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.

ABSTRACT

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.