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Miranda J, Chung JY, Green BL, et al. Treating Depression in Predominantly Low-Income Young Minority WomenA Randomized Controlled Trial. JAMA. 2003;290(1):57–65. doi:10.1001/jama.290.1.57
Context Impoverished minority women experience a higher burden from depression
than do white women because they are less likely to receive appropriate care.
Little is known about the effectiveness of guideline-based care for depression
with impoverished minority women, most of whom do not seek care.
Objective To determine the impact of an intervention to deliver guideline-based
care for depression compared with referral to community care with low-income
and minority women.
Design, Setting, and Participants A randomized controlled trial conducted in the Washington, DC, suburban
area from March 1997 through May 2002 of 267 women with current major depression,
who attended county-run Women, Infants, and Children food subsidy programs
and Title X family planning clinics.
Outcomes Hamilton Depression Rating Scale measured monthly from baseline through
6 months; instrumental role functioning (Social Adjustment Scale) and social
functioning (Short Form 36-Item Health Survey) measured at baseline and 3
and 6 months.
Interventions Participants were randomly assigned to an antidepressant medication
intervention (trial of paroxetine switched to bupropion, if lack of response)
(n = 88), a psychotherapy intervention (8 weeks of manual-guided cognitive
behavior therapy) (n = 90), or referral to community mental health services
(n = 89).
Results Both the medication intervention (P<.001)
and the psychotherapy intervention (P = .006) reduced
depressive symptoms more than the community referral did. The medication intervention
also resulted in improved instrumental role (P =
.006) and social (P = .001) functioning. The psychotherapy
intervention resulted in improved social functioning (P = .02). Women randomly assigned to receive medications were twice
as likely (odds ratio, 2.04; 95% confidence interval, 0.98-4.27; P = .057) to achieve a Hamilton Depression Rating Scale score of 7
or less by month 6 as were those referred to community care.
Conclusions Guideline-concordant care for major depression is effective for these
ethnically diverse and impoverished patients. More women engaged in a sufficient
duration of treatment with medications compared with psychotherapy, and outcome
gains were more extensive and robust for medications.
Major depression, a disorder with early onset and often chronic course,
imposes a high individual burden of pain, suffering, and disability.1 Ethnic minority patients are less likely to obtain
care for depression than white patients2 and
are less likely to receive appropriate treatment when they do seek care.3,4 These disparities are partially due
to minorities being less likely to be insured,2 which
results in poor access to care. In this study, we evaluated whether interventions
that promote guideline-concordant treatments for depression among young, predominantly
minority women would improve rates of appropriate care and clinical and functional
Effective treatments for major depression include antidepressant medications
and psychotherapies.5,6 Most US
psychiatrists favor the selective serotonin reuptake inhibitors for first-line
treatment.7 Two brief, structured psychotherapies,
cognitive behavioral therapy (CBT)8 and interpersonal
psychotherapy,9 have demonstrated effectiveness
in treating psychiatric patients.10-14 However,
efficacy trials have been conducted on predominantly white patients in academic
psychiatric settings. According to a review conducted as part of a surgeon
general's report,2 the studies forming the
evidence base for the American Psychiatric Association5 guidelines
for depression care included 3860 participants; only 27 were identified as
African American and none were of any Latino descent. These trials also included
primarily upper socioeconomic status populations. For example, the National
Institute of Mental Health Treatment of Depression Collaborative Research
Program11 sample included 40% college graduates.
These science implementation studies have yielded a large gap in the knowledge
base underlying treatment of low-income and minority women with depression,
which could contribute to clinician uncertainty about the value of treating
this group. This study addresses this gap in the literature by examining outcomes
of care for low socioeconomic status and minority women.
Recent studies have examined care delivery systems for treating depression
among primary care patients. Although these studies examined a more diverse
population than smaller efficacy studies, the participants were predominantly
insured and were current patients of a primary health care organization.15-22 An
early finding in this literature suggests that management interventions in
primary care may be particularly beneficial for minority individuals,23 but this study examined individuals who were already
engaged in care. Young minority women, a group at high risk for depression,2 are often uninsured24 and
many use county family planning and nutritional programs as a primary location
of care. In addition, trauma and posttraumatic stress disorder (PTSD) are
more prevalent in these subgroups of women with the lowest education and income.25 New literature suggests that care management strategies
are needed to engage low-income minority individuals in treatment.26 Our intervention includes these enhancements. This
study broadens the base of our current knowledge by testing whether guideline-based
care for depression improves depressive symptoms and functioning in low-income
minority women compared with women receiving community referrals for care.
