Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Women's College Hospital
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Recruitment Feasibility (Recruitment Feasibility)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Virtual Psychiatric Care (Behavioral)
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.
Outcomes
Primary Outcomes
Recruitment Feasibility (Recruitment Feasibility)
Time Frame: One year from when the study starts enrolling participants
The number of women recruited to the study at each site
Secondary Outcomes
- Recruitment Feasibility (Recruitment Eligibility)(One year from when the study starts enrolling participants)
- Intervention Acceptability (Qualitative - participants)(At 12 weeks post-randomization)
- State-Trait Anxiety Inventory (STAI)(At 12 weeks post-randomization)
- Edinburgh Postnatal Depressive Scale (EPDS)(At 12 weeks post-randomization)
- Parenting Stress Index, Short Form (PSI)(At 12 weeks post-randomization)
- Recruitment Feasibility (Enrollment)(From enrollment to first treatment visit)
- Intervention Acceptability (Qualitative - physicians)(At 12 weeks post-randomization)
- Intervention Acceptability (Patient-Reported Costs)(At 12 weeks post-randomization)
- Intervention Acceptability (Clinical visits)(Between randomization and 12 weeks post-randomization)
- Trial Protocol Adherence (Study Measure Completion)(At 12 weeks post-randomization)