Psychosis Clinical Trial
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:
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.
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.
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