Women Entering Care was a randomized controlled trial of treatment for
major depression in low-income women who received county health and welfare
services in the Washington, DC, area suburban counties of Prince Georges and
Montgomery, Md, and Arlington and Alexandria, Va. The study was reviewed and
approved by the institutional review boards of Georgetown University, the
University of California at Los Angeles, and the state of Maryland. All participants
gave written informed consent for screening and separate consents for random
assignment to care and for medical record abstraction.
We screened 16 286 women: 11 151 in Prince Georges County
and 3034 in Montgomery County, Md, and 2101 in Arlington and Alexandria, Va.
Women were screened in Women, Infants, and Children food subsidy programs
that target low-income pregnant and postpartum women and their children (≤5
years of age). Women were also screened in county-run Title X family planning
clinics that are funded by national grants for comprehensive family planning
services for young and low-income women. We screened 10 043 women attending
Women, Infants, and Children program services, 5017 attending family planning
services, 1144 bringing children to pediatric services for low-income families,
and 82 living in subsidized housing projects or attending programs for county
Women were screened for major depressive disorder (MDD) while they were
at the service setting. Screenings were conducted from March 1997 through
December 2001, with the treatment ending in May 2002. Refusal rates for screening
were very low. Figure 1 depicts
the screening and enrollment process for the study. To determine whether there
were cultural differences in response to interventions, we recruited 3 distinct
cultural groups: black women born in the United States, Latinas born in Latin
America, and white women born in the United States. Of the 16 286 women
screened for MDD, 13 975 were eligible based on self-reported ethnicity
and country of origin. Approximately 11% of these women screened positive
for MDD based on the Primary Care Evaluation of Mental Disorders,27 and 36% met exclusion criteria, including bereavement,
positive for current alcohol or drug problems, being pregnant or planning
to become pregnant within the next 6 months, current breastfeeding, or current
mental health care. Of those screened, 532 black, 71 white, and 408 Latina
women met eligibility requirements for the study, representing 5.6%, 8.0%,
and 7.6%, respectively, of the total screened within each ethnic group.
Following the initial clinic screenings, we attempted to contact women
who agreed to participate in the telephone diagnostic portion of the study.
Participants were contacted by telephone a mean (SD) of 4.1 (4.4) times before
completing the diagnostic interview by telephone. Despite repeated attempts,
345 participants (33.9%) were not reachable. Of those participants completing
the screening, 427 (42%) completed a structured psychiatric diagnostic telephone
interview (Composite International Diagnostic Interview28)
and met criteria for the study. Of those participants not eligible, the majority
did not meet criteria for major depression.
Clinicians contacted the women a mean (SD) of 7.8 (9.8) times to encourage
them to attend an initial clinical interview; consent for random assignment
was obtained at the beginning of the interview. Eleven women refused randomization.
The clinicians were unaware of a participant's random assignment until the
end of the interview, at which time the computer-generated random treatment
assignment was revealed by the interviewer telephoning a newly recorded message.
A total of 267 Composite International Diagnostic Interview–eligible
women (63%) completed the clinical interview, consented to treatment, and
were randomized into the intervention trial. Women were randomized as follows:
antidepressant medications administered by a primary care nurse practitioner
in consultation with a psychiatrist (n = 88), CBT conducted by a psychologist
(n = 90), or referral to community mental health services (n = 89). Of those
randomized, 117 were black women, 134 were Latina women, and 16 were white
women. Among those women randomized, rates of obtaining care varied by randomized
assignment. Response to follow-up interviews was generally high, with 80%
completing 3 or more of 6 follow-up interviews.
Education Meetings. Participants assigned to
receive either CBT or medications were given both time and opportunity for
discussion of depression and treatment during education meetings with the
clinician overseeing their care before beginning treatment. Up to 4 education
meetings could be scheduled to help participants decide about initiating treatment.
