Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT).
Study Goal
The researchers aimed to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility.
Results Summary
The study is exploratory and ongoing, so specific results are not yet reported, but it aims to measure effects on emotional distress, quality of life, mindfulness skills, and other secondary outcomes using a randomized controlled trial design.
Population
Women, men, and couples experiencing infertility (n=60).
Effective Dosage
Not specified (app-based mindfulness intervention following Mindfulness-Based Stress Reduction format).
Duration
3 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
smartphone-delivered mindfulness apps | decrease | symptoms of emotional distress | clinical and non-clinical populations | - | effectiveness for reducing | #1 |
stand-alone mobile mindfulness app | neutral | symptoms of emotional distress | people experiencing infertility | - | efficacy to be investigated | #2 |
stand-alone mobile mindfulness app | neutral | fertility-related quality of life | people experiencing infertility | - | efficacy to be investigated | #3 |
stand-alone mobile mindfulness app | neutral | mindfulness skills | people experiencing infertility | - | effects to be measured | #4 |
stand-alone mobile mindfulness app | neutral | repetitive negative thinking | people experiencing infertility | - | effects to be measured | #5 |
stand-alone mobile mindfulness app | neutral | self-compassion | people experiencing infertility | - | effects to be measured | #6 |
stand-alone mobile mindfulness app | neutral | user-rated quality of the stand-alone mobile mindfulness app | people experiencing infertility | - | user-rated quality to be evaluated | #7 |
stand-alone mobile mindfulness app | neutral | use of the app | people experiencing infertility | - | use to be evaluated | #8 |
INTRODUCTION: Infertility and its treatment bring a considerable emotional burden. Increasing evidence demonstrates the effectiveness of smartphone-delivered mindfulness apps for reducing symptoms of emotional distress in both clinical and non-clinical populations. Evidence on this topic in women, men and couples experiencing infertility is currently under-represented. The aim of the MoMiFer study is, therefore, to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility. METHODS AND ANALYSIS: This study is an exploratory randomised controlled trial (RCT) with open enrollment. The primary outcomes are symptoms of emotional distress and fertility-related quality of life. Secondary outcomes are mindfulness skills, repetitive negative thinking, self-compassion, user-rated quality of the stand-alone mobile mindfulness app and use of the app. Experience sampling method and standardised self-report questionnaires are combined within a repeated measures design to measure the effects of the stand-alone mobile mindfulness app on the primary and secondary outcomes, apart from the use of the app. The latter will be evaluated through app tracking. People, including women, men and couples, experiencing infertility (n=60) will be randomised to an intervention group receiving the stand-alone mobile mindfulness app for 3 months or a wait-list control group. The app follows the format and content of Mindfulness-Based Stress Reduction. Data will be collected at baseline, at 1.5 months and 3 months after randomisation. Analysis will be according to intention to treat and based on general linear modelling and multilevel mixed-effects modelling. ETHICS AND DISSEMINATION: This study received approval from the Medical Ethical Committee of the Leuven University Hospital (Belgium). The findings of this exploratory RCT will be disseminated through presentations at public lectures, scientific institutions and meetings, and through peer-reviewed scientific articles. TRIAL REGISTRATION NUMBER: NCT04143828.