Virtual Psychiatric Care for Perinatal Depression

NCT ID: NCT03291600

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2018-12-31

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.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Psychiatric Care

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Psychiatric Care

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sinai Health System

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Wasserman, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Ariel Dalfen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20170061B

Identifier Type: -

Identifier Source: org_study_id