Clinical trial NCT06949813: Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
Official title: Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-29
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Postpartum mental health disorders disproportionately occur among the 1 million patients with cesarean deliveries (CD) in the United States (US) each year, with 1 in 3 reporting elevated symptoms of postpartum mood, anxiety, and trauma symptoms (PMATS). Brief, single-session interventions that target anxiety sensitivity (AS) through psychoeducation + exposure have been shown to prevent the development of anxiety and trauma symptoms in non-perinatal populations. Thus, a single session AS-targeted intervention involving psychoeducation about AS + in-vivo exposure to the operating room (OR) and CD procedures may be an effective intervention to prevent the development of PMATS. The primary objective of this proposal is to refine and pilot a 1-hour, single-session brief exposure intervention in the OR (CARE) to reduce AS and thus prevent the development of PMATS among a population of patients with high-risk pregnancies and anticipated CD.

The investigators initially developed CARE for implementation in a maternal-fetal care unit at a children's hospital that has 12 beds, an average daily census of 6 patients, and 130 CDs/year. In this unit, the investigators conducted a pilot RCT study of CARE among a population of pregnant patients at very high risk for PMATS (those with anomalous fetuses). Those who received CARE reported 42% less preoperative anxiety and 40% less postpartum anxiety symptoms at 6-8 weeks following delivery, and significantly less opioid use at postoperative days 2-4 than those who received care as usual. While these results demonstrate the promise of the intervention, its scalability to large L\&D units and a broader population of patients is not established, and a fully powered, multisite randomized controlled trial (m-RCT) is needed. Before the m-RCT, the intervention must be refined to improve its acceptability, appropriateness, and feasibility for implementation in broader contexts with the desired impact on the target mechanism and outcomes. The proposed project engages in Stage 1A/B activities across three phases. Phase 1 involves a process of iterative refinement using key stakeholder workgroups, user-testing design, and repeated engagement with a steering council (SC) in fast feedback loops to facilitate information flow and foster co-creation. Phase 2 involves the design and implementation of a treatment development trial with an emphasis on feasibility, fidelity, and safety, as well as probing efficacy of engagement with the hypothesized mechanism of CARE (AS) at a single large L\&D unit with 50 beds, an average daily census of 34 patients, and 1,000 CDs/year. Phase 3 will involve one additional cycle of rapid iterative refinement to prepare for a future m-RCT with L\&D units across the US. Identified future m-RCT site-based investigators and associated administrators will participate in a community engagement studio to refine/co-create a finalized implementation protocol for the m-RCT to take to the SC for final approval.

Specific Aim 1: To enhance the efficacy, responsiveness to diverse populations, scalability, and sustainability of CARE for implementation in large L\&D units by engaging in an iterative refinement process guided by an Implementation Research Logic Model (IRLM) framework,12 which allows the team to rapidly iterate based on feedback in Plan-Do-Check-Act cycles using 12 workgroups, 12 user-testing design sessions, and repeated engagement with a SC comprised of stakeholders from across the country (clinicians/hospital staff and those with lived experiences/community partners).

Hypothesis 1: Some barriers and determinants must be addressed to refine CARE and its implementation so that it is acceptable and engages the target mechanism in a diverse population of patients and may be incorporated into workflows on L\&D units.

Specific Aim 2: To probe the efficacy of CARE at reducing AS and preventing PMATS using a treatment development trial with high-risk antepartum patients anticipating CD by comparing outcomes among participants randomized to CARE (N=40), Interaction Control (N=20), or Care as Usual Control (N=20) and to establish feasibility, safety, and acceptability of CARE implementation.

Hypothesis 2a: In comparison to patients who receive either control condition, those who receive CARE will have decreased AS before CD.

Hypothesis 2b: Decreased AS before CD will be associated with fewer symptoms of PMATS at 12 weeks postpartum.

Hypothesis 2c: CARE will be administered with high fidelity, yield minimal safety events, and have high acceptability.

Impact Statement: This study is a critical step in preventing PMATS which are among the leading causes of maternal mortality in the US. This study will be the first in a long line of research broadening to additional risk groups, perinatal care settings, and intervention modalities (e.g., virtual reality, nurse- or peer-facilitated).

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

Primary outcomes:
measure: Anxiety-sensitivity Index 3
timeFrame: Baseline
measure: Anxiety-sensitivity Index 3
timeFrame: 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:
measure: Adverse Childhood Experience Questionnaire
timeFrame: Baseline
measure: Wijma Delivery Expectancy/Experience Questionnaire
timeFrame: Baseline
measure: State-Trait Anxiety Inventory
timeFrame: Baseline
measure: Columbia Suicide Severity Rating Scale
timeFrame: Baseline
measure: Edinburgh postpartum depression scale
timeFrame: Baseline
measure: DSM-5 Cross Cutting Assessment
timeFrame: Baseline
measure: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Cesarean Section Anxiety Sensitivity (C-SAS)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: RCADS-25
timeFrame: Baseline
measure: Cesarean Section Anxiety Sensitivity (C-SAS)
timeFrame: 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)
measure: Wijma Delivery Expectancy/Experience Questionnaire
timeFrame: 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)
measure: Intervention and Interaction Control Acceptability
timeFrame: 3 weeks post-delivery
measure: Cesarean Section Anxiety Sensitivity (C-SAS)
timeFrame: 3 weeks post-delivery
measure: HCAHPS
timeFrame: 3 weeks post-delivery
measure: State-Trait Anxiety Inventory
timeFrame: 12 weeks post-delivery
measure: Columbia Suicide Severity Rating Scale
timeFrame: 12 weeks post-delivery
measure: Posttraumatic Stress Disorder Checklist-5
timeFrame: 12 weeks post-delivery
measure: Edinburgh postpartum depression scale
timeFrame: 12 weeks post-delivery
measure: Wijma Delivery Expectancy/Experience Questionnaire
timeFrame: 12 weeks post-delivery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: