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

NCT06383221 | Enrolling By Invitation

• 1 other identifier: 83244570
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Stepped Care; Perinatal Anxiety

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale

  Assessment of the severity of depressive symptoms

  42 days postpartum

Secondary Outcomes (2)

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

  late pregnancy, 42 days postpartum, three months postpartum, six months postpartum

• World Health Organization Five-item Well-Being Index

  late pregnancy, 42 days postpartum

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Combination Product: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care

control group

NO INTERVENTION

The control group received routine care.

Interventions

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

Simple and scientific advice

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suffering from depression being treated with psychotherapy or medication

Sponsors & Collaborators

• Fangbiao Tao: lead

Study Sites (1)

Ma'anshan Maternal and Child Health Center

Ma’anshan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: May 20, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 10, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)