Effects of Mindfulness Meditation and Stress Management Training on Perceived Stress, Psychological Well-being, and Sleep Quality Among Patients Diagnosed With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in Sleep quality
研究概览
简要总结
The primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
- •Access and regular use of the internet
排除标准
- •Non Swedish speaking
- •Previous sever psychiatric illness
结局指标
主要结局
Change in Sleep quality
时间窗: Baseline to 8 week follow-up change
Sleep quality as measured with the Karolinska Sleep Questionnaire (KSQ) a 13-item questionnaire assessing sleep-time and quality as well as perceived satisfaction with sleep, sleepiness and sleep disturbance.
Change in Psychological Well-Being
时间窗: Baseline to 8 week follow-up change
Psychological Well-Being as measured with the Psychological Well-Being (PWB) scale by C Ryff; a questionnaire measuring six dimensions of psychological well-being: environmental mastery; self-acceptance; positive relations with others; purpose in life; personal growth; and autonomy.
Change in Perceived Stress
时间窗: Baseline to 8 week follow-up change
Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention
次要结局
- Change in Perceived stress(Change from baseline to 12 months follow-up)
- Change in Psychological well-being(Change from baseline to 12-month follow-up)
- Change in Sleep quality(Change from baseline to 12-month follow-up)
研究者
Richard Branstrom
Associate Professor
Karolinska Institutet