Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial

D R Singla, S E Meltzer-Brody, R K Silver, S N Vigod, J J Kim, L M La Porte, P Ravitz, C E Schiller, N Schoueri-Mychasiw, S D Hollon, A Kiss, D Clark, A K Dalfen, S Dimidjian, B N Gaynes, S R Katz, A Lawson, M Leszcz, R G Maunder, B H Mulsant, K E Murphy, J A Naslund, M L Reyes-Rodríguez, A M Stuebe, C-L Dennis, V Patel, D R Singla, S E Meltzer-Brody, R K Silver, S N Vigod, J J Kim, L M La Porte, P Ravitz, C E Schiller, N Schoueri-Mychasiw, S D Hollon, A Kiss, D Clark, A K Dalfen, S Dimidjian, B N Gaynes, S R Katz, A Lawson, M Leszcz, R G Maunder, B H Mulsant, K E Murphy, J A Naslund, M L Reyes-Rodríguez, A M Stuebe, C-L Dennis, V Patel

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.

Keywords: Anxiety; Behavioral activation; Depression; Perinatal; Psychological treatments; Randomized controlled trial; Telemedicine.

Conflict of interest statement

The study team and all authors report no conflicts of interest. However, SNV reports royalties from UpToDate Inc. for authorship of materials related to depression and pregnancy. JJK is partly supported by a Small Business Innovation Research award from the National Institute of Mental Health (RS, PI). PR receives support from the Sinai Health System, Morgan Firestone Psychotherapy Chair. SD reports being a co-founder of Mindful Noggin, Inc. and receiving revenue from MindfulNoggin.com, receiving royalties from Guilford Press for books on Behavioral Activation and mindfulness. BHM receives financial support from the Labatt Family Chair in Biology of Depression in Late-Life Adults at the University of Toronto. He directly owns stocks of General Electric (less than $5000). Within the past 3 years, he has also received research support from Eli Lilly (medications for a NIH-funded clinical trial) and Pfizer (medications for a NIH-funded clinical trial). He has been an unpaid consultant to Myriad Neuroscience. AMS is a co-investigator for a Janssen Research and Development study, Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression.

Figures

Fig. 1
Fig. 1
Recruitment pathways
Fig. 2
Fig. 2
SUMMIT treatment arms
Fig. 3
Fig. 3
Study randomization and adaptation due to COVID-19
Fig. 4
Fig. 4
Study flow chart

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