Clinical trial NCT03291600: Virtual Psychiatric Care for Perinatal Depression
Official title: Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Sinai Health System
First posted: 2017-09-25
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Virtual Psychiatric Care for Perinatal Depression
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment Feasibility (Recruitment Feasibility)
timeFrame: One year from when the study starts enrolling participants
Secondary outcomes:
measure: Edinburgh Postnatal Depressive Scale (EPDS)
timeFrame: At 12 weeks post-randomization
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: At 12 weeks post-randomization
measure: Parenting Stress Index, Short Form (PSI)
timeFrame: At 12 weeks post-randomization
measure: Recruitment Feasibility (Recruitment Eligibility)
timeFrame: One year from when the study starts enrolling participants
measure: Recruitment Feasibility (Enrollment)
timeFrame: From enrollment to first treatment visit
measure: Intervention Acceptability (Qualitative - participants)
timeFrame: At 12 weeks post-randomization
measure: Intervention Acceptability (Qualitative - physicians)
timeFrame: At 12 weeks post-randomization
measure: Intervention Acceptability (Patient-Reported Costs)
timeFrame: At 12 weeks post-randomization
measure: Intervention Acceptability (Clinical visits)
timeFrame: Between randomization and 12 weeks post-randomization
measure: Trial Protocol Adherence (Study Measure Completion)
timeFrame: At 12 weeks post-randomization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Lori Wasserman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Ariel Dalfen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: