Brief Intervention for Maternal Mood and Anxiety Symptoms

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Lack of consent, Medical factors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help pregnant individuals expecting a cesarean delivery manage anxiety and mood during high-risk pregnancies. The study focuses on a single, one-hour session that provides information about anxiety and includes a brief walkthrough of the operating room to reduce fear and trauma. This approach, called BE-OR (Brief Intervention to the Operating Room), will be compared with standard care and a session with a nurse educator to determine which is most effective. The trial seeks participants who are between 22 and 37 weeks pregnant, have been admitted for at least three days, and are expecting a cesarean delivery due to pregnancy complications. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for managing anxiety during high-risk pregnancies.

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 prior data suggests that this intervention is safe for maternal mental health?

Research has shown that certain psychological methods can help reduce anxiety in pregnant women. One study found that a simple method, the BE-OR, was easy to use and well-received by many pregnant women. Another study demonstrated that learning more about a cesarean section (C-section) and becoming familiar with the operating room can help reduce anxiety and pain.

These findings suggest that the BE-OR method, which includes education and a brief visit to the operating room, is well-accepted. No reports of serious negative effects have emerged, indicating that this method is safe for women preparing for a C-section. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support maternal mental health using brief interventions right at the point of care. Unlike standard treatments for maternal mood and anxiety, which typically involve longer-term therapy or medication, this approach leverages a short, one-hour session of psychoeducation and immersive exposure in the operating room. This unique method could offer rapid support and potentially ease anxiety and mood symptoms more efficiently. By integrating mental health care directly into the medical setting, it aims to provide immediate relief and improve overall outcomes for expecting mothers.

What evidence suggests that the BE-OR intervention could be effective for perinatal mood and anxiety symptoms?

Research shows that short sessions can help reduce anxiety before surgery. One study found that a single session using a cognitive-behavioral approach, which involves teaching about anxiety and briefly introducing the surgical environment, lowered anxiety levels. Another study found that group sessions were practical and well-received by pregnant women. In this trial, participants in the intervention arm will receive the CARE intervention, focusing on teaching about anxiety and briefly introducing the cesarean delivery environment. This approach could help prevent anxiety and trauma symptoms related to childbirth. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Single or multiple gestation

Nulliparous or multiparous (with prior vaginal or cesarean delivery)

Antepartum admission for at least 3 days

Exclusion Criteria

Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team

Anticipated cesarean within 7 days of enrollment

I am unable to understand or make decisions about my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 1-hour, single-session CARE intervention involving psychoeducation and brief immersive exposure to the operating room

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at 3 and 12 weeks post-delivery

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BE-OR: Brief Intervention to the Operating Room

Trial Overview The trial tests a one-hour intervention called CARE (Communication, Agency, Readiness, Empowerment) designed to prevent mental health issues by providing psychoeducation and exposure to the operating room before cesarean delivery. It involves iterative refinement with stakeholder input before a larger randomized control trial.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Interaction Control Experimental Treatment 1 Intervention

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).

Group III: Care as Usual Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A survey of 156 doulas and interviews with 27 doulas revealed that many felt unprepared to identify and address perinatal mood and anxiety disorders (PMADs) in their clients.

The study highlights the need for a standardized training model for postpartum doulas to better equip them in recognizing PMAD symptoms and referring women to appropriate treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promotion and Prevention of Perinatal Mood and Anxiety Disorders: Doulas' Roles and Challenges. Shklarski, L., Kalogridis, L.[2023]

Citations

1. withpower.com withpower.com/trial/phase-anxiety-disorders-5-2025-48d95

Brief Intervention 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8851863/

Adapting and testing a brief intervention to reduce maternal ... We found that a brief 3-session group-based intervention met our feasibility and acceptability targets for a considerable proportion of pregnant ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596325001149

Evaluating the effectiveness of mandala coloring on post- ... Mandala coloring appears to be an effective intervention for reducing anxiety level in mothers of children undergoing surgery for congenital abnormalities.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4804571/

Adapting and testing a brief intervention to reduce maternal ... This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04203082

Cognitive Behavioral Intervention to Reduce Procedural ... The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative ...

6. bpspsychub.onlinelibrary.wiley.com bpspsychub.onlinelibrary.wiley.com/doi/10.1111/papt.12441

The effectiveness of psychological interventions for anxiety in ... Results indicated that psychological interventions were more effective than control conditions in reducing symptoms of perinatal anxiety ( ...

7. researchgate.net researchgate.net/publication/345779592_The_potential_beneficial_effects_of_education_and_familiarity_with_cesarean_section_procedure_and_the_operating_room_environment_on_promotion_of_anxiety_and_pain_intensity_A_randomized_controlled_clin

A randomized controlled clinical trial The present study aimed to investigate the effect of familiarity with cesarean section and the operating room environment on anxiety and pain intensity among ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8623601/

Interventions for Parental Anxiety in Preparation ... This review provides a brief overview of a broad range of strategies used to alleviate parental anxiety in a preoperative setting.