Fear can be dangerous for pregnant women because it can contribute to painful and sometimes deadly outcomes before and after birth.

In an attempt to reduce what’s known as anxiety sensitivity – or fear of fear – in patients who have complicated pregnancies and are likely to need cesarean births, two Colorado medical experts have launched a clinical trial at UCHealth University of Colorado Hospital.

The researchers, obstetric anesthesiologist, Dr. Cristina Wood, and psychologist, Allison Dempsey, are exploring whether therapy and better education about cesarean births before birth can reduce fear and improve outcomes.

“We know that maternal patients face a disproportionately high risk of mental health conditions and suicide, which are among the leading indirect causes of maternal death in the United States,” said Wood, a UCHealth obstetric anesthesiologist who is also an associate professor at the University of Colorado Anschutz School of Medicine.

“We knew we had to help improve these outcomes,” Wood said.

“The burdens of anxiety sensitivity may have long-term consequences, not only for mothers, but also their babies,” added Dempsey, who also is a professor in the Department of Psychiatry at the University of Colorado Anschutz School of Medicine.

“Mood, anxiety and trauma disorders can affect the way that mothers interact with their babies, she said. “It affects their bonding. It affects the way that they react and respond to their babies’ cues. And we know that in the long term, babies of mothers who have mental health challenges in the post-partum period have a higher likelihood of ending up with their own anxiety, depression and other disorders.”

The clinical trial that the researchers created focuses on preventing these damaging symptoms with an intervention they call CARE (Communication, Agency, Readiness, Empowerment) for cesarean delivery.

Preparing patients for cesarean delivery through therapy and immersive training

The program relies on one session of cognitive behavioral therapy and an “immersive experience” that is a kind of dress rehearsal for patients with complicated pregnancies before cesarean delivery.

The central scene plays out in an operating room, where the patients and their partners get a detailed look at the environment where their deliveries will take place and learn what they can expect. They also get a chance to ask any questions they want of their providers.

The three-year randomized trial, which is recruiting patients, is approaching the end of year two. It aims to enroll 80 patients who are placed in one of three groups. Forty will get the CARE intervention, while 20 will meet face-to-face with a nurse educator and 20 will receive the standard medical care provided to all patients.

The study will measure patients’ levels of anxiety sensitivity in each of the three groups at baseline and shortly after they receive the care designated for their group. The lower the score, the less vulnerable they are to fearing what lies ahead with their delivery and their ability to care for themselves and their babies.

The researchers will follow the patients for three months after they deliver, looking for symptoms of anxiety, depression and suicide, Dempsey said.

Anxiety sensitivity in pregnant women: The fear of fear itself

The concept of anxiety sensitivity can be summed up in the simple question, “how am I going to react in a situation that I am afraid of?” said Dempsey, who practices at the UCHealth Neonatal Intensive Care Unit at University of Colorado Hospital and is also director of the Department of Psychiatry’s Connections Program for High-Risk Infants and Families.

As far back as 2018, she recalled hearing versions of that worry from mothers when she brought mental health services to the Colorado Fetal Care Center. These mothers and their partners delivered their babies at the center due to known fetal anomalies, such as heart defects.

“I found that of course they were worried about their babies’ development and long-term outcomes, but something that repeatedly came up was that they were really worried about the delivery,” Dempsey said. “There was just so much uncertainty.”

Wood, who is also the medical director of anesthesia at the Fetal Care Center, said her years-long interest in administering trauma-informed care that focuses on shared decision making with patients drew her and Dempsey together at that time and ultimately led to the current trial.

Improving mental health outcomes in high‑risk pregnancies

The CARE intervention aims to help mothers answer anxiety-producing questions by shedding light that pierces the darkness of doubt.

During the immersive experience, the patients go into the OR to familiarize themselves with what could be an intimidating environment of bright lights, masked providers, sterile drapes and high-tech equipment.

To part the clouds of uncertainty, the patients and their partners don gowns, masks, hats and shoe covers similar to what they will wear on the day of delivery. They get a roughly 45-minute simulated exposure to the surgical steps, from receiving their anesthesia and lying on the OR table, to experiencing the sensations of a cesarean and what happens after delivery, all without any invasive procedures or medications.

“We provide a very realistic experience to the operating room with all of the sights and sounds and feelings they will encounter on the day of their delivery,” Wood said. After the simulation, they receive a laminated CARE card that contains the personal preferences of each patient.

A commitment to listening to patients and improving experiences

The hope, bolstered by the success of the study’s first-year pilot, is that the therapy and immersive sessions can drain the fear of a looming birth for families, Dempsey said.

“Can we actually improve this experience for families so they can go in saying, ‘I’m not afraid of how this is going to be. I’m not afraid of how I’m going to react. I’m instead going to be focused on birthing my child, which is a big event in and of itself,’” she said.

Wood believes that easing patients’ struggles with fear of what lies ahead can reduce their risk of anxiety and depression, as well as their physical pain. Conversely, mental anguish can exacerbate physical pain and lead to other problems, like dependence on opioids, she said.

“If we can target better mental health outcomes for these patients, can we also reduce the amount of pain medication they take?” Wood said. “We know that physical pain and mental pain are related. Treating mental pain may help improve physical pain for these patients.”

A continuously evolving trial shaped by patient feedback

Both Dempsey and Wood emphasized that the design of the trial relied in large part on feedback from those who experienced the CARE intervention in a user testing design setting and in national focus groups.

The participants included people with “lived experiences,” such as patients, doulas and parent advocates, as well as hospital leaders, administrators and health care providers. Their comments and suggestions during the first-year pilot phase drove changes in the approach for the second year.

For example, first-year participants underscored that the success of the intervention relies on providing trauma-informed care by a dedicated mental health and medical team.

A broader aim to bring CARE intervention to more hospitals

The process reflects a broader ambition that Dempsey and Wood have to eventually test the CARE intervention in a multi-site trial, Wood said.

“We’ve created a novel protocol,” Wood said, adding that “major academic institutions across the United States” have shown “incredible interest” in a larger trial. “We hope this study will provide objective evidence to support the need for widespread adoption of this intervention,” Wood said.

The pay-off could be greatest for patients and their families who could be spared the considerable fear and trauma of facing a difficult birth with little preparation and the possibility of long-term physical and mental pain afterward, Wood added.

“We’re making healthier, psychologically safer families who are going to move forward in a healthy way,” Dempsey said.