A Randomized Controlled Trial of the "Psychological Training Camp & Obstetrician-Led Psychoprenatal Intervention (PICONI)" Stepwise Intervention Model for Depression and Anxiety During Pregnancy.

In this study, pregnant women were screened and managed for depression and anxiety in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression and/or anxiety during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid and late), depression and/or anxiety, randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women with mild anxiety and/or depression self-study the Psychic Fitness Camp, and pregnant women with moderate-to-severe anxiety and/or depression self-study the Psychic Fitness Camp with immediate referral to an obstetrician for one to three Mood Scan. The control group received routine care.

NCT Number	NCT06383221
Lead Sponsor	Fangbiao Tao
Conditions	Perinatal Depression, Stepped Care, Perinatal Anxiety
Enrollment	600 participants
Start Date	2024-05-20
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-07-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-15