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Insomnia symptoms are common during pregnancy, especially in the second and third trimesters, which can reach more than 68%. Insomnia during pregnancy is not only associated with increased risk of preeclampsia, gestational diabetes, preterm labor, and cesarean section, but also increased postpartum poor sleep and postpartum depression. Cognitive behavioral therapy (CBT-I) and drug therapy for insomnia are the two main methods of insomnia treatment. Drug therapy is the more commonly used traditional treatment method, but there may be certain drug risks. Therefore, non-drug methods for Insomnia in pregnant women is much safer.
Cognitive-behavioral therapy for insomnia is a psychological therapy for insomnia. Compared with sedative-hypnotic drugs, its therapeutic effect is slow, but the curative effect is long-lasting, with less relapse after treatment and no invasive side effects. Multiple guidelines recommend it as first-line therapy for insomnia. And "Digital Cognitive Behavioral Therapy" (dCBT-I), is based on CBT-I, a therapy provided by the Internet and smartphones, which simulates face-to-face CBT-I in reality. It can provide more convenient medical services for the special group of pregnant women, improve sleep, improve mental symptoms, life treatment, and reduce the risk of adverse outcomes for mothers and children.
The Womens' Hospital, Zhejiang University School of Medicine is conducting a clinical study on "Digital Cognitive Behavioral Therapy (dCBT-I) for maternal Insomnia during pregnancy". The primary goal of this research project was to examine the efficacy of dCBT-I ("RuMian") in the treatment of maternal insomnia. "RuMian" is a fully automatic dCBT-I application developed in China, and subjects will use it for free.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dCBT-I treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dCBT-I | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of "Insomnia Severity Index(ISI)" | Insomnia Severity Index(ISI),the minimum and maximum values are 0 and 28, and higher scores mean a worse outcome. | From before treatment to the end of treatment (an average of 42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of "Pittsburgh Sleep Quality Index(PSQI)" | Pittsburgh Sleep Quality Index(PSQI),the minimum and maximum values are 0 and 21, and higher scores mean a worse outcome. | From before treatment to the end of treatment (an average of 42 days) |
| Change of "sleep onset latency(SOL)" |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoxia Liang | Contact | +860571-87061501 | xiaozaizai@zju.edu.cn |
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simple questionnaire will be used to assess this outcome of sleep onset latency(SOL) |
| From before treatment to the end of treatment (an average of 42 days) |
| Change of "wake up after sleep onset(WASO)" | simple questionnaire will be used to assess this outcome of WASO | From before treatment to the end of treatment (an average of 42 days) |
| Change of "sleep efficiency(SE)" | combination of questionnaire and calculate will be used to assess this outcome of SE | From before treatment to the end of treatment (an average of 42 days) |
| Change of "Number of wake ups during the night" | Number of wake ups during the night | From before treatment to the end of treatment (an average of 42 days) |
| Change of "total sleep time(TST)" | total sleep time(TST) | From before treatment to the end of treatment (an average of 42 days) |
| Change of "Edinburgh Pregnancy Depression Scale(EPDS)" | Edinburgh Pregnancy Depression Scale(EPDS),the minimum and maximum values are 0 and 30, and higher scores mean a worse outcome. | From before treatment to the end of treatment (an average of 42 days) |
| Change of "Self-rating Anxiety Scale(SAS)" | Self-rating Anxiety Scale(SAS), the minimum and maximum values are 25 and 100, and higher scores mean a worse outcome. | From before treatment to the end of treatment (an average of 42 days) |