NCT05903638进行中（未招募）不适用
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- MBSR course participation rate
研究概览
简要总结
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.
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
- Triple (Care Provider, 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
- 是
入选标准
- •Primary infertility and no prior fertility treatment
排除标准
- •No internet access
- •Non-English speaking
- •History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
- •Psychotropic medication change in the previous month
- •Previously seen at another fertility clinic
- •Previous MBSR course
- •Previous mindfulness meditation retreat
研究组 & 干预措施
Control
No Intervention
Virtual Mindfulness-Based Stress Reduction (MBSR) program
Experimental
干预措施: Mindfulness-Based Stress Reduction course (Behavioral)
结局指标
主要结局
MBSR course participation rate
时间窗: 8-weeks of MBSR course
Survey completion rate
时间窗: Randomization to 3-months after course completion
次要结局
- Perceived Stress Scale(Randomization to 3-months after course completion)
- % involvement in fertility treatment(3-months after course completion)
- Beck Depression Inventory(Randomization to 3-months after course completion)
- Beck Anxiety Inventory(Randomization to 3-months after course completion)
- Fertility Problem Inventory(Randomization to 3-months after course completion)
- Pregnancy rates(3-months after course completion)
研究者
研究点 (1)
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