Abstract
BACKGROUND: Perinatal depression is a predominant and serious condition that adversely affects prenatal and postpartum women and their children. Prenatal depression is a notable predictor of postpartum depression, highlighting the need for mental health care during pregnancy. Therefore, we developed an innovative smartphone application based on interpersonal psychotherapy (IPT) to improve depressive symptoms in women in the perinatal period (i.e., from pregnancy through the first year postpartum). Here, we present a randomized controlled trial (RCT) protocol to investigate the potential of this intervention for prenatal women. METHODS: This study is an 8-week, open-label, parallel-group, stratified block RCT. In total, 350 primiparous women were randomly assigned to the intervention group-combining the smartphone application for mental health care based on IPT and care as usual-and the control group, with only care as usual. The women assigned to the intervention were encouraged to use the application for approximately 5-10 min daily. The primary outcomes included the proportion of participants with moderate-to-high satisfaction (scoring ≥17 on the 8-item Client Satisfaction Questionnaire) and changes in depressive symptoms measured by the Patient Health Questionnaire-9 from baseline to the end of the 8-week intervention. DISCUSSION: To our knowledge, this RCT is the first to investigate the acceptability and efficacy of an IPT-based smartphone application for reducing depressive symptoms in prenatal women. If successful, the findings will contribute to the growing evidence supporting digital mental health interventions during pregnancy, offering a scalable and accessible solution for prenatal mental health care.