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

Perinatal Depression Clinical Trial

Official title:

Evidence-based Pragmatism Re-design：Randomized Controlled Trial and Metabolomics Study of the Intervention Effect of "Self-help and Advanced On-site Referral" Stepped-care Models on Depression Symptoms During Pregnancy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383221
• Other study ID #: 83244570
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: March 10, 2026

Study information

• Verified date: April 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 10, 2026
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Perinatal Depression

Intervention

Combination Product:
• "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care
Simple and scientific advice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fangbiao Tao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale	Assessment of the severity of depressive symptoms	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum
Secondary	Generalized Anxiety Disorder	Assessment of the severity of anxiety symptoms	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum
Secondary	World Health Organization Five-item Well-Being Index	Assessment of the Well-Being index	0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum