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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06383221
Enrollment
600
Registered
2024-04-25
Start date
2024-05-20
Completion date
2026-07-10
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Anxiety, Perinatal Depression, Stepped Care

Brief 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.

Interventions

COMBINATION_PRODUCTMental Fitness Boot Camp - Advanced Counseling Step-by-Step Care

Simple and scientific advice

Sponsors

Fangbiao Tao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale42 days postpartumAssessment of the severity of depressive symptoms

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scalelate pregnancy, 42 days postpartum, three months postpartum, six months postpartumAssessment of the severity of anxiety symptoms, birth outcome, growth and development in children, Mother-infant attachment relationship
World Health Organization Five-item Well-Being Indexlate pregnancy, 42 days postpartumAssessment of the Well-Being index

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026