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Stage-specific Case Management for Early Psychosis

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Psychotic Disorders

Treatments

Behavioral: stage-specific case-management

Study type

Interventional

Funder types

Other

Identifiers

NCT00919620
jcep-rct

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 patients

Sex

All

Ages

26 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

360 participants in 3 patient groups

case management (4 yrs)
Experimental group
Description:
4-year case management and standard care
Treatment:
Behavioral: stage-specific case-management
case management (2 yrs) and standard care (2 yrs)
Active Comparator group
Description:
2-year case management and standard care
Treatment:
Behavioral: stage-specific case-management
standard care (4 yrs)
No Intervention group
Description:
standard care for 4 years

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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