15 de agosto de 2016
Conclusão Primária (Real)
14 de agosto de 2018
Conclusão do estudo (Real)
14 de agosto de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
6 de janeiro de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de janeiro de 2022
Primeira postagem (Real)
8 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IShouU-cholesterol I
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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