MOVIN Pilot Randomized Controlled Trial

NCT04680585 | Completed

• 1 other identifier: 2020-0054-B
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (3)

• Feasibility of the trial protocol: Recruitment

  Measures of recruitment and retention include rate of recruitment, reason for non-participation and rate of completion of follow-up measures.

  12 weeks post randomization

• Feasibility of the trial protocol: Acceptability

  Measures of acceptability include participants' overall experience and satisfaction with and acceptance of the MOVIN platform and the care coordinator, the care coordinator's assessment of the MOVIN platform and its impact on patient care, and primary care providers' assessment of MOVIN's impact on patient care.

  12 weeks post randomization

• Feasibility of the trial protocol: Compliance

  Measures of compliance include rate of completion of MOVIN-specific activities, rate of completion of suggested interventions, and rate of resource use.

  12 weeks post randomization

Secondary Outcomes (14)

• Feasibility of the trial protocol: Recruitment

  24 weeks post randomization

• Feasibility of the trial protocol: Acceptability

  24 weeks post randomization

• Feasibility of the trial protocol: Compliance

  24 weeks post randomization

• Maternal clinical outcomes - depression symptoms

  12 and 24 weeks post randomization

• Maternal clinical outcomes - anxiety symptoms

  12 and 24 weeks post randomization

Other Outcomes (3)

• Co-variates

  Baseline

• Maternal birth outcomes

  Baseline, 12 and 24 weeks post randomization

• Neonatal birth outcomes

  Baseline, 12 and 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: Enhanced Usual Care; Other: MOVIN Care Platform

Interventions

Enhanced Usual Care 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.

Enhanced Usual Care; MOVIN

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:

• Residents of Ontario at least 18 years of age
• 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
• EPDS \> 12
• Registered with a primary care provider

You may not qualify if:

• Experiencing active suicidal ideation (MINI International Neuropsychiatric Interview)
• Active substance use disorder (GAIN-SS), current mania or psychosis (MINI Neuropsychiatric Interview)
• Unable to access the internet or a device that can support the MOVIN platform
• Unable to participate in English
• Unable to provide informed consent

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ariel Dalfen, MD

  Women's College Hospital and Sinai Health System

  PRINCIPAL INVESTIGATOR

• Simone Vigod, MD, MSc

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Psychiatry

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 23, 2020
• Study Start: April 12, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CA (1)