Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy.
- Conditions
- Perinatal DepressionStepped 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 600
- 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.
- Suffering from depression being treated with psychotherapy or medication; Positive screening for bi-directional affective disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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