Stage-specific Case Management for Early Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): stage-specific case-management
Intervention type(s): Behavioral
Intervention description(s): Stage-specific case-management for psychosis by designated key-workers according to specified protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotic disorders; Psychoses