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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT04445805
Eligibility Criteria:
Inclusion Criteria:
* (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
* (2) Insomnia Severity Index score \> 10
* (3) age 18 - 40 years
* (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
Exclusion Criteria:
* High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age\>40)
* Bipolar disorder (contraindicated for CBTI)
* Seizures (contraindicated for CBTI)
* Active suicidal intent
* Shift work
* Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04445805
Study Brief:
Protocol Section:
NCT04445805