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

NCT ID: NCT05229484

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-15
• Study Completion Date: 2018-08-14

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

an integrated multimodal lifestyle intervention (MLifeI)

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I-Shou University

OTHER

Sponsor Role: lead

Responsible Party

Mei-Chi Hsu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei-Chi Hsu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

I-Shou University

Locations

I-Shou University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

IShouU-cholesterol I

Identifier Type: -

Identifier Source: org_study_id