The Effectiveness of Assertive Community Treatment on Schizophrenic Patients

NCT ID: NCT04511663

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-12-31

Brief Summary

Assertive community treatment (ACT) is a community-based, patient-centered, and rehabilitation-oriented model based on multidisciplinary service teams. It has been proved to be suitable for the management of patients with severe mental disorder in the community. In this study, we aimed to investigate the effectiveness of ACT in an urban district of Shanghai with a larger sample size and a 24-month duration of follow up. We hypothesized that patients assigned into ACT would show better improvement in psychiatric symptoms and social function.

Detailed Description

Assertive community treatment (ACT) is a community-based, patient-centered, and rehabilitation-oriented model based on multidisciplinary service teams. It has been proved to be suitable for the management of patients with severe mental disorder in the community. In this study, we aimed to investigate the effectiveness of ACT in an urban district of Shanghai with a larger sample size and a 24-month duration of follow up. We hypothesized that patients assigned into ACT would show better improvement in psychiatric symptoms and social function.The study protocol was approved by the Institutional Review Board in Shanghai Mental Health Center.

Aim of the study: 1.1 To explore the effectiveness of assertive community treatment in patients with schizophrenia. 1.2 The patients were followed up for 24 months to explore the duration of ACT.

Introduction of the study: Patients who previously diagnosed as schizophrenia according to International Classification of Diseases 10th Revision (ICD-10) in the psychiatric hospitals would receive basic public health service in the community. The selected schizophrenic patients were randomly assigned into intervention group and control group by a computer randomization algorithm. During the following 2 years, the control group received basic public health services in the community while the intervention group received ACT. Clinical assessments were conducted at baseline and every 6 months till the end of the 2-year study. A single-blind method was used, in which all the assessments were independently completed by trained psychiatrists who didn't know the grouping.The Positive and Negative Symptoms Scale (PANSS) and the Personal and Social Performance Scale (PSP) were measured at baseline and every 6 months during the study.

Conditions

Schizophrenia

Study Design

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

Study Groups

intervention group

The intervention group received assertive community treatment, in which the team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers.

Group Type: ACTIVE_COMPARATOR

Assertive community treatment

Intervention Type: COMBINATION_PRODUCT

The intervention team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers. The specific services provided by the team include individual service plan. Each patient got a comprehensive evaluation within one month to establish treatment goals and individual intervention plan, rehabilitation training, family intervention peer support group, individual psychological counseling and crisis intervention.

control group

The control group received basic public health services which is regular medical follow-up including symptom and medication evaluation, social function evaluation and physical examination after hospital discharge.

Group Type: OTHER

Basic public health services.

Intervention Type: COMBINATION_PRODUCT

The control group received regular medical follow-up including symptom and medication evaluation, social function evaluation and physical examination after hospital discharge. The frequency was once a quarter.

Interventions

Assertive community treatment

The intervention team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers. The specific services provided by the team include individual service plan. Each patient got a comprehensive evaluation within one month to establish treatment goals and individual intervention plan, rehabilitation training, family intervention peer support group, individual psychological counseling and crisis intervention.

Intervention Type: COMBINATION_PRODUCT

Basic public health services.

The control group received regular medical follow-up including symptom and medication evaluation, social function evaluation and physical examination after hospital discharge. The frequency was once a quarter.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. aged between 18 and 50 years old;

2. course of disease between 2 and 20 years;

3. living with family members who can function as their caregivers;

4. disease condition was stable and the total score of the Positive and Negative Symptoms Scale (PANSS) is less than 60.

Exclusion Criteria

1. women during pregnancy;

2. having mental retardation or psychoactive substance-induced mental disorders;

3. having serious physical condition.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Cai

Role: STUDY_DIRECTOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, , China

Countries

China

Other Identifiers

WeiboZhang

Identifier Type: -

Identifier Source: org_study_id