Psychotic DisordersNCT00919620
Stage-specific Case Management for Early Psychosis
A study testing stage-specific case-management in people with Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 55 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- stage-specific case-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Organic Brain disorder
- Known history of intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- stage-specific case-management
- Keywords
- Psychotic disorders, Psychoses
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stage-specific case-managementBehavioural
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
| Study group | Role | What they receive |
|---|---|---|
| case management (4 yrs) | Experimental | 4-year case management and standard care Receives: Behavioral: stage-specific case-management |
| case management (2 yrs) and standard care (2 yrs) | Active comparator | 2-year case management and standard care Receives: Behavioral: stage-specific case-management |
| standard care (4 yrs) | No intervention | standard care for 4 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning (social and occupational)
Measured: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary outcomes (6)
Psychotic symptoms
Psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline, 12-month, 24-month, 36-month, 48-month
Health economics
Measured: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kwai Chung Hospital, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Shatin Hospital, Tai Po Hospital, North District Hospital, United Christian Hospital, Queen Elizabeth Hospital, Hong Kong
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric YH Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919620
- Sponsor's protocol ID
- jcep-rct
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2009
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
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. 2023 Apr;53(6):2339-2351. doi: 10.1017/S0033291721004189. Epub 2022 Feb 11.
PubMed 35144700Puntis 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.
PubMed 33135811
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00919620
- Acronym / sponsor ID
- jcep-rct
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic disorders, Psychoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kwai Chung Hospital, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Shatin Hospital, Tai Po Hospital, North District Hospital, United Christian Hospital, Queen Elizabeth Hospital, Hong Kong
- Study start
- Jun 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case management (4 yrs) | Experimental | Behavioral: stage-specific case-management4-year case management and standard care |
| case management (2 yrs) and standard care (2 yrs) | Active comparator | Behavioral: stage-specific case-management2-year case management and standard care |
| standard care (4 yrs) | No intervention | –standard care for 4 years |
Who may qualify
- Ages
- 26 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Organic Brain disorder
- Known history of intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stage-specific case-managementStage-specific case-management for psychosis by designated key-workers according to specified protocol | Behavioural | case management (2 yrs) and standard care (2 yrs), case management (4 yrs) |
Primary outcome
Functioning (social and occupational)
Time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
6 secondary outcomes
Psychotic symptoms
Time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Psychotic symptoms
Time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Psychotic symptoms
Time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Depressive symptoms
Time frame: baseline, 12-month, 24-month, 36-month, 48-month
Neurocognitive functioning
Time frame: baseline, 12-month, 24-month, 36-month, 48-month
Health economics
Time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 35144700Hui 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.
- Derived from this study: PubMed 33135811Puntis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric YH Chen, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stage-specific case-management in people with Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning (social and occupational) (time frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919620, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.