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MOVIN Pilot Randomized Controlled Trial

NCT04680585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-05-28

No results posted yet for this study

Summary

Despite available treatments for perinatal mood disorders, only 20% of affected women receive treatment that results in remission of symptoms. In order to address gaps in equitable access to treatment the investigators developed the Reproductive Mental health of Ontario Virtual Intervention Network (MOVIN), a virtual collaborative care platform to optimize access for pregnant and postpartum people in Ontario. MOVIN combines collaborative and stepped-care approaches to treatment of perinatal depression and anxiety. The overall objective of this pilot randomized controlled trial (RCT) is to determine the feasibility of implementing a protocol for studying MOVIN for pregnant and postpartum individuals with significant symptoms of depression and anxiety (EPDS \> 12) in order to inform the conduct of a larger scale evaluation. O will be randomized to either the MOVIN or control condition and will be asked to complete follow-up assessments 12- and 24-weeks post-randomization. Participants in the MOVIN arm will receive access to the MOVIN platform which includes a care coordinator to help them navigate various virtual treatments. Participants in the control condition will receive a resource list and will navigate the various options on their own.

Conditions

  • Depression, Postpartum

Interventions

OTHER

Enhanced Usual Care

A standardized handout with information on what treatment options might be useful to start with based on EPDS score and stage of pregnancy or postpartum.

OTHER

MOVIN Care Platform

Virtual collaborative care intervention with a stepped care approach in which a care coordinator directs participants to one or more evidence-based virtual interventions as appropriate.

Sponsors & Collaborators

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Ariel Dalfen, MD · Women's College Hospital and Sinai Health System

  • Simone Vigod, MD, MSc · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • 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 NCT04680585 on ClinicalTrials.gov