Clinical trial NCT03565055: From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

1. 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;
2. 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;
3. To examine the cost-effectiveness of IPCST in the two cities; and
4. 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.

1. To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness;
2. To provide baseline assessment of their psychosocial stress, mental health, and quality of life;
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Positive and Negative Syndrome Scale (PANSS) score
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
measure: Change of The Personal and Social Performance Scale (PSP) score
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Secondary outcomes:
measure: Change of Employment Outcome Checklist (EOC) score
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
measure: Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
measure: Change of the Vocational Social Skills Assessment Scale (VSSS) score
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
measure: Change of Re-hospitalization rate
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
measure: Change of outpatient follow-up rate
timeFrame: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Other outcomes:
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