MOVIN Pilot Randomized Controlled Trial

NCT ID: NCT04680585

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-12-30

Brief 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.

Detailed Description

People with scores above 12 on the EPDS have a 10 times greater likelihood of having a diagnosis of depression than those with scores with 12 or less, so this is an appropriate cut-off. The primary endpoint is at 12 weeks post-randomization and the secondary endpoint is at 24 weeks post-randomization. Randomization will be performed as block randomization (varying block sizes) with a 1:1 allocation and will be stratified based on EPDS score (13-19 vs. 20 or greater). Participants who score 12 or less on the EPDS in their initial self-referral screen will be informed that they are not at high risk for having depressive or anxiety disorder and the current time, and can re-screen as needed. Participants whose score is in the 9-12 range (i.e. those who are not likely to be experiencing a depressive or anxiety disorder requiring mental health treatment, but might benefit from additional support) will receive an automated message that communicates their score and the acknowledgment of their possible need for support, and provides a list of resources in Ontario that may be helpful for them. These participants will be invited to re-screen at any time into the study, and will be asked permission to be re-contacted in future to determine which supports they used, if any.

Conditions

Depression, Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Enhanced Usual Care

Access to online resources and educational materials about general mental health, maternal mental health, depression and anxiety in the pregnancy and postpartum period, and an up-to-date listing of treatment services available in Ontario. These resources are maintained by the MOVIN study team.

Group Type: OTHER

Enhanced Usual Care

Intervention Type: OTHER

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.

MOVIN

Enhanced Usual Care plus MOVIN Care Platform. The MOVIN Care Platform is 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.

Group Type: EXPERIMENTAL

Enhanced Usual Care

Intervention Type: OTHER

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.

MOVIN Care Platform

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Residents of Ontario at least 18 years of age

2. Currently pregnant or mother* of a live infant 0-12 months of age living at the same residence *through natural birth, adoption or surrogacy, including cis women, non-binary and transgender people in all their diversity

3. EPDS > 12

4. Registered with a primary care provider

Exclusion Criteria

1. Experiencing active suicidal ideation (MINI International Neuropsychiatric Interview)

2. Active substance use disorder (GAIN-SS), current mania or psychosis (MINI Neuropsychiatric Interview)

3. Unable to access the internet or a device that can support the MOVIN platform

4. Unable to participate in English

5. Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Simone Vigod

Chief, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel Dalfen, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital and Sinai Health System

Simone Vigod, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2020-0054-B

Identifier Type: -

Identifier Source: org_study_id