CHAPEL HILL, NC - Depression and anxiety during and after a pregnancy is the most common complication associated with having a child. Up to one in five women experience these issues during what's known as the perinatal period. Talk therapy is a proven and effective treatment method for women experiencing mild to severe symptoms, yet less than one in five women have access to this care.
This study, which kicked off in June, is co-led by Samantha Meltzer-Brody, MD, MPH, director of the UNC Perinatal Psychiatry Program, and Daisy Singla, PhD, assistant professor of psychiatry at University of Toronto and clinician scientist at Lunenfeld-Tanenbaum Research Institute in Sinai Health System. The trial will investigate how to make talk therapy treatment – specifically behavioral activation – more accessible to all women.
"This study attempts to meet the public health need of providing psychotherapy like behavioral activation to perinatal women on a population level," said Meltzer-Brody, UNC School of Medicine Ray M. Hayworth Distinguished professor of psychiatry and co-principal investigator for the study. "Many people don't get the services they need, especially in rural areas. We want to reach people where they are and increase access for these patients."
"It is difficult to access quality talk therapy," said Crystal Schiller, PhD, UNC School of Medicine (SOM) assistant professor of psychiatry and clinical lead of the study. "There's a real limit on the number of specialists in North America and it is also expensive - many of the specialists are out of network so patients have to pay out of pocket. As a result, many women actually get medication as a first step instead of starting with talk therapy."
Behavioral activation (BA) is a form of psychotherapy that focuses on providing patients with the skills needed to make small behavioral changes that can improve their mood and overall mental health. The treatment is traditionally provided by a trained specialist. This $13.2 million study funded by the Patient-Centered Outcomes Research Institute (PCORI) will seek to determine who can successfully provide the treatment, and in what method the treatment is best received by patients.
"We're asking whether it matters if the therapy is done by a specialist or a non-specialist, and does it matter if it is done in person or by telemedicine?" said Brad Gaynes, MD, MPH, UNC SOM professor of psychiatry and co-investigator for the study. "We're really testing whether you can get the same outcome from each method of treatment."
Co-principal investigator and global health researcher Daisy Singla, PhD, of University of Toronto (U of T), says the non-specialists in this study will be nurses trained to deliver BA therapy, an intervention method that's been evaluated worldwide for decades.
"The evidence supporting non-specialist delivered interventions is impressive," Singla said. "In some of the most low-resource contexts in the world, non-specialists such as peers, nurses, teachers and lay counsellors have been trained to effectively deliver psychological treatments. In North America, nurses are at the frontlines of managing women during the perinatal period. They are eager to learn the relevant skills to tackle perinatal depression and anxiety."
Around 1,300 pregnant or postpartum women for the randomized controlled trial will be collectively recruited by participating institutions starting in January 2020. Each participant will be assigned to one of four different BA treatment delivery methods: specialist in person, specialist via telemedicine, non-specialist in person and non-specialist via telemedicine.
"I see many patients who would benefit from this treatment who are not able to get it in the current health care system," said Alison Stuebe, MD, MSc, UNC SOM associate professor of maternal-fetal medicine, associate director of research and program development for the UNC Center for Maternal and Infant Health, and co-investigator for the study. "I'm really hopeful that with these study results we can improve their health and well-being by immediately implementing some of these care-delivery methods and making treatment easier to access."
The five year trial will also allow researchers to study relevant barriers and facilitators to the care offered in the trial, along with long-term sustainability, and determining for which patients these strategies work best.
"NorthShore has been engaged for nearly 20 years in providing leading edge clinical care for pregnant and postpartum women who face depression, anxiety and related mental health," said Richard K. Silver, MD, chairman of the department of obstetrics and gynecology for the NorthShore University HealthSystem and the principal investigator for that location of the study. "We are hopeful that this landmark clinical trial will significantly improve and even eliminate the barriers to treatment currently imposed by our existing health system limitations."