PsychosisNCT03565055
From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
A study testing IPCST and E.A.S.Y in people with Psychosis, run by The Hong Kong Polytechnic University.
Trial summary
This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychosis
- What is being tested?
- IPCST and E.A.S.Y
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Dec 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hong Kong/ China residents
- Age between 18-55 years;
- Primary diagnosis of psychosis (not more than 12 months of clinical diagnosis) by psychiatrist and confirmed with the SCID-I for DSM-IV TR Axis I Disorders (Biometrics Research, 2002);
- Primary six or above education;
- Mentally competent to follow the instructions and training and give informed written consent, as suggested by the attending psychiatrist;
- Able to communicate in Chinese;
- Intend to seek employment.
Who cannot join
- Co-morbidity of learning disability, neurological disorder (e.g., epilepsy) and organic brain disease, or clinically significant medical diseases;
- Recently participated or are participating in other structured psychosocial intervention, and/or
- Visual, language or communication difficulty.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: From Prevention to Community Integration: Service Models, Intervention Strategies, and Outcome Evaluation for Recovery From Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life.
It consists of two major parts with the following study designs \& aims:
Read more
Part I : Developing a comprehensive and integrative psychosocial and community skills training programme (IPCST) and conducing a pilot randomised controlled trial to compare the study outcomes between the two settings in Hong Kong and Beijing.
- To develop IPCST as an innovative intervention model targeting individuals with first or recent onset of psychosis to reduce their stay in mental hospital and bridges them to independent living in the community with optimal social and professional support;
- To evaluate IPCST in terms of the clinical, vocational, and psychosocial outcomes of participants using a randomized controlled trial design and compare these outcomes between Hong Kong and Beijing;
- To examine the cost-effectiveness of IPCST in the two cities; and
- To train professionals and research personnel in Hong Kong and mainland for implementation
Part II: Exploring the health needs of younger family members of individuals with early psychosis and the strategies in preventing this clinical high risk group from developing psychotic episode and developmental problems in later stages of their lives.
- To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness;
- To provide baseline assessment of their psychosocial stress, mental health, and quality of life;
- To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.
Read the detailed description
This research is to develop and test on a pilot basis the clinical efficacy of the IPCST on the clinical and recovery outcomes of outpatients with first and recent-onset psychosis in one-year follow-up period in one regional outpatient care service of both Hong Kong and Beijing, China. All outcomes will be assessed by a trained Research Assistant who is blind to group assignment in each city separately. In Hong Kong, the study venue will be one Early Assessment Service for Young People with Early Psychosis (EASY) in Kwai Chung Hospital under the Kowloon West Hospital Cluster, Hospital Authority Hong Kong. In Beijing, the study venues consist of the Sixth Hospital of Peking University, the Chaoyang Third Hospital, and the Haidian Mental Health Hospital.
In both sites, the study venues are serving for first or recent-onset psychosis residing in the community.
Similar to previous psychosocial interventional studies, the primary outcomes of this study are patients' mental status and level of functioning. Secondary outcomes include the rate and length of psychiatric hospitalizations, vocational status, social skills, family functioning, and quality of life.
A total of 100 participants would be recruited for this project, 50 to be recruited from Hong Kong Kwai Chung; 50 to be recruited from mainland China sites.
Part I: Participants of this part will be randomly allocated to experimental or control group.
Experimental group participants will receive a 12-week, 48-hours of IPCST programme which includes both individual and group training on psychoeducation, motivational interviewing skills, neurocognitive and social cognition, and augmented supported employment with social skills.
Control group participants will receive the usual psychiatric treatment they have been receiving from the hospital.
All participants will receive assessment on their primary (symptom severity and functioning) and secondary (re-hospitalisation rates, family functioning, social skills, and employment status and satisfaction, and quality of life) outcomes at baseline and immediately (Post-test 1), 6 months (Post-test 2), and 12 months (Post-test 3) after completion of the interventions by a research assistant. Each assessment episode lasts about 1.5 hours.
Part II: Participants of this part will undergo a 30 minutes to 1 hour individual interview conducted by a research assistant that covers semi-structured open-ended questions and basic assessment of psychosocial stress, health and mental health status, and quality of life using quantitative measures.
