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Randomized Controlled Trial
. 2022 Nov;76(11):570-578.
doi: 10.1111/pcn.13458. Epub 2022 Sep 16.

The preventive effect of internet-based cognitive behavioral therapy for prevention of depression during pregnancy and in the postpartum period (iPDP): a large scale randomized controlled trial

Affiliations
Randomized Controlled Trial

The preventive effect of internet-based cognitive behavioral therapy for prevention of depression during pregnancy and in the postpartum period (iPDP): a large scale randomized controlled trial

Daisuke Nishi et al. Psychiatry Clin Neurosci. 2022 Nov.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] Psychiatry Clin Neurosci. 2023 May;77(5):304. doi: 10.1111/pcn.13546. Epub 2023 Mar 28. Psychiatry Clin Neurosci. 2023. PMID: 36974903 Free PMC article. No abstract available.

Abstract

Background: Prevention of perinatal depression beginning from the antenatal period is essential. Therefore, this study aimed to investigate the effectiveness of recently developed internet-delivered cognitive behavioral therapy (iCBT) for preventing the onset of a major depressive episode (MDE) in the third trimester and at 3 months postpartum.

Methods: This is a two-arm, parallel-group, general-information controlled, randomized controlled trial. Participants were 5017 pregnant women at 16-20 weeks' gestation without MDE at baseline. They were randomly assigned to an iCBT (intervention; n = 2509) or general-information (control; n = 2508) group, stratified by psychological distress at baseline. The primary outcomes were the numbers of new MDE onsets, measured using the World Health Organization Composite International Diagnostic Interview 3.0, at 32 weeks' gestation and at 3 months postpartum.

Results: New MDE onset was reported by 59 participants (2.35%) in the intervention group and 73 (2.91%) in the control group during follow-up. Compared with the control group, the hazard ratio (HR) of MDE in the intervention group was 0.85 (95% CI 0.61-1.20), which was not significantly different. Among participants who scored between 5 and 8 on K6 at baseline, 10 (1.37%) in the intervention group reported new onset of MDE, compared with 28 (3.81%) in the control group, and the HR of MDE was 0.38 (95%CI 0.19-0.79).

Conclusions: No intervention effect was found for iCBT in preventing new onset of perinatal MDE. iCBT might prevent perinatal depression only among pregnant women with subthreshold depressive symptoms.

Trial registration: UMIN000038190.

Keywords: antenatal depression; postpartum depression; prevention; smartphone-based cognitive behavioral therapy.

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Figures

Fig. 1
Fig. 1
Flow diagram of the study participants.
Fig. 2
Fig. 2
Kaplan–Meier curve of the iCBT program and control group.
Fig. 3
Fig. 3
Kaplan–Meier curve of the iCBT program and control group stratified by K6 at baseline.
Fig. 4
Fig. 4
Change in Edinburgh Postnatal Depression Scale (EPDS) score between groups.

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