Jürgen Unützer

Monitoring Depression Treatment Outcomes With the Patient Health Questionnaire-9

Background:Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring, an efficient method for assessing treatment outcome is lacking. We investigated responsiveness to treatment, reproducibility, and minimal clinically important difference of the Patient Health Questionnaire-9 (PHQ-9), a standard instrument for diagnosing depression in primary care. Methods:This study included 434 intervention subjects from the IMPACT study, a multisite treatment trial of late-life depression (63% female, mean age 71 years). Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period. Test-retest reliability and minimal clinically important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart. Results:The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months (−1.3 versus −0.9) and equivalent at 6 months (−1.3 versus −1.2). With respect to structured diagnostic interviews, both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression, partial remission, and full remission. Test-retest reliability of the PHQ-9 was excellent, and its minimal clinically important difference for individual change, estimated as 2 standard errors of measurement, was 5 points on the 0 to 27 point PHQ-9 scale. Conclusions:Well-validated as a diagnostic measure, the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes. Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research.

The Effectiveness of Depression Care Management on Diabetes-Related Outcomes in Older Patients

Context Many patients have both diabetes and depression. Some hypothesize that treating depression might improve diabetes outcomes. Contribution In this randomized trial, 12 months of depression care management for depressed patients with diabetes improved depression-related outcomes and increased the frequency of exercise. However, care management did not affect diet, diabetes medication adherence, glucose testing, or glycemic control. Cautions The study sample had reasonably good diabetes control at baseline. Whether patients with poorly controlled diabetes would benefit from depression care is not known. The Editors Major depression and dysthymic disorder affect 5% to 10% of older adults seen in primary care settings (1-3). Late-life depression is often chronic or recurrent (4-6) and is associated with substantial suffering, functional impairment, and diminished health-related quality of life (7). Diabetes mellitus affects 7.8% of all adults and almost 1 in 5 of those age 60 years and older (8). Individuals with diabetes mellitus have a 2-fold higher rate of major depression than those without diabetes (9, 10). Depression adversely affects the course of coexisting medical illness, contributing to increased symptom burden, functional impairment, and mortality (11, 12). For patients with diabetes mellitus, depression is associated with decreased glycemic control and increased number of micro- and macrovascular complications (13, 14). The mechanism of effect is not understood but may be related to depression-induced abnormalities in neuroendocrine and neurotransmitter function or decreased self-care behaviors (15-20). Integrating evidence-based depression care for persons with diabetes may improve both depression and diabetes outcomes. Three small randomized, controlled trials have studied the effect of treatment for depression on affective and glycemic outcomes in patients with depression and diabetes mellitus (21-23). These studies have consistently shown improvements in affective outcomes, but effects on glycemic control have been mixed. Primary care physicians are well positioned to provide integrated care for depression and diabetes mellitus but face many barriers. Controlled trials report that treatment for depression is efficacious in approximately 70% of persons who complete treatment compared with 30% of those who receive placebo (24). However, these results are difficult to replicate in routine primary care practice. Barriers to high-quality care include suboptimal recognition; inconsistent treatment with lack of close follow-up and monitoring; and organizational barriers, such as brief visits, poor integration with specialty mental health care, competing clinical priorities, and lack of decision support systems (25-27). Simple interventions, such as depression screening and physician education, have little impact on these barriers and patient outcomes (28-30). Treatment models that use a depression specialist working collaboratively with primary care physicians have shown clinically important improvement in patient outcomes (31-37). We recently reported robust effects of such a model for older adults with major depression or dysthymia (37). In this preplanned analysis, we evaluate the effects on affective and diabetes-specific outcomes. If effective care for depression also benefits adherence to self-care regimens, functional status, and other medical illness outcomes, it would add powerful quality-of-care and economic incentives for the dissemination and maintenance of these models. In addition, if effective care for depression improves self-care behaviors, it may also positively affect other chronic medical illnesses with important self-care components. For this prespecified subgroup analysis, we focused on older adults with clinical depression and coexisting diabetes mellitus. We hypothesized that the collaborative care intervention would improve affective symptoms, functional status, self-care behaviors, and glycemic control. In addition, we hypothesized that effects on glycemic control would be greatest for patients with baseline hemoglobin A1c values of 8.0% or greater. Methods The Improving