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)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Change of Positive and Negative Syndrome Scale (PANSS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
IPCST
Intervention = Patients that participate in IPCST programme
干预措施: IPCST (Behavioral)
E.A.S.Y
Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital
干预措施: E.A.S.Y (Behavioral)
结局指标
主要结局
Change of Positive and Negative Syndrome Scale (PANSS) score
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
TSANG Hector Wing-Hong
Professor and Head
The Hong Kong Polytechnic University