NCT00390169Unknown3 期
Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients
Canadian Breast Cancer Research Alliance2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality
研究概览
简要总结
This study will compare three standard treatment programs commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being, the immune system, and the amount of stress hormones in the bloodstream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study participants must be women diagnosed with Stage I, II, or III breast cancer within the previous 18 months, have completed all treatments with the exception of hormonal therapy at least three months previously, over the age of 18, and have a score of 13 or higher on the BSI-
- •Previous meditation/yoga experience is allowed but will be recorded.
排除标准
- •Participants must not have a concurrent DSM-IV diagnosis of psychosis, substance abuse, bipolar disorder, or active suicidality (as assessed by structured clinical interview), must not be currently using psychotropic medications (antipsychotics, antidepressants, anxiolytics), have a concurrent autoimmune disorder, or have participated previously in MBSR or SET group.
结局指标
主要结局
Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality
Physical:cortisol levels (stress hormone)
次要结局
- emotional repression
- personality
- emotional suppression
研究者
研究点 (2)
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