Stage-specific Case Management for Early Psychosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Behavioral: stage-specific case-management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: case management (4 yrs)<br>4-year case management and standard care | Behavioral: stage-specific case-management<br>* Stage-specific case-management for psychosis by designated key-workers according to specified protocol<br>|
| Active Comparator: case management (2 yrs) and standard care (2 yrs)<br>2-year case management and standard care | Behavioral: stage-specific case-management<br>* Stage-specific case-management for psychosis by designated key-workers according to specified protocol<br>|
| No Intervention: standard care (4 yrs)<br>standard care for 4 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning (social and occupational) |  | baseline, 6-month, 12-month, 24-month, 36-month, 48-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Depressive symptoms | Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS). | baseline, 12-month, 24-month, 36-month, 48-month | 
| 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 | 
| Health economics |  | baseline, 6-month, 12-month, 24-month, 36-month, 48-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotic disorders, Psychoses