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Original Article |

The Pathways Study:  A Randomized Trial of Collaborative Care in Patients With Diabetesand Depression FREE

Wayne J. Katon, MD; Michael Von Korff, ScD; Elizabeth H. B. Lin, MD, MPH; Greg Simon, MD, MPH; Evette Ludman, PhD; Joan Russo, PhD; Paul Ciechanowski, MD, MPH; Edward Walker, MD; Terry Bush, PhD
[+] Author Affiliations

Author Affiliations: Department of Psychiatryand Behavioral Sciences, University of Washington School of Medicine (DrsKaton, Russo, Ciechanowski, and Walker), and Center for Health Studies, GroupHealth Cooperative of Puget Sound (Drs Von Korff, Lin, Simon, Ludman, andBush), Seattle.


Arch Gen Psychiatry. 2004;61(10):1042-1049. doi:10.1001/archpsyc.61.10.1042.
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Published online

Background  There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) and high hemoglobin A1c (HbA1c) levels in patients with diabetes.

Objective  To determine whether enhancing quality of care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.

Design  Randomized controlled trial with recruitment from March 1, 2001, to May 31, 2002.

Setting  Nine primary care clinics from a large health maintenance organization.

Participants  A total of 329 patients with diabetes mellitus and comorbid major depression and/or dysthymia.

Intervention  Patients were randomly assigned to the Pathways case management intervention (n = 164) or usual care (n = 165). The intervention provided enhanced education and support of antidepressant medication treatment prescribed by the primary care physician or problem-solving therapy delivered in primary care.

Main Outcome Measures  Independent blinded assessments at baseline and 3, 6, and 12 months of depression (Hopkins Symptom Checklist 90), global improvement, and satisfaction with care. Automated clinical data were used to evaluate adherence to antidepressant regimens, percentage receiving specialty mental health visits, and HbA1c levels.

Results  When compared with usual care patients, intervention patients showed greater improvement in adequacy of dosage of antidepressant medication treatment in the first 6-month period (odds ratio [OR], 4.15; 95% confidence interval [CI], 2.28-7.55) and the second 6-month period (OR, 2.90; 95% CI, 1.69-4.98), less depression severity over time (z = 2.84, P = .004), a higher rating of patient-rated global improvement at 6 months (intervention 69.4% vs usual care 39.3%; OR, 3.50; 95% CI, 2.16-5.68) and 12 months (intervention 71.9% vs usual care 42.3%; OR, 3.50; 95% CI, 2.14-5.72), and higher satisfaction with care at 6 months (OR, 2.01; 95% CI, 1.18-3.43) and 12 months (OR, 2.88; 95% CI, 1.67-4.97). Although depressive outcomes were improved, no differences in HbA1c outcomes were observed.

Conclusion  The Pathways collaborative care model improved depression care and outcomes in patients with comorbid major depression and/or dysthymia and diabetes mellitus, but improved depression care alone did not result in improved glycemic control.

Figures in this Article

Approximately 10% to 15% of patients with diabetes mellitus meet criteriafor comorbid major depression.1,2 Depressionis a risk factor for development of diabetes mellitus,3,4 itis associated with adverse diabetes outcomes,59 anddiabetes may worsen the course of depression.10 Researchsuggests that the presence of comorbid chronic physical disease, such as diabetesmellitus, is a negative prognostic factor for depression treatment outcomes.11,12 Patients with diabetes mellitus andmajor depression, compared with those with diabetes mellitus alone, have beenshown to have higher symptom burden5; increasedfunctional impairment5,6; pooreradherence to diet, exercise, and taking medications2,5,6;higher hemoglobin A1c (HbA1c) levels7;and more diabetes complications.8,9 Giventhe high comorbidity of depression and diabetes mellitus and the potentialreciprocal adverse impact of these conditions, there is a need for treatmenttrials to assess whether enhancing recognition and treatment of depressionimproves diabetes and depression outcomes.

Several small tertiary care–based trials have shown that antidepressantmedication was more effective than placebo in treating major depression inpatients with diabetes mellitus.13,14 Onetertiary care–based trial15 also foundthat cognitive behavior therapy was more effective than a diabetes educationalintervention in relieving depressive symptoms and significantly decreasedHbA1c levels in patients with comorbid major depression and diabetesmellitus. A more recent, larger trial16 amongelderly, depressed, diabetic patients with relatively low baseline mean HbA1c levels did not find improvement in glycemic control resulting fromimproved depression outcomes. These studies may not have been adequately poweredto detect effects on glycemic control due to the sample size or low baselineHbA1c levels.

Most patients with diabetes mellitus and major depression are treatedwithin primary care rather than specialty care. Primary care diabetic patientsare more likely to have type 2 diabetes mellitus, less likely to be treatedwith insulin, and likely to have fewer diabetic complications and medicalcomorbidities.2,5,6,17 Healthservices research in primary care systems has improved the quality of diabetescare with telephone or in-person case management interventions.18,19 However,these studies have not addressed treatment of comorbid major depression.18,19 Only a minority of patients withdiabetes mellitus and major depression receive adequate treatment for depression.20 Population-based strategies to improve quality ofcare and outcomes in patients with diabetes mellitus in primary care havefound depression to be an important barrier to enhancing diabetes self-management.21 The present randomized controlled trial tested theeffect of a health services intervention aimed at improving quality of depressioncare on both depression and glycemic control outcomes among primary care patientswith diabetes mellitus and depression.

The Pathways Study was developed by a multidisciplinary team in theDepartment of Psychiatry and Behavoiral Sciences at the University of Washingtonand the Center for Health Studies at Group Health Cooperative (GHC), Seattle.The GHC is a nonprofit health maintenance organization with 30 primary careclinics in western Washington State. The study protocol was reviewed and approvedby institutional review boards at the University of Washington and the GHC.All participants gave written informed consent.