Medication. Women assigned to the medication
intervention were treated by primary care nurse practitioners supervised by
a board-certified psychiatrist (J.Y.C.). The duration of the medication intervention
was 6 months, in line with Agency for Healthcare Research and Quality guidelines
for the acute and maintenance phases of depression treatment.29 Women
were initially treated with paroxetine, which was prescribed according to
a written dosing protocol. Adjustments in dosage were based on changes in
Hamilton Depression Rating Scale (HDRS)30 scores
and adequate time for medication effect. The range of paroxetine dose was
10 to 50 mg daily with a mean dose of 30 mg. Clinicians also assessed participants
at face-to-face meetings by using the Clinical Global Impression Scale.31 If a patient did not tolerate paroxetine because
of adverse effects or, if by the ninth week, the patient did not show a significant
clinical response despite dose adjustments, buproprion, an antidepressant
with a different presumed mechanism of action as well as a different adverse
effect profile, was administered. Participants treated with medications were
observed in person every 2 weeks until a stable dose was achieved, and then
every 4 weeks thereafter. The nurses scheduled weekly telephone calls to assess
adverse effects, adherence, and treatment effects.
Cognitive Behavioral Therapy. Women assigned
to the psychotherapy intervention were treated by experienced psychotherapists
supervised by a licensed clinical psychologist with CBT expertise. The psychotherapy
intervention consisted of 8 weekly sessions, either in group or individually,
depending on feasibility of women attending group. Sessions were conducted
at the county clinics, Women Entering Care offices and, if necessary because
of child-care or elder-care constraints, in a participant's home. Participants
were each given a CBT manual that they kept after treatment was concluded.
The manual-guided treatment was adapted from 12-session patient and therapist
manuals developed for low-income English- and Spanish-speaking medical patients.32,33 The manual was also shortened to
8 sessions by including more topics per session and modified to be more sensitive
to the issues of young women and those with histories of interpersonal trauma.
Therapists received training in understanding PTSD and trauma. The therapy
protocol involved homework and daily monitoring, with a focus on cognitive
management of mood, engaging in pleasant activities, and improving relationships
with others. Improvement was assessed by using the HDRS and Beck Depression
Inventory.34 If after 8 weeks of treatment
a participant's scores were still elevated, an additional 8-week treatment
Referral to Community Care. Women assigned
to community referral as usual were educated about depression and mental health
treatments available in the community. The clinician offered to make an appointment
for the woman at the end of the clinical interview to facilitate the referral
and to speak with the mental health care clinician. Approximately one quarter
of the women declined referral. Referred participants were contacted to encourage
them to attend the intake appointment for care.
Cultural Adaptation of Care. Bilingual providers
treated all Spanish-speaking women. All written materials, including psychotherapy
manuals, were available in Spanish. Of the 6 psychotherapists, 1 was black
and 3 were Spanish speaking; none of the 4 nurse practitioners were black,
and 2 were Spanish speaking. All psychotherapists and nurse practitioners
had extensive experience with and commitment to treating low-income and minority
All measures were read to participants based on the high proportion
of women who had not finished high school. Screening interviews assessed age,
marital status, employment status, ethnicity, country of birth, and level
of education. The mood disorders section of the Primary Care Evaluation of
Mental Disorders27 was used to identify women
at high risk for MDD. Alcohol problems were ascertained using the 5-item TWEAK
(Tolerance, Worry about drinking, Eye-opener drinks, Amnesia, Cut down on
drinking) designed for obstetric-gynecology clinic patients.35 Substance
abuse problems were assessed by using items from the Structured
Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition (SCID).36
To determine whether women met criteria for MDD, the Composite International
Diagnostic Interview28 was administered by
telephone, assessing 12-month major depressive episode, alcohol abuse or dependence,
drug abuse or dependence, and lifetime mania and psychosis. To be eligible
for the study, participants needed to have current major depression and a
negative score for mania, psychosis, or past month alcohol or drug abuse or
During the initial in-person interview with clinicians, women completed
a measure of trauma history (Stressful Life Event Screening Questionnaire).37 Up to 3 events were evaluated for current PTSD by
using the PTSD module of the SCID.36 Women
were reimbursed $15 for completing this interview.
