ChiCTR-TRC-10000907已完成Unknown
A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care
Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2010年7月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Anxiety symptoms will be measured using the Chinese version Beck Anxiety Inventory and the validated Chinese version Penn State Worry Questionnaire.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 21 至 65（—）
- 性别
- All
入选标准
- •being 21-65 years of age;
- •having, at baseline assessment, a DSM-IV TR principal diagnosis of generalized anxiety disorder on SCID 14 and a score of 10 or above using the Chinese version of the Beck Anxiety Inventory;
- •can understand Cantonese;
- •are willing to attend the MBCT programme.
排除标准
- •past participation in an MBSR or MBCT group;
- •illiterate subjects as they will not be able to complete the meditation diary;
- •psychiatric and medical comorbidities that are potentially life threatening (i.e. psychosis. Suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g. psychosis, current substance abuse, dementia, pregnancy);
- •those already seeing a psychiatrist, a cognitive behavioural therapist or psychotherapists/counselors;
- •commencement of psychotropic medication within 2 months.
研究组 & 干预措施
Two groups
mindfulness-based cognitive therapy versus Psycho-education group (PEG) based on cognitive behavioural therapy principles / Waitlist control
结局指标
主要结局
Anxiety symptoms will be measured using the Chinese version Beck Anxiety Inventory and the validated Chinese version Penn State Worry Questionnaire.
次要结局
- medication use including changes in medication will be monitored at 3 month interval.
- Depressive symptoms will be measured by the validated Chinese version of the Centre for Epidemiological Studies-Depression Scale (CES-D).
- Health related quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).
- “Mindfulness” will be measured by the Five Facet Mindfulness Questionnaire.
- Health service utilization including visits to primary care doctors (both private and public) and hospitalizations will be recorded.
- The frequency and duration of practice of both MBSR and PEG in each group will be documented
- Response rate (enrolment of subjects), retention rate (number and proportion attended each class) of the MBCT and the psycho-education group will be documented.
研究者
研究点 (1)
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