MoodPromoting Access to Collaborative Treatment (IMPACT) study is a multisite randomized, controlled trial of a collaborative care intervention program for late-life depression in primary care (37, 38). Institutional review boards at participating sites approved study protocols, and all participants gave written informed consent. Patients Seven study sites representing 8 diverse health care organizations with a total of 18 primary care clinics in 5 states participated in the study. From July 1999 to August 2001, depressed older adults were recruited through referrals from primary care practitioners and other clinic staff or through systematic depression screening with a 2-item depression screener adapted from the Primary Care Evaluation of Mental Disorders (39). Of the 2190 patients referred to the study, 308 (14%) declined the initial eligibility screening or additional interviews, 54 (3%) had incomplete initial screenings, and 202 (9%) were ineligible because they were younger than 60 years of age or they did not plan to use the participating clinic over the coming 12 months. Of the 32908 patients approached for screening, 5246 (16%) declined the initial screening or follow-up interviews. A total of 1791 (5%) of the initial screenings were incomplete and 23233 (71%) of those screened were not eligible because they did not have one of the core depression symptoms (95%) or because of logistic reasons such as lack of transportation or access to a telephone (5%). The remaining 1626 (74%) of those referred and 2638 (8%) of those screened completed a computer-assisted structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), to assess whether patients met research diagnostic criteria for major depression or dysthymia (40). Inclusion criteria were age 60 years or older, plans to use one of the participating clinics as the main source of general medical care in the coming year, and a diagnosis of current major depression or dysthymic disorder according to the structured clinical interview for DSM-IV. Otherwise eligible persons were excluded because of a current drinking problem (a score of 2 on the CAGE questionnaire) (41), a history of bipolar disorder or psychosis (38), ongoing treatment with a psychiatrist, or severe cognitive impairment defined by a score less than 3 on a 6-item cognitive screener (42). We identified 2102 eligible older adults with major depression or dysthymic disorder, of whom 1801 (86%) enrolled in the study. As part of the structured baseline interview, enrolled patients were asked Has a doctor or another health care worker diagnosed you with or treated you for high blood sugar or diabetes in the past 3 years? The 417 patients who endorsed this question are the focus of the diabetes-specific analyses. After the baseline interview, we randomly assigned participants to the IMPACT intervention or usual care. The randomization was stratified by recruitment method (screening or referral) and clinic. Randomization information was contained in a set of numbered, sealed envelopes for each stratum that were used sequentially for newly enrolled patients at each clinic (38). Diagnoses were communicated to enrolled patients and their primary care physicians. Intervention Patients in the intervention group received a 20-minute educational videotape and a booklet about late-life depression and were encouraged to have an initial visit with a depression care manager at the primary care clinic (43, 44). Care managers were nurses or psychologists who were trained for the study as a depression clinical specialist (38, 45). During the initial visit, the depression clinical specialist conducted a clinical and psychosocial history, reviewed the educational materials, and discussed patient preferences for depression treatment (antidepressant medications or psychotherapy). New patients and patients needing treatment plan adjustments were discussed with a supervising team psychiatrist and a liaison primary care physician during a weekly team meeting. The depression clinical specialist then worked with the patient and his or her regular primary care provider to establish a treatment plan according to an evidence-based treatment algorithm (38). The IMPACT algorithm suggested an initial choice of an antidepressant (usually a selective serotonin reuptake inhibitor) or a course of Problem-Solving Treatment in Primary Care (PST-PC), which consisted of 6 to 8 brief sessions of structured psychotherapy for depression, delivered by the depression clinical specialist in primary care (46-49). For patients who were already receiving antidepressant medications but who were still depressed, the recommendation for partial responders was to increase the dose or augment the antidepressant with a trial of PSTPC; the recommendation for nonresponders was to switch to a different medication or use a trial of PSTPC. Depression clinical specialists also encouraged patients to increase behavioral activation and referred them to additional health or social services, as clinically indicated. The intervention did not specifically address diabetes mellitus or other coexisting medical illnesses. As care managers, depression clinical specialists attempted to follow patients for up to 12 months; they monitored treatment response with the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (50) and a Web-based clinical information system (51). During the acute treatment phase, in-person or telephone follow-up contacts were suggested at least every other week. Patients who recovered from depression ( 50% reduction in the Patient Health Questionnaire score and <3 of 9 symptoms of major depression) were engaged in developing a relapse prevention plan and were then follo

