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NCT04153864 · ClinicalTrials.gov registry record · NA
Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
A NA study of Perinatal Depression, sponsored by Mount Sinai Hospital, Canada.
- Completed
- Registry status
- NA
- Development phase
- 1,230
- Enrollment target
- 5
- Study locations
NCT04153864: Completed NA study of Perinatal Depression, sponsored by Mount Sinai Hospital, Canada.
NCT04153864 is a NA study of Perinatal Depression that has completed, run by Mount Sinai Hospital, Canada. The registered enrollment target is 1,230 participants, above the 377-participant average among 12 other Perinatal Depression trials with a reported enrollment target (226% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04153864, a NA study of Perinatal Depression, has completed, sponsored by Mount Sinai Hospital, Canada.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,230 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,230 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2025-02-13 |
| Phase | NA |
What the finished NCT04153864 record still lists
NCT04153864 is an interventional study that assigns participants to a tested intervention. Its 1,230 participants enrollment target places it among the larger protocols in the corpus, above the 377-participant average among 12 other Perinatal Depression trials with a reported enrollment target (226% higher).
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.
NCT04153864 lists 5 locations in 3 states (Ontario, Illinois, North Carolina).
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.
What interventions are being tested in trial NCT04153864?
The interventions under investigation include: Brief Behavioral Activation Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT04153864?
This trial is sponsored by Mount Sinai Hospital, Canada, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04153864's enrollment target sits among peer trials
1,230 2nd of 12 the highest of 12 other Perinatal Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Perinatal Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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