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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: an integrated multimodal lifestyle intervention (MLifeI)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • I-Shou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Control group; The control group is the Treatment as Usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kilograms	Clinical Assessment: weight.	Change of weight from baseline and 6 months (3-month follow-up)
Height in meters	Clinical Assessment: height.	Change of weight from baseline and 6 months (3-month follow-up)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: I-Shou University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lifestyle Intervention; Lipid Profile; Management of Violence
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: IShouU-cholesterol I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No