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

NCT06949813 | Recruiting DMC

• 2 other identifiers: 23-24991R34MH133685-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety in Pregnancy; Mood Disorder Due to Specified Medical Condition

Keywords

perinatal mood and anxiety disorders; cesarean delivery; Single session immersive intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Anxiety-sensitivity Index 3

  18-item scale that yields a primary outcome score and subscale scores. Higher scores indicate higher anxiety sensitivity. Minimum score 0. Maximum score 72.

  Baseline

• Anxiety-sensitivity Index 3

  18-item scale that yields a primary outcome score and subscale scores. Higher scores indicate higher anxiety sensitivity. Minimum score 0. Maximum score 72.

  Approximately 3 days (range=1-5) after intervention (CARE and interaction control conditions) or approximately 5 days (range = 3-7) after enrollment (care as usual condition)

Secondary Outcomes (21)

• Adverse Childhood Experience Questionnaire

  Baseline

• Wijma Delivery Expectancy/Experience Questionnaire

  Baseline

• State-Trait Anxiety Inventory

  Baseline

• Columbia Suicide Severity Rating Scale

  Baseline

• Edinburgh postpartum depression scale

  Baseline

Study Arms (3)

Intervention

EXPERIMENTAL

Intervention: (N= 40) Participants will be scheduled to receive the 1-hour, single-session CARE intervention administered by a medical and mental health provider trained in the intervention. CARE will consist of psychoeducation and brief immersive exposure to the operating room.

Behavioral: BE-OR: Brief Intervention to the Operating Room

Interaction Control

EXPERIMENTAL

Interaction Control: (N = 20) Participants will receive a 1-hour, single-session meeting with a nurse educator that will occur within a single patient room on L\&D. This condition will provide the same front-line clinician facetime as the treatment condition but will not include the clinical content of the intervention (psychoeducation + exposure).

Other: Interaction: Facetime with Clinical Provider

Care as Usual

NO INTERVENTION

Care as Usual Control: (N = 20) Participants will receive all the standard prenatal and CD education. The participants will not receive any additional face-to-face interaction with front-line clinicians as part of the study.

Interventions

Interaction: Facetime with Clinical Provider OTHER

See Interaction group section for details

Interaction Control

BE-OR: Brief Intervention to the Operating Room BEHAVIORAL

See intervention group section for details

Also known as: CARE-CD: Comfort, Agency, Readiness, Empowerment for Cesarean Delivery

Intervention

Eligibility Criteria

• Gender Eligibility Details: Must be able to become pregnant, biological female. No exclusion will be made for how a person identifies regarding gender.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After providing informed consent, participants will be randomized (2:1:1) to condition using an Excel spreadsheet uploaded into a REDCap® database. This will ensure allocation concealment. At the time of consent, patients will be informed that the study involves randomization to one of three conditions, two of which involve a one-hour session with one or more clinicians to prepare the participants for delivery. Participants assigned to BE-OR versus Interaction Control conditions will be informed that they are assigned to a condition in which they receive an intervention but will be masked to whether they were assigned to BE-OR or Interaction Control "intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2:1:1 randomization allocation of 3 study groups. Intervention: (N= 40) Participants will be scheduled to receive the 1-hour, single-session CARE intervention administered by a medical and mental health provider trained in the intervention. CARE will consist of psychoeducation and brief immersive exposure to the operating room. Interaction Control: (N = 20) Participants will receive a 1-hour, single-session meeting with a nurse educator that will occur within a single patient room on L\&D. This condition will provide the same front-line clinician facetime as the treatment condition but will not include the clinical content of the intervention (psychoeducation + exposure). Care as Usual Control: (N = 20) Participants will receive all the standard education. The participants will not receive any additional face-to-face interaction with front-line clinicians as part of the study.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: April 29, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will be made available to the scientific community on the date that the grant award period ends. Sharing of materials will be facilitated as part of the normal conduct of collaborative research. All terms will comply with published NIH guidelines for the dissemination of research resources. All resource tools generated in conjunction with this project will be distributed freely and shared with the scientific community via peer-reviewed publications and poster/oral presentations at national/international meetings. The investigators will also openly share unpublished results with the scientific community as opportunities present and/or the data is requested.
• Access Criteria: For all shared data, any interested reseacher can have access to this data through a data use agreement from the university of colorado.

Locations

US (1)