The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen's College Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Usual Care
Other interventionAccess 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 Platform
Other interventionVirtual 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 interventionAccess 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.
Treatment groups
570 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual CareOther 1 intervention
Group B: MOVINExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
24 weeks post randomizationSecondary outcomes
1
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 randomization2
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 randomization3
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 randomization4
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 randomizationOther outcomes
1
Clinician perspective survey
Time frame
24 weeks post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Women's College Hospital
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Mount Sinai Hospital, Canada
Collaborator
The Ottawa Hospital
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
Source ClinicalTrials.gov