NCT04511663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Schizophrenia

Keywords

SchizophreniaAssertive community treatmentCommunity rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • PSP

    6 months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

control group

OTHER

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.

Interventions

Assertive community treatmentCOMBINATION_PRODUCT

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 group
Basic public health services.COMBINATION_PRODUCT

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.

control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • women during pregnancy;
  • having mental retardation or psychoactive substance-induced mental disorders;
  • having serious physical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Community Mental Health Services

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jun Cai

    Shanghai Mental Health Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A single-blind method was used, in which all the assessments were independently completed by trained psychiatrists who didn't know the grouping.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 13, 2020

Study Start

July 1, 2017

Primary Completion

September 18, 2019

Study Completion

December 31, 2019

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)