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.
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.
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. ;
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