Stage-specific Case Management for Early Psychosis
- Conditions
- Psychotic Disorders
- Interventions
- Behavioral: stage-specific case-management
- Registration Number
- NCT00919620
- Lead Sponsor
- The University of Hong Kong
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- 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
- Organic Brain disorder
- Known history of intellectual disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description case management (4 yrs) stage-specific case-management 4-year case management and standard care case management (2 yrs) and standard care (2 yrs) stage-specific case-management 2-year case management and standard care
- Primary Outcome Measures
Name Time Method Functioning (social and occupational) baseline, 6-month, 12-month, 24-month, 36-month, 48-month
- Secondary Outcome Measures
Name Time Method Depressive symptoms baseline, 12-month, 24-month, 36-month, 48-month Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS).
Psychotic symptoms baseline, 6-month, 12-month, 24-month, 36-month, 48-month Psychotic symptoms will be assessed using Scale for the Assessment of Negative Symptoms (SANS).
Neurocognitive functioning baseline, 12-month, 24-month, 36-month, 48-month 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.
Health economics baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Trial Locations
- Locations (1)
The University of Hong Kong
🇨🇳Hong Kong, China