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Study identifier: NCT06949813 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery

Condition: Anxiety in Pregnancy · Mood Disorder Due to Specified Medical Condition  ·  Sponsor: University of Colorado, Denver

PhaseNA
Planned participants80
Who can joinFemale, N/A to no upper limit
Healthy volunteersNo

About this study

Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma symptoms (PMATS). There is a deficit in resources and access to mental health treatment for pregnant patients, with some treatments being cost-prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to trauma. The investigators developed a low-cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. To revise the implementation plan and intervention (CARE: Communication, Agency, Readiness, Empowerment for cesarean delivery \[CD\]) for use in large L\&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Before initiating such a trial, work needs to be done to modify the intervention and implementation through a process of iterative refinement to en…

This description comes directly from the study's public registry record.

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Locations (1)

University of Colorado HospitalAurora, Colorado, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06949813