The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network

NCT07066631 | Recruiting

• 1 other identifier: CTO Project ID: 5038
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 2

Brief Summary

Depression, anxiety, and related disorders such as post-traumatic stress and obsessive compulsive disorder affect about 20% of pregnant and postpartum people. When not treated properly, these issues negatively impact not only affected people, but also their children's health and development. Only 1 in 5 receive adequate treatment, so identifying new system-wide approaches to reliably deliver recommended care to perinatal mental health patients all is a crucial health care priority. The Pregnancy and Postpartum Mental health Optimization Virtual Intervention Network (MOVIN) is a scalable perinatal mental health platform building on the evidence-based Collaborative care delivery model. MOVIN's online platform allows patients to connect with a care coordinator to co-develop personalized treatment recommendations, in collaboration with their primary care clinician and a perinatal psychiatrist when needed; progress is tracked to re-evaluate.

Conditions

Depression; Postpartum; Anxiety; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms

  The primary objective of this trial is to determine the effect of MOVIN versus a control condition on perinatal depression symptoms. Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30.

  24 weeks post randomization

Secondary Outcomes (13)

• Maternal Remission of depression

  24 weeks post randomization

• Maternal Depressive symptoms

  12 weeks post randomization

• Maternal Depressive symptoms

  12 and 24 weeks post randomization

• Obsessive-Compulsive Inventory-Revised

  12 and 24 weeks post randomization

• Maternal Posttraumatic Stress Disorder Checklist

  12 and 24 weeks post randomization

Other Outcomes (1)

• Clinician perspective survey

  24 weeks post randomization

Study Arms (2)

Enhanced Usual Care

OTHER

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.

Other: Enhanced Usual Care

MOVIN

EXPERIMENTAL

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.

Other: MOVIN Care Platform; Other: Enhanced Usual Care

Interventions

Enhanced Usual Care OTHER

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.

Enhanced Usual Care

MOVIN Care Platform 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.

MOVIN

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age 18 years or older)
• Pregnant or postpartum and living with their infant 0-6 months old. This includes all individuals who identify as women, as well as those of female sex who do not identify as women (e.g., non-binary, trans) who are the primary parent for their infant. This includes via natural birth, adoption, or surrogacy.
• EPDS score \>10 at eligibility screening.

You may not qualify if:

• Active alcohol or substance use disorder, mania or psychotic disorder (as these conditions are better managed in direct specialty care).
• Active suicide plan or intent (as emergent hospital-based care is likely required),
• Plan to move out of Ontario during the study.
• Unable to complete relevant study procedures and measures online. For the few participants without access to devices/home internet, we will budget for tablets/data plans.
• Unable to complete study activities in English. Note that Google translate is available for the intervention platform and language lines are available for participants so that they can be served in their language of choice, however we are unable to provide translations of all study assessment and questionnaire materials that participants will need to complete during the study.
• No primary care clinician (required for collaborative mental health care delivery model).
• Currently enrolled in a collaborative mental health care model.

Sponsors & Collaborators

• Women's College Hospital: lead
• Sunnybrook Health Sciences Centre: collaborator
• Mount Sinai Hospital, Canada: collaborator
• The Ottawa Hospital: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

ACTIVE NOT RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Simone Vigod

CONTACT

416-323-6400; simone.vigod@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)