eMBC for Perinatal Depression and Anxiety (eMBC)

• ClinicalTrials.gov Identifier: NCT04836585
• Recruitment Status: Recruiting
• First Posted: April 8, 2021
• Last Update Posted: February 4, 2022
• Sponsor: Women's College Hospital
• Information provided by (Responsible Party): Simone Vigod, Women's College Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression, Postpartum; Anxiety	Other: eMBC Intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The RA randomizing the participant will be not be blinded to the treatment allocation because they have to inform the provider of the treatment allocation. This RA will not be collecting outcome measures. The RA collecting outcome measures will be blinded to the treatment allocation.
• Primary Purpose: Health Services Research
• Official Title: Technology-Enabled (Electronic) Measurement Based Care(MBC) for Perinatal Depression and Anxiety: A Pilot Randomized Controlled Trial
• Actual Study Start Date: January 4, 2022
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Care As Usual; Participants in the control condition are followed by their RLS psychiatrists during the study as per usual care.
Experimental: 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.	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: Edinburgh Postnatal Depression Scale (EPDS) for symptoms of depression and anxiety; PROMIS Neuro-QOL and PROMIS ASCQ-Me Social Functioning Short form for measures of functional capacity; 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the trial protocol: Recruitment [ Time Frame: 12 weeks post randomization ]
   Measures of recruitment include rate of recruitment and reason for non-participation.
2. Feasibility of the trial protocol: Participant Acceptability [ Time Frame: 12 weeks post randomization ]
   Surveys and interviews will be used to capture data relating to perceived usefulness and acceptability of technology and its perceived benefit. These will be combined to capture an overall acceptability measure.
3. Feasibility of the trial protocol: Provider Acceptability [ Time Frame: 12 weeks post randomization ]
   Surveys and focus groups will be used to capture data relating to usability and tolerability of eMBC in clinical practice.
4. Feasibility of the trial protocol: Adherence [ Time Frame: 12 weeks post randomization ]
   Chart review will be used to measure the number of visits, the proportion of visits with completed scales and which scales were completed, proportion of visits where review of symptom scales was documented in the patient record, the proportion of visits where providers recorded that they used the data from symptom scales to inform the treatment, and proportion of visits where medication was started, changed, dose adjusted or stopped. These will be combined to provide an overall measure of how closely the intervention protocol was followed.

Secondary Outcome Measures :

1. Clinical outcomes - clinician-assessed depression symptoms [ Time Frame: 4, 8, and 12 weeks post randomization ]
   The Montgomery-Asberg Depressive Rating Scale (MADRS) is a standard clinician-administered measure of depressive symptoms with good reliability and validity in clinical populations. The MADRS has good responsiveness to the effect of anti-depressant treatments. The 17-items are rated on a 7-point (0-6) (score range 0-60), with lower scores indicating fewer symptoms of depression and higher scores indicating a higher degree of symptoms.
2. Clinical outcomes - self-report depression symptoms [ Time Frame: each clinical appointment up to 12 weeks post randomization ]
   Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30. EPDS scores >12 are predictive of a diagnosis of depression, with higher scores indicating more severe symptoms.
3. Clinical outcomes - anxiety symptoms [ Time Frame: 4, 8, and 12 weeks post randomization ]
   The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated measure that assesses the severity of symptoms of anxiety. The HAM-A has good reliability and validity in populations with depression and anxiety. The 14-items are rated on a 5-point scale (0-4) with scores ranging from 0-56. Scores <17 indicate mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe symptoms.
4. Clinical outcomes - functional capacity [ Time Frame: each clinical appointment up to 12 weeks post randomization ]
   The PROMIS Neuro-QOL - Ability to Participate in Social Roles and Activities - Short Form is a brief self-report tool used to measure functional capacity.
5. Clinical outcomes - social functioning [ Time Frame: each clinical appointment up to 12 weeks post randomization ]
   PROMIS ASCQ-Me Social Functioning - Short Form is a brief self-report tool used to measure functional capacity.
6. Clinical outcomes - antidepressant side effects [ Time Frame: each clinical appointment up to 12 weeks post randomization ]
   The Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale is a brief 3-item scale used to measure three domains of anti-depressant side effects including frequency, intensity, and burden of antidepressant medication. The last question relating to burden is scored 0-6 with low scores indicating no medication adjustment is needed, and high scores indicating that the dose needs to be decreased or the medication changed.

Other Outcome Measures:

1. Co-variates: Participants [ Time Frame: Baseline ]
   Sociodemographic, obstetrical, and psychiatric history data will be collected on the Baseline Questionnaire. A diagnostic phone interview using the Mini International Neuropsychiatric Interview (MINI) will be conducted for major depressive disorder, obsessive-compulsive disorder, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and post-traumatic stress disorder.
2. Co-variates: Providers [ Time Frame: Baseline ]
   Provider co-variates including age, number of years in practice, familiarity with technology, use of technology in their practice, and use of MBC prior to this study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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. Major depressive disorder or generalized anxiety disorder confirmed by RLS psychiatrist
4. EPDS >12 at enrollment
5. Recommended antidepressant medication for major depressive disorder or generalized anxiety disorder by the treating RLS psychiatrist
6. Are expected to be under the care of a RLS psychiatrist and have 3+ RLS psychiatric visits in the upcoming 12 weeks

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

Contacts and Locations

Contacts

Contact: Simone Vigod, MD, MSc; 416-323-6400 ext 4080; simone.vigod@wchospital.ca

Locations

Canada, Ontario

Women's College Hospital; Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contact: Simone Vigod 4163236400 ext 4080 simone.vigod@wchospital.ca

Principal Investigator: Simone Vigod

Sponsors and Collaborators

Women's College Hospital

Investigators

• Principal Investigator: Renu Gupta, MD; Women's College Hospital

More Information

• Responsible Party: Simone Vigod, Chief, Department of Psychiatry, Women's College Hospital
• ClinicalTrials.gov Identifier: NCT04836585
• Other Study ID Numbers: 2020-0090-B
• First Posted: April 8, 2021
• Last Update Posted: February 4, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simone Vigod, Women's College Hospital:

Measurement based care

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications