eMBC for Perinatal Depression and Anxiety

NCT04836585 | Completed

• 1 other identifier: 2020-0090-B
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression, Postpartum; Anxiety

Keywords

Measurement based care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Clinical outcomes - clinician-assessed depression symptoms

  4, 8, and 12 weeks post randomization

• Clinical outcomes - self-report depression symptoms

  each clinical appointment up to 12 weeks post randomization

• Clinical outcomes - anxiety symptoms

  4, 8, and 12 weeks post randomization

• Clinical outcomes - functional capacity

  each clinical appointment up to 12 weeks post randomization

• Clinical outcomes - social functioning

  each clinical appointment up to 12 weeks post randomization

Other Outcomes (2)

• Co-variates: Participants

  Baseline

• Co-variates: Providers

  Baseline

Study Arms (2)

Care As Usual

NO INTERVENTION

Participants in the control condition are followed by their RLS psychiatrists during the study as per usual care.

eMBC Intervention

EXPERIMENTAL

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

Interventions

eMBC Intervention OTHER

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.

eMBC Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (1)

• 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.

  PMID: 40301831 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Renu Gupta, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The RA randomizing the participant will be not be blinded to the treatment allocation because they have to inform the provider of the treatment allocation. This RA will not be collecting outcome measures. The RA collecting outcome measures will be blinded to the treatment allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Psychiatry

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: January 4, 2022
• Primary Completion: October 27, 2023
• Study Completion: June 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CA (1)