NCT06949813 Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
| NCT ID | NCT06949813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Anxiety in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-13 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Pregnant Patients at 22-37 weeks gestation * Single or multiple gestation * Nulliparous or multiparous (with prior vaginal or cesarean delivery) * Antepartum admission for at least 3 days * High-risk pregnancy due to maternal/fetal comorbidities * Anticipated cesarean delivery at the University of Colorado Exclusion Criteria: * Lack of capacity to consent * Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team. * Anticipated cesarean within 7 days of enrollment
Frequently Asked Questions
Who can join the NCT06949813 clinical trial?
This trial is open to female participants only, studying Anxiety in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06949813 currently recruiting?
Yes, NCT06949813 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Colorado, Denver to inquire about joining.
Where is the NCT06949813 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06949813 clinical trial?
NCT06949813 is sponsored by University of Colorado, Denver. The trial plans to enroll 80 participants.
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