Stress Reduction for PCOS and Non-PCOS Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from Baseline in Toronto Mindfulness Scale at 8 weeks
研究概览
简要总结
The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.
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
- 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
- •Women, age 18 years or older
- •Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)
排除标准
- •Current pregnancy
- •Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
- •Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
- •Severe active neuropsychological disorder such as psychosis or suicidal ideation
- •Severe untreated depression or anxiety. Women with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study.
- •History of an inpatient admission for psychiatric disorder within the past two years
- •Active alcohol or drug abuse
- •Inability to read, speak or write English
- •Inability to commit to the intervention and follow-up
- •Current enrollment in a stress reduction program
- •Mindfulness practice within the past 6 months (regular formal practice at least once a week)
- •Current enrollment in other investigative studies
- •Type 1 diabetes
研究组 & 干预措施
Stress reduction
Mindfulness-based stress reduction
干预措施: Stress reduction (Behavioral)
Stress reduction with Health education
General stress management and health education
干预措施: Stress reduction with Health education (Behavioral)
结局指标
主要结局
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
时间窗: baseline and 8 weeks
次要结局
- Change from Baseline in Hemoglobin A1c at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Mean Arterial Pressure at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Brief Symptom Inventory-18 at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Toronto Mindfulness Scale at 16 weeks(baseline and 16 weeks)
- Change from Baseline in SF-36 at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Mean Arterial Pressure at 8 weeks(baseline and 8 weeks)
- Change from Baseline in SF-36 at 8 weeks(baseline and 8 weeks)
- Change from Baseline in Brief Symptom Inventory-18 at 8 weeks(baseline and 8 weeks)
- Change from Baseline in Hemoglobin A1c at 8 weeks(baseline and 8 weeks)
研究者
Nazia Raja-Khan
M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism
Milton S. Hershey Medical Center