eMBC for Perinatal Depression and Anxiety (eMBC)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression, Postpartum; Anxiety
• Intervention / Treatment: Other: eMBC Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone Vigod, MD, MSc; Phone Number: 4080 416-323-6400; Email: simone.vigod@wchospital.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18

2. 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

3. EPDS >12 at enrollment

Exclusion Criteria:

1. Active suicidal ideation, substance abuse or dependence
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care As Usual; Participants in the control condition are followed by their RLS psychiatrists during the study as per usual care.
Experimental: eMBC Intervention; Participants in the intervention arm are followed by their RLS psychiatrists during the study at clinically appropriate intervals with the addition of eMBC.	Other: eMBC Intervention; The treating psychiatrist sets a flag in the patient's electronic chart that prompts them to complete self-report scales prior to each appointment: Edinburgh Postnatal Depression Scale (EPDS) for symptoms of depression and anxiety; PROMIS Neuro-QOL and PROMIS ASCQ-Me Social Functioning Short form for measures of functional capacity; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the trial protocol: Recruitment	Measures of recruitment include rate of recruitment and reason for non-participation.	12 weeks post randomization
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.	12 weeks post randomization
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.	12 weeks post randomization
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.	12 weeks post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4, 8, and 12 weeks post randomization
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.	each clinical appointment up to 12 weeks post randomization
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.	4, 8, and 12 weeks post randomization
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.	each clinical appointment up to 12 weeks post randomization
Clinical outcomes - social functioning	PROMIS ASCQ-Me Social Functioning - Short Form is a brief self-report tool used to measure functional capacity.	each clinical appointment up to 12 weeks post randomization
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.	each clinical appointment up to 12 weeks post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-variates: Participants	Sociodemographic, obstetrical, and psychiatric history data will be collected on the Baseline Questionnaire. A diagnostic phone interview using the Mini International Neuropsychiatric Interview (MINI) will be conducted for major depressive disorder, obsessive-compulsive disorder, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and post-traumatic stress disorder.	Baseline
Co-variates: Providers	Provider co-variates including age, number of years in practice, familiarity with technology, use of technology in their practice, and use of MBC prior to this study.	Baseline

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Investigators: Principal Investigator: Renu Gupta, MD, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): October 27, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Measurement based care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Anxiety Disorders; Depression, Postpartum
• Other Study ID Numbers: 2020-0090-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No