During baseline and follow-up telephone interviews, participants completed
a structured version of the HDRS30 each month
for 6 months. Functional outcomes, including instrumental role functioning
(employee or homemaker role assessed by the Social Adjustment Scale38 interview) and social functioning (measured by the
Short Form 36-Item Health Survey)39-41 were
completed at baseline and months 3 and 6. Telephone interviewers were blinded
to random assignment of the participants, and women were reimbursed $10 for
completing each interview.
Clinical outcomes were determined through a mixed-effects repeated-measures
analysis comparing mean depression symptom and functioning scores across assigned
treatment groups over successive time periods. For depressive symptom outcomes
that were measured monthly, we fit models using outcomes from month 1 through
6 while controlling for the baseline values. For instrumental role and social
functioning outcomes, we fit models using the baseline, month 3, and month
6 scores. In every model, we allowed for the within-participant correlations
over time by using a random intercept or random intercept and slope covariance
structure. We examined the effect of treatment over time, as well as the interaction
of treatment and ethnicity.
We also examined the interaction of treatment and PTSD on outcomes.
In this study, the assigned clinician completed the PTSD measure during an
initial clinical interview. All other measures were conducted by telephone
by trained assessors. Despite comprehensive training on the standardized instrument
(SCID), we found that nurse practitioners were significantly more likely to
diagnose PTSD (61% of women interviewed) compared with psychologists (34%, P<.001), suggesting that nurses used less stringent
criteria in judging presence of symptoms. Because of the importance of PTSD
in this population, we performed analyses of medication vs community referral
among participants diagnosed with PTSD by nurses and separate analyses for
psychotherapy participants vs community referral among participants diagnosed
by psychologists. There was no interaction of PTSD and treatment for either
group, and PTSD was not included in other analyses.
To examine the robustness of our findings, we performed intent-to-treat
unadjusted analysis of variance and permutation comparisons of 6-month outcomes.
Because these 2 analytic approaches produce similar findings, we report only
analysis of variance results. In addition, we replicated the major longitudinal
analyses by using multiple imputed data sets. With the exception of income
(n = 10), no baseline data were missing. The extent of missing data at follow-up
was similar across the 3 randomized groups. In total, 11 women (4%) missed
all but the baseline interview, and 64 (24%) missed at least the last 2 interviews.
Of all possible interviews, 29% were missing. To impute item-level missing
data, we used an extended hot-deck multiple imputation technique that modifies
the predictive mean-matching method.42 We used
an approximate Bayesian bootstrap method to impute unit-level missing data.43 Imputations were produced separately for each intervention
and the community referral groups. SAS statistical software version 8.2 was
used for all analyses (SAS Institute, Cary, NC), and P<.05
was considered significant.
The participants in this study were primarily working poor Latina and
black women. The mean (SD) age of participants was 29.3 (7.9) years (Table 1). Less than half were married or
living with a partner, and 34.1% had never married. More than one third of
the women (37.1%) had not graduated from high school or received a general
equivalency diploma, and only 6.7% had completed college. The average woman
in this study had 2 or more children, and 64.8% of women were medically uninsured.
The sample was predominantly poor. More than half (60%) of the women
lived at or below the federal guidelines for poverty (during the years from
1997 to 2001). Furthermore, another 34.2% were near poor (between 100%-200%
of poverty guidelines). In addition, the women in this study experienced extremely
high rates of trauma exposure. More than one third had been raped and/or experienced
child abuse, and 49.2% had experienced domestic violence. High rates of PTSD
were also found.
Given the multiple demands on these working-poor women, outreach was
an essential part of this study. Following the clinical interview, nurse practitioners
spoke with women a mean (SD) of 8.8 (11.2) times to enable a first medication
visit. The psychologists spoke with patients a mean (SD) of 10.2 (12.2) times
before they attended a psychotherapy visit. Women who were reluctant to begin
medications or psychotherapy could attend education sessions to teach them
about depression treatment before agreeing to enter care. Eighty-five women
(96%) attended a mean (SD) of 1.89 (0.91) educational sessions before beginning
medications, and 60 women (67%) attended 2.37 (1.76) educational sessions
before beginning psychotherapy. Of the women who were randomly assigned to
medication treatment, 18 (20%) were switched to buproprion. Of the women assigned
to psychotherapy, 15 (17%) received an additional 8 sessions of CBT. Transportation
to care visits and child care funds were provided to enable women to participate
in the 2 interventions. Child care was provided by either reimbursing women
$10 per hour of treatment so that they could pay someone they knew for child
care or when they were unable to identify a potential child care provider,
child care was provided at the treatment site by study research assistants.
