Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
an integrated multimodal lifestyle intervention (MLifeI)
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring Lifestyle Intervention, Management of Violence, Lipid Profile
Eligibility Criteria
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.
Sites / Locations
- I-Shou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)
Control group
Arm Description
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 control group is the Treatment as Usual (TAU).
Outcomes
Primary Outcome Measures
Weight in kilograms
Clinical Assessment: weight.
Height in meters
Clinical Assessment: height.
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.
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.
Violence Risk Screening (Change is being assessed)
Questionnaires of violence. A higher score indicates a higher violence risk.
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.).
Modified Overt Aggression Scale (Change is being assessed)
Questionnaires of aggression frequency.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05229484
Brief Title
Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I-Shou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Lifestyle Intervention, Management of Violence, Lipid Profile
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)
Arm Type
Experimental
Arm Description
The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group is the Treatment as Usual (TAU).
Intervention Type
Other
Intervention Name(s)
an integrated multimodal lifestyle intervention (MLifeI)
Intervention Description
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 Outcome Measure Information:
Title
Weight in kilograms
Description
Clinical Assessment: weight.
Time Frame
Change of weight from baseline and 6 months (3-month follow-up)
Title
Height in meters
Description
Clinical Assessment: height.
Time Frame
Change of weight from baseline and 6 months (3-month follow-up)
Title
Body Mass Index (BMI)
Description
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.
Time Frame
Change of weight from baseline and 6 months (3-month follow-up)
Title
Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
Description
Lipid profiles. Assessment of serum metabolites.
Time Frame
Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
Title
Violence Risk Screening (Change is being assessed)
Description
Questionnaires of violence. A higher score indicates a higher violence risk.
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Title
Attribution Questionnaire (Change is being assessed)
Description
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.).
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Title
Modified Overt Aggression Scale (Change is being assessed)
Description
Questionnaires of aggression frequency.
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Title
Buss-Perry Aggression Questionnaire (Change is being assessed)
Description
Questionnaires of violence/aggression. The higher the score is, the higher the participant has the violent behavior.
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Title
Barratt Impulsiveness Scale (Change is being assessed)
Description
Questionnaires of impulsivity. The score ranged from 1 (rarely/never) to 4 (almost always/always). The higher the scores indicates the greater the impulsivity.
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Title
Mini-Mental State Examination (Change is being assessed)
Description
Questionnaires of cognitive functioning. The MMSE ranged from 0 to 30, where higher scores indicate better cognitive functioning.
Time Frame
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chi Hsu, Ph.D
Organizational Affiliation
I-Shou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I-Shou University
City
Kaohsiung City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
We'll reach out to this number within 24 hrs