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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153864 on ClinicalTrials.gov