Brief Intervention for Maternal Mood and Anxiety Symptoms
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment BE-OR: Brief Intervention to the Operating Room for maternal mood and anxiety symptoms?
Research shows that providing perioperative education and music therapy can help reduce anxiety in surgical patients. This suggests that similar interventions, like BE-OR, which may include educational components, could be effective in reducing anxiety for mothers in the operating room setting.12345
How is the BE-OR treatment different from other treatments for maternal mood and anxiety symptoms?
The BE-OR treatment is unique because it involves a brief intervention specifically designed for the operating room setting, which is not a common approach for addressing maternal mood and anxiety symptoms. This setting may provide immediate support and intervention during a critical time, potentially improving outcomes for mothers compared to traditional postpartum care.678910
What is the purpose of this trial?
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
This trial is for pregnant individuals at risk of perinatal mood, anxiety, and trauma symptoms who are scheduled for a cesarean delivery. The study aims to help those without sufficient access to mental health resources. Specific eligibility criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive a 1-hour, single-session CARE intervention involving psychoeducation and brief immersive exposure to the operating room
Follow-up
Participants are monitored for safety and effectiveness after the intervention, with assessments at 3 and 12 weeks post-delivery
Treatment Details
Interventions
- BE-OR: Brief Intervention to the Operating Room
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator