Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy.

Not Applicable

Not yet recruiting

• Conditions: Perinatal Depression; Stepped Care
• Interventions: Combination Product: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care

• Registration Number: NCT06383221
• Lead Sponsor: Fangbiao Tao

Brief Summary

In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care.

Detailed Description

The intervention group used the "Mental Fitness Boot Camp - Advanced Counseling" stepwise care model, which incorporated cognitive-behavioral therapy and mindfulness in both phases, with the Mental Fitness Boot Camp being a self-help learning experience and the Advanced Counseling being a perinatal clinic doctor guiding pregnant women in behavioral design.

Metabolic markers of perinatal depression 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, and 42 days postpartum, respectively, samples were collected and stored in a refrigerator at -80 degrees Celsius.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-05-20
• Primary Completion: 2025-10-20
• Study Completion: 2026-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• Suffering from depression being treated with psychotherapy or medication; Positive screening for bi-directional affective disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care	Pregnant women in the intervention group attend a one-week Mental Fitness Boot Camp, are assessed at 3 weeks, and receive 3 one-on-one counseling sessions with their obstetrician if they still screen positive for depression.

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum	Assessment of the severity of depressive symptoms

Secondary Outcome Measures

Name	Time	Method
World Health Organization Five-item Well-Being Index	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum	Assessment of the Well-Being index
Generalized Anxiety Disorder	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum	Assessment of the severity of anxiety symptoms