MoMiFer-Study: Evaluation of a Mobile Mindfulness Program (mMP) in Individuals/Couples Experiencing Fertility Problems
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fertility related quality of life
研究概览
简要总结
Infertility and its treatment result in a considerate emotional burden and a recent guideline of the European Society of Human Reproduction (ESHRE) highlight the importance to support couples facing fertility problems. Mindfulness-based programs (MBPs) have been proven effective in improving well-being and combatting mood disturbances in a wide range of conditions in both treatment and prevention. The overall aim of this project is to evaluate the impact of a mobile mindfulness programme (mMP) on quality of life and emotional well-being in individuals/couples experiencing fertility problems. The present study is a two-group randomized controlled trial with assessments at baseline, at 1,5 months and at 3 months. Sixty couples experiencing fertility problems will be enrolled. They will be assigned to either an intervention group (immediate access to the mMP) or a control group (waitlist condition). The mobile MBP is developed by a team of experienced mindfulness trainers, clinical psychologists, and a psychiatrist and adheres to a standardized protocol. The primary outcomes will be quality of life and emotional distress. Secondary outcomes will be repetitive negative thinking, self-compassion and mindfulness skills. Additionally, the feasibility of the mMP will be evaluated.
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 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals/couples experiencing fertility problems (using the criteria for the definition of 'infertility', as in: the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse) (Zegers-Hochschild et al., 2017)
- •Both partners possess a smartphone
- •Both partners understand and speak Dutch
- •Written informed consent after been informed on all aspects of the study
排除标准
- •Not applicable
研究组 & 干预措施
Mobile Mindfulness Programme
The mobile mindfulness program is delivered via a mobile application.
干预措施: mobile mindfulness programme (Behavioral)
Wait-list control condition
When assigned to the control condition, participants will be wait-listed for 3 months during the study. After the final assessment participants will receive access to the mobile mindfulness program.
结局指标
主要结局
Fertility related quality of life
时间窗: Data collected at baseline (before randomisation), after 1.5 and 3 months
Change in scores on the Fertility Quality of Life Questionnaire (FertiQol) - 24 items; scoring: 0-100 (the higher the better the quality of life)
emotional distress
时间窗: Data collected at baseline (before randomisation), after 1.5 and 3 months
Change in scores on experienced stress, anxiety and depression as measured by Experience Sampling Method (record emotions several times a day during 4 consecutive days); scoring with a sliding bar: 0-100 (the lower the less emotional distress)
次要结局
- use of the mobile Mindfulness Programme (mMP)(After 1.5 and 3 months in the intervention group)
- subjective quality of the mobile Mindfulness Programme (mMP)(after 3 months in the intervention group)
- self-compassion(Data collected at baseline (before randomisation), after 1.5 and 3 months)
- mindfulness skills(Data collected at baseline (before randomisation), after 1.5 and 3 months)
- repetitive negative thoughts(Data collected at baseline (before randomisation), after 1.5 and 3 months)
- Emotional distress(Data collected at baseline (before randomisation), after 1,5 and 3 months)
- Mindfulness skills(Data collected at baseline (before randomisation), after 1,5 and 3 months)
研究者
Katleen Van der Gucht
PhD, Senior Investigator at Leuven Mindfulness Centre - KU Leuven
KU Leuven