STUDY SETTING

Nine GHC primary care clinics in western Washington were selected forthe study. We estimated that 150 participants in both the intervention andusual care arms (assuming 15% patient attrition) were required to have 80%power to detect as significant a 0.23 (SD, 0.7) difference in the mean scoreof the 20 depression items from the Hopkins Symptom Checklist-90 (SCL-90).22 We estimated that 162 participants in both the interventionand control arms (assuming 15% patient attrition) were required to have 80%power to detect as significant a 0.5% (SD, 1.65%) mean difference in HbA1c values.

SAMPLE RECRUITMENT

Case identification was facilitated by prior development by the GHCof a population-based diabetes registry23 thatsupports patient care. A survey mailed to patients on the diabetes registryassessed age, sex, years of education, employment status, race, and maritalstatus. Questions about clinical status included the following: age at onsetof diabetes, duration of diabetes, current diabetic treatments, and diabetestreatment at onset of disease. When surveys were not returned, second andthird mailings and telephone reminders were used to achieve a final responserate of 61.7%.

Eligible patients were ambulatory, were English speaking, had adequatehearing to complete a telephone interview, and planned to continue to be enrolledin GHC during the next year. Psychiatric exclusions were as follows: (1) currentlyin care with a psychiatrist; (2) a diagnosis based on GHC's automateddiagnostic data of bipolar disorder or schizophrenia; (3) use of antipsychoticor mood stabilizer medication based on GHC's automated pharmacy data;and (4) mental confusion on interview, suggesting significant dementia.

The Patient Health Questionnaire 9 (PHQ-9) was used to screen for depression.24,25 The PHQ-9 (at a cutting score of≥10 with ≥5 symptoms scored as being present more than half of the days)has been found to have high agreement with structured interview in establishinga diagnosis of major depression.24,25 Althoughwe did not require patients to meet criteria for major depression, they wererequired to have a score of 10 or greater on the PHQ-9 in the initial screeningand persistent symptoms, as evidenced by an SCL-90 depression22 meanitem score of higher than 1.1 at a second telephone screen 2 weeks later.Patients were not excluded if they were taking antidepressants in the prior3 months as long as they had persistent symptoms.

A total of 9063 questionnaires were mailed, and 7841 patients were foundto meet initial eligibility criteria (Figure 1); 4839 questionnaires (61.7% of those eligible) were returned,and 1038 were eligible for baseline screening based on a PHQ-9 score of 10or greater. A total of 851 (82.0%) of the 1038 respondents were successfullyreached by telephone for baseline screening, and 375 met criteria for therandomized trial (based on a second screening SCL-90 score of >1.1). Only46 (12%) of 375 eligible patients refused to participate.

Place holder to copy figure label and caption
Figure 1

. Recruitment for the randomized controlledtrial. Patients were eligible for baseline screening based on a Patient HealthQuestionnaire 9 score of 10 or higher. Patients were categorized as “ineligible–other”if (1) they were enrolled in another study, (2) their spouse was enrolledin the Pathways Study, (3) they were at high risk for self-harm or they refuseda self-harm assessment, or (4) they fulfilled other special circumstances(ie, there was 1 case in which the team deemed someone ineligible owing toa recent hospitalization for drug overdose).

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MEASURES

For measuring change in depression, the SCL-90 depression scale22 was chosen as the primary dependent variable, basedon previous studies that showed the high reliability, validity, and sensitivityto change of this measure.16,22,26 Giventhe higher percentage of patients with dysthymia than with major depression,response to treatment at 6 and 12 months was defined as 40% or greater reductionin SCL-90 scores, based on a National Institutes of Health consensus panelrecommendation regarding measurement of outcomes in dysthymia.27 Wealso report 50% or greater reduction in SCL-90 scores at 6 and 12 months.We used the Patient Global Impression28 scoreat 6 and 12 months as a subject-rated global assessment of improvement indepression since baseline. Patients rated their satisfaction with depressioncare at baseline and 6 and 12 months on a 5-point ordinal scale that ratedtreatment from poor to excellent.26

Hemoglobin A1c measures exposure of red blood cells to glucoseduring a 90-day period.29 Study participantsagreed to blood draws at their GHC primary care clinic to measure HbA1c at baseline and 6 and 12 months.

The GHC's computerized pharmacy and utilization records wereused to measure the number of specialty mental health visits, for examinationof refills of antidepressant medications, and to determine whether the patientreceived an adequate dosage based on evidence-based guideline standards for90 days or more within each 6-month period.30 Thelowest doses in the ranges recommended in the Agency for Health Care Policyand Research Guidelines and in guidelines developed for newer agents wereused to define minimum dosage standards.31,32

Computerized pharmacy records were used to compute a chronic diseasecomorbidity score known as RxRisk.33 The RxRiskhas been found to be comparable to using ambulatory care groups34 inpredicting total future health costs.

A measure was developed based on previous literature35 todefine 2 aspects of diabetes using automated diagnostic, pharmacy, and laboratorydata: (1) diabetes complications and (2) treatment intensity required. International Classification of Diseases, Ninth Revision, codeswere used to identify 7 potential types of diabetic complications (retinopathy,nephropathy, neuropathy, cerebrovascular, cardiovascular, peripheral vascular,and ketoacidosis).35 Pharmacy data regardingthe use of oral hypoglycemic agents and insulin indicated treatment intensity.

RANDOMIZATION

Using a computerized algorithm, patients were randomized to the interventionor usual care group. After completion of the baseline interview, interventionpatients were called by a nurse within 1 week to set up an appointment. Usualcare patients were given recommendations to work with their primary care physicianon issues related to depression. After randomization, telephone interviewswere provided at 3, 6, and 12 months by a telephone survey team who were blindedto intervention status.

INTERVENTION DESIGN

The intervention was designed to improve quality of care and outcomesof depression but not to directly improve diabetes education or care. Theintervention was an individualized, stepped-care depression treatment programprovided by a depression clinical specialist nurse in collaboration with theprimary care physician.

