Smartphone cognitive behavioral therapy for prevention of depressive symptoms in patients with recurrent pregnancy loss: an exploratory decentralized, parallel‐group, multicenter, open, individually randomized, fully factorial trial

Aim The aim was to explore the preventive effects of smartphone cognitive behavioral therapy (CBT) in addressing depression and anxiety in patients with recurrent pregnancy loss (RPL) due to lack of such previous studies. Methods This was an exploratory decentralized, parallel‐group, multicenter, open, individually randomized, fully factorial trial. A total of 432 patients with RPL were randomized and patients who completed the psychoeducation component of the app within 2 weeks of consent were included. Five CBT components—namely, self‐monitoring, behavioral activation, cognitive restructuring, assertion training, and problem solving—were randomly assigned as present or absent, resulting in 2 5 = 32 combinations. The primary outcomes were changes in Patient Health Questionnaire‐9 and Generalized Anxiety Disorder‐7 scores at weeks 8 and 12 from baseline. Results A total of 419 patients were analyzed. The presence or absence of specific CBT components did not significantly affect patient outcomes. However, patients experienced a statistically significant overall reduction in depressive symptoms from baseline to weeks 8 and 12. Pre–post effect sizes for overall improvement ranged from −0.30 to −0.38 at week 8 and from −0.22 to −0.33 at week 12. No significant overall reduction in anxiety symptoms was observed. Conclusion The CBT application significantly reduced depressive symptoms in patients with RPL; however, no specific CBT component showed superior effects. The findings did not indicate efficacy in comparison to the pure treatment‐as‐usual group. Further research is required to enhance its impact on anxiety and refine the selection and delivery of individual CBT components.