Clinical trial NCT05229484: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Lifestyle Intervention
Management of Violence
Lipid Profile
Lead sponsor: I-Shou University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Weight in kilograms
timeFrame: Change of weight from baseline and 6 months (3-month follow-up)
measure: Height in meters
timeFrame: Change of weight from baseline and 6 months (3-month follow-up)
measure: Body Mass Index (BMI)
timeFrame: Change of weight from baseline and 6 months (3-month follow-up)
measure: Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
timeFrame: Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
measure: Violence Risk Screening (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
measure: Attribution Questionnaire (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
measure: Modified Overt Aggression Scale (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
measure: Buss-Perry Aggression Questionnaire (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
measure: Barratt Impulsiveness Scale (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
measure: Mini-Mental State Examination (Change is being assessed)
timeFrame: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: I-Shou University
Study officials:
affiliation: I-Shou University
name: Mei-Chi Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: