effectiveness of treatments for major depression in primary medical care practice: a post hoc...

Journal of Affective Disorders 53 (1999) 185–192

Preliminary communication

Effectiveness of treatments for major depression in primary medicalcare practice: a post hoc analysis of outcomes for African

American and white patients

*Charlotte Brown , Herbert C. Schulberg, David Sacco, James M. Perel, Patricia R. Houck

University of Pittsburgh School of Medicine and The Western Psychiatric Institute and Clinic, 3811 O’Hara Street, Pittsburgh, PA15213, USA

Received 25 February 1998; accepted 5 April 1998

Abstract

Objective: To retrospectively determine whether race differentially influences treatment adherence and clinical outcomesamong 68 African Americans and 92 whites treated for major depression in four urban, primary care settings. Method: Studyparticipants were randomly assigned to standardized interpersonal psychotherapy or pharmacotherapy with nortriptyline, andwere assessed at baseline, and successive time points up to 8 months for severity of depression, and mental and physicalhealth-related functioning. Results: Intent-to-treat analyses revealed no treatment or race-specific differences in symptomaticrecovery when both groups were provided standardized psychotherapy or pharmacotherapy. However, African Americanshad poorer functional outcomes than whites. Conclusions: African American and white primary medical care patients areeffectively treated with standardized psychotherapy and pharmacotherapy. Future research should assess the impact ofcultural context on symptom presentation, psychosocial functioning, and treatment adherence and response. 1999Elsevier Science B.V. All rights reserved.

Keywords: Major Depression; Primary Care Practice; Treatment Outcomes; African Americans; Whites

1. Introduction (Brown et al., 1996; Cooper-Patrick et al., 1994;Olfson and Klerman, 1992; Sussman et al., 1987)

Similar prevalence rates of 2% to 17% have been suggest possible interracial differences in adherencereported for major depression among African Ameri- and response to psychotherapeutic and pharmacolog-cans and whites (Kessler et al., 1994; Somervell et ic treatments. Undertaking such analyses is con-al., 1989). However, racial differences in the phe- sistent with the growing interest in cultural, racial,nomenology of depression and help-seeking patterns and ethnic factors affecting treatment planning and

implementation (Comas-Diaz and Greene, 1994; Lin*Corresponding author. et al., 1993).

0165-0327/99/$ – see front matter 1999 Elsevier Science B.V. All rights reserved.PI I : S0165-0327( 98 )00120-7

186 C. Brown et al. / Journal of Affective Disorders 53 (1999) 185 –192

The efficacy of treatments for depression is well personal psychotherapy (IPT) provided within treat-documented (AHCPR, 1993). However, we could ment manual standards (Klerman et al., 1984); oridentify no randomized trials evaluating the efficacy nortriptyline (NT) provided within manualized phar-of psychotherapy provided African Americans nor macotherapy standards (Fawcett et al., 1987). Re-studies investigating racial differences in response to cruitment and study eligibility criteria are detailed bysuch interventions. In a nonrandomized, retrospective Schulberg et al. (1996).study, Jones (1982) found no racial differences in Sociodemographic characteristics measured attherapists’ evaluations of clinical outcome following baseline included a patient’s age, gender, race,psychotherapy. Only three clinical trials and one marital status, educational attainment, employmentretrospective study analyzed differences between status, and socioeconomic status (SES) establishedAfrican Americans and whites. Depressed African on the basis of education and occupation usingAmericans showed greater clinical improvement than Hollingshead’s (Hollingshead, 1965) Two Factorwhites, especially in the initial phases of treatment, Index. Clinical characteristics assessed at baselinewhen treated with imipramine or chlorpromazine included severity of depression with the Center for(Raskin and Crook, 1975), and with tricyclic and Epidemiologic Studies-Depression Scale (CES-D:phenothiazine medications (Overall et al., 1969). Radloff, 1977), the Beck Depression InventoryWith regard to whether the pharmacokinetics of (BDI: Beck et al., 1961), and the 17-item Hamiltonantidepressant drugs are race specific, Ziegler and Rating Scale-Depression (HRS-D: Hamilton, 1986);Biggs (1977) found that African Americans pre- medical severity (excluding depression) with thescribed nortriptyline achieved 50% higher mean Duke Severity of Illness Scale (DUSOI: Parkerson etplasma levels than whites, possibly because of a al., 1993); functional impairment with the Globalslower drug metabolism. In a retrospective examina- Assessment Scale (GAS: Endicott et al., 1976) andtion of tricyclic antidepressant plasma levels after the Medical Outcomes Scale Short Form-36 (MOSamitriptyline overdose, Rudorfer and Robins (1982) SF-36: Ware and Sherbourne, 1992); social supportfound racial differences in the level /dose ratio and with the Interpersonal Support Evaluation Listhigher plasma concentrations in African American (ISEL: Cohen et al., 1985); and stressful life eventswomen compared to white women. These reports with the Psychiatric Epidemiology Research Inter-suggest that African Americans respond to antide- view Life Events Scale (PERI: Dohrenwend et al.,pressants more rapidly than whites, and they may 1978). Clinical evaluators unaware of patients’ treat-also be more sensitive to the effects of tricyclics. ment assignment administered the HRS-D after

Using data from a study of treatments for major achieving interrater reliability exceeding 0.90.depression in primary care patients (Schulberg et al., Clinical response to the assigned intervention was1996), this report analyzes interracial differences in assessed at months one, two, three, four, six andadherence and outcomes for pharmacotherapy and eight with the 17-item HRS-D. Mental and physicalpsychotherapy delivered in a standardized manner. health-related functioning were assessed with the

MOS SF-36 at months four and eight.Experienced psychologists and psychiatrists pro-

vided the standardized IPT whose acute phase con-2. Method sisted of approximately 16 weekly sessions con-

ducted at the patient’s health center. ContinuationPatients ages 18–64 presenting at four urban phase treatment consisted of four monthly sessions.

ambulatory medical centers were recruited for a Patients randomized to pharmacotherapy receivedUniversity of Pittsburgh School of Medicine IRB- nortriptyline at no cost in their usual medical careapproved randomized clinical trial of treatments for site from board-certified family practitioners ormajor depression. Patients meeting DSM-III-R general internists trained in standardized protocolcriteria for a current major depression and scoring procedures. Pharmacotherapy’s acute phase was con-$ 13 on the 17-item Hamilton Rating Scale-Depres- sidered complete when the patient was assessed assion (Hamilton, 1986) were randomized to inter- having reached a ‘‘point of stability’’ (POS). This

C. Brown et al. / Journal of Affective Disorders 53 (1999) 185 –192 187

determination was based on the patient’s symptomat- 3. Resultsic improvement, i.e., a 33%–50% reduction in BDIscore; an NT blood level within the 50–150 ng/ml Both racial cohorts were predominantly female,therapeutic window on three consecutive tests; and and did not differ in age, education, or SES. How-the treating physician considering monthly visits ever, significantly fewer African Americans thansufficient. Patients entering the treatment continua- whites were married or employed when startingtion phase remained on the same therapeutic dosage treatment (Table 1). African Americans and whitesof NT, and were seen for six monthly visits. acknowledged similar levels of depression on the

Outcome analyses were conducted on the intent- self-report CES-D and the BDI. However, Africanto-treat sample of 160 patients randomized to IPT or Americans were rated as more depressed on theNT. Clinical outcome was determined through sepa- HRS-D, a difference largely accounted for byrate mixed model (random effects) repeated-mea- psychiatrists rating somatic symptoms as more se-sures analyses of variance (ANOVA) comparing vere among African American than white patients,mean scores on the HRS-D and MOS scales across i.e., as having more severe sleep disturbance, de-groups and at successive time points (Dixon and creased libido (t 5 4.2, df 5 158, P 5 0.0001) andMerdian, 1992). The mixed model repeated-mea- weight loss (t 5 2.5, df 5 158, P 5 0.01) on thesures ANOVA, with race, treatment group and time HRS-D factor scores (Brown et al., 1995). Race wasas fixed effects and intercept as a random effect, unrelated to the patients’ self-reported number ofassumes an unstructured covariance matrix. The prior depressive episodes or inpatient hospitaliza-individual specific intercepts and fixed race, treat- tions, but significantly fewer African Americans thanment group and time parameters were used to impute whites acknowledged prior outpatient mental health

2missing HRS-D and MOS data points for months M1 treatment (37% vs. 55%, x 5 4.3, df 5 1, P 5 0.04).through M8 (Gibbons et al., 1993). The amount of No racial differences in psychosocial functioningmissing data was similar across treatments and were found at baseline on the clinician-rated GAS orbetween racial groups. When ANOVA analyses were on the patient self-report MOS MCS (see Table 1).

2significant at the 0.05 level with the Wald x African Americans reported significantly greaterstatistic, post hoc group t-tests were conducted at impairment in physical functioning on the MOS PCSeach assessment point to identify specific group than whites despite similar levels of general medicaldifferences significant at the .01 level. Frank et al.’s severity as assessed by the Duke Severity of Illness(Frank et al., 1991) criteria for recovery from a Scale (DUSOI; Table 1). While no racial differencesmajor depressive episode were applied to actual and were evident in overall level of perceived socialimputed data to classify patients as fully recovered support, African Americans reported significantly(HRS-D # 7) versus partially or fully symptomatic more stressful life events in the preceding six months(HRS-D $ 8). Chi-square analyses were used to (t 5 3.2, df 5 157.4, P 5 0.002).assess differences in the proportions of African Adherence to the full acute and continuation phaseAmericans and whites who had recovered at eight protocols was similarly poor among the two racialmonths when treated with NT or IPT. Changes in groups (29% for African Americans and 42% forpatients’ mental and physical health-related func- whites). However, inter-group differences weretioning were assessed with MOS SF-36 data. The found in specific aspects of treatment participation.eight MOS scales were aggregated into the Physical Similar proportions of African Americans and whitesComponent Scale (MOS PCS) score and the Mental appeared for the first treatment session (81% andComponent Scale (MOS MCS) score (Ware et al., 93%, respectively) and completed the acute phase of1995). Racial differences in medication side effects pharmacotherapy (45% for African Americans andwere determined through a repeated measures analy- 61% for whites) or psychotherapy (41% for Africansis of variance (ANOVA) comparing mean total Americans and 54% for whites). However, participa-scores on the Side Effects Scale. Chi-square analyses tion in both NT and IPT’s continuation phasewere used to assess the significance of differences in differed significantly by race. Thus, 100% of Africanpatterns of attrition. Americans but only 76% of whites completed IPT’s


Table 1Baseline demographic and clinical characteristics of patients randomized to psychotherapy or pharmacotherapy

aAfrican-American White Statistic P

SociodemographicMean (S.D.) Age 37.0 10.5 68 37.4 11.5 92 0.20 0.84% Female 84% 68 80% 92 0.30 0.58% $ HS Educ 87% 68 78% 92 1.9 0.16% Employed Fullor Part Time 32% 66 52% 91 6.1 0.01% Married 19% 68 34% 92 4.2 0.04Mean (S.D.) SESScore 49.5 12.4 68 47.8 12.2 92 0.86 0.39

Distribution by SES Category1.2 0.75

II 6% 8%III 22% 27%IV 44% 43%V 28% 22%

ClinicalMean (S.D.) BDI 26.7 9.7 56 24.9 11.0 82 1.0 0.33Mean (S.D.) HRS-D 24.4 5.0 68 22.1 4.9 92 2.9 0.005Mean (S.D.) CES-D 36.7 8.2 67 37.5 9.4 90 0.52 0.60Mean (S.D.) GAS 49.8 6.6 68 50.7 6.7 92 0.84 0.40Mean (S.D.) DUSOISeverity Index 36.3 15.8 68 33.1 15.8 91 1.3 0.21

MOS ScalesMean (S.D.) MentalComponent Scale 27.2 7.6 58 26.3 10.1 81 0.62 0.54Mean (S.D.) PhysicalComponent Scale 38.7 10.3 58 44.3 9.9 81 3.3 0.001a 2t-test for ordinal variables and x for categorical variables

continuation phase, while 35% of African Americans plasma atropinic indices and non-compliance sig-compared to 61% of whites completed NT’s con- nificantly correlated (r 5 0.72, P 5 0.02). Non-com-

2tinuation phase (x 5 6.4, df 5 1, P 5 0.04). pliers had a mean atropine equivalent /ml of 1.08Compliance with the prescribed NT dosages was (60.69); while compliers had a mean of 0.50,

analyzed for the 65% of African American and 71% (60.11). The higher the atropine index, particularlyof white patients for whom sufficient data points values $ 0.50, the more marked were side effects.were available. Using blood plasma samples, steady- This implies that African Americans possibly did notstate concentrations of NT and hydroxy metabolites adhere initially because of greater atropine-likewere measured and plasma level /dosage (L/D) intolerance. Non-compliance with pharmacotherapyratios calculated. Intraindividual variability in the was also associated with attrition for African Ameri-L/D ratio was used to classify patients as compliant can but not white patients. Thus, among Africanor non-compliant, with the latter judgement applying Americans, continuation phase drop-outs were sig-when their L/D ratio differed by more than 1.5 nificantly more non-compliant than completers (67%

2standard deviations on at least two samples during vs. 0%; x 5 5.8, df 5 1, P 5 0.02). Among whites,the study period (Perel, 1988). Within this criterion, similar proportions of continuation phase drop-outs52% of African Americans and 31% of whites were and treatment completers were non-compliant (13%

2non-compliant (x 5 2.8, df 5 1, P 5 0.09), with vs. 23%, respectively).


