Clinical trial focused on reducing anxiety and improving mental health outcomes in high-risk pregnancies

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

In an effort to reduce what is known as anxiety sensitization — or fear of panic — in patients who have complicated pregnancies and are likely to require a cesarean delivery, two Colorado medical professionals have begun a clinical trial at the University of Colorado Hospital UCHealth.

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And UCHealth psychologist Alison Dempsey is looking into whether prenatal care and better education about cesarean delivery can reduce fear and improve outcomes.

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

“We knew we had to help improve those results,” Wood said.

“Anxiety sensitivity may have long-term consequences, not only for the mothers, but also for their children,” added Dempsey, who is also a professor in the department of psychiatry at Colorado’s Anschutz School of Medicine.

She said: “Mood, anxiety and trauma disorders can affect the way mothers interact with their babies. It affects the way 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 postpartum period are more likely to end up with anxiety, depression and other disorders.”

The clinical trial the researchers developed focused on preventing these harmful symptoms with an intervention they called CARE (Communication, Management, Preparedness, Empowerment) for cesarean delivery.

Preparing patients for cesarean delivery through therapy and intensive training

The central scene is played in the operating room, where patients and their partners get a detailed idea of ​​the environment in which their delivery will take place and learn what they can expect. They also get the opportunity to ask their providers any questions they want.

The three-year randomized trial, which is recruiting patients, is nearing the end of its second year. It aims to enroll 80 patients who are randomized into three groups. Forty will receive the CARE intervention, while 20 will be face-to-face with a nurse educator and 20 will receive the standard medical care provided to all patients.

The study will measure patients’ anxiety sensitivity levels in each of the three groups at baseline and shortly after they receive the care assigned to their group. The lower the score, the less vulnerable they are to fearing what may happen to their fertility and their ability to care for themselves and their children.

Researchers will follow patients for three months after birth, looking for signs of anxiety, depression and suicidality, Dempsey said.

Anxiety sensitivity in pregnant women: fear of anxiety itself

The concept of anxiety sensitivity can be summed up in a simple question, “How do I react in a situation that I fear?” said Dempsey, who practices in the UCHealth Neonatal Intensive Care Unit at the University of Colorado and is also director of the Psychiatric Liaison Program for High-Risk Infants and Families.

By 2018, she recalled hearing versions of this concern from mothers when she brought mental health services to the Colorado Fetal Care Center. These mothers and their partners gave birth to their babies at the center because of known fetal abnormalities such as heart defects.

“I found that certainly they were concerned about their children’s development and long-term outcomes, but something that came up frequently was that they were really concerned about the birth,” Dempsey said. “There was just so much disbelief.”

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

Improving mental health outcomes in high-risk pregnancies

Caregiving interventions aim to help mothers answer anxiety-producing questions by shedding light on the darkness of doubt.

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

To dispel the clouds of uncertainty, patients and their friends are given gowns, masks, hats and shoe covers similar to what they will wear on their birthday. They receive approximately 45 minutes of simulated exposure to the surgical steps, receiving their anesthesia and lying on the OR table, experiencing the sensations of a cesarean and what happens after delivery, all without any invasive procedures or drugs.

“We’re providing the operating room with a very realistic experience with all the sights and sounds and sensations they’ll encounter on the day of delivery,” Wood said. Wood said. After processing, they receive a laminated CARE card that includes each patient’s personal preferences.

A commitment to listening and improving the patient experience

The hope, bolstered by the success of the study’s first-year pilot, is that therapy and spontaneous sessions can alleviate the fear of childbirth for families, Dempsey said.

“Can we really improve the experience for families so that they can say ‘I’m not afraid of how this is going to be. I’m not afraid of how I’m going to react. I’d rather focus on the birth of my baby, which is a big event in itself,'” she said.

Wood believes that making it easier for patients to cope with fear of what lies ahead can reduce their risk of anxiety and depression, as well as their physical pain. Conversely, psychological distress can increase physical pain and lead to other problems, such as opioid dependence, 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 psychological pain are related. Treating psychological pain can improve physical pain for these patients.”

The continuously evolving trial is shaped by patient feedback

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

Participants included people with “lived experiences,” such as patients, caregivers, and parent advocates, as well as hospital leaders, administrators, and health care providers. Their feedback and suggestions during the pilot phase of the first year lead to changes in behavior for the second year.

For example, first-year participants emphasized that the success of the intervention depended on the provision of trauma-informed care by the mental health and medical team.

A broader goal to bring care interventions to more hospitals

Wood said the process reflects broad expectations that Dempsey and Wood should eventually test the CARE intervention in a multi-site trial.

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

Wood added that the payoff can be huge for patients and their families who, with little preparation, can be spared significant fear and trauma from facing difficult births and the potential for long-term physical and psychological pain.

“We’re creating healthy, psychologically safe families that run healthy,” Dempsey said.