Effectiveness of Mindfulness Intervention in Prevention of Relapse in Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Number of participants with psychotic relapse(s)
研究概览
简要总结
Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive disorders. However, its role in relapse prevention among patients with psychosis has not been tested.
The investigators therefore propose a multi-site, single-blind, 12-month randomized controlled trial in Hong Kong to examine the effectiveness of mindfulness intervention in prevention of relapse among 152 remitted psychosis patients.
详细描述
Objectives and hypotheses
- Primary objective:
• To examine if mindfulness-based intervention can reduce rates of relapse at 1 year in remitted patients with psychosis. 2. Secondary objectives:
- To test whether mindfulness-based intervention can reduce stress, depressive symptoms, and improve functioning and quality of life at 1 year in remitted patients with psychosis.
Participants Patients will be recruited from the Early Assessment Service for Young people with psychosis (EASY). This service provides specialized psychiatric care for the first three years for young persons with first episode psychosis and covers the entire population of Hong Kong of approximately seven million people. The sample will consist of 152 fully remitted patients diagnosed with schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychotic disorder not otherwise specified)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •aged 18 to 55 years
- •in full symptomatic remission for at least 6 months
- •have been ill for no more than 3 years following first episode psychosis
- •have sufficient proficiency in Chinese to understand verbal instructions and to give informed consent.
排除标准
- •known diagnosis of intellectual disability
- •organic brain disorder
- •current or previous use of illicit drugs
- •substance-induced psychosis or alcohol intake in excess of 5 standard units per day
- •people who practice mindfulness and meditation exercise for more than twice a week over the past 1 month.
研究组 & 干预措施
Mindfulness intervention
This arm consists of seven weekly-session mindfulness-based intervention for psychosis (MBI-p). The MBI-p is a protocol-based, low intensity intervention developed to help patients achieve a greater sense of peace and calmness, and facilitates participants in handling everyday stress and conflicts.
干预措施: Mindfulness intervention (Behavioral)
Psychoeducation intervention
This arm consists of seven weekly-sessions of psychoeducation. Topics to be discussed in the sessions include the signs and symptoms of psychosis, aetiology of psychosis, as well as pharmacological and non-pharmacological interventions.
干预措施: Psychoeducation intervention (Behavioral)
结局指标
主要结局
Number of participants with psychotic relapse(s)
时间窗: 12 months post-intervention
Psychotic relapse is defined as an increase in at least one of the following PANSS (Kay et al., 1987) items: delusion and/or hallucinatory behavior to a score of 3 or above; conceptual disorganization or unusual thought content to a score of 4 or above; and suspiciousness to a score of 5 or above.
次要结局
未报告次要终点