TRAINING

Three half-time registered nurses were hired to implement collaborativecare treatment. Nurses received an initial 1-week training course on diagnosisand pharmacotherapy and an introduction to problem-solving treatment methodsbased on the intervention developed for the Improving Mood–PromotingAccess to Collaborative Treatment (IMPACT) study.36,37 Apsychiatrist (W.J.K.), primary care physician (E.H.B.L.), and psychologist(E.L.) participated in the training. An intervention manual from the IMPACTtrial was used to train nurses on collaborative care, stepped-care principles,pharmacology, and problem-solving treatment.38

Nurses were also trained using the manual for problem-solving treatmentof depressive disorders in primary care (PST-PC) following the protocol describedby Hegel and colleagues,39 which included didactics,role play, observation of a videotaped demonstration, and review of the PST-PCtreatment manual.40 Each nurse was requiredto treat at least 4 depressed patients with 6 sessions of PST-PC during a2-month period. Each session was audiotaped, and sessions 1, 3, and 5 wererated using the PST-PC Adherence and Competency Rating Scale.39,40 Nurseswere required to have at least 3 audiotaped treatment sessions from differentpatients rated as satisfactory by the team psychologist (E.L.).

COLLABORATIVE CARE

Patients were offered an initial choice of 2 evidence-based treatments:antidepressant medication or PST. Treatment included an initial 1-hour visitfollowed by twice-a-month, half-hour appointments (telephone and in person)in the acute phase of treatment (0 to 12 weeks).

STEPPED-CARE ALGORITHM

A stepped-care approach was used in which patients received differenttypes and intensities of services tailored to their observed outcomes.41 If patients still had persistent depressive symptoms(<50% decrease in severity based on the PHQ-9) 10 to 12 weeks after initialtreatment with either PST or antidepressant medication, they could (1) switchto a second antidepressant with a different mechanism or side effect profile;(2) switch to the alternative treatment (from PST to medication or vice versa);(3) receive augmentation with PST or antidepressant medication with the firsttreatment they had received; or (4) receive a psychiatric consultation. Thischange in treatment at 10 to 12 weeks was labeled step 2 care. In situationswhere patients received 1 or more step 2 interventions, where symptoms persisted(<50% improvement), or where there was a lack of patient and cliniciansatisfaction with outcome after a second treatment (8 to 12 weeks), referralto specialty care by the GHC mental health system for longer-term follow-upwas made (step 3).

Once patients reached a significant decrease in clinical symptoms (≥50%decrement in symptoms), the nurse began continuation phase treatment, whichconsisted of monthly scheduled telephone contacts. For patients with persistentsymptoms or social isolation, nurses offered monthly continuation groups insteadof monthly telephone calls.

SUPERVISION

Each nurse had supervision twice a month with a team that included apsychiatrist (W.J.K., G.S., or E.W.), psychologist (E.L.) (pertaining to PST),and family physician (E.H.B.L.) to review new cases and patient progress.Nurses interacted regularly (via written notes and verbally) with the primarycare physician treating the patient. On alternate weeks, nurses reviewed casesby telephone with the psychiatrist supervisor. The psychiatrist supervisorregularly reviewed choices and dosages of medication and clinical responseand recommended changes, which the nurse discussed with the primary care physicianand patient. During the study, 45 audiotapes were reviewed by the team psychologistto provide ongoing feedback to nurses and to assess treatment fidelity.

USUAL CARE

Usual care patients were advised to consult with their primary carephysician regarding depression. Primary care physicians at the GHC frequentlyprescribe antidepressant medication and can refer patients to the GHC MentalHealth Services. Both intervention and usual care patients could also self-referto a GHC mental health care provider. Usual care for diabetes mellitus inthe GHC is provided by the primary care physician, with occasional supportfrom diabetes nurses for patients with persistently high HbA1c levels.

STATISTICAL ANALYSIS

χ2 Analyses with correction for continuity and 2-tailedindependent group t tests were used to examine differencesbetween the intervention and usual care groups on demographic and clinicalvariables. Group differences in the adequacy of dosage of antidepressants,patient global improvement, and percentage of patients with at least a 40%and 50% decrease in depression were examined using logistic analyses to accountfor baseline group differences and to calculate odds ratios and 95% confidenceintervals (CIs). To examine treatment group trends over time (baseline and3, 6, and 12 months) in antidepressant medication use, we used mixed-effectlongitudinal logistic regression models with 2 random effects (intercept andtime) and 2 fixed effects (treatment group and its interaction with time).We initially tested models with time as both a random and a fixed effect.In both models, the intercept was always assumed to be random. The 2 modelshad similar levels of significance for their main effects and interaction.Comparing the log likelihoods for the 2 models revealed a better fit for themodel with time as a random effect (eg, slopes of the line over time beingrandom effects). For the clinical outcomes of the continuous SCL-90 depressionscale scores and HbA1c values, mixed-effect continuous longitudinalmodels were used, following the same strategy described herein. In the eventof significant effects, planned post hoc analyses were performed using F teststo elucidate the findings (adjusted for baseline values).

Effect modification of the pattern of change in depression over timebetween the treatment groups was examined for patient subgroups with majordepression, patients with dysthymia, and those taking antidepressants at baseline.This was tested by individually examining the 3-way interaction of group bytime by effect modifier (major depression, dysthymia, or antidepressant use).

Figure 1 illustrates the flowof patient selection for the study, including reasons for exclusion at variouspoints. Of the 329 patients enrolled (164 intervention patients and 165 usualcare patients), the following percentages completed 3-, 6-, and 12-month assessments:3-month assessment, 151 (91.5%) intervention patients and 154 (93.3%) usualcare patients; 6-month assessment, 143 (87.8%) intervention patients and 149(90.9%) usual care patients; and 12-month assessment, 146 (88.5%) interventionpatients and 142 (86.1%) usual care patients. A total of 132 interventionpatients (80.5%) and 131 usual care patients (79.4%) completed all 3 assessments.

PATIENTS

There were no significant differences between groups in any variable(Table 1). The population was middle-agedto elderly, with approximately 1 patient in 5 from a racial/ethnic minoritypopulation. Most patients had type 2 diabetes mellitus, and approximatelytwo fifths were treated with insulin. The mean glycosylated hemoglobin levelwas 8.0%, and the mean number of complications was 1.5. This population hada high rate of lifetime dysthymia (approximately 70%), and approximately twothirds met criteria for major depression. Only 13% of patients did not meetmajor depression or dysthymia criteria at baseline. Approximately half weretreated with an antidepressant medication within the last 3 months.