- Conditions
- Psychosis
- Being tested
- IPCST, E.A.S.Y
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPCSTBehavioural
Integrative Psychosocial \& Community Skills Training (IPCST) programme
The IPCST programme includes:
- psychoeducation, internalized stigma reduction, \& strength and coping enhancement
- motivational interviewing skills
- Neurocognitive and social cognitive training (Au, Tsang, So, Bell, Cheung, et al., 2015)
- augmented supported employment with social skills training (Tsang, Fung, Li, Leung \& Cheung, 2010) and
- family and patient involvement in care
E.A.S.YBehavioural
The E.A.S.Y. (Early Assessment Service for Young People with Early Psychosis) Programme is a service programme for people suffering from early psychosis.
The E.A.S.Y programme includes:
- Extensive public education
- Early referral and assessment
- Ongoing treatment services
| Study group | Role | What they receive |
|---|---|---|
| IPCST | Experimental | Intervention = Patients that participate in IPCST programme Receives: Behavioral: IPCST |
| E.A.S.Y | Active comparator | Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital Receives: Behavioral: E.A.S.Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Positive and Negative Syndrome Scale (PANSS) score
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.
Participants will be assessed by medical specialist who will complete their PANSS at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program.
The Change of PANSS score over the above time course is the study's primary outcome measure.
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of The Personal and Social Performance Scale (PSP) score
The Personal and Social Performance scale (PSP) is widely used to assess social functioning in patients with schizophrenia.
Participants will be assessed by medical specialist who will complete their PSP score at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program.
The Change of PSP score over the above time course is the study's primary outcome measure.
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Secondary outcomes (5)
Change of Employment Outcome Checklist (EOC) score
The Employment Outcome Checklist (EOC) is used to assess participants' employment outcomes such as the number of job interviews attended, the number of jobs obtained, number of hours per week worked, and salary received from each of the jobs that were obtained .
Participants will be assessed by research assistant who will complete their EOC questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program.
The Changes in EOC over the above time course is the study's secondary outcome measure.
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) is a self-report quality of life measure for people with schizophrenia.
Participants complete on their own the SQLS-R4 questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program.
The Change of SQLS-R4 score over the above time course is the study's secondary outcome measure.
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of the Vocational Social Skills Assessment Scale (VSSS) score
The Vocational Social Skills Assessment Scale (VSSS) is a self-administered checklist that measures the participants' subjective perception of their competence in handling work-related social situations.
Participants complete on their own the VSSS questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program.
The Change of VSSS score over the above time course is the study's secondary outcome measure.
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of Re-hospitalization rate
Re-Hospitalization rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of outpatient follow-up rate
The changes in outpatient follow-up rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Measured: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565055
- Sponsor's protocol ID
- 1-ZVKP
- Status last verified
- Jun 2018
- First submitted
- 28 Aug 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Prevention to Community Integration: Service Models, Intervention Strategies, and Outcome Evaluation for Recovery From Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
- ClinicalTrials.gov ID
- NCT03565055
- Acronym / sponsor ID
- 1-ZVKP
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Jun 2018 (actual)
- 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.
This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life.
It consists of two major parts with the following study designs \& aims:
Part I : Developing a comprehensive and integrative psychosocial and community skills training programme (IPCST) and conducing a pilot randomised controlled trial to compare the study outcomes between the two settings in Hong Kong and Beijing.
- To develop IPCST as an innovative intervention model targeting individuals with first or recent onset of psychosis to reduce their stay in mental hospital and bridges them to independent living in the community with optimal social and professional support;
- To evaluate IPCST in terms of the clinical, vocational, and psychosocial outcomes of participants using a randomized controlled trial design and compare these outcomes between Hong Kong and Beijing;
- To examine the cost-effectiveness of IPCST in the two cities; and
- To train professionals and research personnel in Hong Kong and mainland for implementation
Part II: Exploring the health needs of younger family members of individuals with early psychosis and the strategies in preventing this clinical high risk group from developing psychotic episode and developmental problems in later stages of their lives.
- To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness;
- To provide baseline assessment of their psychosocial stress, mental health, and quality of life;
- To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.
Detailed description
This research is to develop and test on a pilot basis the clinical efficacy of the IPCST on the clinical and recovery outcomes of outpatients with first and recent-onset psychosis in one-year follow-up period in one regional outpatient care service of both Hong Kong and Beijing, China. All outcomes will be assessed by a trained Research Assistant who is blind to group assignment in each city separately. In Hong Kong, the study venue will be one Early Assessment Service for Young People with Early Psychosis (EASY) in Kwai Chung Hospital under the Kowloon West Hospital Cluster, Hospital Authority Hong Kong. In Beijing, the study venues consist of the Sixth Hospital of Peking University, the Chaoyang Third Hospital, and the Haidian Mental Health Hospital.
