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Depression, PostpartumeMBCNCT04836585

eMBC for Perinatal Depression and Anxiety

A study testing eMBC Intervention in people with Depression, Postpartum and Anxiety, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Postpartum, Anxiety
What is being tested?
eMBC Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
4 Jan 2022to 30 Jun 2024
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

  • Age ≥18
  • Currently pregnant or mother* of a live infant 0-12 months of age and living at the same residence
  • Through natural birth, adoption, surrogacy, including cis women, non-binary and transgender people in all their diversity
  • EPDS >12 at enrollment

Who cannot join

  • Active suicidal ideation, substance abuse or dependence
  • Current or past mania or psychosis or current major depressive episode with psychosis
  • 4. Incapable of consenting to participation 5. Unable to read or unable to speak English

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: Technology-Enabled (Electronic) Measurement Based Care(MBC) for Perinatal Depression and Anxiety: A Pilot Randomized Controlled Trial

Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated.

Read the detailed description

A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting patients with depression and/or anxiety will be randomized in a 1:1 ratio to either the eMBC condition or a control condition. The study will be stratified by diagnosis (major depressive disorder vs generalized anxiety disorder).

80 patient participants will be recruited from the Reproductive Life Stages (RLS) Program at Women's College Hospital. The active treatment phase of the study is 12 weeks.

Outcomes will be measured online and by phone at 4-, 8-, and 12- weeks post-randomization. Following the completion of the study, some participants will be asked to participate in follow-up interviews. RLS psychiatrists whose patients participated in the study will participate in a focus group.

Being tested
eMBC Intervention
Keywords
Measurement based care
Medical subject headings
Depression, Postpartum, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eMBC InterventionOther

    The treating psychiatrist sets a flag in the patient's electronic chart that prompts them to complete self-report scales prior to each appointment:

    1. Edinburgh Postnatal Depression Scale (EPDS) for symptoms of depression and anxiety
    2. PROMIS Neuro-QOL and PROMIS ASCQ-Me Social Functioning Short form for measures of functional capacity
    3. Adapted Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale for participants taking antidepressant medication to measure side effects

    Patient participants and providers can view the questionnaire results over time in the electronic chart item by item, and/or see them in graphical format. During the clinical encounter, the provider and patient participant review the results of the scales, as part of a collaborative re-evaluation of the treatment plan.

Study groups in NCT04836585
Study groupRoleWhat they receive
Care As UsualNo interventionParticipants in the control condition are followed by their RLS psychiatrists during the study as per usual care.
eMBC InterventionExperimentalParticipants in the intervention arm are followed by their RLS psychiatrists during the study at clinically appropriate intervals with the addition of eMBC.
Receives: Other: eMBC Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the trial protocol: Recruitment

    Measures of recruitment include rate of recruitment and reason for non-participation.

    Measured: 12 weeks post randomization

  2. Feasibility of the trial protocol: Participant Acceptability

    Surveys and interviews will be used to capture data relating to perceived usefulness and acceptability of technology and its perceived benefit. These will be combined to capture an overall acceptability measure.

    Measured: 12 weeks post randomization

  3. Feasibility of the trial protocol: Provider Acceptability

    Surveys and focus groups will be used to capture data relating to usability and tolerability of eMBC in clinical practice.

    Measured: 12 weeks post randomization

  4. Feasibility of the trial protocol: Adherence

    Chart review will be used to measure the number of visits, the proportion of visits with completed scales and which scales were completed, proportion of visits where review of symptom scales was documented in the patient record, the proportion of visits where providers recorded that they used the data from symptom scales to inform the treatment, and proportion of visits where medication was started, changed, dose adjusted or stopped. These will be combined to provide an overall measure of how closely the intervention protocol was followed.

    Measured: 12 weeks post randomization

Secondary outcomes (6)

  1. Clinical outcomes - clinician-assessed depression symptoms

    The Montgomery-Asberg Depressive Rating Scale (MADRS) is a standard clinician-administered measure of depressive symptoms with good reliability and validity in clinical populations. The MADRS has good responsiveness to the effect of anti-depressant treatments. The 17-items are rated on a 7-point (0-6) (score range 0-60), with lower scores indicating fewer symptoms of depression and higher scores indicating a higher degree of symptoms.

    Measured: 4, 8, and 12 weeks post randomization

  2. Clinical outcomes - self-report depression symptoms

    Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30. EPDS scores >12 are predictive of a diagnosis of depression, with higher scores indicating more severe symptoms.

    Measured: each clinical appointment up to 12 weeks post randomization

  3. Clinical outcomes - anxiety symptoms

    The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated measure that assesses the severity of symptoms of anxiety. The HAM-A has good reliability and validity in populations with depression and anxiety. The 14-items are rated on a 5-point scale (0-4) with scores ranging from 0-56. Scores <17 indicate mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe symptoms.

    Measured: 4, 8, and 12 weeks post randomization

  4. Clinical outcomes - functional capacity

    The PROMIS Neuro-QOL - Ability to Participate in Social Roles and Activities - Short Form is a brief self-report tool used to measure functional capacity.

    Measured: each clinical appointment up to 12 weeks post randomization

  5. Clinical outcomes - social functioning

    PROMIS ASCQ-Me Social Functioning - Short Form is a brief self-report tool used to measure functional capacity.

    Measured: each clinical appointment up to 12 weeks post randomization

  6. Clinical outcomes - antidepressant side effects

    The Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale is a brief 3-item scale used to measure three domains of anti-depressant side effects including frequency, intensity, and burden of antidepressant medication. The last question relating to burden is scored 0-6 with low scores indicating no medication adjustment is needed, and high scores indicating that the dose needs to be decreased or the medication changed.

    Measured: each clinical appointment up to 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.

  1. First posted8 Apr 2021
  2. Study start4 Jan 2022
  3. Primary completion27 Oct 2023
  4. Study completion30 Jun 2024

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04836585
Sponsor's protocol ID
2020-0090-B
Acronym
eMBC
Status last verified
Jul 2024
First submitted
31 Mar 2021
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Askari N, Gupta R, Hussain-Shamsy N, Barker LC, Champagne T, Lam RW, Bishop K, Pirmohamed J, Michalowska M, Shah V, Katzman H, Jalan A, Shanmuganathan A, Wang V, Vigod SN. Electronic Measurement-based care (eMBC) for perinatal depression and anxiety: a pilot randomized controlled trial. BMC Psychiatry. 2025 Apr 29;25(1):437. doi: 10.1186/s12888-025-06876-3.

    PubMed 40301831

Questions about this trial

What is this clinical trial studying?

A study testing eMBC Intervention in people with Depression, Postpartum and Anxiety, run by Women's College Hospital at 1 site 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 4 inclusion and 3 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Feasibility of the trial protocol: Recruitment (time frame: 12 weeks post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04836585, which also lists 1 linked publication.

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 24 Jul 2024.

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