Fertility & Well-Being: Mind/Body Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Feasibility 2: Time
研究概览
简要总结
This pilot-study assesses the feasibility and acceptability of an Online Mind/Body Fertility Program, designed to help individuals and/or couples cope with the physical and emotional impact of infertility by learning special relaxation strategies and improving lifestyle habits. Participants included women experiencing infertility who had not given birth to a child. Half of participants received access to the 10-week Online Mind-Body Program and the other half were placed on a waiting-list.
详细描述
Infertility is defined as the inability to conceive a child. A couple may be acknowledged as infertile if conception has not occurred after 12 months of having regular, unprotected intercourse. Over six million couples in the United States are affected by infertility. Research suggests that there is a relationship between psychological distress and infertility, but the relationship is complex. The information from this study will be used to better understand the relationship between psychological distress and infertility among couples. Furthermore, the investigators are interested in testing Dr. Alice Domar's Mind/Body Fertility Program that was designed to help individuals regain control of their life and learn new lifestyle habits that can increase their chances of conceiving. There is evidence that individuals that participated in the group format of this treatment protocol showed statistically significant decreases in physical and psychological symptoms of stress and increases in conception rates. Our primary goals are to evaluate patients willingness to be recruited and randomized as well as their adherence and attrition to the program. Our secondary goals are to evaluate reductions in emotional distress (i.e., anxiety, depression, and stress) and enhance emotion regulation skills as well as pregnancy rates.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and Men
- •Infertility diagnosis
- •Trying to get pregnant
- •18 years or older
- •Read and write English
排除标准
- •No current diagnosis for an active psychotic disorder, eating disorder, substance abuse or dependence
- •Not reporting current suicidal ideation/intent
- •No psychotropic medication changes in the last four weeks
- •Has not completed a formal mind/body program focused on infertility that included relaxation, yoga, mindfulness, cognitive restructuring, stress reduction strategies, listening and communication skills, goal setting and assertiveness training.
研究组 & 干预措施
Intervention: Online Mind/Body
Participants randomized to the intervention group (i.e., Online Mind/Body Program for Fertility) were provided the 10 online modules provided weekly (one module per week), intended to be completed over 10 weeks. Additionally, participants received weekly therapeutic feedback.
干预措施: Online Mind/Body Program for Fertility (Behavioral)
Wait-List
After 10-weeks being in the wait-list group, participants had the potential to participate in the intervention protocol if they desire.
结局指标
主要结局
Feasibility 2: Time
时间窗: Approximately 12 months
Time between recruitment and completion of the study. Time between recruitment and randomization; time between each of the modules; time between each of the assessments (pre-assessment; mid-assessment; post-assessment, and follow-up).
Feasibility 1: Feasibility of recruitment and randomization
时间窗: Approximately 12 months
Number of participants recruited and randomized. From time study began to when recruitment closed.
Feasibility 3: Participant retention and acceptability
时间窗: Approximately 12 months
Percentage of enrolled participants that completed each stage of the study (mid-assessment, post-assessment, follow-up, and each of the ten modules for the intervention group only).
次要结局
- Acceptability 1: Ease of modules(Approximately 12 months)
- Acceptability 2: Helpfulness(Approximately 12 months)
- Satisfaction of Intervention(Approximately 12 months)
- Fertility Problem Inventory: Between group changes(Approximately 12 months)
- Emotion Regulation: Between group comparison(Approximately 12 months)
- Relationship Quality: Between group comparison(Approximately 12 months)
- Pregnancy: Between group comparison(Approximately 12 months)
- Anxiety 2: Between group changes(Approximately 12 months)
- Depression 1: Individual changes(Approximately 12 months)
- Stress: Between group changes(Approximately 12 months)
- Anxiety 1: Individual changes(Approximately 12 months)
- Depression 2: Between group changes(Approximately 12 months)
- Mindfulness: Between group comparison(Approximately 12 months)
研究者
Jessica Clifton
Post-Doctoral Associate
University of Vermont