In both sites, the study venues are serving for first or recent-onset psychosis residing in the community.
Similar to previous psychosocial interventional studies, the primary outcomes of this study are patients' mental status and level of functioning. Secondary outcomes include the rate and length of psychiatric hospitalizations, vocational status, social skills, family functioning, and quality of life.
A total of 100 participants would be recruited for this project, 50 to be recruited from Hong Kong Kwai Chung; 50 to be recruited from mainland China sites.
Part I: Participants of this part will be randomly allocated to experimental or control group.
Experimental group participants will receive a 12-week, 48-hours of IPCST programme which includes both individual and group training on psychoeducation, motivational interviewing skills, neurocognitive and social cognition, and augmented supported employment with social skills.
Control group participants will receive the usual psychiatric treatment they have been receiving from the hospital.
All participants will receive assessment on their primary (symptom severity and functioning) and secondary (re-hospitalisation rates, family functioning, social skills, and employment status and satisfaction, and quality of life) outcomes at baseline and immediately (Post-test 1), 6 months (Post-test 2), and 12 months (Post-test 3) after completion of the interventions by a research assistant. Each assessment episode lasts about 1.5 hours.
Part II: Participants of this part will undergo a 30 minutes to 1 hour individual interview conducted by a research assistant that covers semi-structured open-ended questions and basic assessment of psychosocial stress, health and mental health status, and quality of life using quantitative measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPCST | Experimental | Behavioral: IPCSTIntervention = Patients that participate in IPCST programme |
| E.A.S.Y | Active comparator | Behavioral: E.A.S.YTreatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Hong Kong/ China residents
- Age between 18-55 years;
- Primary diagnosis of psychosis (not more than 12 months of clinical diagnosis) by psychiatrist and confirmed with the SCID-I for DSM-IV TR Axis I Disorders (Biometrics Research, 2002);
- Primary six or above education;
- Mentally competent to follow the instructions and training and give informed written consent, as suggested by the attending psychiatrist;
Key exclusion criteria (3 listed)
- Co-morbidity of learning disability, neurological disorder (e.g., epilepsy) and organic brain disease, or clinically significant medical diseases;
- Recently participated or are participating in other structured psychosocial intervention, and/or
- Visual, language or communication difficulty.
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 |
|---|---|---|
| IPCSTIntegrative Psychosocial \& Community Skills Training (IPCST) programme The IPCST programme includes: 1. psychoeducation, internalized stigma reduction, \& strength and coping enhancement 2. motivational interviewing skills 3. Neurocognitive and social cognitive training (Au, Tsang, So, Bell, Cheung, et al., 2015) 4. augmented supported employment with social skills training (Tsang, Fung, Li, Leung \& Cheung, 2010) and 5. family and patient involvement in care | Behavioural | IPCST |
| E.A.S.YThe E.A.S.Y. (Early Assessment Service for Young People with Early Psychosis) Programme is a service programme for people suffering from early psychosis. The E.A.S.Y programme includes: 1. Extensive public education 2. Early referral and assessment 3. Ongoing treatment services | Behavioural | E.A.S.Y |
Primary outcome
Change of Positive and Negative Syndrome Scale (PANSS) score
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PANSS at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program. The Change of PANSS score over the above time course is the study's primary outcome measure.
Change of The Personal and Social Performance Scale (PSP) score
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
The Personal and Social Performance scale (PSP) is widely used to assess social functioning in patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PSP score at baseline, immediately following the completion of the 3-month program, and at 6- \& 12- months after completion of the program. The Change of PSP score over the above time course is the study's primary outcome measure.
5 secondary outcomes
Change of Employment Outcome Checklist (EOC) score
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of the Vocational Social Skills Assessment Scale (VSSS) score
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of Re-hospitalization rate
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of outpatient follow-up rate
Time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IPCST and E.A.S.Y in people with Psychosis, run by The Hong Kong Polytechnic University.
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 7 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Hector Wing-Hong TSANG, PhD (27666704, hector.tsang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Positive and Negative Syndrome Scale (PANSS) score (time frame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.