Clinical trial NCT04680585: MOVIN Pilot Randomized Controlled Trial
Official title: Reproductive Mental Health of Ontario Virtual Intervention Network (MOVIN): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite available treatments for perinatal mood disorders, only 20% of affected women receive treatment that results in remission of symptoms. In order to address gaps in equitable access to treatment the investigators developed the Reproductive Mental health of Ontario Virtual Intervention Network (MOVIN), a virtual collaborative care platform to optimize access for pregnant and postpartum people in Ontario. MOVIN combines collaborative and stepped-care approaches to treatment of perinatal depression and anxiety. The overall objective of this pilot randomized controlled trial (RCT) is to determine the feasibility of implementing a protocol for studying MOVIN for pregnant and postpartum individuals with significant symptoms of depression and anxiety (EPDS \> 12) in order to inform the conduct of a larger scale evaluation. O will be randomized to either the MOVIN or control condition and will be asked to complete follow-up assessments 12- and 24-weeks post-randomization. Participants in the MOVIN arm will receive access to the MOVIN platform which includes a care coordinator to help them navigate various virtual treatments. Participants in the control condition will receive a resource list and will navigate the various options on their own.

Detailed description: People with scores above 12 on the EPDS have a 10 times greater likelihood of having a diagnosis of depression than those with scores with 12 or less, so this is an appropriate cut-off. The primary endpoint is at 12 weeks post-randomization and the secondary endpoint is at 24 weeks post-randomization. Randomization will be performed as block randomization (varying block sizes) with a 1:1 allocation and will be stratified based on EPDS score (13-19 vs. 20 or greater). Participants who score 12 or less on the EPDS in their initial self-referral screen will be informed that they are not at high risk for having depressive or anxiety disorder and the current time, and can re-screen as needed. Participants whose score is in the 9-12 range (i.e. those who are not likely to be experiencing a depressive or anxiety disorder requiring mental health treatment, but might benefit from additional support) will receive an automated message that communicates their score and the acknowledgment of their possible need for support, and provides a list of resources in Ontario that may be helpful for them. These participants will be invited to re-screen at any time into the study, and will be asked permission to be re-contacted in future to determine which supports they used, if any.

Eligibility criteria: Inclusion criteria:

1. Residents of Ontario at least 18 years of age
2. Currently pregnant or mother\* of a live infant 0-12 months of age living at the same residence \*through natural birth, adoption or surrogacy, including cis women, non-binary and transgender people in all their diversity
3. EPDS \> 12
4. Registered with a primary care provider

Exclusion criteria:

1. Experiencing active suicidal ideation (MINI International Neuropsychiatric Interview)
2. Active substance use disorder (GAIN-SS), current mania or psychosis (MINI Neuropsychiatric Interview)
3. Unable to access the internet or a device that can support the MOVIN platform
4. Unable to participate in English
5. Unable to provide informed consent

Primary outcomes:
measure: Feasibility of the trial protocol: Recruitment
timeFrame: 12 weeks post randomization
measure: Feasibility of the trial protocol: Acceptability
timeFrame: 12 weeks post randomization
measure: Feasibility of the trial protocol: Compliance
timeFrame: 12 weeks post randomization
Secondary outcomes:
measure: Feasibility of the trial protocol: Recruitment
timeFrame: 24 weeks post randomization
measure: Feasibility of the trial protocol: Acceptability
timeFrame: 24 weeks post randomization
measure: Feasibility of the trial protocol: Compliance
timeFrame: 24 weeks post randomization
measure: Maternal clinical outcomes - depression symptoms
timeFrame: 12 and 24 weeks post randomization
measure: Maternal clinical outcomes - anxiety symptoms
timeFrame: 12 and 24 weeks post randomization
measure: Maternal clinical outcomes - quality of life
timeFrame: 12 and 24 weeks post randomization
measure: Health service use: participant time
timeFrame: 12 and 24 weeks post randomization
measure: Health service use: participant cost
timeFrame: 12 and 24 weeks post randomization
measure: Health service use: health system costs
timeFrame: 12 and 24 weeks post randomization
measure: Care coordinator time
timeFrame: 12 and 24 weeks post randomization
measure: Care coordinator cost
timeFrame: 12 and 24 weeks post randomization
measure: Dyadic relationship
timeFrame: 12 and 24 weeks post randomization
measure: Maternal child relationship
timeFrame: 12 and 24 weeks post randomization
measure: Infant temperament
timeFrame: Baseline, 12 and 24 weeks post randomization
Other outcomes:
measure: Co-variates
timeFrame: Baseline
measure: Maternal birth outcomes
timeFrame: Baseline, 12 and 24 weeks post randomization
measure: Neonatal birth outcomes
timeFrame: Baseline, 12 and 24 weeks post randomization
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital and Sinai Health System
name: Ariel Dalfen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Simone Vigod, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: