Perinatal DepressionVirtual-PNDNCT03291600
Virtual Psychiatric Care for Perinatal Depression
A study testing Virtual Psychiatric Care in people with Perinatal Depression, run by Women's College Hospital at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Virtual Psychiatric Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Oct 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Women's College Hospital
Toronto, Ontario, M5S 1B2
About this study
Official title: Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
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.
Read the 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 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.
- Conditions
- Perinatal Depression
- Being tested
- Virtual Psychiatric Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Psychiatric CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Recruitment Feasibility)
The number of women recruited to the study at each site
Measured: One year from when the study starts enrolling participants
Secondary outcomes (10)
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.
Measured: At 12 weeks post-randomization
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.
Measured: At 12 weeks post-randomization
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.
Measured: At 12 weeks post-randomization
Recruitment Feasibility (Recruitment Eligibility)
The proportion of participants eligible to participate at each recruitment site
Measured: One year from when the study starts enrolling participants
Recruitment Feasibility (Enrollment)
Average length of time from enrollment to 1st psychiatrist visit
Measured: From enrollment to first treatment visit
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.
Measured: At 12 weeks post-randomization
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.
Measured: At 12 weeks post-randomization
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.
Measured: At 12 weeks post-randomization
Intervention Acceptability (Clinical visits)
Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.
Measured: Between randomization and 12 weeks post-randomization
Trial Protocol Adherence (Study Measure Completion)
Proportion of participants who complete follow-up measures.
Measured: At 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start24 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: Virtual Psychiatric Care for Perinatal Depression
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System
- Responsible party
- Sponsor
- Investigators
- Lori Wasserman, MD, FRCPC, Principal investigator, Women's College HospitalAriel Dalfen, MD, FRCPC, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291600
- Sponsor's protocol ID
- 20170061B
- Acronym
- Virtual-PND
- Status last verified
- Feb 2019
- First submitted
- 19 Sep 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03291600
- Acronym / sponsor ID
- Virtual-PND / 20170061B
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Sinai Health System
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral: Virtual Psychiatric Care for Perinatal Depression
| Arm | Type | Receives |
|---|---|---|
| Virtual Psychiatric Care Group | Experimental | Behavioral: Virtual Psychiatric CareParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Psychiatric CareVirtual 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. | Behavioural | Virtual Psychiatric Care Group |
Primary outcome
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
10 secondary outcomes
Edinburgh Postnatal Depressive Scale (EPDS)
Time frame: At 12 weeks post-randomization
State-Trait Anxiety Inventory (STAI)
Time frame: At 12 weeks post-randomization
Parenting Stress Index, Short Form (PSI)
Time frame: At 12 weeks post-randomization
Recruitment Feasibility (Recruitment Eligibility)
Time frame: One year from when the study starts enrolling participants
Recruitment Feasibility (Enrollment)
Time frame: From enrollment to first treatment visit
Intervention Acceptability (Qualitative - participants)
Time frame: At 12 weeks post-randomization
Intervention Acceptability (Qualitative - physicians)
Time frame: At 12 weeks post-randomization
Intervention Acceptability (Patient-Reported Costs)
Time frame: At 12 weeks post-randomization
Intervention Acceptability (Clinical visits)
Time frame: Between randomization and 12 weeks post-randomization
Trial Protocol Adherence (Study Measure Completion)
Time frame: At 12 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Perinatal Depression
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Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
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Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
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Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
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Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Wasserman, MD, FRCPC principal investigator
Women's College Hospital
Ariel Dalfen, MD, FRCPC principal investigator
Sinai Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Psychiatric Care in people with Perinatal Depression, run by Women's College Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (Recruitment Feasibility) (time frame: One year from when the study starts enrolling participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.