Stage-specific Case Management for Early Psychosis

Psychotic Disorders Clinical Trial

Official title:

Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919620
• Other study ID #: jcep-rct
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.

Description:

Psychotic disorder is a debilitating illness which imposes substantial impact to the patients, their families, and the society. The provision of early intervention provides a window of opportunity to minimize the social and economic burden incurred by the illness.

Many previous studies of effectiveness of early intervention used the historical control approach and are subjected to cohort effects. For example, change of medication pattern over time could potentially lead to differences in outcome. In addition, few studies provide longer-term outcome data of treatment program beyond two years. The optimal length of intervention has not been determined, and many programmes used 12-24 month intervention mainly based on resources available. It is also important to ask whether favorable effects of early intervention could be sustained over time. Further analyses will be done to assess whether EI effects are more pronounced in particular subgroups including DUP, age, sex and diagnosis.

The proposed study aims to address these issues by using a randomized controlled design to investigate the longer-term (4 year) outcome of patients with first episode psychosis. The study randomizes 360 patients with first episode psychotic disorders into 3 groups: (1) standard care (outpatient based care with inpatient and community care as required); (2) standard care with 2 years of add-on stage specific case-management (individualized care delivered by designated case managers according to specific protocol); and (3) standard care with 4 years of add-on stage specific case management.

The study hypothesis are: (1) both 2 years and 4 years of case management produce better outcomes than standard care alone; (2) 4 years of case management produces better outcome than 2 years of case management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 55 Years

Eligibility

Inclusion Criteria:

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis nos or delusional disorder

• Cantonese-speaking Chinese

• Ability to understand the nature of the study and sign informed consent

• Capacity to participate in cognitive testing

Exclusion Criteria:

• Organic Brain disorder

• Known history of intellectual disability

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (10)

Lead Sponsor	Collaborator
The University of Hong Kong	Castle Peak Hospital, Kowloon Hospital, Hong Kong, Kwai Chung Hospital, Hong Kong, North District Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Shatin Hospital, Tai Po Hospital, United Christian Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functioning (social and occupational)		baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary	Psychotic symptoms	Psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)	baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary	Psychotic symptoms	Psychotic symptoms will be assessed using Scale for the Assessment of Positive Symptoms (SAPS)	baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary	Psychotic symptoms	Psychotic symptoms will be assessed using Scale for the Assessment of Negative Symptoms (SANS).	baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary	Depressive symptoms	Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS).	baseline, 12-month, 24-month, 36-month, 48-month
Secondary	Neurocognitive functioning	A battery of neurocognitive tests will be conducted, including Handedness, Trail Making, Wisconsin Card Sorting Test, Semantic Verbal Fluency, Logical Verbal Memory, Visual Patterns Test, Letter Number Span, Monotone Counting, and Soft Neurological Signs.	baseline, 12-month, 24-month, 36-month, 48-month
Secondary	Health economics		baseline, 6-month, 12-month, 24-month, 36-month, 48-month