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Stage-specific Case Management for Early Psychosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00919620
Enrollment
360
Registered
2009-06-12
Start date
2009-06-30
Completion date
2015-12-31
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders

Keywords

Psychotic disorders, Psychoses

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.

Interventions

BEHAVIORALstage-specific case-management

Stage-specific case-management for psychosis by designated key-workers according to specified protocol

Sponsors

Queen Mary Hospital, Hong Kong
CollaboratorOTHER
Kwai Chung Hospital
CollaboratorOTHER
Kowloon Hospital, Hong Kong
CollaboratorOTHER
Castle Peak Hospital
CollaboratorOTHER_GOV
Shatin Hospital
CollaboratorOTHER
Tai Po Hospital
CollaboratorOTHER_GOV
North District Hospital, Hong Kong
CollaboratorUNKNOWN
United Christian Hospital
CollaboratorOTHER
Queen Elizabeth Hospital, Hong Kong
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
26 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Functioning (social and occupational)baseline, 6-month, 12-month, 24-month, 36-month, 48-month

Secondary

MeasureTime frameDescription
Psychotic symptomsbaseline, 6-month, 12-month, 24-month, 36-month, 48-monthPsychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
Depressive symptomsbaseline, 12-month, 24-month, 36-month, 48-monthDepressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS).
Neurocognitive functioningbaseline, 12-month, 24-month, 36-month, 48-monthA 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 economicsbaseline, 6-month, 12-month, 24-month, 36-month, 48-month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026