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eMBC for Perinatal Depression and Anxiety

NCT04836585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-07-24

No results posted yet for this study

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

Interventions

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: 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.

Sponsors & Collaborators

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Renu Gupta, MD · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2023-10-27
Completion
2024-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836585 on ClinicalTrials.gov