Reproductive Mental Health of Ontario Virtual Intervention Network (MOVIN): A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression, Postpartum
- Sponsor
- Women's College Hospital
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Feasibility of the trial protocol: Recruitment
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Simone Vigod
Chief, Department of Psychiatry
Women's College Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of the trial protocol: Recruitment
Time Frame: 12 weeks post randomization
Measures of recruitment and retention include rate of recruitment, reason for non-participation and rate of completion of follow-up measures.
Feasibility of the trial protocol: Acceptability
Time Frame: 12 weeks post randomization
Measures of acceptability include participants' overall experience and satisfaction with and acceptance of the MOVIN platform and the care coordinator, the care coordinator's assessment of the MOVIN platform and its impact on patient care, and primary care providers' assessment of MOVIN's impact on patient care.
Feasibility of the trial protocol: Compliance
Time Frame: 12 weeks post randomization
Measures of compliance include rate of completion of MOVIN-specific activities, rate of completion of suggested interventions, and rate of resource use.
Secondary Outcomes
- Feasibility of the trial protocol: Compliance(24 weeks post randomization)
- Health service use: participant cost(12 and 24 weeks post randomization)
- Care coordinator cost(12 and 24 weeks post randomization)
- Dyadic relationship(12 and 24 weeks post randomization)
- Feasibility of the trial protocol: Acceptability(24 weeks post randomization)
- Feasibility of the trial protocol: Recruitment(24 weeks post randomization)
- Maternal clinical outcomes - depression symptoms(12 and 24 weeks post randomization)
- Care coordinator time(12 and 24 weeks post randomization)
- Maternal clinical outcomes - anxiety symptoms(12 and 24 weeks post randomization)
- Health service use: participant time(12 and 24 weeks post randomization)
- Maternal child relationship(12 and 24 weeks post randomization)
- Infant temperament(Baseline, 12 and 24 weeks post randomization)
- Maternal clinical outcomes - quality of life(12 and 24 weeks post randomization)
- Health service use: health system costs(12 and 24 weeks post randomization)