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【ChiCTR2100043804】减少心理应激和改善新生儿结果的线上围产期正念干预的随机对照试验

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基本信息

登记号

ChiCTR2100043804

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2021-03-03

临床申请受理号

靶点

适应症

Perinatal stress, depression and anxiety symptoms

试验通俗题目

减少心理应激和改善新生儿结果的线上围产期正念干预的随机对照试验

试验专业题目

减少心理应激和改善新生儿结果的线上围产期正念干预:随机对照试验

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

The present research is to develop and evaluate a prenatal mindfulness intervention for reducing psychological stress and improving neonatal outcomes among Chinese pregnant women. The objectives of the study are: 1. To evaluate the efficacy of the intervention in terms of the changes of primary outcome variable depression at T1, T2 & T3; 2. To evaluate the efficacy of the proposed intervention in terms of the changes of process outcome variables including trait mindfulness and equanimity at T1, T2 & T3; 3. To evaluate the efficacy of the intervention in terms of the changes of secondary outcome variables including anxiety, general and pregnant related stress, stress coping, satisfaction with life, and self-compassion at T1, T2 & T3; 4. To examine the trajectory of depression and anxiety in relation to obstetric and neonatal outcomes after participants have given birth; 5. To evaluate the effect of process outcome variables on mediating primarily outcome variables.

试验分类

试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Randomization was conducted by the study leader, utilizing the block randomization method. Participants were ranked in an order based on their current gestation weeks. Then a block size of four was adopted, with each block having two participants randomly assigned to the intervention group and control group res

盲法

It was not feasible to mask participants to their respective treatment conditions, owning to the nature of the psychological intervention, but participants were blinded with regard to the purpose and hypotheses of the study. Participants were informed that they would be randomized to one of two treatment conditions that we expected were equally effective, and access to the mindfulness intervention was provided to participants in the control group after the completion of assessment at 1-month postpartum. In addition, outcome measures were self-reported and submitted through online links. And data remained sealed to researchers and stored in the cloud until the 1-month postpartum follow-up assessment was completed by all participants.

试验项目经费来源

Self-financed

试验范围

目标入组人数

37;38

实际入组人数

第一例入组时间

2020-02-01

试验终止时间

2021-04-01

是否属于一致性

入选标准

1. Pregnancy at 2nd trimester (between 12th to 28th week gestation); 2. Chinese adults (age 18 or above) able to communicate in Chinese; 3. Being able to give informed consent; 4. Being willing and able to attend at least 7 sessions of the intervention/control program.；

排除标准

1. Not able to understand Chinese (the intervention will be delivered in Chinese); 2. Undertaking any psychological treatments/meditation practices during pregnancy; 3. High-risk pregnancy status determined by obstetrician report (e.g., preterm labor, placental abnormality, multiple gestations, required bed rest, or morbid obesity); 4. Current psychiatric and mental disorders that necessitated priority attention (e.g., schizoaffective disorder, bipolar disorder, or current psychosis; organic mental disorder or pervasive developmental delay; current eating disorder; current substance abuse or dependence; Post-traumatic stress disorders; imminent suicide or homicide risk. 5. History of neurological problems such as epilepsy and seizures.；

研究者信息

研究负责人姓名

试验机构

The University of Hong Kong

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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