Table Graphic Jump LocationTable 1. Baseline Demographic and Clinical Comparisons
INTERVENTION IMPLEMENTATION

Most (97.6%) of the 164 intervention patients completed an initial visitwith a nurse. Intervention patients had a mean ± SD of 5.06 ± 3.43in-person visits and 5.87 ± 4.32 telephone contacts witha nurse, and 4.9% were seen for a consultation by a team psychiatrist. A totalof 84 intervention patients (51.3%) took medication and underwent PST, 13(7.9%) underwent PST only, 53 (32.3%) took medications only, and only 14 (8.5%)did not take medication or undergo PST. Of the 97 patients receiving PST,62 (64%) had 4 or more in-person treatment sessions.

PROCESS OF CARE

Patients receiving the intervention were more likely to receive 4 ormore specialty mental health treatment visits (including nurse interventionvisits and GHC specialty mental health visits) compared with patients receivingusual care (67.7% vs 6.7%). Controlling for prebaseline 6-month rate of adequacy,the intervention group had significantly higher rates of adequate dosage inthe first 6-month period (57.3% for intervention vs 40% in the usual caregroup) and the second 6-month period (53.0% for intervention vs 38.2% in theusual care group) (Table 2).

Table Graphic Jump LocationTable 2. Intervention vs Control Differences in Quality of Care

A mixed-effect logistic regression model using baseline and 3-, 6-,9-, and 12-month refills of antidepressant medication based on automated datawas performed. The 2 random-effects models (slope and intercept) showed asignificant time × treatment group interaction (z = 3.30, P < .001)and nonsignificant main effects of time (z = 0.29)and intervention group (z = 1.08). At baseline,the usual care and intervention groups did not differ in adherence (43.6%vs 35.4%, χ21 = 2.02, P = .16). At each of the follow-up assessments, the interventiongroup had significantly greater medication adherence than the usual care group,controlling for baseline adherence, with the odds ratios ranging from 2.18to 3.20 (Table 2).

At baseline, rates of satisfaction in the intervention and usual caregroups were very similar, but at 6 and 12 months, the intervention group reportedsignificantly greater satisfaction (Table 2)than the usual care group.

CLINICAL OUTCOMES

Mixed-effect regression models using baseline and 3-, 6-, and 12-monthfollow-up SCL-90 continuous data were performed. The 2 random-effects models(slope and intercept) showed a significant group × time interaction(z = 2.84, P = .004);both the main effects of time (z = 8.92, P < .001) and intervention group (z = 2.14, P = .03) werestatistically significant. Figure 2 showsthe depression means over time for the treatment groups (all follow-up meansadjusted for the baseline SCL-90 score). The baseline SCL-90 depression meanscores (F1,327 = 2.21, P = .14)and the 3-month assessment (F1,302 = 1.45, P = .23) did not differ significantly between the groups.However, by 6 months, the intervention group had a significantly lower adjustedmean than the usual care group (F1,290 = 4.11, P = .04), and this difference continued to bestatistically significant at the 12-month assessment (F1,285 = 4.96, P = .03). The average change from baseline to6 months was 0.39 (95% CI, 0.28-0.49) for the usual care group and 0.56 (95%CI, 0.46-0.67) for the intervention group. The average change between baselineand 12 months was 0.44 (95% CI, 0.33-0.56) for the usual care group and 0.65(95% CI, 0.54-0.76) for the intervention group.

Place holder to copy figure label and caption
Figure 2

. Intervention vs control differenceson mean depression scores (range, 0-4) from the 20 depression items from theHopkins Symptoms Checklist-90 (SCL-90). Error bars indicate standard errors.The 3-, 6-, and 12-month means were adjusted for baseline. Asterisk indicates P = .04; dagger, P = .03.

Graphic Jump Location

Results of our effect modification analyses showed trend-level effectmodification for patients treated with an antidepressant in the 3 months beforerandomization (z = 1.59, P = .11) and nonsignificant modification for major depression(z = 0.65, P = .52)or dysthymia (z = 0.45, P = .65). The trend-level modification by antidepressantsshowed a greater intervention vs usual care treatment effect over time forthose who had not had previous exposure to antidepressants.

Table 3 shows significant differencesin the percentage of patients with a 40% decrease in SCL-90 depression scoresbetween the intervention and usual care groups at 12 months and similar butnonsignificant trends at 6 months. Approximately 10% more intervention vsusual care patients also improved 50% or more from baseline on SCL-90 scoresat 6 and 12 months, but these trends were not statistically significant.

Table Graphic Jump LocationTable 3. Intervention vs Control Differences in Recovery From Depression

At 6 months, a significantly higher percentage of the intervention patientsreported improvement on the Patient Global Impression measure from baseline,compared with usual care patients. These differences were greatest at the12-month assessment, when 71.9% of the intervention group reported improvementin their depression from baseline, compared with 42.3% of the usual care patients(Table 3).

A mixed-effect regression model compared HbA1c values atbaseline and 6 and 12 months. There was no statistically significant group× time interaction (z = 0.60, P = .55) and no main effect of intervention;however, the time effect was statistically significant. We refit the modelwithout the interaction term, and there was no statistically significant treatmentgroup effect (z = 0.89, P = .37), but there was a statistically significant timeeffect (z = 3.65, P < .001). Figure 3 shows that HbA1c levels decreasedover time for both groups: baseline (overall mean ± SD),7.99% ± 1.55%; 6-month assessment, 7.58% ± 1.47%;and 12-month assessment, 7.64% ± 1.57%. The follow-up meanswere adjusted for baseline HbA1c levels. There were no statisticallysignificant group differences at any of the time points: baseline, F1,315 = 0.24, P = .62;6 months, F1,282 = 0.67, P = .41;and 12 months, F 1,274 = 0.61, P = .44.

Place holder to copy figure label and caption
Figure 3

. Intervention vs control differencesin mean hemoglobin A1c (HbA1c) levels. Error bars indicatestandard errors. The 3-, 6-, and 12-month means were adjusted for baseline.