Transportation was provided through taxi vouchers, a prepaid hired van, or
reimbursement of subway or bus costs, depending on the availability of transportation
at a particular site.
Participation in care was low for women in the community referral condition.
After referral to a specific community provider, 74 (83%) of the women offered
community referral failed to attend even 1 session. Only 8 women (9%) attended
4 or more sessions of community care. Of those randomly assigned to receive
medications, 67 (75%) received 9 or more weeks of a guideline-concordant course
of medications, and 40 (45%) received a guideline-concordant course for 24
or more weeks. Women were less likely to complete an adequate course of CBT.
Of those randomly assigned to receive psychotherapy, 48 (53%) received 4 or
more CBT sessions and 32 (36%) received 6 or more sessions. Likelihood of
receiving an adequate course of treatment did not differ by ethnicity.
Results of repeated-measures analyses assessing change across time revealed
a significant decrease in depressive symptoms for women in the medication
(P<.001) and psychotherapy (P = .006) interventions compared with the community referral group
when measured by the HDRS (Figure 2).
There were no significant interactions in depression outcomes between the
interventions and ethnicity. The women randomly assigned to receive medication
and psychotherapy reported improved functioning compared with those referred
to community care. Results on instrumental role functioning revealed a significant
impact of the medication intervention (P = .006),
but not the psychotherapy intervention (P = .38)
when compared with the group referred to community care. Both medication (P = .001) and psychotherapy (P =
.02) interventions were effective in improving social functioning vs community
referral. The women randomly assigned to receive medications were twice as
likely (odds ratio, 2.04; 95% confidence interval, 0.98-4.27; P = .057) to achieve an HDRS score of 7 or less by month 6 as were
those referred to community care. By month 6, 44.4% of medication, 32.2% of
psychotherapy, and 28.1% of community referral patients had achieved an HDRS
score of 7 or less.
Comparisons were made between adjusted mean scores of those in the intervention
groups and those in the community referral group at months 1, 3, and 6 (Table 2). Women in the medication intervention
had lower depressive symptoms at months 3 and 6 and higher instrumental role
and social functioning by month 6 than did those referred to community care.
Women assigned to receive psychotherapy had lower depressive symptoms by month
6 and improved social functioning at month 6 compared with the referred participants.
Women in the psychotherapy group did not differ from the referred controls
on the instrumental role functioning measure. Women receiving medication reported
lower depressive symptoms and better instrumental role functioning than did
those receiving psychotherapy at month 6.
To examine the robustness of our longitudinal findings, we reexamined
the major analyses using intent-to-treat analysis of variance test at 6 months,
with no covariates. We replicated our finding that the medication intervention
was superior to community referral in decreasing depressive symptoms (P = .04), improving instrumental role functioning (P = .01), and social functioning (P =
.01). The psychotherapy intervention was not superior to community referral
in decreasing depressive symptoms (P = .32) or improving
role functioning (P = .58), but did result in improved
social functioning (P = .06).
As an additional test of robustness, we used 5 imputed data sets to
ensure that our results were not due to missing data. The results for the
medication intervention compared with community referral were replicated for
decreasing depressive symptoms (P = .04) and improving
instrumental role (P = .009) and social (P = .03) functioning. With the exception of improving social functioning
(P = .03), there were no significant differences
between the psychotherapy participants and the community referral group for
the imputed data.
To examine the likely outcomes of current practice guideline treatment
in this population, we compared those women in the medication group who received
at least 9 weeks of guideline-concordant treatment (n = 67) and those in the
psychotherapy group who received at least 6 CBT visits (n = 32) with those
in the community referral group who did not receive any mental health treatment
(n = 74). Guideline medications (P<.001) and psychotherapy
(P = .003) were significantly more effective than
no treatment in decreasing depressive symptoms. There were no interactions
between treatment and ethnicity. Medication (P =
.003) was superior in improving instrumental role functioning compared with
no treatment; psychotherapy was not (P = .07). The
medication (P<.001) and the psychotherapy (P = .003) interventions resulted in improved social functioning
compared with no treatment.
