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The Effectiveness of Assertive Community Treatment on Schizophrenic Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Assertive community treatment
Basic public health services.
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Assertive community treatment, Community rehabilitation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

intervention group

control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2020
Last Updated
August 11, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04511663
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Assertive community treatment, Community rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A single-blind method was used, in which all the assessments were independently completed by trained psychiatrists who didn't know the grouping.
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
The intervention group received assertive community treatment, in which the team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers.
Arm Title
control group
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Assertive community treatment
Intervention Description
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
Intervention Name(s)
Basic public health services.
Intervention Description
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.
Primary Outcome Measure Information:
Title
PANSS
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PSP
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 18 and 50 years old; course of disease between 2 and 20 years; living with family members who can function as their caregivers; disease condition was stable and the total score of the Positive and Negative Symptoms Scale (PANSS) is less than 60. Exclusion Criteria: women during pregnancy; having mental retardation or psychoactive substance-induced mental disorders; having serious physical condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Cai
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectiveness of Assertive Community Treatment on Schizophrenic Patients

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