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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT07302893
Eligibility Criteria:
Inclusion Criteria:
* First time parents with infants between 4-12 months of age
* Caregiver is over 18 years old
* Caregiver meets clinical threshold for insomnia (11 or greater on the ISI)
* Own a smartphone that can support downloaded apps
* Fluency in English
Exclusion Criteria:
* A diagnosis of any of the following conditions: self-reported schizophrenia, psychosis, depression, self-harm bipolar disorder, seizure disorder, substance use disorder, recent trauma to the head or brain damage, severe cognitive impairment, serious physical health concerns necessitating surgery or with a prognosis of less than 6 months, or pregnancy. Two or more hospitalizations within the past 6 months for psychiatric reasons.
* Prior enrollment in another CBT-I program
* Regular mindfulness meditation practice
* Diagnosed sleep disordered breathing
* Parents of infants with health complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07302893
Study Brief:
Protocol Section:
NCT07302893