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Compared with usual care patients, the Pathways intervention patientsreceived more adequate depression treatment, were more satisfied with theircare for depression, and showed significantly greater improvements in depressivesymptoms during a 12-month period. These results add to the expanding literaturethat shows that depression can be effectively treated in the context of majorchronic medical illness.42

Unlike many trials in younger adults, where differences between interventionand control patients in depressive outcomes at 4 to 6 months tended to decreaseby 9 to 12 months,26,43 the datafrom this trial suggest sustained intervention effects at longitudinal follow-upfor 1 year. A similar pattern of sustained benefits during a 12-month periodwas also seen in the recently published IMPACT trial, which tested a similarnurse intervention vs usual care in elderly patients.36 Theseresults may reflect the fact that both the current study and the IMPACT trial36 built in a continuation phase of the interventionin which nurses continued to monitor adherence and outcomes by telephone duringa 1-year period.

An extremely high rate of dysthymia (approximately 70%) and prior depressiontreatment was found in these patients. In contrast, we found rates of dysthymiaof 20% to 30%26,43 in primarycare studies that tested collaborative care depression interventions withmixed-age populations in the same health maintenance organization. The datathat show high rates of chronic depression are consistent with other datathat have shown that chronic medical illness is a negative prognostic factorin recovering from depression.11,12 Althougha higher percentage of intervention patients compared with controls improvedduring the 12 months, approximately 45% of intervention patients still hadsignificant depressive symptoms, suggesting continued need for improved interventionmodels. The high rates of coexisting chronic depression in this populationsuggest that many patients may benefit from longer-term interventions thatcombine medication and evidenced-based psychotherapy.44 Arecently reported trial that enrolled patients with 2 or more years of depressionfound that a combined antidepressant medication and cognitive behavior analysistherapy intervention was more effective than either medication or cognitivebehavior analysis therapy alone in improving outcomes.44

In this trial, the enhancement in quality of care and outcomes of depressionwas not accompanied by significant differences in HbA1c levelsbetween intervention and control patients during a 12-month period. Only 1of 4 prior trials with patients with depression and diabetes mellitus hasfound that an effective depression intervention was associated with improvedHbA1c levels.1316 However,the mean baseline HbA1c level in that efficacy study was approximately10.0% vs approximately 8.0% in the current trial.15 Also,the controls in that trial received diabetes education only,15 whereasapproximately half of the usual care controls in this study received antidepressanttreatment, which probably decreased intervention vs usual care differencesin depression outcomes. Similar to research showing that focusing only onbiomedical aspects of diabetes is not an optimal treatment for patients withcomorbid diabetes mellitus and depression,21 ourresults suggest that the alternative approach of focusing on depression careonly is not likely to achieve optimal diabetes outcomes. Given that depressedpatients with diabetes mellitus have more severe disease2 andhigher numbers of behavioral risk factors (obesity, smoking, and sedentarylifestyle) than diabetic patients without depression,2,45 anintegrated biopsychosocial intervention program that focuses on improvingboth depression and diabetes mellitus management may be needed to improveclinical outcomes in both of these chronic illnesses.

This randomized trial was completed in 1 large health care system inthe Pacific Northwest, limiting generalizability. Participants had enhancedusual care, since routine care patients were encouraged to discuss depressionwith their primary care physician. Primary care physicians treated both interventionand control patients, leaving room for a spillover effect due to potentialphysician improvements in knowledge and skills in treating depression. Therelatively low baseline HbA1c levels in this primary care populationmay have limited the effectiveness of the intervention on glycemic control.These potential biases would tend to result in underestimation of the effectivenessof the intervention, not overestimation.

In conclusion, the collaborative care model used in this study seemsto be a feasible and effective approach for improving the quality of careand outcomes of depression in primary care patients with diabetes mellitus.Enhanced depression care did not result in improved glycemic control. Furtherresearch is needed to determine how to improve diabetes outcomes in patientswith depression and diabetes mellitus.

Correspondence: Wayne J. Katon, MD, HealthServices Research and Psychiatric Epidemiology, Department of Psychiatry andBehavioral Sciences, Campus Box 356560, University of Washington School ofMedicine, 1959 NE Pacific, Seattle, WA 98195-6560 (wkaton@u.washington.edu).

Accepted for Publication: April 29, 2004.

Funding/Support: This study was supported bygrants MH4-1739 and MH01643 from the National Institute of Mental Health ServicesDivision, Bethesda, Md (Dr Katon).

