Clinical trial NCT04511663: The Effectiveness of Assertive Community Treatment on Schizophrenic Patients
Official title: The Effectiveness of a 2-year Assertive Community Treatment on Schizophrenic Patients in an Urban District of Shanghai
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Assertive community treatment
Community rehabilitation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PANSS
timeFrame: 6 months
Secondary outcomes:
measure: PSP
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Jun Cai
role: STUDY_DIRECTOR
References: