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.