Virtual Psychiatric Care for Perinatal Depression

Perinatal Depression Clinical Trial

— Virtual-PND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291600
• Other study ID #: 20170061B
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Perinatal Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Sinai Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Edinburgh Postnatal Depressive Scale (EPDS)	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.	At 12 weeks post-randomization
Secondary	State-Trait Anxiety Inventory (STAI)	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.	At 12 weeks post-randomization
Secondary	Parenting Stress Index, Short Form (PSI)	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.	At 12 weeks post-randomization
Secondary	Recruitment Feasibility (Recruitment Eligibility)	The proportion of participants eligible to participate at each recruitment site	One year from when the study starts enrolling participants
Secondary	Recruitment Feasibility (Enrollment)	Average length of time from enrollment to 1st psychiatrist visit	From enrollment to first treatment visit
Secondary	Intervention Acceptability (Qualitative - participants)	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.	At 12 weeks post-randomization
Secondary	Intervention Acceptability (Qualitative - physicians)	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.	At 12 weeks post-randomization
Secondary	Intervention Acceptability (Patient-Reported Costs)	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.	At 12 weeks post-randomization
Secondary	Intervention Acceptability (Clinical visits)	Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.	Between randomization and 12 weeks post-randomization
Secondary	Trial Protocol Adherence (Study Measure Completion)	Proportion of participants who complete follow-up measures.	At 12 weeks post-randomization