Comparisons were made between mean scores at months 1, 3, and 6 for
women receiving guideline treatment compared with women receiving community
referral with no treatment (Table 3).
To determine the impact of guideline care above care received in the community,
we also compared women receiving guideline medication or psychotherapy treatment
with community referral individuals who entered community care (n = 15). Guideline
medications were more effective than community care at month 6 for reducing
depressive symptoms (P<.001), increasing instrumental
role functioning (P = .01) and social functioning
(P<.001). Guideline psychotherapy was more effective
than community care at 6 months for reducing depressive symptoms (P = .01) and social functioning (P = .006),
but did not improve instrumental role functioning (P =
These results demonstrate the effectiveness of the study interventions
for depression when provided to low-income and minority women. The interventions
included intensive outreach, child care and transportation to care when needed,
and encouragement to comply with evidence-based medication or psychotherapy
treatment. As a result of this care, women not only achieved lower levels
of depressive symptoms, but they also achieved higher levels of instrumental
role and social functioning.
The results for community referral show that few impoverished women
engage in community care that is available to them. Although we could obtain
appointments for care, very few women actually attended such care. Without
the outreach, child care and transportation, and flexible scheduling of care
offered, few impoverished women are likely to receive appropriate treatment
Engagement of women in care was demanding throughout this study. We
were unable to obtain telephone diagnostic interviews for nearly one third
of the women who screened positive for depression, despite persistent attempts.
Of those who were interviewed, 26% who had screened positive did not meet
criteria for major depression. Many reported that their mood was low at screening
because of life circumstances but their mood had subsequently improved. Once
diagnosed, our clinicians spent considerable time gaining the trust of the
women, often through telephone contact, before they were comfortable receiving
We found no ethnic differences in response to care. Although our sample
of white women was extremely small, these results argue against concerns that
evidence-based treatment may not be effective for black and Latina women.
Evidence-based interventions appear effective for poor and minority women
if they are given support to overcome barriers to care. The interventions
were moderately tailored for each ethnic population, providing care in Spanish
when appropriate, and using professionals sensitive to low-income and minority
populations. With these sensitivities, evidence-based treatment for depression
appears effective for diverse populations.
Results of this study suggest that medication interventions may be more
effective for low-income and minority women than are psychotherapy interventions.
More women engaged in a sufficient duration of guideline treatment with medications
compared with psychotherapy, and outcomes of care were more extensive and
robust for medications. The nurse practitioners may be more accustomed to
providing patient outreach than are psychotherapists. This finding could also
reflect the lower time demands on patients of taking medications vs attending
psychotherapy. Also, the results of psychotherapy may be slower to unfold.
Several limitations of this study should be considered. First, all measures
were self-report, although the study measures have been used extensively in
previous depression studies. Second, our measure of PTSD appears to be influenced
by type of clinician completing the diagnosis. Nonetheless, presence of PTSD
did not appear to lessen the impact of depression care. Third, nearly half
of the women who screened positive for depression did not follow-up with diagnostic
interviews, and others claimed to no longer be depressed when interviewed
later. Thus, the extent to which this sample represents low-income young women
in general is not known. Fourth, all women in the study received monthly telephone
interviews to assess study outcomes. According to their self-reports, the
women experienced these calls as helpful. The impact of multiple contacts
for obtaining study measures could attenuate the results of the interventions
compared with community referral. Finally, the impact of evidence-based treatment
without the enhancements necessary to bring women to treatment cannot be determined
in this study.
We conclude that our interventions, including medications and psychotherapy
consistent with depression-treatment guidelines, are superior to community
referral for low socioeconomic status young women. The health policy implications
of this study are important. Engaging impoverished minority women in care
is demanding, but outcomes are clearly beneficial. Engaging women through
trusted providers could prove easier. Our results demonstrate that treating
depression in this population has clear advantages, both in terms of reducing
personal suffering and improving the ability of these young women to function.
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