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
Gender
Country of Origin
Mexico
Colombia
Guatemala
Male
Female
Honduras
El Salvador
Puerto Rico
Peru
Others
CLTD Demographics:
146 patients evaluated

Average age (years
old):
37.75 ± 9.65 (SD)
 Ages ranged from 1866 y/o
Educational Level


Average number of
years in the USA:
11.22 ± 7.65 (SD)
 Ranged from 1 to 40
years

Did not finish HS
HS graduate
trade school
some college
bachelor's
masters
doctoral
CLTD Demographics:
146 patients evaluated
Marital Status
Number of children
Married
Separated
Single - Living
with partner
Single - Living
Alone
Divorced
Widowed - living
with new partner
Widowed
No children
1 Child
2 Children
3 Children
4 Children
≥ 5 Children
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
Withdrew consent
Number (%) at main clinic
Total randomized: 163
19 (11.7%)
Lost to follow up
6 (14.3%)
Scheduling Conflict
3 (7.1%)
9 (5.5%)
MD Decision
2 (1.2%)
Disinterest
2 (1.2%)
Adverse Event
2 (4.7%)
Noncompliance
1 (0.6%)
Medical reasons
1 (0.6%)
Intolerance to medication
1 (2.3%)
1 (0.6%)
Relocation
1 (2.3%)
1 (0.6%)
Suicide attempt
1 (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
