Schizophrenia Clinical Trial
Official title:
The Effectiveness of a 2-year Assertive Community Treatment on Schizophrenic Patients in an Urban District of Shanghai
Verified date | August 2020 |
Source | Shanghai Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 198 |
Est. completion date | December 31, 2019 |
Est. primary completion date | September 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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