A Randomized Controlled Trial of an iCBT Program to Reduce Infertility-Related Stress: A Novel Digital Approach

The global burden of infertility and its associated psychological distress is substantial, yet many individuals face barriers to accessing psychological support. A scalable, low-cost online intervention presents a promising solution. A randomized controlled trial (RCT) was conducted (experimental vs. waitlist control group) to evaluate the efficacy of a fully automated cognitive behavioral therapy (CBT) program in reducing infertility-related stress among women attempting to conceive. Data were analyzed using linear mixed models on an intention-to-treat basis. The study enrolled 63 Icelandic women experiencing infertility-related stress. The intervention, Overcome Fertility Stress, is an online program designed to identify and modify maladaptive behaviors and thought patterns contributing to infertility-related distress. It delivers personalized treatment through prewritten text, audio, and video responses based on user input. Infertility-related stress was measured using the 46-item Fertility Problem Inventory (FPI), which assesses a global stress score and five domains of infertility-related stress. Participants in the experimental group demonstrated a significant reduction in infertility-related stress (mean reduction score = 22.85, p < 0.05), whereas the control group showed no significant changes (p > 0.05). The within-group effect was large, but controlled between-group effects and confidence intervals should be prioritized when interpreting treatment benefit. These findings provide preliminary controlled evidence that a fully automated CBT program may reduce infertility-related stress, although the underpowered sample and low adherence require cautious interpretation. This RCT, alongside prior feasibility studies, suggests that Overcome Fertility Stress may be a promising low-intensity intervention for infertility-related stress. No significant effects were observed on secondary outcomes measuring depression, anxiety, stress, or worry, suggesting the program is specific to infertility-related stress rather than a broader intervention for emotional disorder symptoms. Larger, adequately powered trials with stronger engagement strategies are needed. Future research should focus on expanding access and integrating digital psychological support into standard fertility care.