Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383221
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy
Sponsor:
Fangbiao Tao
Organization:
Anhui Medical University
Study Overview
Official Title:
Evidence-based Pragmatism Re-designRandomized 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 earlymidlate and randomly assigned to the intervention and control groups on a 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None