Side Effects Scale scores were examined at the sented at baseline with substantially impaired mentalfirst session, the POS session, and the last session for health-related functioning. Both treatment groups

2continuation phase dropouts. African Americans had improved significantly over time (x 5 132.2, df 5

significantly higher side effect scores than whites at 2, P 5 0.0001) and there was a trend for whites tothe first and the POS sessions but not at their final exhibit greater improvement in mental health-relatedsessions (F 5 3.9, df 5 1, 34, P 5 0.05). The African functioning than African Americans by month 8

2Americans’ mean side effect score at baseline was at (x 5 6.0, df 5 2, P 5 0.05; see Fig. 2). Whileleast 33% higher than that of whites, and it remained neither treatment group improved in physical func-higher throughout treatment even though scores of tioning over time, African Americans exhibited moreboth racial groups decreased significantly over time. impairment in physical functioning than whites at all

2HRS-D scores from baseline to eight months (Fig. time points (x 5 6.2, df 5 1, P 5 0.01). This finding1) for intent-to-treat cohorts of African Americans persisted when marital status and life stress wereand whites randomized to IPT or NT revealed no added as covariates.treatment or race-specific differences in symptomaticrecovery. However, depressive severity was signifi-cantly reduced in both treatment and racial groups 4. Discussion

2over the 8-month trial (x 5 241.2, df 5 6, P 5

0.0001). These results did not change when baseline African American and white primary medical careHRS-D score was added as a covariate. patients with major depression are effectively treated

When clinical recovery was analyzed with eight- with standardized pharmacotherapy or psychothera-month HRS-D score, racial differences were not py. However, our retrospective analyses do notevident in the proportions of NT or IPT patients permit examination of whether cultural context in-classified as fully recovered (HRS-D # 7). Among fluences pharmacotherapy and psychotherapy partici-IPT patients, 50% of whites and 41% of African pation and outcome. Such factors include the in-Americans had recovered at eight months and there dividual’s racial or cultural identity, the role ofwas a trend for fewer African Americans than whites cultural context in the expression and evaluation ofto have recovered fully among those randomized to symptoms and dysfunction, and the impact of patient

2NT (32% vs. 52%; x 5 3.0, df 5 1, P 5 0.08). and clinician race or culture on the therapeuticBoth African American and white patients pre- alliance and treatment outcome (American Psychiat-

Fig. 1. Course of depressive symptoms from baseline to Month 8 among African Americans and White ‘‘intent-to-treat’’ cohorts providedinterpersonal psychotherapy (IPT) or nortriptyline (NT).


Fig. 2. Changes in physical and mental health-related functioningfrom baseline to Month 8 among African Americans and White‘‘intent-to-treat’’ cohorts provided interpersonal psychotherapy (IPT),or nortriptyline (NT).

ric Association, 1994, Diagnostic and Statistical more likely than whites to complete IPT’s continua-Manual of Mental Disorders; Myers, 1993). We tion phase, thereby attesting to this treatment’srecognize the importance of these factors and our acceptability to such minority patients undertaking it.findings should be interpreted as hypothesis-raising However, twice as many whites as African Ameri-rather than definitive. cans completed pharmacotherapy’s continuation

Racial differences in treatment attrition have been phase (71% vs. 35%).previously reported, with African Americans having The extremely low rate (16%) at which Africanhigher rates of ‘‘premature termination’’ and shorter Americans prescribed nortriptyline completed thedurations of treatment than whites in routine practice full pharmacotherapy protocol may appear counterin-settings (O’Sullivan et al., 1989; Sue et al., 1991). tuitive. Given their more somatic presentationGiven these earlier findings, our analysis of attrition (Brown et al., 1996), medication presumably wouldpatterns from treatments delivered within manualized be acceptable, if not preferred, by such depressedstandards is particularly meaningful in the present individuals. However, depressed patients who somat-era of managed care and guideline-recommended ize are already keenly sensitive to physical dis-interventions. Thus, it is of interest that racial comfort (Meresman et al., 1995) and may be par-differences in treatment participation appear to be ticularly intolerant of the early side-effects of medi-phase-specific. While similar proportions of African cation. This speculation is consistent with our findingAmerican and whites appeared for the first treatment that compared to whites, African American patientssession and completed the acute phase of psychother- who prematurely terminated pharmacotherapy re-apy or pharmacotherapy, significant racial differ- ported more severe side effects at baseline whichences in adherence were evident during each treat- possibly never decreased to a subjectively tolerablement’s continuation phase. African Americans were level. Further, fewer African Americans (48%) con-


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effectiveness of treatments for major depression in primary medical care practice: a post hoc...

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