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临床试验/NCT07349368
NCT07349368已完成不适用

Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 3,314 人开始时间: 2021年3月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,314
试验地点
1
主要终点
Edinburgh Postnatal Depression Scale (EPDS) Score

研究概览

简要总结

This scale-up study aimed to explore the effectiveness of simultaneous screening and intervention of antenatal depression and anxiety in preventing postpartum depression and anxiety and how scale-up might be successfully achieved. The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones. Exclude those with abnormal comprehension and expression abilities. The implementation group, 1. screening during pregnancy and 42 days postpartum; 2. Stratified iCBT Intervention, usual care. Low-intensity: Mild cases (EPDS≥9/GAD-7≥5) received 11 animated video sessions adapted from WHO's Thinking Healthy Programme manual. High-intensity: Moderate-severe cases (EPDS≥12/GAD-7≥10) received low-intensity components and supplemental telehealth counseling. The control group, screening at 42 days postpartum, usual care.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones.

排除标准

  • Exclude those with abnormal comprehension and expression abilities

研究组 & 干预措施

usual care group

No Intervention

no additional intervention

Stratified iCBT group

Experimental

Stratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care

干预措施: implementation group (Behavioral)

结局指标

主要结局

Edinburgh Postnatal Depression Scale (EPDS) Score

时间窗: at 42 days postpartum

The EPDS is a 10-item self-report questionnaire. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.

Generalized Anxiety Disorder 7-item (GAD-7) Scale Score

时间窗: at 42 days postpartum

The GAD-7 is a 7-item self-report questionnaire. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.

次要结局

未报告次要终点

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fangbiao Tao

Professor

Anhui Medical University

研究点 (1)

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