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Cole  MBellavance  FMarsour  A Prognosis of depression in elderly community and primary care populations:a systematic review and meta-analysis. Am J Psychiatry 1999;1561182- 1189
PubMed
Lustman  PJGriffith  LSClouse  REFreedland  KEEisen  SARubin  EHCarney  RMMcGill  JB Effects of nortriptyline on depression and glycemic control in diabetes:results of a double-blind, placebo-controlled trial. Psychosom Med 1997;59241- 250
PubMed Link to Article
Lustman  PJFreedland  KEGriffith  LSClouse  RE Fluoxetine for depression in diabetes: a randomized double-blind placebo-controlledtrial. Diabetes Care 2000;23618- 623
PubMed Link to Article
Lustman  PJGriffith  LSFreedland  KEKissel  SSClouse  RE Cognitive behavior therapy for depression in type 2 diabetes mellitus:a randomized, controlled trial. Ann Intern Med 1998;129613- 621
PubMed Link to Article
Williams  J  JrKaton  WLin  ENöel  PWorchel  JCornell  JHarpole  LFultz  BHunkeler  EMika  VUnützer  J Effectiveness of depression care management for older adults with coexistingdepression and diabetes mellitus. Ann Intern Med 2004;1401015- 1024
PubMed Link to Article
Chin  MHZhang  JXMerrell  K Specialty differences in the care of older patients with diabetes. Med Care 2000;38131- 140
PubMed Link to Article
Aubert  REHerman  WHWaters  JMoore  WSutton  DPeterson  BLBailey  CMKoplan  JP Nurse case management to improve glycemic control in diabetic patientsin a health maintenance organization: a randomized, controlled trial. Ann Intern Med 1998;129605- 612
PubMed Link to Article
Weinberger  MKirkman  MSSamsa  GPShortliffe  EALandsman  PBCowper  PASimel  DLFeussner  JR A nurse-coordinated intervention for primary care patients with non-insulin-dependentdiabetes mellitus: impact on glycemic control and health-related quality oflife. J Gen Intern Med 1995;1059- 66
PubMed Link to Article
Katon  WSimon  GRusso  JVon Korff  MLin  EHBLudman  ECiechanowski  PBush  T Quality of depression care in a population-based sample of patientswith diabetes and major depression. Med Care In press
Grant  RWHamrick  HESullivan  CMDubey  AKChueh  HCCagliero  EMeigs  JB Impact of population management with direct physician feedback on careof patients with type 2 diabetes. Diabetes Care 2003;262275- 2280
PubMed Link to Article
Derogatis  LRickels  KUnlenhuth  ECoui  C The Hopkins Symptom Checklist: a measure of primary symptom dimensions. Pichot  Ped.Psychological Measurement inPsychopharmacology: Problems in Psychopharmacology. Basel, Switzerland Kargerman1974;79- 110
McCulloch  DPrice  MHindmarsh  MWagner  E A population-based approach to diabetes management in a primary caresetting: early results and lessons learned. Eff Clin Pract 1998;112- 22
PubMed
Kroenke  KSpitzer  RLWilliams  JB The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16606- 613
PubMed Link to Article
Spitzer  RLKroenke  KWilliams  JB Validation and utility of a self-report version of PRIME-MD: the PHQprimary care study: primary care evaluation of mental disorders. Patient HealthQuestionnaire. JAMA 1999;2821737- 1744
PubMed Link to Article
Katon  WVon Korff  MLin  EWalker  ESimon  GEBush  TRobinson  PRusso  J Collaborative management to achieve treatment guidelines: impact ondepression in primary care. JAMA 1995;2731026- 1031
PubMed Link to Article
Gwirtsman  HEBlehar  MCMcCullough  JP  JrKocsis  JHPrien  RF Standardized assessment of dysthymia: report of a National Instituteof Mental Health conference. Psychopharmacol Bull 1997;333- 11
PubMed
Guy  W ECDEU Assessment Manual for Psychopharmacology.  Rockville, Md US Dept of Health, Education and Welfare, Public HealthService, Alcohol, Drug Abuse and Mental Health Administration, NIMH PsychopharmacologyResearch Branch, Division of Extramural Research Programs1976;218- 222RevisedDHEW publication WOADM 76-338
Goldstein  DELittle  RRLorenz  RAMalone  JINathan  DPeterson  CM Tests of glycemia in diabetes. Diabetes Care 1995;18896- 909
PubMed
Simon  GEVonKorff  MWagner  EHBarlow  W Patterns of antidepressant use in community practice. Gen Hosp Psychiatry 1993;15399- 408
PubMed Link to Article
Agency for Health Care Policy and Research, Depression in Primary Care: Treatment of Major Depression. 2 Rockville, Md US Dept of Health &Human Services1993;Publication AHCPR 93-0511
Katzelnick  DJKobak  KAJefferson  JWGreist  JHHenk  HJ Prescribing patterns of antidepressant medications for depression inan HMO. Formulary 1996;31374- 388
Fishman  PAGoodman  MJHornbrook  MCMeenan  RTBachman  DJO'Keeffe Rosetti  MC Risk adjustment using automated ambulatory pharmacy data: the RxRiskmodel. Med Care 2003;4184- 99
PubMed Link to Article
Starfield  BWeiner  JMumford  LSteinwachs  D Ambulatory care groups: a categorization of diagnoses for researchand management. Health Serv Res 1991;2653- 74
PubMed
Rosenzweig  JLWeinger  KPoirier-Solomon  LRushton  M Use of a disease severity index for evaluation of healthcare costsand management of comorbidities of patients with diabetes mellitus. Am J Manag Care 2002;8950- 958
PubMed
Unützer  JKaton  WCallahan  CMWilliams  JW  JrHunkeler  EHarpole  LHoffing  MPenna  RD DellaNoel  PHLin  EHArean  PAHegel  MTTang  LBelin  TROishi  SLangston  CIMPACT Investigators, Collaborative care management of late-life depression in the primarycare setting: a randomized controlled trial. JAMA 2002;2882836- 2845
PubMed Link to Article
Mynors-Wallis  LGath  DLloyd-Thomas  ATomlinson  D Randomized controlled trial comparing problem solving treatment withamitriptyline and placebo for major depression in primary care. BMJ 1995;310441- 445
PubMed Link to Article
Unützer  JIMPACT Investigators, IMPACT Intervention Manual.  Los Angeles, Calif Center for Health Services Research, UCLA NeuropsychiatricInstitute1999;
Hegel  MTBarrett  JEOxman  TE Training therapists in problem-solving treatment of depressive disordersin primary care (PST-PC): lessons learned from the Treatment EffectivenessProject. Fam Syst Health 2000;18423- 435
Link to Article
Hegel  MTArean  P Problem-solving Treatment for Primary Care (PST-PC):A Treatment Manual for Depression.  Hanover, NH Dartmouth University Press2003;
Katon  WVon Korff  MLin  ESimon  G Rethinking practitioner roles in chronic illness: the specialist, primarycare physician, and the practice nurse. Gen Hosp Psychiatry 2001;23138- 144
PubMed Link to Article
Gill  DHatcher  S Antidepressants for depression in medical illness. Cochrane Database Syst Rev 2000;4CD001312
PubMed
Katon  WRobinson  PVon Korff  MLin  EBush  TLudman  ESimon  GWalker  E A multifaceted intervention to improve treatment of depression in primarycare. Arch Gen Psychiatry 1996;53924- 932
PubMed Link to Article
Keller  MBMcCullough  JPKlein  DNArnow  BDunner  DLGelenberg  AJMarkowitz  JCNemeroff  CBRussell  JMThase  METrivedi  MHZajecka  J A comparison of nefazodone, the cognitive behavioral-analysis systemof psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med 2000;3421462- 1470
PubMed Link to Article
Kinder  LKamarck  TBaum  AOrchard  T Depressive symptomatology and coronary heart disease in type 1 diabetesmellitus: a study of possible mechanisms. Health Psychol 2002;21542- 552
PubMed Link to Article

