Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
9. april 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
62
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kaohsiung City, Taiwan
- I-Shou University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Control group
The control group is the Treatment as Usual (TAU).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight in kilograms
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
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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)
Tidsramme: 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)
|
|
Violence Risk Screening (Change is being assessed)
Tidsramme: 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)
Tidsramme: 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)
|
|
Modified Overt Aggression Scale (Change is being assessed)
Tidsramme: 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)
|
|
Buss-Perry Aggression Questionnaire (Change is being assessed)
Tidsramme: 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)
|
|
Barratt Impulsiveness Scale (Change is being assessed)
Tidsramme: 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.
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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)
Tidsramme: 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.
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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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Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. august 2016
Primær færdiggørelse (Faktiske)
14. august 2018
Studieafslutning (Faktiske)
14. august 2018
Datoer for studieregistrering
Først indsendt
6. januar 2022
Først indsendt, der opfyldte QC-kriterier
27. januar 2022
Først opslået (Faktiske)
8. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IShouU-cholesterol I
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