S E Meltzer-Brody1, R K Silver2, J J Kim2,3, L M La Porte2, P Ravitz4,5, C E Schiller1, C-L Dennis5,6,7, V Patel8,9, D R Singla10,11, S N Vigod5,12, N Schoueri-Mychasiw4, S D Hollon13, A Kiss14, D Clark15, A K Dalfen4,5, S Dimidjian16, B N Gaynes1, S R Katz4, A Lawson3, M Leszcz4,5, R G Maunder4,5, B H Mulsant17, K E Murphy5,18, J A Naslund19, M L Reyes-Rodríguez1, A M Stuebe8. 1. Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA. 2. Department of Obstetrics & Gynecology, NorthShore University HealthSystem, Chicago, IL, USA. 3. Department of Obstetrics & Gynecology, University of Chicago Pritzker School of Medicine, Chicago, USA. 4. Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada. 5. Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada. 6. Lawrence S. Bloomberg Faculty of Nursing and Department of Psychiatry, University of Toronto, Toronto, Canada. 7. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. 8. Department of Obstetrics & Gynecology, School of Medicine, University of North Carolina, Chapel Hill, USA. 9. Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 10. Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada. daisy.singla@utoronto.ca. 11. Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada. daisy.singla@utoronto.ca. 12. Women's College Hospital and Research Institute, Toronto, Canada. 13. Department of Psychology, Vanderbilt University, Nashville, TN, USA. 14. Sunnybrook Research Institute, Toronto, ON, Canada. 15. Department of Experimental Psychology, University of Oxford, Oxford, UK. 16. Renee Crown Wellness Institute and Department of Psychology and Neuroscience, University of Colorado, Boulder, CO, USA. 17. Department of Obstetrics and Gynecology, Sinai Health and University of Toronto, Toronto, Canada. 18. Centre for Addiction and Mental Health, Toronto, Canada. 19. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
Abstract
BACKGROUND:Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven. METHODS: This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms. DISCUSSION: The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153864 . Registered on November 6, 2019.
RCT Entities:
BACKGROUND:Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven. METHODS: This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms. DISCUSSION: The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153864 . Registered on November 6, 2019.
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