RecruitingNot ApplicableNCT06949813

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


Sponsor

University of Colorado, Denver

Enrollment

80 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 enhance the acceptability, appropriateness, and feasibility of implementation in L\&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, and hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a steering council. Following this refinement process, a treatment development pilot RCT at a large L\&D unit will assess the efficacy of CARE for CD by probing engagement with the target mechanism, as well as assess the feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is testing a guided meditation program to help prevent mood problems, anxiety, and trauma-related symptoms in pregnant women who are admitted to the hospital and are likely to deliver by cesarean section (C-section). Researchers want to know if this mental wellness intervention during the hospital stay can improve emotional outcomes after birth. **You may be eligible if...** - You are pregnant, between 22 and 37 weeks gestation - You have been admitted to the hospital for at least 3 days due to a high-risk pregnancy - You are expected to deliver by cesarean section at the University of Colorado - You are carrying one or more babies **You may NOT be eligible if...** - You are expected to have a cesarean delivery within 7 days of enrolling (too soon for the intervention) - You do not have the capacity to consent - Your medical team determines the intervention is not appropriate for your situation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBE-OR: Brief Intervention to the Operating Room

See intervention group section for details

OTHERInteraction: Facetime with Clinical Provider

See Interaction group section for details


Locations(1)

University of Colorado Hospital

Aurora, Colorado, United States

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NCT06949813


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