Acceptability and efficacy of a smartphone intervention informed by interpersonal psychotherapy for perinatal mental health: A randomized controlled trial.

Abstract

Perinatal depression is a global health concern linked to adverse maternal and neonatal outcomes. Although evidence-based psychological interventions, such as interpersonal psychotherapy (IPT), are effective, women lack access to in-person perinatal care. Smartphone-based interventions may offer scalable support; however, evidence from randomized controlled trials (RCTs) evaluating IPT-informed smartphone interventions remains limited. This study assessed the acceptability and efficacy of an IPT-informed smartphone intervention for perinatal mental well-being. Participants were recruited nationwide through online advertisements and postcards. In this nonblinded RCT, 350 pregnant women were assigned to a fully self-guided smartphone application (intervention) or usual care (control). No minimum depression symptom score was required for participation. Acceptability in the intervention group at 8 weeks after enrolment was indicated by the Japanese version of the Client Satisfaction Questionnaire-8 (CSQ-8J) scores of ≥17. Efficacy was defined as the change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 8 weeks following enrolment. Depressive symptoms were assessed at 1 month postpartum. The application achieved acceptability, with 90.2% (157/174) of participants scoring ≥17 on the CSQ-8J. No significant between-group differences in depressive symptoms were observed during pregnancy (standardized mean difference (SMD) = 0.11). At 1 month postpartum, the intervention group exhibited significantly lower depressive symptom scores (SMD = 0.28). The smartphone application was highly acceptable. While no significant differences in depressive symptoms were observed during pregnancy, differences favoring the intervention group were observed at 1 month postpartum. An IPT-informed smartphone intervention may represent a promising approach to perinatal mental health support.