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Trial record 42 of 1505 for:    depression AND (woman OR women OR female)

Virtual Psychiatric Care for Perinatal Depression (Virtual-PND)

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ClinicalTrials.gov Identifier: NCT03291600
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Sinai Health System
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Perinatal Depression Behavioral: Virtual Psychiatric Care Not Applicable

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 secondary end-point will be 1 year postpartum, as participants are followed clinically to 1-year postpartum at both study sites. 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Behavioral: Virtual Psychiatric Care for Perinatal Depression
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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.
No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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. Edinburgh Postnatal Depressive Scale (EPDS) [ Time Frame: At approximately 1 year postpartum (at discharge from the clinical program) ]
    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.

  3. 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.

  4. State-Trait Anxiety Inventory (STAI) [ Time Frame: At approximately 1 year postpartum (at discharge from the clinical program) ]
    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.

  5. 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.

  6. Parenting Stress Index, Short Form (PSI) [ Time Frame: At approximately 1 year postpartum (at discharge from the clinical program) ]
    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.

  7. 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

  8. Recruitment Feasibility (Enrollment) [ Time Frame: From enrollment to first treatment visit ]
    Average length of time from enrollment to 1st psychiatrist visit

  9. 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.

  10. 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.

  11. 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.

  12. Intervention Acceptability (Patient-Reported Costs) [ Time Frame: At approximately 1 year postpartum (at discharge from the clinical program) ]
    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.

  13. 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.

  14. Trial Protocol Adherence (Study Measure Completion) [ Time Frame: At 12 weeks post-randomization ]
    Proportion of participants who complete follow-up measures.

  15. Trial Protocol Adherence (Study Measure Completion) [ Time Frame: At approximately 1 year postpartum (at discharge from the clinical program) ]
    Proportion of participants who complete follow-up measures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291600


Contacts
Contact: Simone Vigod, MD,FRCPC,MSc 416-323-6400 ext 4080 simone.vigod@wchospital.ca
Contact: Emily VonderPorten, MPH 416-351-3732 ext 2302 emily.vonderporten@wchospital.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
Sinai Health System
Investigators
Principal Investigator: Lori Wasserman, MD, FRCPC Women's College Hospital
Principal Investigator: Ariel Dalfen, MD, FRCPC Sinai Health System

Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03291600     History of Changes
Other Study ID Numbers: 20170061B
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Asphyxia Neonatorum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases