DepressionMOVINNCT07066631
The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network
A study testing MOVIN Care Platform in people with Depression and Postpartum, run by Women's College Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Anxiety
- What is being tested?
- MOVIN Care Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Oct 2025to 31 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Hailey Katzman, 416-323-6400 ext. 5242, movin@wchospital.ca
Simone Vigod
- Recruiting
Women's College Hospital
Toronto, Ontario
About this study
Official title: The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network (MOVIN): Randomized Controlled Trial
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.
Read the detailed description
The Pregnant and Postpartum Mental Health Optimization Virtual Intervention Network (MOVIN) is a model of stepped, collaborative care delivered virtually, accessible to pregnant and postpartum individuals across Ontario based at Women's College Hospital. Access to MOVIN includes access to a web platform with curated educational material and treatment resources, personalized treatment planning between a participant and the MOVIN Care Coordinator (informed by systematic measurement-based follow-up of mental health symptoms), liaison between the MOVIN Care Coordinator and the participant's primary care clinician, and direct referral to a perinatal psychiatrist if required. Participants will be allocated 1:1 (intervention: control) using a computer-generated random allocation sequence in randomly varying block sizes. The primary outcome will be depressive symptoms (considered as a continuous variable) at 24-weeks post-randomization, measured using the patient-reported Edinburgh Postnatal Depression Scale (EPDS). The main secondary outcome is symptom remission (EPDS <10) at 24-weeks post-randomization.
- Conditions
- Depression, Postpartum, Anxiety, Pregnancy
- Being tested
- Enhanced Usual Care, MOVIN Care Platform
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareOther
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.
MOVIN Care PlatformOther
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.
Enhanced Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MOVIN Care Platform; Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post randomization
Secondary outcomes (13)
Maternal Remission of depression
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. A EPDS score of <10 indicates remission.
Measured: 24 weeks post randomization
Maternal Depressive 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.
Measured: 12 weeks post randomization
Maternal Depressive symptoms
Depressive symptoms will be measured using the Patient Health Questionnaire Scale (PHQ-9), a self-report scale that has been validated for use in pregnancy and postpartum. PHQ-9 scores range from 0 to 27.
Measured: 12 and 24 weeks post randomization
Obsessive-Compulsive Inventory-Revised
OCD symptoms will be measured using the Obsessive-Compulsive Inventory-Revised (OCI-R) Scale, a self-report scale that has been validated for use. OCI-R scores range from 0 to 72.
Measured: 12 and 24 weeks post randomization
Maternal Posttraumatic Stress Disorder Checklist
PTSD symptoms will be measured using the Posttraumatic Stress Disorder Checklist (PCL-5), a self report scale that has been validated to assess for PTSD symptoms. PCL-5 scores range from 0 to 80.
Measured: 12 and 24 weeks post randomization
Maternal anxiety symptoms
Anxiety symptoms will be measured using the General Anxiety Disorder-7 (GAD-7) scale, which is a self-report scale with good discriminate validity in perinatal populations. GAD-7 scores range from 0 to 21, with higher scores indicating more severe symptoms.
Measured: 12 and 24 weeks post randomization
Maternal quality of life symptoms
Quality of life will be measured using the 5 Level-5 Dimension EuroQol 5 (EQ-5D-5L) which is a multi-attribute utility instrument for measuring quality-adjusted life year (QALY), a preference-based utility measure of health-related quality of life as perceived by the patient. It can define 3125 different health states ranging from 11111 (full health) to 55555 (worst health).
Measured: 12 and 24 weeks post randomization
Health service use: participant time
Measured by participant self-report of activities related to attending appointments and obtaining services.
Measured: 12 and 24 weeks post randomization
Health service use: participant cost
Measured by participant self-report of costs related to attending appointments and obtaining services.
Measured: 12 and 24 weeks post randomization
Health service use: health system costs
Calculated from participant self-report of medical costs such as hospitalizations, visits with health professionals and medications.
Measured: 12 and 24 weeks post randomization
Maternal child relationship
All participants who are postpartum at any time point will complete Parenting Stress Index short form (PSI-SF) to measure parenting stress. This is a 36-item measure consisting of 3 sub-scales: parental distress, dysfunction in the parent-child relations and difficult child. Scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum
Dyadic relationship
The Dyadic Adjustment Scale (DAS) is a self-report measure of relationship adjustment with an intimate partner and will be used to measure relationship distress. The first 15 items of the 32-item measure will be used to assess dyadic consensus. Scores range from 0 to 75. Higher scores indicate a higher degree of dyadic consensus.
Measured: 12 and 24 weeks post randomization
Child Development
Assessed using the Ages \& Stages Questionnaire, Third Edition [ASQ-3 (12 Months)], and the Ages \& Stages Questionnaires: Social-Emotional, Second Edition [(ASQ:SE-2 (12 Months)]. A 30-item instrument that screens for child development at 11 months 0 days through 12 months 30 days and 9 months 0 days through 14 months 30 days, respectively. Scores are compared to norms. For the ASQ-3, the minimum value is 0 while the maximum value is 60. For the ASQ:SE-2, The minimum value is 0 while the maximum value is 155. A lower score indicates there may be a concern and further assessment from a professional may be needed, while a higher score indicates no concern and the child's development appears to be on track.
Measured: If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start29 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Mount Sinai Hospital, Canada, The Ottawa Hospital, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066631
- Sponsor's protocol ID
- CTO Project ID: 5038
- Acronym
- MOVIN
- Status last verified
- Oct 2026
- First submitted
- 4 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No