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Depression - Major Depressive DisorderRITA-PCNCT06799078

Racial Disparities in Antidepressant Treatment After a Psychiatric Consultation

An observational study of Depression - Major Depressive Disorder and Depression Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observation while participants receive treatment by their primary care provider
How many people
60 participants
Where
1 siteCanada
Study dates
4 Mar 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who received an outpatient psychiatric consultation at CAMH within the past 3 months and received a diagnosis of depression, after which they were discharged to the care of their primary care provider

Who may be able to join

  • Able and willing to sign and date the informed consent form
  • Stated willingness to comply with all study procedures
  • Age 18 years and older
  • Diagnosis of depression in a psychiatric consultation at CAMH in the last 3 months
  • Not currently followed by a psychiatrist
  • Able to complete the REDCap questionnaire in English using the internet

Who cannot join

  • Presence of a life-time diagnosis of bipolar disorder or schizophrenia
  • 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)
  • Acute psychosis (e.g., MDD with psychotic features)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: Racial Disparities in Antidepressant Initiation, Titration, and Adherence After Receiving a Psychiatric Consultation

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.

Read the 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.

Being tested
Observation while participants receive treatment by their primary care provider
Keywords
antidepressant, consultation, depression, major depressive disorder, Race
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observation while participants receive treatment by their primary care providerOther

    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.

Study groups in NCT06799078
Study groupRoleWhat they receive
Participants that self-identify as being BIPOCNot described
Participants that self-identify as being WhiteNot described
Receives: Other: Observation while participants receive treatment by their primary care provider

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychotropic medication initiation or change after psychiatric consultation

    This information will be obtained during the first and second online surveys

    Measured: From the psychiatric consultation to three months after the consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start4 Mar 2024
  3. Primary completion31 Aug 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799078
Sponsor's protocol ID
2023-174
Acronym
RITA-PC
Status last verified
Apr 2026
First submitted
23 Jan 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This will require additional consent from the study participants as well as REB approval.

Publications

  • Svarstad BL, Chewning BA, Sleath BL, Claesson C. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999 Jun;37(2):113-24. doi: 10.1016/s0738-3991(98)00107-4.

    PubMed 14528539
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171
  • Snowden LR, Thomas K. Medicaid and African American outpatient mental health treatment. Ment Health Serv Res. 2000 Jun;2(2):115-20. doi: 10.1023/a:1010161222515.

    PubMed 11256718
  • Simon GE, Coleman KJ, Waitzfelder BE, Beck A, Rossom RC, Stewart C, Penfold RB. Adjusting Antidepressant Quality Measures for Race and Ethnicity. JAMA Psychiatry. 2015 Oct;72(10):1055-6. doi: 10.1001/jamapsychiatry.2015.1437. No abstract available.

    PubMed 26352783
  • Rossom RC, Shortreed S, Coleman KJ, Beck A, Waitzfelder BE, Stewart C, Ahmedani BK, Zeber JE, Simon GE. ANTIDEPRESSANT ADHERENCE ACROSS DIVERSE POPULATIONS AND HEALTHCARE SETTINGS. Depress Anxiety. 2016 Aug;33(8):765-74. doi: 10.1002/da.22532. Epub 2016 Jun 20.

    PubMed 27320786
  • Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.

    PubMed 22428358
  • Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.

    PubMed 26398658
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941
  • Kales HC, Nease DE Jr, Sirey JA, Zivin K, Kim HM, Kavanagh J, Lynn S, Chiang C, Neighbors HW, Valenstein M, Blow FC. Racial differences in adherence to antidepressant treatment in later life. Am J Geriatr Psychiatry. 2013 Oct;21(10):999-1009. doi: 10.1016/j.jagp.2013.01.046. Epub 2013 Feb 6.

    PubMed 23602306
  • Ishrat Husain M, Rodie DJ, Perivolaris A, Sanches M, Crawford A, Fitzgibbon KP, Levinson A, Geist R, Kurdyak P, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. A Collaborative-Care Telephone-Based Intervention for Depression, Anxiety, and at-Risk Drinking in Primary Care: The PARTNERs Randomized Clinical Trial. Can J Psychiatry. 2023 Oct;68(10):732-744. doi: 10.1177/07067437231156243. Epub 2023 Feb 28.

    PubMed 36855791
  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

    PubMed 34785096
  • Fortuna LR, Alegria M, Gao S. Retention in depression treatment among ethnic and racial minority groups in the United States. Depress Anxiety. 2010 May;27(5):485-94. doi: 10.1002/da.20685.

    PubMed 20336808
  • Donneyong M, Reynolds C, Mischoulon D, Chang G, Luttmann-Gibson H, Bubes V, Guilds M, Manson J, Okereke O. Protocol for studying racial/ethnic disparities in depression care using joint information from participant surveys and administrative claims databases: an observational cohort study. BMJ Open. 2020 Jan 7;10(1):e033173. doi: 10.1136/bmjopen-2019-033173.

    PubMed 31915172
  • Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

    PubMed 16731240
  • Breslau J, Cefalu M, Wong EC, Burnam MA, Hunter GP, Florez KR, Collins RL. Racial/ethnic differences in perception of need for mental health treatment in a US national sample. Soc Psychiatry Psychiatr Epidemiol. 2017 Aug;52(8):929-937. doi: 10.1007/s00127-017-1400-2. Epub 2017 May 26.

    PubMed 28550518

Questions about this trial

What is this clinical trial studying?

An observational study of Depression - Major Depressive Disorder and Depression Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychotropic medication initiation or change after psychiatric consultation (time frame: From the psychiatric consultation to three months after the consultation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06799078, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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