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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Mount Sinai Hospital, Canada | OTHER |
| The Ottawa Hospital | OTHER |
| St. Joseph's Healthcare Hamilton |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician perspective survey | 24 weeks post randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Vigod | Contact | 416-323-6400 | 4080 | simone.vigod@wchospital.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Active, not recruiting | Toronto | Ontario | M5S 1B2 | Canada | |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| OTHER |
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| 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. |
|
| 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum. |
| Women's College Hospital |
| Recruiting |
| Toronto |
| Ontario |
| Canada |