NCT05395546

Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia

Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia During Pregnancy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-07-15
• Completion: 2023-06-01
• First posted: 2022-05-27
• Last updated: 2022-05-27