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

NCT03565055 | Unknown

• 1 other identifier: 1-ZVKP
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 3.To examine the cost-effectiveness of IPCST in the two cities; and
4. 4.To train professionals and research personnel in Hong Kong and mainland for implementation
5. 5.To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness;
6. 6.To provide baseline assessment of their psychosocial stress, mental health, and quality of life;
7. 7.To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

Secondary Outcomes (5)

• Change of Employment Outcome Checklist (EOC) score

  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

  Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

• Change of the Vocational Social Skills Assessment Scale (VSSS) score

  Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

• Change of Re-hospitalization rate

  Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

• Change of outpatient follow-up rate

  Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

Study Arms (2)

IPCST

EXPERIMENTAL

Intervention = Patients that participate in IPCST programme

Behavioral: IPCST

E.A.S.Y

ACTIVE COMPARATOR

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

Behavioral: E.A.S.Y

Interventions

IPCST 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

IPCST

E.A.S.Y 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

E.A.S.Y

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Hector Wing-Hong TSANG, PhD

CONTACT

27666704; hector.tsang@polyu.edu.hk

Tracy Li, BSc

CONTACT

27666770; tracy.wy.li@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: June 21, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 21, 2018

Record last verified: 2018-06