A Randomized Controlled Trial of the "Psychological Training Camp & Obstetrician-Led Psychoprenatal Intervention (PICONI)" Stepwise Intervention Model for Depression and Anxiety During Pregnancy.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale
研究概览
简要总结
In this study, pregnant women were screened and managed for depression and anxiety in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression and/or anxiety during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid and late), depression and/or anxiety, randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women with mild anxiety and/or depression self-study the Psychic Fitness Camp, and pregnant women with moderate-to-severe anxiety and/or depression self-study the Psychic Fitness Camp with immediate referral to an obstetrician for one to three Mood Scan. The control group received routine care.
详细描述
The intervention group used the "Psychological Training Camp & Obstetrician-Led Psychoprenatal Intervention (PICONI)" stepwise care model, which incorporated cognitive-behavioral therapy, mindfulness,etc., with the Psychic Fitness Camp being a self-help learning experience and the Mood Scan being a perinatal clinic doctor guiding pregnant women in unhealthy thinking alternatives and behavior design.
Metabolic markers of perinatal depression anxiety 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 respectively, samples were collected and stored in a refrigerator at -80 degrees Celsius.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women; Informed consent, able to complete the questionnaire independently; Positive first depression screening (EPDS ≥ 10) or anxiety screening (GAD-7≥5) in early and mid pregnancy; Intention to have children in this pregnancy.
排除标准
- •Suffering from depression being treated with psychotherapy or medication
结局指标
主要结局
Edinburgh Postnatal Depression Scale
时间窗: 42 days postpartum
Assessment of the severity of depressive symptoms
次要结局
- Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scale(late pregnancy, 42 days postpartum, three months postpartum, six months postpartum)
- World Health Organization Five-item Well-Being Index(late pregnancy, 42 days postpartum)
研究者
Fangbiao Tao
Professor
Anhui Medical University