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COMPLETED NA

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

NCT04153864 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • BEHAVIORAL Brief Behavioral Activation Treatment

Study Locations (5)

Ontario

  • St. Michael's Hospital — Toronto
  • Sinai Health System — Toronto
  • Women's College Hospital — Toronto

Illinois

  • NorthShore University Health System — Evanston

North Carolina

  • University of North Carolina — Chapel Hill

Trial Details

FieldValue
Enrollment Target 1,230 participants
Start Date 2020-01-06
Est. Completion 2025-02-13
Phase NA

Sponsor

Mount Sinai Hospital, Canada

33 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04153864

The ClinicalTrials.gov registry entry for NCT04153864 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mount Sinai Hospital, Canada, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Perinatal Depression appearing as the primary indexed condition, and to 1 intervention — of which Brief Behavioral Activation Treatment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04153864 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Ontario, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04153864 about?

NCT04153864 is a clinical study titled "Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)". 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, r...

What is the current status of trial NCT04153864?

This trial is currently completed. It is a NA study. The enrollment target is 1,230 participants. The study started on 2020-01-06. Estimated completion is 2025-02-13.

What conditions does trial NCT04153864 study?

This clinical trial studies the following conditions: Perinatal Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04153864?

The interventions under investigation include: Brief Behavioral Activation Treatment (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04153864?

This trial is sponsored by Mount Sinai Hospital, Canada, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04153864 being conducted?

This trial has 5 study locations across Illinois, North Carolina, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial