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Completed

NCT Number: NCT05229484

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I-Shou University

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Weight in kilograms

    Time frame: Change of weight from baseline and 6 months (3-month follow-up)

    Clinical Assessment: weight.

  2. Height in meters

    Time frame: Change of weight from baseline and 6 months (3-month follow-up)

    Clinical Assessment: height.

  3. Body Mass Index (BMI)

    Time frame: 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.

  4. Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)

    Time frame: Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)

    Lipid profiles. Assessment of serum metabolites.

  5. Violence Risk Screening (Change is being assessed)

    Time frame: 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.

  6. Attribution Questionnaire (Change is being assessed)

    Time frame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)

    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.).

  7. Modified Overt Aggression Scale (Change is being assessed)

    Time frame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)

    Questionnaires of aggression frequency.

  8. Buss-Perry Aggression Questionnaire (Change is being assessed)

    Time frame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)

    Questionnaires of violence/aggression. The higher the score is, the higher the participant has the violent behavior.

  9. Barratt Impulsiveness Scale (Change is being assessed)

    Time frame: 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.

  10. Mini-Mental State Examination (Change is being assessed)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

I-Shou University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2022
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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