- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291600
Virtual Psychiatric Care for Perinatal Depression (Virtual-PND)
February 1, 2019 updated by: Women's College Hospital
Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
Perinatal depression occurs in 15% of pregnant women and new mothers, yet as few as 1 in 5 receive adequate treatment.
It has a negative impact on the woman herself, as well as a potential for serious consequences for her child.
Virtual psychiatric care is a potential model that may provide accessible mental health care during this time, as barriers to in-person care often include unpredictable infant schedules, competing childcare demands, or travel/cost challenges.
The Virtual-PND intervention consists of 12-weeks of the option of supplementing in-person psychiatric care with secure, in-home real-time video-visits through the Ontario Telemedicine Network.
This pilot RCT will demonstrate the feasibility of proceeding to a future large-scale RCT evaluation of virtual psychiatric care for this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a two-site pilot randomized controlled trial (RCT) to evaluate the feasibility of a Virtual Psychiatric Care for Perinatal Depression (Virtual-PND) intervention protocol, comparing virtual care to in-person care only.
Participants will be pregnant or postpartum women with a major depressive disorder who are referred for care at one of the participating study sites.
Each study site is a specialist reproductive psychiatric program where women from the greater Toronto area are referred, and generally treated with in-person care.
Those randomized to the virtual care group will be able to receive psychiatric visits with video-based visits.
Those randomized to the in-person care group will receive in-person care only, as per usual clinical practice at the study sites.
The length of the active treatment phase will be 12 weeks from enrolment.
The overall objective of this pilot RCT is to determine the feasibility of conducting a larger RCT to evaluate the efficacy of the treatment model, comparing outcomes among those with and without access to virtual care, and cost-effectiveness.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Toronto, Ontario, Canada, M5S 1B2
- Women's College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ≥18 years old
- Pregnant or 0-12 months postpartum
- Experiencing clinically significant depressive symptoms (defined as a score of ≥12 on the Edinburgh Postnatal Depressive Scale, EPDS, during eligibility screening)
- Able to access the internet on a device (i.e. mobile phone, tablet, personal computer) with video-visit capacity (including web camera and speakers)
- Comfortable with email communication
Exclusion Criteria:
- Active alcohol/substance use disorder in the past 12 months
- Active suicidal ideation
- Current mania or psychosis
- Unsuitable for virtual care, as per assessment of the treating psychiatrist
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Psychiatric Care Group
Participants randomized to the intervention group will have the option to receive video-based psychiatrist care in addition to care as usual.
Participants will be assigned to begin immediately after randomization.
|
Virtual psychiatric care for perinatal depression will be offered to participants, in addition to care as usual, for a 12-week period by their treating perinatal psychiatrist.
Virtual care will be delivered by video-based visits through the Ontario Telemedicine Network (OTN).
The treating psychiatrist may request that an intervention group participant present for in-person care at any visit, and this may include need for behavioural activation, or another health-related indication at the discretion of the treating psychiatrist.
|
No Intervention: Control Group
Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Feasibility (Recruitment Feasibility)
Time Frame: One year from when the study starts enrolling participants
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The number of women recruited to the study at each site
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One year from when the study starts enrolling participants
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depressive Scale (EPDS)
Time Frame: At 12 weeks post-randomization
|
The investigators will measure depressive symptoms using the EPDS, a self-report, 10-item depression screening measure that has been validated for use in pregnancy.
EPDS scores >12 are predictive of a diagnosis of major depressive disorder.
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At 12 weeks post-randomization
|
State-Trait Anxiety Inventory (STAI)
Time Frame: At 12 weeks post-randomization
|
The investigators will measure anxious symptoms using the STAI, a self-report, 40-item anxiety screening measure that has shown good discriminate validity in perinatal populations.
STAI scores >48 are predictive of having an anxiety disorder diagnosis.
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At 12 weeks post-randomization
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Parenting Stress Index, Short Form (PSI)
Time Frame: At 12 weeks post-randomization
|
The investigators will measure stress in the parent-child relationship using the PSI short form, a 36-item measure which consists of three sub-scales.
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At 12 weeks post-randomization
|
Recruitment Feasibility (Recruitment Eligibility)
Time Frame: One year from when the study starts enrolling participants
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The proportion of participants eligible to participate at each recruitment site
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One year from when the study starts enrolling participants
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Recruitment Feasibility (Enrollment)
Time Frame: From enrollment to first treatment visit
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Average length of time from enrollment to 1st psychiatrist visit
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From enrollment to first treatment visit
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Intervention Acceptability (Qualitative - participants)
Time Frame: At 12 weeks post-randomization
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Virtual-PND Participant Program Evaluation Questionnaire.
This is comprised of Likert-type scale questions to elicit feedback on acceptability of the virtual care experience and model.
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At 12 weeks post-randomization
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Intervention Acceptability (Qualitative - physicians)
Time Frame: At 12 weeks post-randomization
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Virtual-PND Physician Program Evaluation Questionnaire.
This is comprised of open and closed-ended questions to elicit feedback on the acceptability of the virtual care experience and model.
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At 12 weeks post-randomization
|
Intervention Acceptability (Patient-Reported Costs)
Time Frame: At 12 weeks post-randomization
|
Patient-Reported Costs Questionnaire.
This is comprised of open and closed-ended questions regarding: a) time spent travelling to visits and on missed work; and b) cost of travel, food, childcare and data charges.
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At 12 weeks post-randomization
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Intervention Acceptability (Clinical visits)
Time Frame: Between randomization and 12 weeks post-randomization
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Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.
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Between randomization and 12 weeks post-randomization
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Trial Protocol Adherence (Study Measure Completion)
Time Frame: At 12 weeks post-randomization
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Proportion of participants who complete follow-up measures.
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At 12 weeks post-randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lori Wasserman, MD, FRCPC, Women's College Hospital
- Principal Investigator: Ariel Dalfen, MD, FRCPC, Sinai Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
September 19, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170061B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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