Psychotic DisordersNCT01202357
Optimal Duration of Early Intervention for Psychosis
A study testing Community Case Management in people with Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
Trial summary
A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Community Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jun 2012
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
- Received EASY service for 2 years following a first-episode psychosis
- Cantonese-speaking Chinese
- Ability to understand the study and to provide written informed consent
Who cannot join
- Organic brain disorder
- Known history of intellectual disability
- Drug-induced psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.
Read the detailed description
Psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. In order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness.
In Hong Kong, early intervention for psychotic disorder was provided since 2001. The integrated Early Assessment Service for Young people with psychosis (EASY) provide specialized care to early psychosis patients up to age 25. Evaluation of the EASY programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis.
In the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. It is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further.
The proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. The study recruit patients who had completed the first 2 years of case management in the EASY programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. The hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.
- Conditions
- Psychotic Disorders
- Being tested
- Community Case Management
- Keywords
- Psychotic Disorders, Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Case ManagementBehavioural
Community case management for psychosis by designated key-worker according to specified protocol
| Study group | Role | What they receive |
|---|---|---|
| Case Management (1 year) | Experimental | Not described Receives: Behavioral: Community Case Management |
| Standard Care (1 year) | No intervention | Not described Receives: Behavioral: Community Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning (social and occupational)
Measured: baseline, 12-month
Secondary outcomes (1)
Symptoms, quality of life and health economics
Measured: baseline, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwai Chung Hospital
- Investigators
- Eric YH Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202357
- Sponsor's protocol ID
- CM-RCT
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang WC, Kwong VWY, Lau ESK, So HC, Wong CSM, Chan GHK, Jim OTT, Hui CLM, Chan SKW, Lee EHM, Chen EYH. Sustainability of treatment effect of a 3-year early intervention programme for first-episode psychosis. Br J Psychiatry. 2017 Jul;211(1):37-44. doi: 10.1192/bjp.bp.117.198929. Epub 2017 Apr 6.
PubMed 28385705
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01202357
- Acronym / sponsor ID
- CM-RCT
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic Disorders, Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwai Chung Hospital
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 15 Sep 2010 (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.
A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.
Detailed description
Psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. In order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness.
In Hong Kong, early intervention for psychotic disorder was provided since 2001. The integrated Early Assessment Service for Young people with psychosis (EASY) provide specialized care to early psychosis patients up to age 25. Evaluation of the EASY programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis.
In the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. It is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further.
The proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. The study recruit patients who had completed the first 2 years of case management in the EASY programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. The hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management (1 year) | Experimental | Behavioral: Community Case Management |
| Standard Care (1 year) | No intervention | Behavioral: Community Case Management |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
- Received EASY service for 2 years following a first-episode psychosis
- Cantonese-speaking Chinese
- Ability to understand the study and to provide written informed consent
Key exclusion criteria (3 listed)
- Organic brain disorder
- Known history of intellectual disability
- Drug-induced psychosis
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 |
|---|---|---|
| Community Case ManagementCommunity case management for psychosis by designated key-worker according to specified protocol | Behavioural | Case Management (1 year), Standard Care (1 year) |
Primary outcome
Functioning (social and occupational)
Time frame: baseline, 12-month
1 secondary outcome
Symptoms, quality of life and health economics
Time frame: baseline, 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
- Derived from this study: PubMed 28385705Chang WC, Kwong VWY, Lau ESK, So HC, Wong CSM, Chan GHK, Jim OTT, Hui CLM, Chan SKW, Lee EHM, Chen EYH. Sustainability of treatment effect of a 3-year early intervention programme for first-episode psychosis. Br J Psychiatry. 2017 Jul;211(1):37-44. doi: 10.1192/bjp.bp.117.198929. Epub 2017 Apr 6.
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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 Community 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 3 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: status not confirmed, as of the sponsor's last update on 15 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric YH Chen, MD (852-22554488, eyhchen@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning (social and occupational) (time frame: baseline, 12-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 NCT01202357, which also lists 1 linked publication.
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 15 Sep 2010.