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

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 NCT 04153864. Registered on November 6, 2019.

Resuming In-Person Psychotherapy Sessions with Perinatal Women amid the COVID-19 Pandemic: A Multistakeholder Perspective

“…We examined reported barriers to accessing in-person healthcare due to COVID-19, perceived barriers that are speci c to the COVID-19 pandemic, and potential facilitators to resuming in-person psychotherapy sessions during COVID-19 speci c to perinatal women with symptoms of depression and anxiety in the context of the SUMMIT trial [20]. One key nding that emerged was perinatal participants and providers reported that perinatal women experienced barriers to accessing healthcare and in-person psychotherapy throughout the COVID-19 pandemic.…”

“…SUMMIT, a multi-site, four-arm, randomized, non-inferiority trial, is being conducted across three hubs in . Full details of the SUMMIT trial protocol have been published elsewhere [ 20 ].…”

“…We selected perinatal participants for interviews from the larger SUMMIT trial, which recruits women who are 18 years of age or older and are either pregnant (up to 36 weeks) or postpartum (4 to 30 weeks) with depressive symptoms (EPDS ≥ 10). Exclusion criteria for the larger trial were: non-English or non-Spanish speakers; women with active suicidal intent, active symptoms of psychosis or mania, and/or active substance abuse or dependence; women whose psychotropic medication dose or medication changed within 2 weeks of enrolment or beginning the BA sessions; women who were in ongoing psychotherapy; and women who experienced severe fetal anomalies; stillbirth, or infant death at the time of enrolment for index pregnancy [ 20 ]. To be eligible to participate in the current study, perinatal participants must have consented to participate in qualitative interviews during the original SUMMIT consent process and must have completed at least ve BA sessions.…”

Barriers and Facilitators to Resuming In-Person Psychotherapy with Perinatal Patients amid the COVID-19 Pandemic: A Multistakeholder Perspective

“…Therefore, in this qualitative study, our primary aim was to examine the barriers that might impact perinatal patients' access to in-person psychotherapy sessions and facilitators to resuming in-person sessions from the perspectives of perinatal patients, providers, and relevant community-and hospital-based stakeholders. The current study was conducted within the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial, which is aimed at increasing access to mental health treatment among perinatal patients with symptoms of depression and anxiety in Canada and the United States by delivering a form of psychotherapy called behavioral activation (BA) [22]. Though a central aim of the SUMMIT trial is to compare whether BA delivered via telemedicine is as effective as when it is delivered in-person, similar to many other clinical research and practices, all perinatal participants in the SUMMIT trial were exclusively randomized to telemedicine beginning in mid-March 2020 due to COVID-19.…”

“Mental health support is like a secret society”: A qualitative study of the impact of peer support on women’s mental health treatment experiences during the perinatal period.

“…For example, women reported feeling less isolated, more con dent as mothers, and more likely to seek or continue with formal mental health support [13][14] . In recognition of the potential of these roles and bene ts, there has been growing international interest and investment in the peer support role across a range of service contexts 12,15 . Despite this, however, the evidence-base on where peer supporters may most effectively t within perinatal mental health service delivery remains unclear.…”