Clinical trialNCT04919967CompletedInterventional

Online Training for Addressing Perinatal Depression

SponsorUniversity of Massachusetts, WorcesterEnrollment140Anxiety DisordersMood Disorders

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The study team is developing an e-learning course to train obstetric providers to address perinatal mood and anxiety disorders. The study team will conduct a formative evaluation of the e-learning course with 10 obstetric providers and revise/refine the course based on feedback and then conduct a summative evaluation using a cluster Randomized Controlled Trial (RCT). The three-arm cluster RCT will evaluate the effectiveness of 1) a virtual implementation protocol and e-learning/toolkit as compared to 2) e-learning/toolkit alone as compared to 3) treatment-as-usual. Effectiveness will be evaluated based on rates and quality of care for perinatal mood and anxiety disorders. Using 2:2:1 randomization, the study team will randomize a minimum of 15 to a maximum of 25 obstetric practices into three groups: (1) virtual implementation protocol plus e-learning/toolkit (n=6 to 10); (2) e-learning/toolkit alone (n=6 to 10); and (3) treatment-as-usual (n=3 to 5), which will yield a maximum of 1000 patient charts evaluated for care received from obstetric providers in the randomized practices. Charts from 40 patients per practice will be evaluated at 3 different time points.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Nancy Byatt, DO, MS, MBA, FACLP
University of Massachusetts Medical School/UMass Memorial Health
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Tiffany Moore Simas, MD, MPH, MEd, FACOG
University of Massachusetts Medical School/UMass Memorial Health
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Montachusett Women'S Health - Umass Memorial Health Alliance
Leominster, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Aug 2021
Primary completion: 31 May 2023
Completion: 1 Jun 2023
Last update posted: 5 Jun 2023
Registered enrollment: 140
Registry id: NCT04919967

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.