Participants
mania, psychosis, blood transfusions, depression, Depression
RECRUITMENT
We randomized 234 pregnant individuals recruited primarily from obstetrics clinics at 2 major medical centers in the Denver, Colorado, metropolitan area. Recruitment began July 2017 and ended August 2021 with a pause from mid-April through mid-June 2020 due to the COVID-19 pandemic. Initial screening was performed based on medical record review. Eligibility criteria included 18 to 45 years of age, English speaking, 25 weeks’ gestational age (GA) or less, singleton pregnancy, and endorsing elevated depression symptoms when screened as part of standard of care (Edinburgh Postnatal Depression Scale [EPDS] score ≥10). Exclusion criteria included current illicit drug or methadone use and major health conditions requiring invasive treatments (eg, dialysis, blood transfusions, chemotherapy). Additional assessment for eligibility was performed at baseline to exclude (1) current or past psychosis or mania and (2) currently receiving cognitive behavioral therapy or IPT. The trial protocol is available in This study followed the Consolidated Standards of Reporting Trials (