Figures

Place holder to copy figure label and caption
Figure 1

. Recruitment for the randomized controlledtrial. Patients were eligible for baseline screening based on a Patient HealthQuestionnaire 9 score of 10 or higher. Patients were categorized as “ineligible–other”if (1) they were enrolled in another study, (2) their spouse was enrolledin the Pathways Study, (3) they were at high risk for self-harm or they refuseda self-harm assessment, or (4) they fulfilled other special circumstances(ie, there was 1 case in which the team deemed someone ineligible owing toa recent hospitalization for drug overdose).

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2

. Intervention vs control differenceson mean depression scores (range, 0-4) from the 20 depression items from theHopkins Symptoms Checklist-90 (SCL-90). Error bars indicate standard errors.The 3-, 6-, and 12-month means were adjusted for baseline. Asterisk indicates P = .04; dagger, P = .03.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3

. Intervention vs control differencesin mean hemoglobin A1c (HbA1c) levels. Error bars indicatestandard errors. The 3-, 6-, and 12-month means were adjusted for baseline.

Graphic Jump Location

Tables

Table Graphic Jump LocationTable 1. Baseline Demographic and Clinical Comparisons
Table Graphic Jump LocationTable 2. Intervention vs Control Differences in Quality of Care
Table Graphic Jump LocationTable 3. Intervention vs Control Differences in Recovery From Depression

