Evaluation of the effect of a midwife-led online program using cognitive behavioral therapy for pregnant women at risk for anxiety disorder in Japan: A pilot randomized controlled trial

AIM: This study aimed to conduct a pilot randomized controlled trial (RCT) to examine the appropriateness and feasibility of a midwife-led cognitive behavioral therapy (CBT)-based, three-session program delivered remotely to pregnant women at risk for anxiety disorders. METHODS: The study design was a pilot RCT. Outcome was the difference between the two groups in the change in generalized anxiety disorder-7 (GAD-7), Kessler6 (K6) and Edinberg Postnatal Depression Scale (EPDS) etc. Recruitment was conducted from August 2020 to July 2021 in clinics and web-based survey monitors in Japan, with follow-up through November 2021. RESULTS: This program involving 63 pregnant women were administered. Although the intervention was remote, a total of three sessions was completed during pregnancy. The change in GAD-7 scores from pre- to 1 month postpartum, was mean -1.77 in the intervention group and mean -0.97 in the control group, with a p-value of .521, indicating no significant difference between the two groups, although GAD-7 scores were lower in the intervention group. The change in K6 score from pre- to 1 month postpartum, was mean -3.55 in the intervention group and mean -1.62 in the control group, with a p-value of .168, indicating no significant difference between the two groups, although the intervention group showed a greater decrease. In particular, in primiparas, the change in GAD-7 scores in the intervention group was large, and some expressed a desire for a postpartum session, suggesting that a follow-up session after delivery may be effective. In multiparas, the control group showed an increase in both GAD-7 and K6 scores from late pregnancy to 1 month postpartum, while the intervention group showed a decrease in scores. CONCLUSION: The program was implemented using CBT conducted by midwife, anxiety decreased in primiparas. In future RCTs, it was suggested that additional postpartum sessions may be effective. TRIAL REGISTRATION: UMIN Clinical trial registry ID: UMIN000040304.