Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)

Completed · Not applicable

Conditions studied: Perinatal Depression

In brief

SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.

Key facts

Study ID

NCT04153864

Run by

Mount Sinai Hospital, Canada

People needed

1230

Starts

2020-01-06

Expected to finish

2025-02-13

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• EPDS≥10
• ≥18 years
• Pregnant up to 36 weeks or 4-30 weeks postpartum
• Speaks English or (US sites) Spanish

You may not qualify if…

• Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
• Psychotropic medication dose or medication change within two weeks of enrollment or beginning treatment
• Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
• Active substance abuse or dependence
• Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
• Non-English, non-Spanish speakers

Where it is running

• NorthShore University Health System — Evanston, Illinois, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• Sinai Health System — Toronto, Ontario, Canada
• Women's College Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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