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

NCT06383221 — Not applicable, Enrolling by invitation, 600 participants, Fangbiao Tao

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Registry	NCT06383221
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	600 (Estimated)
Sponsor	Fangbiao Tao (Other)
Conditions	Perinatal Depression, Stepped Care, Perinatal Anxiety
Interventions	"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care (Combination product)
Dates	start 2024-05-20, primary completion 2025-12-30 (estimated), completion 2026-07-10 (estimated), first posted 2024-04-25, last updated 2025-12-15
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
intervention group	Experimental	Combination Product: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care	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.
control group	No intervention		The control group received routine care.

"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care (Combination product): Simple and scientific advice

+Outcome measures

Primary outcomes

Edinburgh Postnatal Depression Scale [42 days postpartum]: Assessment of the severity of depressive symptoms

Secondary outcomes

Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scale [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
World Health Organization Five-item Well-Being Index [late pregnancy, 42 days postpartum]: Assessment of the Well-Being index

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Ma'anshan Maternal and Child Health Center	Ma’anshan	China