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

NCT05229484 | Completed

• 1 other identifier: IShouU-cholesterol I
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Lifestyle Intervention; Management of Violence; Lipid Profile

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (2)

Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)

EXPERIMENTAL

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)

Control group

NO INTERVENTION

The control group is the Treatment as Usual (TAU).

Interventions

an integrated multimodal lifestyle intervention (MLifeI) OTHER

The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.

Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I-Shou University: lead

Study Sites (1)

I-Shou University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Mei-Chi Hsu, Ph.D

  I-Shou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 8, 2022
• Study Start: August 15, 2016
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)