The Effectiveness of Assertive Community Treatment on Schizophrenic Patients

The Effectiveness of a 2-year Assertive Community Treatment on Schizophrenic Patients in an Urban District of Shanghai

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Combination product: Assertive community treatment; Combination product: Basic public health services.

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; The intervention group received assertive community treatment, in which the team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers.	Combination product: 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANSS	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSP	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	6 months

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Director: Jun Cai, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Assertive community treatment; Community rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: WeiboZhang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No