Cohort Study on the Outcome and Influencing Factors of Perinatal Depression

• Conditions: Perinatal Depression; Prognosis
• Interventions: Behavioral: Psychological intervention; Other: Comprehensive intervention

• Registration Number: NCT04517981
• Lead Sponsor: Shanghai Mental Health Center, Jingan District

Brief Summary

1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;

2. Factors affecting the outcome of the disease;

3. Recurrence of PND in pregnancy again;

4. The influence of different intervention methods on the course of the disease.

Detailed Description

Research objectives

1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;

2. Factors affecting the outcome of the disease;

3. Recurrence of PND in pregnancy again;

4. The influence of different intervention methods on the course of the disease. Research process: 1. The pregnant women who were filed at Xinhua Hospital and Tongji Hospital and were receiving perinatal care from July 2019 to December 2019 were evaluated in the third trimester of pregnancy using the General Situation Questionnaire, SSRS, PHQ-9, and GAD-7. Those with PHQ-9 score ≥ 5 or GAD ≥ 5 were classified as having symptoms of depression and anxiety, and those who were screened positive were included in the study cohort; 42 days postpartum, 3 months postpartum, 6 months postpartum, 12 months postpartum, 18 months postpartum , 24 months postpartum, use PHQ-9, GAD-7 scale, 6 quality of life questionnaires, and SSRS to evaluate the cohort. If the PHQ-9 score is greater than or equal to 5 or the GAD is greater than or equal to 5, the psychiatrist will perform a clinical examination based on DSM-IV to make a clinical diagnosis; the outcome of the cohort and the incidence and influencing factors; 2 . During the follow-up process, the cohort developed high-risk pregnant women with depression, anxiety symptoms and other perinatal depressive disorders during the follow-up process. Based on the WeChat platform, integrated general hospitals, psychological counseling centers, social families and other service resources were carried out throughout the prenatal and first delivery period. Intervention methods such as community intervention for perinatal depression that focus on the comprehensive "physiology, psychology, and society" of the whole process after the first childbirth. Pregnant women diagnosed with PND will be evaluated by a psychiatrist to determine the treatment plan, and follow-up will continue.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19
• Primary Completion: 2022-02-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug intervention	Psychological intervention	Antidepressant
Drug intervention	Comprehensive intervention	Antidepressant
Comprehensive intervention	Psychological intervention	Psychological intervention, community intervention combined with drug intervention

Primary Outcome Measures

Name	Time	Method
Fate	2019.9.1-2022.2.1	Progression of high-risk pregnant women with perinatal depression in the third trimester
Influencing factors	2019.9.1-2022.2.1	Influencing factors of disease progression
Impact of intervention	2019.9.1-2022.2.1	The influence of different intervention methods on the course of the disease

Trial Locations

Locations (1)

Jing'an District Mental Health Center; 🇨🇳 Shanghai, Jing'an District, China