NCT06383221

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Fangbiao Tao · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The intervention group used the "Psychological Training Camp \& Obstetrician-Led Psychoprenatal Intervention (PICONI)" stepwise care model, which incorporated cognitive-behavioral therapy, mindfulness,etc., with the Psychic Fitness Camp being a self-help learning experience and the Mood Scan being a perinatal clinic doctor guiding pregnant women in unhealthy thinking alternatives and behavior design. Metabolic markers of perinatal depression anxiety and the mitigating effects of the stepped care model were explored by collecting blood and urine samples from the study participants during early, mid and late pregnancy respectively, samples were collected and stored in a refrigerator at -80 degrees Celsius.

Conditions

• Perinatal Depression
• Stepped Care
• Perinatal Anxiety

Interventions

Type	Name	Description
COMBINATION_PRODUCT	"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care	Simple and scientific advice

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-12-30
• Completion: 2026-07-10
• First posted: 2024-04-25
• Last updated: 2025-12-15

Locations

1 site across 1 country: China