The Effectiveness of Assertive Community Treatment on Schizophrenic Patients

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Combination Product: Assertive community treatment; Combination Product: Basic public health services.

• Registration Number: NCT04511663
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-09-18
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Assertive community treatment	The intervention group received assertive community treatment, in which the team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers.
control group	Basic public health services.	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.

Primary Outcome Measures

Name	Time	Method
PANSS	6 months	PANSS（Positive and Negative Syndrome Scale） is a relatively mature assessment tool commonly used in clinical research to assess the severity of schizophrenia symptoms. It consists of a positive symptom subscale (7 items), a negative symptom subscale (7 items) and a general psychopathological symptom subscale (16 items), a total of 30 items.Each item has specific definitions and operational grading criteria. It is divided into 7 grades according to the level of psychopathology (1\~7 points). The higher the score, the heavier the symptoms. The total score of PANSS is 30- 210 points, the positive symptom subscale and the negative symptom subscale are 7-49 points, and the general psychopathological symptoms subscale is 16 to 112 points.

Secondary Outcome Measures

Name	Time	Method
PSP	6 months	PSP (The Personal and Social Performance Scale) uses a 100-point rating scale to assesses social functioning. A score of 71-100 indicates mild difficulties in social functioning; 31-70 indicates varying degrees of impairment and disability; and 0-30 indicates poor functioning that requires intensive support or supervision. Chinese version of the PSP demonstrated good psychometric characteristics

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China