Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- The Depression Anxiety Stress Scale - short form (DASS-21)
研究概览
简要总结
People with psychosis demonstrated a tendency to use maladaptive cognitive emotion regulation strategies as compared with healthy control groups.
The present study is the first randomized controlled trial of group mindfulness-based intervention for psychosis. Half group will join the mindfulness-based cognitive intervention while another half will participate in psychoeducation to examine whether mindfulness will have a positive impact on emotion regulation and distress.
详细描述
Concurrently with positive and negative symptoms, affective symptoms and full affective disorder episodes are common in psychotic disorders particularly in the acute phase of illness.
Affective symptoms are a significant risk factor accounting for approximately 5-6% of suicide rates which remain or becomes higher shortly after a psychotic episode or hospital discharge (American Psychiatric Association, 2013). It has been proved that the emotion management and cognitive reappraisal were negatively associated with schizophrenia.
In the study, it is hypothesized that the intervention will have a positive impact on psychotic symptoms, general symptoms such as affective symptoms, psychological flexibility, mindfulness skills, quality of life and re-hospitalization by facilitating strategies on emotion regulation.
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)
盲法说明
Assignment to the study groups will be made independently of staff involved in the recruitment and management of participants in the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be Chinese residents and aged above 18
- •Have a primary diagnosis of psychosis (non-affective) and/or other psychotic disorders met the Diagnostic and Statistical Manual DSM-5
- •Have been diagnosed equivalent to or less than 5 years
- •Mentally stable as assessed by the researcher and a psychiatrist to comprehend the education and training provided (a pre-recruitment briefing session for potential participants will be conducted to verify their ability to follow instructions and understanding in participation, and case files will be reviewed to ensure a stable medication regime for at least 6 months) in order to ensure their ability to make a valid consent
- •Able to read and understand Chinese
排除标准
- •Have recently participated in (less than 3 months) or are receiving other structured psycho-education and/or psychotherapies
- •Have comorbidities (a) developmental impairment (b) learning disability, (c) personality disorders, and/or (d) any clinically significant medical diseases (by case-file review).
- •Have organic psychosis or a primary drug or alcohol addiction
结局指标
主要结局
The Depression Anxiety Stress Scale - short form (DASS-21)
时间窗: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
). It is chosen as the primary outcome measurement because scales of anxiety and depression possess the capacity to differentiate from the related state of tension and stress linking with environmental demands and emotional and physical disturbance. It is a 21-item instrument that measures over the past week symptoms of depression, anxiety and stress rated by 4-point severity or frequency scale. The scale is from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).
次要结局
- Positive and Negative Syndrome Scale (PANSS)(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)
- Five Facet Mindfulness Questionnaire (FFMQ)(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)
- The number of re-hospitalization(It will be measured 6-month post-intervention)
- The Emotion Regulation Questionnaire (ERQ)(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)
- Acceptance and Action Scale (AAQII)(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)
- The length of re-hospitalization(It will be measured 6-month post-intervention)
- The WHOQOL-100(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)
研究者
YIP Lai King
Senior Clinical Associate
The Hong Kong Polytechnic University