Abstract
BackgroundDepression 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT 04153864. Registered on November 6, 2019.
Highlights
Depression is a leading cause of disability worldwide [1] with an estimated 10 to 15% of women worldwide experiencing depression during pregnancy or the year following childbirth [2, 3]
The SUMMIT trial is expected to generate evidence on the non-inferiority of behavioral activation (BA) delivered by a nonspecialist provider compared to specialist and telemedicine compared to in-person
Results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety
Summary
Background Depression is a leading cause of disability worldwide [1] with an estimated 10 to 15% of women worldwide experiencing depression during pregnancy or the year following childbirth [2, 3]. The negative impact of these disorders on mother and child [8,9,10] underscores the importance of addressing perinatal mental health Psychological treatments, such as cognitive, behavioral, and interpersonal therapies, are first-line, effective interventions for perinatal depression and anxiety [11, 12] and are preferred by many women over pharmacotherapy [13, 14]. Costs, transportation, and stigma [13, 17], in addition to the paucity and inequitable distribution of mental health professionals across settings Given their prevalence and detrimental impact, developing low-cost, innovative solutions to improve access to psychological treatments for perinatal depression and anxiety is a public health priority. The equivalence of these strategies to specialist and in-person models remains unproven
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