eMBC for Perinatal Depression and Anxiety

NCT ID: NCT04836585

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2024-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Care As Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

eMBC Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Simone Vigod

Chief, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renu Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40301831 (View on PubMed)

Other Identifiers

2020-0090-B

Identifier Type: -

Identifier Source: org_study_id