Stand-Alone Mobile Mindfulness App for People Experiencing Infertility: A Pilot Randomised Controlled Trial (MoMiFer-RCT).

Objectives: Infertility and its treatments result in considerable emotional burden. This study aimed to examine the impact of a stand-alone mobile mindfulness application (MoMiFer-app). Methods: A pilot RCT was conducted with participants randomized into an intervention group (n = 34) using the MoMiFer-app, and a wait-list control group (n=38). Outcomes were collected at baseline, 1.5 months, and 3 months post-randomization using experience sampling method (ESM) and self-report questionnaires. Primary outcomes included symptoms of emotional distress (DASS-21+ESM) and fertility-related quality of life (FertiQoL). Secondary outcomes assessed repetitive negative thinking (PTQ), self-compassion (SCS-SF), and mindfulness skills (CHIME-SF+ESM). App usage was evaluated through app-tracking. Results: Multilevel analysis showed no significant improvement in primary outcomes. However, the MoMiFer-app significantly enhanced self-compassion and mindfulness skills, as assessed by self-report questionnaires. A significant condition×time effect was observed for mindfulness skills at 1.5 months (T1; p = .02) and 3 months (T2; p = .02), and for self-compassion at 3 months (T2; p = .006). No effect was observed on repetitive negative thinking. The app was rated as good quality, but nearly half of the participants (47%) practiced mindfulness with the app once a week or less. Conclusions: Online mindfulness-based interventions can be valuable in fertility care providing easily accessible low-intensive mental support, even if they do not directly improve emotional distress or quality of life in the short term. The trial's timing during the COVID-19 pandemic and low app usage may have influenced outcomes. Further research on potential stressors and ways to increase user adherence is needed to better understand the app's impact.