Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Conversion of psychosis
研究概览
简要总结
This study aims to examine the effectiveness of the cognitive behavioral therapy in preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.
详细描述
Eligible subjects with informed consent provided will be randomly assigned to the cognitive behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session spanning for 8 week.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women of age 18-64
- •at-risk mental state as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS)
- •with an informed consent
- •able to understand Cantonese and read/write Chinese
排除标准
- •those mental conditions that requires other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
- •those medical conditions that severely limits participation, comprehension, or adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness);
- •those who are receiving structured psychotherapy or counselling
结局指标
主要结局
Conversion of psychosis
时间窗: 12-month post-intervention
Proportion of subject that convert from at-risk state to psychosis
Functioning: Measured by Role Functioning Scale (RFS)
时间窗: Changes from baseline to immediate, 6- and 12-month post-intervention
Measured by Role Functioning Scale (RFS). The RFS is comprised of four single rating scaled for evaluating the functioning of individuals in specified areas of everyday life. The four role functions assessed are:(1)Working: productivity, (2) Independent living and self care, (3) Immediate social network relationships, and (4) Extended social network relationship. The values on each of the four scales range from 1 (minimal level of role functioning), to 7 (hypothetically optimal level of role functioning). Each of the seven points on the scales is accompanied by a behaviorally defined description.
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
时间窗: Changes from baseline to immediate, 6- and 12-month post-intervention
Measured by Social and Occupational Functioning Assessment Scale (SOFAS). The SOFAS is an observer rating scale. Ratings should be based on subject's behavior during the last 1 month. The score ranges from 0-100. A higher score represents a better outcome.
次要结局
- Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)(Immediate, 6- and 12-month post-intervention)
- Depressive symptoms(Immediate, 6- and 12-month post-intervention)
- Positive psychotic symptoms(Immediate, 6- and 12-month post-intervention)
- Beliefs about the auditory hallucination(Immediate, 6- and 12-month post-intervention)
研究者
Professor Eric Y.H. Chen
Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry
The University of Hong Kong