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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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.
Mount Sinai Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Recruitment Feasibility (Recruitment Feasibility)
The number of women recruited to the study at each site
Time frame: One year from when the study starts enrolling participants
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.
Time frame: At 12 weeks post-randomization
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.
Time frame: At 12 weeks post-randomization
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.
Time frame: At 12 weeks post-randomization
Recruitment Feasibility (Recruitment Eligibility)
The proportion of participants eligible to participate at each recruitment site
Time frame: One year from when the study starts enrolling participants
Recruitment Feasibility (Enrollment)
Average length of time from enrollment to 1st psychiatrist visit
Time frame: From enrollment to first treatment 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.
Time frame: At 12 weeks post-randomization
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.
Time frame: At 12 weeks post-randomization
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.
Time frame: At 12 weeks post-randomization
Intervention Acceptability (Clinical visits)
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
Trial Protocol Adherence (Study Measure Completion)
Proportion of participants who complete follow-up measures.
Time frame: At 12 weeks post-randomization
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