Diet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maslach-Burnout-Inventory (MBI)
研究概览
简要总结
Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.
详细描述
Ayurveda is a traditional Indian medicine: as a whole medical system it consists of diagnostic procedures and complex treatments. Ayurveda-treatment is based on Ayurvedic diagnosis and has a special focus on lifestyle and nutritional counseling, based on the individual constitution of the patient. Ayurvedic counseling can easily be followed by the patients in their day-to-day life and is an inexpensive way of self-care. In Ayurveda it is often used for the treatment of burnout-syndrome. However, no systematic data is available on its effectiveness in comparison to conventional standard diet and lifestyle counseling. The aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •age between 18 and 50
- •mother of ≥ 1 child ≤ 12 years of age
- •job, education or studies ≥ 20 hours per week
- •subjective feeling of physical and mental exhaustion since ≥ 3 month
- •≥ 18 points in the MBI Subscale "emotional exhaustion" at screening
排除标准
- •change of psychotropic drug medication ≤ 6 weeks before inclusion
- •pregnancy or breastfeeding
- •pre-diagnosed major depression
- •serious chronic co-morbidity (e.g. CHF NYHA IV)
- •serious acute somatic health conditions
- •intake of opiods
- •simultaneous participation in other trials
- •praticipation in other trials during ≤ 6 month before inclusion
结局指标
主要结局
Maslach-Burnout-Inventory (MBI)
时间窗: 3 month
次要结局
- Maslach-Burnout-Inventory (MBI)(6 month)
- Hospital Anxiety and Depression Scale (HADS-D)(3 and 6 month)
- Cohen Perceived Stress Scale (CPSS)(3 and 6 month)
- SF-36(3 and 6 month)
- Aspects of Spirituality (ASP)(3 and 6 month)
- Pittsburgh Sleep Quality Index (PSQI)(3 and 6 month)
研究者
Andreas Michalsen
Prof. Dr. med. Andreas Michalsen
Charite University, Berlin, Germany