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Scaling up psychological treatments for perinatal depression and anxiety symptoms via telemedicine
Investigator (PI): Singla, Daisy R
Performing Organization (PO): (Current): Sinai Health System / (416) 596-4200
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2025
Record Source/Award ID: PCORI/PCS-2018C1-10621
Funding: Total Award Amount: $13,153,426
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Comparing Methods for Treating Depression and Anxiety among Pregnant and Postpartum Women PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.  This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? Depression and anxiety affect 10 to 20 percent of women during pregnancy or in the year after childbirth. Talk therapy is effective for depression and anxiety, and women prefer it over medicine. But many women can’t access talk therapy because of its cost, problems with transportation, or a lack of mental health professionals. Behavioral activation, or BA, is a form of talk therapy that requires as few as eight sessions. BA is usually given in person by a mental health professional. But research has shown that people without formal training in mental health therapy, such as peers, nurses, or lay counselors, can provide effective BA. This study is comparing the effectiveness of BA provided by a mental health professional versus a nurse or midwife. It is also comparing in-person BA with BA given through telemedicine, or by videoconference. In this study, pregnant and postpartum women are in one of four groups: In-person BA with a mental health professional In-person BA with a nurse or midwife Telemedicine BA with a mental health professional Telemedicine BA with a nurse or midwife Who can this research help? Clinicians, patients, and health systems could use these findings when considering how to treat depression and anxiety in pregnant and postpartum women. What is the research team doing? The research team is enrolling 1,368 women receiving care from clinics in Toronto, Ontario; Chapel Hill, North Carolina; and Chicago, Illinois. Women in the study are either pregnant or gave birth within the past six months. The team is assigning patients by chance to receive BA in person or by telemedicine and from a mental health professional or a trained nurse. Women in all four groups are receiving six to eight BA sessions. During these sessions, women are focusing on increasing enjoyable and fulfilling activities that align with their values. Women receiving in-person BA are having sessions at the study clinics and health centers. Those receiving telemedicine BA are having sessions by phone, tablet, or computer. Women in the study are completing surveys on depression and anxiety symptoms before starting BA and after 3, 6, and 12 months. Mothers, patient advocates who have experienced depression or anxiety, mental health professionals, clinicians, insurers, and policy makers are helping the research team plan and carry out the study. Research methods at a glance Design Element Description Design Randomized controlled trial Population 1,368 pregnant or postpartum women Interventions/ Comparators In-person BA with a mental health professional In-person BA with a nurse or midwife Telemedicine BA with a mental health professional Telemedicine BA with a nurse or midwife Outcomes Primary: depressive symptoms Secondary: anxiety symptoms, patient-clinician relationship quality, patient activation levels, perceived support, therapeutic alliance, patient satisfaction, health service utilization, treatment dose, dropout, session-wise depression scores, homework adherence, child birthweight and length, child mental development, and child psychosocial stimulation Timeframe 3-month follow-up for primary outcome.
Abstract Archived: Depression and anxiety symptoms pose the most significant burden and costs than any other medical condition among mothers worldwide. Psychological treatments (PTs) or "talk therapies" have a robust evidence base and are preferred by women and their families over pharmacological treatments. Unfortunately, as few as 1 in 5 women access these effective treatments due to a dearth of available specialists and barriers, including lack of flexibility, transportation, and access to new mothers. Furthermore, psychological treatments are expensive. There is therefore a need for widely accessible, low-cost, and innovative PTs for depression and anxiety in pregnancy and postpartum. Scalable solutions are available and have been tested. Non-specialist providers--individuals without formal training in psychiatry or psychology, including nurses, peers, midwives, and undergraduate students--have been successfully trained to deliver one brief psychological treatment known as behavioural activation (BA). BA is as effective as longer courses of cognitive behavioural therapy among perinatal populations. In addition, delivering talk therapies using telemedicine has been proven to be as effective as in-person treatments; similarly, non-specialists, including nurses, peers, and lay counsellors have been trained worldwide to deliver brief treatments and shown to be as effective as specialists in reducing depressive and anxiety symptoms. In the current randomized controlled trial, we seek to determine how to optimize our limited resources. Specifically, we will test whether nurses (referred to as non-specialist providers) can deliver one brief talking therapy of behavioral activation (BA) as well as specialist psychiatrists, psychologists, and social workers. In addition, we will test whether telemedicine is as effective as in-person treatment. Finally, we wish to study relevant barriers and facilitators related to the program delivery and long-term sustainability and determining for whom these strategies work best. The study will take place over the course of 5 years across Toronto, Canada, Chapel Hill, NC, and Chicago, IL--large, ethnically diverse populations that represent urban and rural populations. During the study, 1,220 pregnant or postpartum women will receive the brief, BA treatment in one of four conditions: 1) in person by a specialist, 2) telemedicine by a specialist, 3) in person by a public health nurse, or 4) telemedicine by a public health nurse. Examining these two innovative strategies within real-world settings allow us to inform existing health care services and potentially increase access to talk therapies which are otherwise limited. In doing so, more mothers and their children may benefit from more from access to effective treatments and suffer less from the longstanding impact of depression and anxiety. This research will be patient-centered, which means that a range of stakeholders, including mothers with lived experience, patient advocacy groups (e.g., Peer Support International), a range of clinicians (nurses, family physicians, pediatricians, obstetricians, psychologists and psychiatrists), academics, and policy makers will collaborate to inform the study's development, implementation, and dissemination. In doing so, this research has the potential to increase the accessibility, scalability, and cost-effectiveness of evidence-based PTs to address the burden of perinatal depression and anxiety worldwide.

MeSH Terms:
  • Access to Health Care
  • Anxiety /complications
  • /*therapy
  • Behavior Therapy /*methods
  • Chicago
  • Depression /complications
  • /*therapy
  • Female
  • Humans
  • Mental Health Services /organization & administration
  • Multicenter Studies as Topic
  • North Carolina
  • Ontario
  • Peer Group
  • Postpartum Period
  • Pregnancy Complications
  • Psychotherapy /methods
  • Public Health Nursing
  • Telemedicine /*methods
Country: Canada
State:
Zip Code: M5G 1X5
UI: 20194245
CTgovId: NCT04153864
Project Status: Ongoing
Record History: ('2021: Abstract archived and replaced. ',)