Guided internet‐delivered compassion‐focused therapy for women with recurrent pregnancy loss: A protocol of a randomized controlled trial

Aim This randomized controlled trial aims to examine the effects of an internet‐delivered compassion‐focused therapy program on depressive symptoms in women with recurrent pregnancy loss. Methods The target population will be non‐pregnant women aged 18–50 years with at least two pregnancy losses who visit the recurrent pregnancy loss outpatient clinics. Participants who fulfill the eligibility criteria will be randomly assigned to either a 5‐week intervention group ( n = 55) or a waitlist control group ( n = 55). Participants in the intervention group will be asked to complete four weekly video modules (20–25 min each), including psychoeducation, experiential exercises, and homework assignments based on compassion‐focused therapy principles. The intervention incorporates psychiatrist‐guided support through weekly messages encouraging participants to share insights and questions about the program. The primary outcome is depression severity measured by the Patient Health Questionnaire‐9. Secondary outcomes are psychological distress, perinatal grief, self‐compassion, rumination, and worry about future pregnancies. Assessments will be conducted at baseline, 5‐week follow‐up (post‐intervention), and 13‐week follow‐up. Mixed model analyses will be conducted to test the effectiveness of the intervention. Results As this is a study protocol, results are not yet available. Conclusion If the intervention program demonstrates significant benefits, it could be offered to all women with recurrent pregnancy loss in Japan.