Stage-specific Case Management for Early Psychosis
Primary Purpose
Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stage-specific case-management
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic disorders, Psychoses
Eligibility Criteria
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
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
case management (4 yrs)
case management (2 yrs) and standard care (2 yrs)
standard care (4 yrs)
Arm Description
4-year case management and standard care
2-year case management and standard care
standard care for 4 years
Outcomes
Primary Outcome Measures
Functioning (social and occupational)
Secondary Outcome Measures
Psychotic symptoms
Psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
Psychotic symptoms
Psychotic symptoms will be assessed using Scale for the Assessment of Positive Symptoms (SAPS)
Psychotic symptoms
Psychotic symptoms will be assessed using Scale for the Assessment of Negative Symptoms (SANS).
Depressive symptoms
Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS).
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.
Health economics
Full Information
NCT ID
NCT00919620
First Posted
June 10, 2009
Last Updated
November 10, 2020
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Kwai Chung Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Shatin Hospital, Tai Po Hospital, North District Hospital, Hong Kong, United Christian Hospital, Queen Elizabeth Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00919620
Brief Title
Stage-specific Case Management for Early Psychosis
Official Title
Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Kwai Chung Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Shatin Hospital, Tai Po Hospital, North District Hospital, Hong Kong, United Christian Hospital, Queen Elizabeth Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Psychotic disorders, Psychoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
case management (4 yrs)
Arm Type
Experimental
Arm Description
4-year case management and standard care
Arm Title
case management (2 yrs) and standard care (2 yrs)
Arm Type
Active Comparator
Arm Description
2-year case management and standard care
Arm Title
standard care (4 yrs)
Arm Type
No Intervention
Arm Description
standard care for 4 years
Intervention Type
Behavioral
Intervention Name(s)
stage-specific case-management
Intervention Description
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
Primary Outcome Measure Information:
Title
Functioning (social and occupational)
Time Frame
baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary Outcome Measure Information:
Title
Psychotic symptoms
Description
Psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
Time Frame
baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Title
Psychotic symptoms
Description
Psychotic symptoms will be assessed using Scale for the Assessment of Positive Symptoms (SAPS)
Time Frame
baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Title
Psychotic symptoms
Description
Psychotic symptoms will be assessed using Scale for the Assessment of Negative Symptoms (SANS).
Time Frame
baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Title
Depressive symptoms
Description
Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS).
Time Frame
baseline, 12-month, 24-month, 36-month, 48-month
Title
Neurocognitive functioning
Description
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.
Time Frame
baseline, 12-month, 24-month, 36-month, 48-month
Title
Health economics
Time Frame
baseline, 6-month, 12-month, 24-month, 36-month, 48-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric YH Chen, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35144700
Citation
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. 2023 Apr;53(6):2339-2351. doi: 10.1017/S0033291721004189. Epub 2022 Feb 11.
Results Reference
derived
PubMed Identifier
33135811
Citation
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.
Results Reference
derived
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Stage-specific Case Management for Early Psychosis
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