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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
570
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.
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.
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.
Women's College Hospital
Toronto, Ontario, Canada
ACTIVE_NOT_RECRUITINGWomen's College Hospital
Toronto, Ontario, Canada
RECRUITINGDepressive 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.
Time frame: 24 weeks post randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum.
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