Insomnia during pregnancy
Conditions
Interventions
Trial group:Electronic Cognitive Behavioral Therapy for Insomnia. Duration, cycle, and frequency: 60 min/session, 1 session/week, for a total of 6 weeks. Adjustments will be made flexibly based on the
Control group:Conventional intervention: provision of a sleep hygiene education booklet.
Sponsors
International Peace Maternal and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged betwen 18 and 45 years; 2. Pregnancy during 8W to 28W (confirmed by ultrasound); 3. Insomnia Severity Index score (ISI)>=8; 4. Primiparous women who can regularly use internet connected computers, tablets, or smartphones.
Exclusion criteria
Exclusion criteria: 1. Individuals with other sleep disorders, such as obstructive sleep apnea based on the Berlin questionnaire, restless leg syndrome based on the International Restless Leg Syndrome Scale, and self-reported episodic sleepiness; 2. Multiple pregnancies; 3. History of two or more natural abortions in the past; 4. Women with assisted reproductive therapy; 5. Planned termination of pregnancy; 6. Shift workers; 7. Severe mental illness, e.g., severe depression indicated by Edinburgh Postnatal Depression Scale (EPDS) = 15, self-reported diagnosis of bipolar disorder or schizophrenia, suicidal tendencies (defined as a score greater than 1 on EPDS item 10, or reporting specific suicide plans, or recent suicide attempts).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment Rate;Enrollment Rate;Adherence;Report Completeness;Adverse Event Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia;Sleep Parameters;Stress;Self-efficacy;Depression;Anxiety;Diversity of gut microbiota; | — |
Countries
China
Contacts
Public ContactCai Yanqing
International Peace Maternal and Child Health Hospital
Outcome results
None listed