From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)

NCT ID: NCT03565055

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPCST

Intervention = Patients that participate in IPCST programme

Group Type: EXPERIMENTAL

IPCST

Intervention Type: BEHAVIORAL

Integrative 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

E.A.S.Y

Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital

Group Type: ACTIVE_COMPARATOR

E.A.S.Y

Intervention Type: BEHAVIORAL

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:

1. Extensive public education

2. Early referral and assessment

3. Ongoing treatment services

Interventions

IPCST

Integrative 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

Intervention Type: BEHAVIORAL

E.A.S.Y

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:

1. Extensive public education

2. Early referral and assessment

3. Ongoing treatment services

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

TSANG Hector Wing-Hong

Professor and Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hector Wing-Hong TSANG, PhD

Role: CONTACT

hector.tsang@polyu.edu.hk

27666704

Tracy Li, BSc

Role: CONTACT

tracy.wy.li@polyu.edu.hk

27666770

Other Identifiers

1-ZVKP

Identifier Type: -

Identifier Source: org_study_id