Developing and evaluating the effectiveness of a web-based application to improve the mental health of infertile women: a multi-phase study protocol
摘要
Infertility is a chronic bio-psycho-social condition associated with substantial psychological distress, particularly among women. High rates of anxiety, depression, reduced quality of life, low self-efficacy, and impaired resilience have been widely reported, while access to psychological support remains limited due to financial, social, and stigma-related barriers. Web-based mental health interventions offer a promising, accessible, and cost-effective approach to address these unmet needs. This study aims to develop and evaluate the effectiveness of a user-centered, web-based psychoeducational and supportive application designed to improve the mental health of infertile women.
MethodsThis developmental-applied study will be conducted in three phases. Phase 1 involves a comprehensive needs assessment through systematic literature reviews and qualitative interviews with infertile women and multidisciplinary experts to identify educational and supportive mental health needs. Phase 2 focuses on the design and development of a web-based application using user-centered design principles, incorporating evidence-based psychoeducational content, interactive exercises, and supportive resources targeting depression, anxiety, stress, quality of life, infertility self-efficacy, and resilience. Phase 3 will evaluate the application through a randomized controlled clinical trial conducted in infertility clinics affiliated with Tabriz University of Medical Sciences. Eligible infertile women will be randomly assigned to either the intervention group, receiving access to the application for six weeks, or a control group receiving routine care. Outcomes will be assessed using validated instruments, including Depression, (Anxiety and Stress Scale – 21) DASS-21, (Fertility Quality of life) FertiQoL, Infertility Self-Efficacy Scale, Connor–Davidson Resilience Scale, and the Questionnaire for User Interaction Satisfaction. Linear mixed models will be applied to compare post-intervention outcomes between groups.
DiscussionThis study contributes to the growing body of evidence supporting the role of digital mental health interventions in reproductive medicine and highlights the potential of technology-driven, patient-centered approaches to improve psychological outcomes in infertile women.