The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network

Official title

The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network (MOVIN): Randomized Controlled Trial

Overview

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.

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.

Interventions

• Other Enhanced Usual Care
  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 MOVIN Care Platform
  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
  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.

Primary outcome measures

• Depressive symptoms [Time frame: 24 weeks post randomization]

Secondary outcome measures (12)

• Maternal Remission of depression [Time frame: 24 weeks post randomization]
• Maternal Depressive symptoms [Time frame: 12 weeks post randomization]
• Maternal Depressive symptoms [Time frame: 12 and 24 weeks post randomization]
• Obsessive-Compulsive Inventory-Revised [Time frame: 12 and 24 weeks post randomization]
• Maternal Posttraumatic Stress Disorder Checklist [Time frame: 12 and 24 weeks post randomization]
• Maternal anxiety symptoms [Time frame: 12 and 24 weeks post randomization]
• Maternal quality of life symptoms [Time frame: 12 and 24 weeks post randomization]
• Health service use: participant time [Time frame: 12 and 24 weeks post randomization]
• Health service use: participant cost [Time frame: 12 and 24 weeks post randomization]
• Health service use: health system costs [Time frame: 12 and 24 weeks post randomization]
• Maternal child relationship [Time frame: If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum]
• Dyadic relationship [Time frame: 12 and 24 weeks post randomization]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Canada · 2 centers

• Women's College Hospital — Toronto
• Women's College Hospital — Toronto

Identifiers

NCT: NCT07066631 · CTO Project ID: 5038

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