NCT04836585

eMBC for Perinatal Depression and Anxiety

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Depression, Postpartum
• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-04
• Primary completion: 2023-10-27
• Completion: 2024-06-30
• First posted: 2021-04-08
• Last updated: 2024-07-24

Locations

1 site across 1 country: Canada