An interventional study of dCBT-I in Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), sponsored by Women's Hospital School Of Medicine Zhejiang University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Other: dCBT-I
1. Complete the evaluation of various scales and record a 7-day sleep diary before entering the group 2. Receive a 6-week treatment after enrollment, insist on using the app every day (about 5-10 minutes), and receive regular follow-up from the project doctor 3. Scale assessment needs to be completed at the end of treatment 4. One month after the end of treatment, cooperate with relevant follow-up and complete the scale evaluation
Also known as: Device: smartphone
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.
Time frame: From before treatment to the end of treatment (an average of 42 days)
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.
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "sleep onset latency（SOL）"
simple questionnaire will be used to assess this outcome of sleep onset latency（SOL）
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "total sleep time（TST）"
total sleep time（TST）
Time frame: 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.
Time frame: 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.
Time frame: From before treatment to the end of treatment (an average of 42 days)
No study locations are listed for this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Women's Hospital School Of Medicine Zhejiang University