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Enrolling by Invitation

NCT Number: NCT06383221

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.

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Key information

Conditions

Perinatal Depression Perinatal Anxiety Stepped Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ma'anshan Maternal and Child Health Center

Ma’anshan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women; Informed consent, able to complete the questionnaire independently; Positive first depression screening (EPDS ≥ 10) or anxiety screening (GAD-7≥5) in early and mid pregnancy; Intention to have children in this pregnancy.

Exclusion criteria

  • Suffering from depression being treated with psychotherapy or medication

Treatment and study plan

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

Combination Product

Simple and scientific advice

Primary outcomes

  1. Edinburgh Postnatal Depression Scale

    Time frame: 42 days postpartum

    Assessment of the severity of depressive symptoms

Secondary outcomes

  1. Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scale

    Time frame: late pregnancy, 42 days postpartum, three months postpartum, six months postpartum

    Assessment of the severity of anxiety symptoms, birth outcome, growth and development in children, Mother-infant attachment relationship

  2. World Health Organization Five-item Well-Being Index

    Time frame: late pregnancy, 42 days postpartum

    Assessment of the Well-Being index

Sponsors and collaborators

Lead sponsor

Fangbiao Tao

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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