Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT04443959
Eligibility Criteria:
Inclusion Criteria:
* (1) Gestational age at time of study enrollment must be 18-30 weeks.
* (2) Insomnia Severity Index score of 11 or higher
* (3) age between 18 and 40 years
* (4) reliable and adequately fast internet connection at home, which is required to engage in online treatment and online study outcome assessments
Exclusion Criteria:
* (1) High risk pregnancy as reported by the patient, which includes but is not limited to pre-eclampsia, gestational diabetes, maternal age \> 40, ectopic pregnancy, fetal problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and placental abruption.
* (2) bipolar disorder or seizure disorders \[contraindicated for insomnia therapy\] as reported by the patient
* (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible to participate as multiple pregnancy can increase risk of complications and often leads to preterm or early-term birth
* (4) any conditions or difficulties that would prevent the patient from completing online treatment and/or online surveys, including but not limited to language difficulties, literacy issues, visual or auditory impairment, and cognitive deficits
* (5) active suicidal intent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04443959
Study Brief:
Protocol Section:
NCT04443959