Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence Through Regulation of Serum Lipid Profile in Schizophrenia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229484
• Other study ID #: IShouU-cholesterol I
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: April 2022
• Source: I-Shou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	I-Shou University	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
I-Shou University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kilograms	Clinical Assessment: weight.	Change of weight from baseline and 6 months (3-month follow-up)
Primary	Height in meters	Clinical Assessment: height.	Change of weight from baseline and 6 months (3-month follow-up)
Primary	Body Mass Index (BMI)	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)
Primary	Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)	Lipid profiles. Assessment of serum metabolites.	Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
Primary	Violence Risk Screening (Change is being assessed)	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)
Primary	Attribution Questionnaire (Change is being assessed)	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)
Primary	Modified Overt Aggression Scale (Change is being assessed)	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)
Primary	Buss-Perry Aggression Questionnaire (Change is being assessed)	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)
Primary	Barratt Impulsiveness Scale (Change is being assessed)	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)
Primary	Mini-Mental State Examination (Change is being assessed)	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)