Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
NCT04153864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1230
Last updated 2025-08-14
Summary
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.
Conditions
- Perinatal Depression
Interventions
- BEHAVIORAL
-
Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Sponsors & Collaborators
-
University of North Carolina, Chapel Hill
collaborator OTHER -
Endeavor Health
collaborator OTHER -
Women's College Hospital
collaborator OTHER -
Unity Health Toronto
collaborator OTHER -
Sunnybrook Health Sciences Centre
collaborator OTHER -
University of Colorado, Boulder
collaborator OTHER -
Harvard Medical School (HMS and HSDM)
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Mount Sinai Hospital, Canada
lead OTHER
Principal Investigators
-
Daisy R Singla, PhD · Sinai Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-06
- Primary Completion
- 2024-02-26
- Completion
- 2025-02-13
Countries
- United States
- Canada
Study Locations
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