WORKING TOWARDS TRUE REPRESENTATION: INCREASING HISPANIC PARTICIPATION IN A CLINICAL RESEARCH TRIAL FOR DEPRESSION Vivianne R. Aponte Rivera, MD Emory University Department of Psychiatry and Behavioral Sciences

Objectives Understand the demographic characteristics of patients attending an exclusively Hispanic psychiatric (depression) research clinic Understand how clinical research studies can help decrease health disparities

The Emory PReDICT study 600 patient, NIH-funded study of Major Depressive Disorder Aim: identify predictors of response to treatment in treatment naïve patients 12 week study Random assignment Medication (Escitalopram or Duloxetine) Cognitive Behavioral Therapy (CBT) Extension study Treatment up to 2 years from date of randomization Evaluate factors leading to relapse or sustained remission/response

The Emory PReDICT Study Predictive factors assessed Demographic and clinical factors Functional Magnetic resonance imaging (fMRI) Genetics Hypothalamus-Pituitary-Adrenal Axis (HPA axis) activity Immune and inflammatory markers Personality Early life trauma Primary site is located in a specialized clinical research unit at Emory University in the suburbs of Atlanta, and is solely for English speaking patients

Clínica Latina para el Tratamiento de la Depresión (CLTD) Satellite research clinic for the Emory PReDICT study Located within the International Medical Center (IMC) at Grady Memorial Hospital in Atlanta, GA One of the largest public health hospitals in the US IMC: health clinic for limited English proficient patients Most patients are Spanish speaking Bilingual and bicultural staff

Clínica Latina para el Tratamiento de la Depresión Fully established 18 months ago Part-time clinic 1,291 Hispanics have called expressing interest in the study Psychoeducation and referrals provided for those who do not qualify 146 screening evaluations performed 42 patients randomized

Clínica Latina para el Tratamiento de la Depresión Research staff works at primary research site when CLTD is closed Greater staff to patient ratio Patient navigators Offices in IMC exclusively reserved for the research team when CLTD is open Patients first sign a consent to undergo a clinical interview/evaluation If eligible, they are then offered the PReDICT study specific consent

Informed consent process questions Concerns about documentation/legal aspects Concerns about confidentiality Requests for further clarification of protocol and study related procedures Concerns about medications and study procedures Guinea pig, medication side effects

CLTD Demographics: 146 patients evaluated

Average age (years old): ± 9.65 (SD) Ages ranged from y/o Average number of years in the USA: ± 7.65 (SD) Ranged from 1 to 40 years

CLTD Demographics: 146 patients evaluated

Show and Retention Rates No show rates for screening visit CLTD: 50/239 (20.9%) Main clinic: 420/1475 (28.5%) Retention Rates CLTD: 29/42 (69%) Main clinic: 122/163 (74.8%)

Reasons for early termination Reason for early termination Number (%) at CLTD Total randomized: 42 Number (%) at main clinic Total randomized: 163 Withdrew consent19 (11.7%) Lost to follow up6 (14.3%)9 (5.5%) Scheduling Conflict3 (7.1%) MD Decision2 (1.2%) Disinterest2 (1.2%) Adverse Event2 (4.7%) Noncompliance1 (0.6%) Medical reasons1 (0.6%) Intolerance to medication1 (2.3%)1 (0.6%) Relocation1 (2.3%)1 (0.6%) Suicide attempt1 (2.3%)

Final remarks Adding bilingual and bicultural research clinics to ongoing or new depression research studies Increases diversity in the study population Leads to treatment recommendations that take ethnicity into account Biologically Socioculturally Leads to more specific and effective interventions Provides treatment to an underserved population Increases awareness about mental health and depression within the Hispanic community and helps decrease stigma