Clinical trial NCT04836585: eMBC for Perinatal Depression and Anxiety
Official title: Technology-Enabled (Electronic) Measurement Based Care(MBC) for Perinatal Depression and Anxiety: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Anxiety
Keywords: Measurement based care
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility of the trial protocol: Recruitment
timeFrame: 12 weeks post randomization
measure: Feasibility of the trial protocol: Participant Acceptability
timeFrame: 12 weeks post randomization
measure: Feasibility of the trial protocol: Provider Acceptability
timeFrame: 12 weeks post randomization
measure: Feasibility of the trial protocol: Adherence
timeFrame: 12 weeks post randomization
Secondary outcomes:
measure: Clinical outcomes - clinician-assessed depression symptoms
timeFrame: 4, 8, and 12 weeks post randomization
measure: Clinical outcomes - self-report depression symptoms
timeFrame: each clinical appointment up to 12 weeks post randomization
measure: Clinical outcomes - anxiety symptoms
timeFrame: 4, 8, and 12 weeks post randomization
measure: Clinical outcomes - functional capacity
timeFrame: each clinical appointment up to 12 weeks post randomization
measure: Clinical outcomes - social functioning
timeFrame: each clinical appointment up to 12 weeks post randomization
measure: Clinical outcomes - antidepressant side effects
timeFrame: each clinical appointment up to 12 weeks post randomization
Other outcomes:
measure: Co-variates: Participants
timeFrame: Baseline
measure: Co-variates: Providers
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Renu Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: