Virtual Psychiatric Care for Perinatal Depression (Virtual-PND)
Primary Purpose
Perinatal Depression
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Psychiatric Care
Sponsored by
About this trial
This is an interventional treatment trial for Perinatal Depression
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Hospital
- Women's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Psychiatric Care Group
Control Group
Arm Description
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.
Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.
Outcomes
Primary Outcome Measures
Recruitment Feasibility (Recruitment Feasibility)
The number of women recruited to the study at each site
Secondary Outcome Measures
Edinburgh Postnatal Depressive Scale (EPDS)
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.
State-Trait Anxiety Inventory (STAI)
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.
Parenting Stress Index, Short Form (PSI)
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.
Recruitment Feasibility (Recruitment Eligibility)
The proportion of participants eligible to participate at each recruitment site
Recruitment Feasibility (Enrollment)
Average length of time from enrollment to 1st psychiatrist visit
Intervention Acceptability (Qualitative - participants)
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.
Intervention Acceptability (Qualitative - physicians)
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.
Intervention Acceptability (Patient-Reported Costs)
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.
Intervention Acceptability (Clinical visits)
Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.
Trial Protocol Adherence (Study Measure Completion)
Proportion of participants who complete follow-up measures.
Full Information
NCT ID
NCT03291600
First Posted
September 19, 2017
Last Updated
February 1, 2019
Sponsor
Women's College Hospital
Collaborators
Sinai Health System
1. Study Identification
Unique Protocol Identification Number
NCT03291600
Brief Title
Virtual Psychiatric Care for Perinatal Depression
Acronym
Virtual-PND
Official Title
Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Sinai Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral: Virtual Psychiatric Care for Perinatal Depression
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Psychiatric Care Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Psychiatric Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Feasibility (Recruitment Feasibility)
Description
The number of women recruited to the study at each site
Time Frame
One year from when the study starts enrolling participants
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depressive Scale (EPDS)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
Parenting Stress Index, Short Form (PSI)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
Recruitment Feasibility (Recruitment Eligibility)
Description
The proportion of participants eligible to participate at each recruitment site
Time Frame
One year from when the study starts enrolling participants
Title
Recruitment Feasibility (Enrollment)
Description
Average length of time from enrollment to 1st psychiatrist visit
Time Frame
From enrollment to first treatment visit
Title
Intervention Acceptability (Qualitative - participants)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
Intervention Acceptability (Qualitative - physicians)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
Intervention Acceptability (Patient-Reported Costs)
Description
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.
Time Frame
At 12 weeks post-randomization
Title
Intervention Acceptability (Clinical visits)
Description
Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.
Time Frame
Between randomization and 12 weeks post-randomization
Title
Trial Protocol Adherence (Study Measure Completion)
Description
Proportion of participants who complete follow-up measures.
Time Frame
At 12 weeks post-randomization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Wasserman, MD, FRCPC
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariel Dalfen, MD, FRCPC
Organizational Affiliation
Sinai Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Psychiatric Care for Perinatal Depression
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