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NCT06949813 · ClinicalTrials.gov registry record · NA
Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
A NA study of Anxiety in Pregnancy and Mood Disorder Due to Specified Medical Condition, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06949813 is a NA study of Anxiety in Pregnancy and Mood Disorder Due to Specified Medical Condition that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06949813, a NA study of Anxiety in Pregnancy and Mood Disorder Due to Specified Medical Condition, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 workgroup
Conditions Studied
Interventions
- BEHAVIORAL BE-OR: Brief Intervention to the Operating Room
- OTHER Interaction: Facetime with Clinical Provider
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-13 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06949813
The ClinicalTrials.gov registry entry for NCT06949813 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anxiety in Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which BE-OR: Brief Intervention to the Operating Room is the first listed.
NCT06949813 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06949813 about?
NCT06949813 is a clinical study titled "Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery". 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...
What is the current status of trial NCT06949813?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-10-13. Estimated completion is 2027-04-30.
What conditions does trial NCT06949813 study?
This clinical trial studies the following conditions: Anxiety in Pregnancy, Mood Disorder Due to Specified Medical Condition.
What interventions are being tested in trial NCT06949813?
The interventions under investigation include: BE-OR: Brief Intervention to the Operating Room (BEHAVIORAL), Interaction: Facetime with Clinical Provider (OTHER).
Who is sponsoring clinical trial NCT06949813?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06949813 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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