Virtual Psychiatric Care for Perinatal Depression (Virtual-PND)
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|ClinicalTrials.gov Identifier: NCT03291600|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression||Behavioral: Virtual Psychiatric Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Behavioral: Virtual Psychiatric Care for Perinatal Depression|
|Masking:||None (Open Label)|
|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 :||December 2018|
|Estimated Study Completion Date :||March 2019|
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.
- 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
- 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.
- 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.
- 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.
- 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
- Recruitment Feasibility (Enrollment) [ Time Frame: From enrollment to first treatment visit ]Average length of time from enrollment to 1st psychiatrist visit
- 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.
- 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.
- 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.
- 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.
- Trial Protocol Adherence (Study Measure Completion) [ Time Frame: At 12 weeks post-randomization ]Proportion of participants who complete follow-up measures.
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
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|
|Principal Investigator:||Lori Wasserman, MD, FRCPC||Women's College Hospital|
|Principal Investigator:||Ariel Dalfen, MD, FRCPC||Sinai Health System|