Racial Disparities in Antidepressant Treatment After a Psychiatric Consultation

NCT ID: NCT06799078

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-12-31

Brief Summary

Patients from black, indigenous, and people of color (BIPOC) communities are reported to have lower rates of antidepressant adherence and response. The investigators have a limited understanding of why this disparity exists. The majority of outpatient psychiatric consultations are one-time assessments that provide treatment recommendations to the primary care provider. It is important to identify whether there are racial differences in accessing and adhering to recommended treatment plans to provide more equitable care. To the investigators' knowledge, there are no studies that examined racial differences in access and barriers to receiving antidepressant treatment after a one-time psychiatric assessment. This study focuses on patients who were diagnosed with major depressive disorder during a psychiatric consultation 3 months prior. We are examining whether there are racial differences in being a) recommended an antidepressant, b) started/switched to a recommended antidepressant, c) treated at a therapeutic dosage, d) adherence to treatment, and e) whether sociodemographic factors, discrimination in medical settings, and patient perception of depression and antidepressant treatment moderate these differences. This study will inform the development of treatment strategies that minimize racial disparities in the treatment of depression.

Detailed Description

Overall Design:

The research design of this study combines two online questionnaires, a semi-structured qualitative interview (for a subset of participants), and a structured chart review. All participants who provide consent to participate in the study will be emailed the first online questionnaire a few days later and then the second online questionnaire three months after they have completed their consult. Twenty-four of these participants will also be invited to participate in the semi-structured qualitative interview in addition to the online questionnaires. The participants will have to complete the second online questionnaire prior to the qualitative interview. Chart review will be performed in all participants. Chart review will occur in parallel with the online questionnaires and the interview.

Participants will be recruited from the Centre for Addiction and Mental Health (CAMH) among patients: (1) diagnosed with depression during a one-time psychiatric consultation; (2) who either assent to be contacted regarding potential participation in research during their CAMH consultation, or who have indicated their agreement to be contacted regarding potential participation in research during the CAMH registration process. Potential participants will also be referred to the study by psychiatrists at CAMH after the patient completes a one-time outpatient psychiatric consultation if they assent to be contacted by the research team. Psychiatrists at CAMH will also be provided with REB-approved recruitment pamphlets to give to patients who express an interest in participating in the study, after which the patients can contact the research team directly if they are interested using the contact information provided in the pamphlet.

Shortly after the consultation is completed, potential participants will be contacted to confirm their interest in participation and to obtain informed consent. Shortly after, the participants will be emailed a link to complete a baseline 20-40 minute REDCap online questionnaire. The first online questionnaire will have two parts, the first part including questions about demographic information and the second part including clinical status and previously validated scales. Also, using a structured form adapted from another study conducted at CAMH, the participants' electronic health records will be reviewed to determine the content, structure, and length of the consultation note, the diagnoses given during the consultation, and treatment recommendations, including pharmacological (i.e., names and dosages of psychotropic medications) and non-pharmacological recommendations. Three months after they complete the psychiatric consultation, the participants will be emailed a link to complete the second 10- 20 minute REDCap online questionnaire, assessing treatment processes and outcomes.

In addition, a subgroup of 24 participants will be invited complete a semi-structured qualitative interview after they complete the second survey (using Webex). The participants will have to complete the second online questionnaire prior to the interview. All participants will be invited to take part in both the online questionnaires and the interview at the beginning of the study. This will continue until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed the interview.

Participant Recruitment and Screening:

The target is to have 50 - 100 participants completing the questionnaires, of which half will be participants who self-report as being from BIPOC communities. Invitation to participate in the interview will be offered to all participants from the beginning until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed it.

All potential participants will be contacted by phone by an investigator or a Research Analyst (RA) to screen for eligibility criteria and engage them in a consent discussion.

Sample Size Determination:

Assuming that there will be a 20 - 40% difference between participants who are from BIPOC communities and participants who are White in treatment outcomes (Kales et al., 2013; Simon et al., 2015), α = 0.05, power = 80%, sample size between 46 - 186 participants is sufficient to detect a between-group difference.

A systematic review of qualitative studies reported that the average sample size to reach saturation is 12-13 for homogeneous populations (Hennink & Kaiser, 2022). As the study will consist of at least 2 distinct populations (participants who are White vs. from BIPOC communities), 12 participants from each group is sufficient.

Statistical Methods:

Between-group analyses will be performed by comparing White participants vs. participants from BIPOC communities. If there is a sufficient number of participants from a specific race/ethnicity to perform between-group analyses, secondary analyses will be performed by treating them as a separate group (e.g., White vs. Asian-South vs. Others).

Logistic regression analyses will be used to examine if there is an interaction effect between race/ ethnicity and potential moderators on observed racial disparities in treatment processes. Self-reported gender, annual income, any experience of discrimination in medical settings (DMS scale answer rarely or higher in any of the items), and having a negative perception of antidepressant treatment (Brief IPQ item 4 score < 5) will be explored as potential moderators.

Control of Bias:

Interviewer bias may occur during the semi-structured qualitative interview if the interviewer becomes aware of the participant's race/ ethnicity. To minimize this, interviewers will be unaware of the results of the REDCap questionnaires containing the race/ ethnicity information. Furthermore, interviewers will have a script they have to adhere to.

Conditions

Depression - Major Depressive Disorder; Depression Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants that self-identify as being BIPOC

No interventions assigned to this group

Participants that self-identify as being White

Observation while participants receive treatment by their primary care provider

Intervention Type: OTHER

Participants complete a consultation with a psychiatrist who makes some recommendations for the treatment of their depression. The participant's primary care provider decides whether to implement some of these recommendations.

Interventions

Observation while participants receive treatment by their primary care provider

Participants complete a consultation with a psychiatrist who makes some recommendations for the treatment of their depression. The participant's primary care provider decides whether to implement some of these recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Able and willing to sign and date the informed consent form

2. Stated willingness to comply with all study procedures

3. Age 18 years and older

4. Diagnosis of depression in a psychiatric consultation at CAMH in the last 3 months

5. Not currently followed by a psychiatrist

6. Able to complete the REDCap questionnaire in English using the internet

Exclusion Criteria

1. Presence of a life-time diagnosis of bipolar disorder or schizophrenia

2. Potential participants with a suicidal plan or intent whose consulting psychiatrist determined are in need of immediate clinical attention (e.g., referral to CAMH ED, voluntary or involuntary hospitalization)

3. Acute psychosis (e.g., MDD with psychotic features)

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

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Benoit Mulsant

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benoit H Mulsant, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

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Related Links

https://www.guilford.com/books/Introduction-to-Mediation-Moderation-and-Conditional-Process-Analysis/Andrew-Hayes/9781462549030?srsltid=AfmBOoqbNFXLu4YnMqUraR7XMp56CkmEDXiotVfdSXEXZmoJUGxOx1M8

Hayes, A. F. (2022). Introduction to Mediation, Moderation, and Conditional Process Analysis. A Regression-Based Approach (Tgurd ed.). New York: Guilford Press

https://www.unilus.ac.zm/lms/e-books/books/Basic_Sciences/Behavioural%20sciences%20and%20public%20health/Fundamentals%20of%20Biostatistics%20%287th%20Edition%29.pdf

Rosner, B. (2011). Fundamentals of Biostatistics (7th Ed. ed.): Brooks/Cole.

Other Identifiers

2023-174

Identifier Type: -

Identifier Source: org_study_id