MedTrace Logo

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

NCT06383221 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Perinatal Depression
  • Stepped Care
  • Perinatal Anxiety

Interventions

COMBINATION_PRODUCT

"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care

Simple and scientific advice

Sponsors & Collaborators

  • Fangbiao Tao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-12-30
Completion
2026-07-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06383221 on ClinicalTrials.gov