Randomized Control Trial of Acceptance and Commitment Therapy Adapted for Women With Infertility-related Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fertility Quality of Life tool (Fertiqol)
研究概览
简要总结
This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.
详细描述
Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed seven weekly 15-minute videos, each providing instructions on a new Acceptance and Commitment Therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. Fertility-related quality of life and psychological flexibility will be measured before and after the program. Outcomes will also be measured at one-month follow-up. Feedback about how to improve the program will also be collected.
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
盲法说明
Blinding will not be implemented as condition assignment through randomization will be obvious to both the participants and the primary investigator. Participants will be provided with an introduction and rationale for the respective condition they are assigned to. Participants in the waitlist control condition will be given the opportunity to enroll in the intervention after completing the follow-up measures.
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments
- •Lives in Canada or the United States
- •Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 71
排除标准
- •Is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the Suicide Behaviours Questionnaire - Revised (SBQ-R)
结局指标
主要结局
Fertility Quality of Life tool (Fertiqol)
时间窗: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Pre-to-post change in quality of life related to a diagnosis of infertility. Scores range from 0-100, with higher scores indicating better quality of life.
Psychological flexibility (MPFI)
时间窗: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module))
- Generalized Anxiety Disorder-7 (GAD-7)(Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module))
研究者
Jennifer Gordon
Principal Investigator
University of Regina