Status:
UNKNOWN
Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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 pre...
Eligibility Criteria
Inclusion
- Age 18-40 years old
- 20-32 weeks of pregnancy, singleton pregnancy and regular obstetric examination at Zhejiang University Women's Hospital
- There has been a high frequency of insomnia symptoms
- According to the preliminary assessment by the project team, it meets the diagnostic criteria for insomnia
- Possess a smart phone and can operate it proficiently, with normal reading and writing comprehension ability, clear consciousness, and able to cooperate with the research to complete the questionnaire independently.
Exclusion
- Assess the risk of preterm birth and concurrent pregnancy-related diseases;
- Completion of the 7-day sleep diary in the baseline period \< 4 days;
- Combined with severe anxiety/depression;
- Suicidal tendencies or severe mental illness (bipolar disorder, schizophrenia, paranoid psychosis, etc.);
- Edinburgh Pregnancy Depression Scale (EPDS) total score ≥ 15;
- Have drug dependence or have taken anti-anxiety, anti-depression, sedative or hypnotic drugs for mental diseases within the past 3 months;
- Participated in interventions such as meditation courses, childbirth yoga or cognitive behavioral therapy in the past 1 year;
- Complicated with serious physical diseases such as heart failure and tumor;
- Combined with sleep disorders such as severe obstructive sleep apnea that require further evaluation and treatment;
- There is alcohol and cigarette dependence;
- Shift work;
- Severe visual or hearing impairment and unable to use mobile phones normally;
- Physical illness with unstable condition, or illness itself that may interfere with cognitive behavioral therapy for insomnia.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05395546
Start Date
June 1 2022
End Date
June 1 2023
Last Update
May 27 2022
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