Depression, PostpartumMOVINNCT04680585
MOVIN Pilot Randomized Controlled Trial
A study testing MOVIN Care Platform in people with Depression, Postpartum, run by Women's College Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- MOVIN Care Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Ontario at least 18 years of age
- 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
- EPDS > 12
- Registered with a primary care provider
Who cannot join
- Experiencing active suicidal ideation (MINI International Neuropsychiatric Interview)
- Active substance use disorder (GAIN-SS), current mania or psychosis (MINI Neuropsychiatric Interview)
- Unable to access the internet or a device that can support the MOVIN platform
- Unable to participate in English
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproductive Mental Health of Ontario Virtual Intervention Network (MOVIN): A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depression, Postpartum
- Being tested
- Enhanced Usual Care, MOVIN Care Platform
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareOther
A standardized handout with information on what treatment options might be useful to start with based on EPDS score and stage of pregnancy or postpartum.
MOVIN Care PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Other | 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. Receives: Other: Enhanced Usual Care |
| MOVIN | Experimental | Enhanced Usual Care plus MOVIN Care Platform. The MOVIN Care Platform is 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. Receives: Other: Enhanced Usual Care; Other: MOVIN Care Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the trial protocol: Recruitment
Measures of recruitment and retention include rate of recruitment, reason for non-participation and rate of completion of follow-up measures.
Measured: 12 weeks post randomization
Feasibility of the trial protocol: Acceptability
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.
Measured: 12 weeks post randomization
Feasibility of the trial protocol: Compliance
Measures of compliance include rate of completion of MOVIN-specific activities, rate of completion of suggested interventions, and rate of resource use.
Measured: 12 weeks post randomization
Secondary outcomes (14)
Feasibility of the trial protocol: Recruitment
Measures of recruitment and retention include rate of recruitment, reason for non-participation and rate of completion of follow-up measures.
Measured: 24 weeks post randomization
Feasibility of the trial protocol: Acceptability
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.
Measured: 24 weeks post randomization
Feasibility of the trial protocol: Compliance
Measures of compliance include rate of completion of MOVIN-specific activities, rate of completion of suggested interventions, and rate of resource use.
Measured: 24 weeks post randomization
Maternal clinical outcomes - 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. EPDS scores >12 are predictive of a diagnosis of depression, with higher scores indicating more severe symptoms.
Measured: 12 and 24 weeks post randomization
Maternal clinical outcomes - 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.
Measured: 12 and 24 weeks post randomization
Maternal clinical outcomes - quality of life
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 and 24 weeks post randomization
Care coordinator time
Care coordinator time per participant will be measured as the time spent per participant on the MOVIN platform, time spent on phone assessments and other related activities.
Measured: 12 and 24 weeks post randomization
Care coordinator cost
Care coordinator cost per participant will be measured as the cost per participant on the MOVIN platform, on phone assessments and other related activities.
Measured: 12 and 24 weeks post randomization
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 fro 0 to 75. Higher scores indicate a higher degree of dyadic consensus.
Measured: 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.
Measured: 12 and 24 weeks post randomization
Infant temperament
Infant temperament will be measured using the Infant Characteristics Questionnaire (ICQ), an instrument that assesses parental perceptions of difficult infant temperament. Scores range from 28 to 196. Higher scores indicate a higher level of parental perceptions of difficult infant temperament.
Measured: Baseline, 12 and 24 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start12 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Vigod, Women's College Hospital
- Investigators
- Ariel Dalfen, MD, Principal investigator, Women's College Hospital and Sinai Health SystemSimone Vigod, MD, MSc, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680585
- Sponsor's protocol ID
- 2020-0054-B
- Acronym
- MOVIN
- Status last verified
- May 2025
- First submitted
- 7 Dec 2020
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Mental Health of Ontario Virtual Intervention Network (MOVIN): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04680585
- Acronym / sponsor ID
- MOVIN / 2020-0054-B
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Other | Other: Enhanced Usual CareAccess 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 | Experimental | Other: Enhanced Usual Care, Other: MOVIN Care PlatformEnhanced Usual Care plus MOVIN Care Platform. The MOVIN Care Platform is 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residents of Ontario at least 18 years of age
- 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
- EPDS > 12
- Registered with a primary care provider
Key exclusion criteria (5 listed)
- Experiencing active suicidal ideation (MINI International Neuropsychiatric Interview)
- Active substance use disorder (GAIN-SS), current mania or psychosis (MINI Neuropsychiatric Interview)
- Unable to access the internet or a device that can support the MOVIN platform
- Unable to participate in English
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual CareA standardized handout with information on what treatment options might be useful to start with based on EPDS score and stage of pregnancy or postpartum. | Other | Enhanced Usual Care, MOVIN |
| MOVIN Care PlatformVirtual 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 | MOVIN |
Primary outcome
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.
14 secondary outcomes
Feasibility of the trial protocol: Recruitment
Time frame: 24 weeks post randomization
Feasibility of the trial protocol: Acceptability
Time frame: 24 weeks post randomization
Feasibility of the trial protocol: Compliance
Time frame: 24 weeks post randomization
Maternal clinical outcomes - depression symptoms
Time frame: 12 and 24 weeks post randomization
Maternal clinical outcomes - anxiety symptoms
Time frame: 12 and 24 weeks post randomization
Maternal clinical outcomes - quality of life
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
Care coordinator time
Time frame: 12 and 24 weeks post randomization
Care coordinator cost
Time frame: 12 and 24 weeks post randomization
Dyadic relationship
Time frame: 12 and 24 weeks post randomization
Maternal child relationship
Time frame: 12 and 24 weeks post randomization
Infant temperament
Time frame: Baseline, 12 and 24 weeks post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Dalfen, MD principal investigator
Women's College Hospital and Sinai Health System
Simone Vigod, MD, MSc principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVIN Care Platform in people with Depression, Postpartum, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the trial protocol: Recruitment (time frame: 12 weeks post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.