Virtual Psychiatric Care for Perinatal Depression

NCT03291600 | Completed

• 1 other identifier: 20170061B
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• Recruitment Feasibility (Recruitment Feasibility)

  The number of women recruited to the study at each site

  One year from when the study starts enrolling participants

Secondary Outcomes (10)

• Edinburgh Postnatal Depressive Scale (EPDS)

  At 12 weeks post-randomization

• State-Trait Anxiety Inventory (STAI)

  At 12 weeks post-randomization

• Parenting Stress Index, Short Form (PSI)

  At 12 weeks post-randomization

• Recruitment Feasibility (Recruitment Eligibility)

  One year from when the study starts enrolling participants

• Recruitment Feasibility (Enrollment)

  From enrollment to first treatment visit

Study Arms (2)

Virtual Psychiatric Care Group

EXPERIMENTAL

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.

Behavioral: Virtual Psychiatric Care

Control Group

NO INTERVENTION

Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.

Interventions

Virtual Psychiatric Care 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.

Virtual Psychiatric Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Sinai Health System: collaborator

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Study Officials

• Lori Wasserman, MD, FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Ariel Dalfen, MD, FRCPC

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavioral: Virtual Psychiatric Care for Perinatal Depression

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: October 24, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)