eMBC for Perinatal Depression and Anxiety

Women's College Hospital

Status: Completed

Conditions: Depression, Postpartum; Anxiety

Treatments: Other: eMBC Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04836585

2020-0090-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

3. Incapable of consenting to participation 5. Unable to read or unable to speak English

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Care As Usual

No Intervention group

Description:

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

eMBC Intervention

Experimental group

Description:

Participants in the intervention arm are followed by their RLS psychiatrists during the study at clinically appropriate intervals with the addition of eMBC.

Treatment:

Other: eMBC Intervention