Stage-specific Case Management for Early Psychosis

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders
• Intervention / Treatment: Behavioral: stage-specific case-management

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Kowloon Hospital, Hong Kong; Castle Peak Hospital; Tai Po Hospital; United Christian Hospital; Shatin Hospital; Kwai Chung Hospital, Hong Kong; North District Hospital, Hong Kong

Publications and helpful links

General Publications

• Hui CLM, Wong AKH, Ho ECN, Lam BST, Hui PWM, Tao TJ, Chang WC, Chan SKW, Lee EHM, Suen YN, Lam MML, Chiu CPY, Li FWS, Leung KF, McGhee SM, Law CW, Chung DWS, Yeung WS, Yiu MGC, Pang EPF, Tso S, Lui SSY, Hung SF, Lee WK, Yip KC, Kwan KL, Ng RMK, Sham PC, Honer WG, Chen EYH. Effectiveness and optimal duration of early intervention treatment in adult-onset psychosis: a randomized clinical trial. Psychol Med. 2022 Feb 11:1-13. doi: 10.1017/S0033291721004189. Online ahead of print.
• Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013288. doi: 10.1002/14651858.CD013288.pub2.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Psychotic disorders; Psychoses
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: jcep-rct