References

Anderson  RFreedland  KClouse  RLustman  P Prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care 2001;241069- 1078
PubMed Link to Article
Katon  WVon Korff  MCiechanowski  PRusso  JLin  ESimon  GLudman  EWalker  EBush  TYoung  B Behavioral and clinical factors associated with depression among individualswith diabetes. Diabetes Care 2004;27914- 920
PubMed Link to Article
Eaton  WArmenian  HGallo  JPratt  LFord  D Depression and risk for onset of type II diabetes: a prospective population-basedstudy. Diabetes Care 1996;191097- 1102
PubMed Link to Article
Carnethon  MKinder  LFair  JStafford  RFortmann  S Symptoms of depression as a risk factor for incident diabetes: findingsfrom the National Health and Nutrition Examination Epidemiology Follow-UpStudy 1971-1992. Am J Epidemiol 2003;158416- 423
PubMed Link to Article
Ciechanowski  PSKaton  WJRusso  JEHirsch  IB The relationship of depressive symptoms to symptom reporting, self-careand glucose control in diabetes. Gen Hosp Psychiatry 2003;25246- 252
PubMed Link to Article
Ciechanowski  PSKaton  WJRusso  JE Depression and diabetes: impact of depressive symptoms on adherence,function, and costs. Arch Intern Med 2000;1603278- 3285
PubMed Link to Article
Lustman  PJAnderson  RFreedland  Kde Groot  MCarney  RMClouse  RE Depression and poor glycemic control: a meta-analytic review of theliterature. Diabetes Care 2000;23934- 942
PubMed Link to Article
de Groot  MAnderson  RFreedland  KClouse  RELustman  PJ Association of depression and diabetes complications: meta-analysis. Psychosom Med 2001;63619- 630
PubMed Link to Article
Black  SAMarkides  KSRay  LA Depression predicts increased incidence of adverse health outcomesin older persons with type 2 diabetes. Diabetes Care 2003;261822- 1828
Link to Article
Lustman  PJGriffith  LSClouse  RE Depression in adults with diabetes: results of 5-yr follow-up study. Diabetes Care 1988;11605- 612
PubMed Link to Article
Katon  WRusso  JFrank  EBarrett  JWilliams  JW  JrOxman  TSullivan  MCornell  J Predictors of nonresponse to treatment in primary care patients withdysthymia. Gen Hosp Psychiatry 2002;2420- 27
PubMed Link to Article
Cole  MBellavance  FMarsour  A Prognosis of depression in elderly community and primary care populations:a systematic review and meta-analysis. Am J Psychiatry 1999;1561182- 1189
PubMed
Lustman  PJGriffith  LSClouse  REFreedland  KEEisen  SARubin  EHCarney  RMMcGill  JB Effects of nortriptyline on depression and glycemic control in diabetes:results of a double-blind, placebo-controlled trial. Psychosom Med 1997;59241- 250
PubMed Link to Article
Lustman  PJFreedland  KEGriffith  LSClouse  RE Fluoxetine for depression in diabetes: a randomized double-blind placebo-controlledtrial. Diabetes Care 2000;23618- 623
PubMed Link to Article
Lustman  PJGriffith  LSFreedland  KEKissel  SSClouse  RE Cognitive behavior therapy for depression in type 2 diabetes mellitus:a randomized, controlled trial. Ann Intern Med 1998;129613- 621
PubMed Link to Article
Williams  J  JrKaton  WLin  ENöel  PWorchel  JCornell  JHarpole  LFultz  BHunkeler  EMika  VUnützer  J Effectiveness of depression care management for older adults with coexistingdepression and diabetes mellitus. Ann Intern Med 2004;1401015- 1024
PubMed Link to Article
Chin  MHZhang  JXMerrell  K Specialty differences in the care of older patients with diabetes. Med Care 2000;38131- 140
PubMed Link to Article
Aubert  REHerman  WHWaters  JMoore  WSutton  DPeterson  BLBailey  CMKoplan  JP Nurse case management to improve glycemic control in diabetic patientsin a health maintenance organization: a randomized, controlled trial. Ann Intern Med 1998;129605- 612
PubMed Link to Article
Weinberger  MKirkman  MSSamsa  GPShortliffe  EALandsman  PBCowper  PASimel  DLFeussner  JR A nurse-coordinated intervention for primary care patients with non-insulin-dependentdiabetes mellitus: impact on glycemic control and health-related quality oflife. J Gen Intern Med 1995;1059- 66
PubMed Link to Article
Katon  WSimon  GRusso  JVon Korff  MLin  EHBLudman  ECiechanowski  PBush  T Quality of depression care in a population-based sample of patientswith diabetes and major depression. Med Care In press
Grant  RWHamrick  HESullivan  CMDubey  AKChueh  HCCagliero  EMeigs  JB Impact of population management with direct physician feedback on careof patients with type 2 diabetes. Diabetes Care 2003;262275- 2280
PubMed Link to Article
Derogatis  LRickels  KUnlenhuth  ECoui  C The Hopkins Symptom Checklist: a measure of primary symptom dimensions. Pichot  Ped.Psychological Measurement inPsychopharmacology: Problems in Psychopharmacology. Basel, Switzerland Kargerman1974;79- 110
McCulloch  DPrice  MHindmarsh  MWagner  E A population-based approach to diabetes management in a primary caresetting: early results and lessons learned. Eff Clin Pract 1998;112- 22
PubMed
Kroenke  KSpitzer  RLWilliams  JB The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16606- 613
PubMed Link to Article
Spitzer  RLKroenke  KWilliams  JB Validation and utility of a self-report version of PRIME-MD: the PHQprimary care study: primary care evaluation of mental disorders. Patient HealthQuestionnaire. JAMA 1999;2821737- 1744
PubMed Link to Article
Katon  WVon Korff  MLin  EWalker  ESimon  GEBush  TRobinson  PRusso  J Collaborative management to achieve treatment guidelines: impact ondepression in primary care. JAMA 1995;2731026- 1031
PubMed Link to Article
Gwirtsman  HEBlehar  MCMcCullough  JP  JrKocsis  JHPrien  RF Standardized assessment of dysthymia: report of a National Instituteof Mental Health conference. Psychopharmacol Bull 1997;333- 11
PubMed
Guy  W ECDEU Assessment Manual for Psychopharmacology.  Rockville, Md US Dept of Health, Education and Welfare, Public HealthService, Alcohol, Drug Abuse and Mental Health Administration, NIMH PsychopharmacologyResearch Branch, Division of Extramural Research Programs1976;218- 222RevisedDHEW publication WOADM 76-338
Goldstein  DELittle  RRLorenz  RAMalone  JINathan  DPeterson  CM Tests of glycemia in diabetes. Diabetes Care 1995;18896- 909
PubMed
Simon  GEVonKorff  MWagner  EHBarlow  W Patterns of antidepressant use in community practice. Gen Hosp Psychiatry 1993;15399- 408
PubMed Link to Article
Agency for Health Care Policy and Research, Depression in Primary Care: Treatment of Major Depression. 2 Rockville, Md US Dept of Health &Human Services1993;Publication AHCPR 93-0511
Katzelnick  DJKobak  KAJefferson  JWGreist  JHHenk  HJ Prescribing patterns of antidepressant medications for depression inan HMO. Formulary 1996;31374- 388
Fishman  PAGoodman  MJHornbrook  MCMeenan  RTBachman  DJO'Keeffe Rosetti  MC Risk adjustment using automated ambulatory pharmacy data: the RxRiskmodel. Med Care 2003;4184- 99
PubMed Link to Article
Starfield  BWeiner  JMumford  LSteinwachs  D Ambulatory care groups: a categorization of diagnoses for researchand management. Health Serv Res 1991;2653- 74
PubMed
Rosenzweig  JLWeinger  KPoirier-Solomon  LRushton  M Use of a disease severity index for evaluation of healthcare costsand management of comorbidities of patients with diabetes mellitus. Am J Manag Care 2002;8950- 958
PubMed
Unützer  JKaton  WCallahan  CMWilliams  JW  JrHunkeler  EHarpole  LHoffing  MPenna  RD DellaNoel  PHLin  EHArean  PAHegel  MTTang  LBelin  TROishi  SLangston  CIMPACT Investigators, Collaborative care management of late-life depression in the primarycare setting: a randomized controlled trial. JAMA 2002;2882836- 2845
PubMed Link to Article
Mynors-Wallis  LGath  DLloyd-Thomas  ATomlinson  D Randomized controlled trial comparing problem solving treatment withamitriptyline and placebo for major depression in primary care. BMJ 1995;310441- 445
PubMed Link to Article
Unützer  JIMPACT Investigators, IMPACT Intervention Manual.  Los Angeles, Calif Center for Health Services Research, UCLA NeuropsychiatricInstitute1999;
Hegel  MTBarrett  JEOxman  TE Training therapists in problem-solving treatment of depressive disordersin primary care (PST-PC): lessons learned from the Treatment EffectivenessProject. Fam Syst Health 2000;18423- 435
Link to Article
Hegel  MTArean  P Problem-solving Treatment for Primary Care (PST-PC):A Treatment Manual for Depression.  Hanover, NH Dartmouth University Press2003;
Katon  WVon Korff  MLin  ESimon  G Rethinking practitioner roles in chronic illness: the specialist, primarycare physician, and the practice nurse. Gen Hosp Psychiatry 2001;23138- 144
PubMed Link to Article
Gill  DHatcher  S Antidepressants for depression in medical illness. Cochrane Database Syst Rev 2000;4CD001312
PubMed
Katon  WRobinson  PVon Korff  MLin  EBush  TLudman  ESimon  GWalker  E A multifaceted intervention to improve treatment of depression in primarycare. Arch Gen Psychiatry 1996;53924- 932
PubMed Link to Article
Keller  MBMcCullough  JPKlein  DNArnow  BDunner  DLGelenberg  AJMarkowitz  JCNemeroff  CBRussell  JMThase  METrivedi  MHZajecka  J A comparison of nefazodone, the cognitive behavioral-analysis systemof psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med 2000;3421462- 1470
PubMed Link to Article
Kinder  LKamarck  TBaum  AOrchard  T Depressive symptomatology and coronary heart disease in type 1 diabetesmellitus: a study of possible mechanisms. Health Psychol 2002;21542- 552
PubMed Link to Article

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