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Completed

NCT Number: NCT03291600

Virtual Psychiatric Care for Perinatal Depression

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.

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Key information

Conditions

Perinatal Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Edinburgh Postnatal Depressive Scale (EPDS)

    Time frame: At 12 weeks post-randomization

    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.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: At 12 weeks post-randomization

    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.

  3. Parenting Stress Index, Short Form (PSI)

    Time frame: At 12 weeks post-randomization

    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.

  4. Recruitment Feasibility (Recruitment Eligibility)

    Time frame: One year from when the study starts enrolling participants

    The proportion of participants eligible to participate at each recruitment site

  5. Recruitment Feasibility (Enrollment)

    Time frame: From enrollment to first treatment visit

    Average length of time from enrollment to 1st psychiatrist visit

  6. Intervention Acceptability (Qualitative - participants)

    Time frame: At 12 weeks post-randomization

    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.

  7. Intervention Acceptability (Qualitative - physicians)

    Time frame: At 12 weeks post-randomization

    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.

  8. Intervention Acceptability (Patient-Reported Costs)

    Time frame: At 12 weeks post-randomization

    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.

  9. Intervention Acceptability (Clinical visits)

    Time frame: Between randomization and 12 weeks post-randomization

    Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.

  10. Trial Protocol Adherence (Study Measure Completion)

    Time frame: At 12 weeks post-randomization

    Proportion of participants who complete follow-up measures.

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Sinai Health System

Registry information

Official study title

Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial

Acronym: Virtual-PND

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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