Long term outcomes from the IMPACT randomised trial for depressed elderly patients in primary care

Abstract Objective To determine the long term effectiveness of collaborative care management for depression in late life. Design Two arm, randomised, clinical trial; intervention one year and follow-up two years. Setting 18 primary care clinics in eight US healthcare organisations. Patients 1801 primary care patients aged 60 and older with major depression, dysthymia, or both. Intervention Patients were randomly assigned to a 12 month collaborative care intervention (IMPACT) or usual care for depression. Teams including a depression care manager, primary care doctor, and psychiatrist offered education, behavioural activation, antidepressants, a brief, behaviour based psychotherapy (problem solving treatment), and relapse prevention geared to each patients needs and preferences. Main outcome measures Interviewers, blinded to treatment assignment, conducted interviews in person at baseline and by telephone at each subsequent follow up. They measured depression (SCL-20), overall functional impairment and quality of life (SF-12), physical functioning (PCS-12), depression treatment, and satisfaction with care. Results IMPACT patients fared significantly (P < 0.05) better than controls regarding continuation of antidepressant treatment, depressive symptoms, remission of depression, physical functioning, quality of life, self efficacy, and satisfaction with care at 18 and 24 months. One year after IMPACT resources were withdrawn, a significant difference in SCL-20 scores (0.23, P < 0.0001) favouring IMPACT patients remained. Conclusions Tailored collaborative care actively engages older adults in treatment for depression and delivers substantial and persistent long term benefits. Benefits include less depression, better physical functioning, and an enhanced quality of life. The IMPACT model may show the way to less depression and healthier lives for older adults.

Treatment costs, cost offset, and cost-effectiveness of collaborative management of depression

Objective This report estimates the treatment costs, cost-offset effects, and cost-effectiveness of Collaborative Care of depressive illness in primary care. Study Design Treatment costs, cost-offset effects, and cost-effectiveness were assessed in two randomized, controlled trials. In the first randomized trial (N = 217), consulting psychiatrists provided enhanced management of pharmacotherapy and brief psychoeducational interventions to enhance adherence. In the second randomized trial (N = 153), Collaborative Care was implemented through brief cognitive-behavioral therapy and enhanced patient education. Consulting psychologists provided brief psychotherapy supplemented by educational materials and enhanced pharmacotherapy management. Results Collaborative Care increased the costs of treating depression largely because of the extra visits required to provide the interventions. There was a modest cost offset due to reduced use of specialty mental health services among Collaborative Care patients, but costs of ambulatory medical care services did not differ significantly between the intervention and control groups. Among patients with major depression there was a modest increase in cost-effectiveness. The cost per patient successfully treated was lower for Collaborative Care than for Usual Care patients. For patients with minor depression, Collaborative Care was more costly and not more cost-effective than Usual Care. Conclusions Collaborative Care increased depression treatment costs and improved the cost-effectiveness of treatment for patients with major depression. A cost offset in specialty mental health costs, but not medical care costs, was observed. Collaborative Care may provide a means of increasing the value of treatment services for major depression.

Improving primary care for depression in late life: the design of a multicenter randomized trial.

Background.Late life depression can be successfully treated with antidepressant medications or psychotherapy, but few depressed older adults receive effective treatment. Research Design. A randomized controlled trial of a disease management program for late life depression. Subjects.Approximately 1,750 older adults with major depression or dysthymia are recruited from seven national study sites. Intervention.Half of the subjects are randomly assigned to a collaborative care program where a depression clinical specialist supervised by a psychiatrist and a primary care expert supports the patient’s regular primary care provider to treat depression. Intervention services are provided for 12 months using antidepressant medications and Problem Solving Treatment in Primary Care according to a stepped care protocol that varies intervention intensity according to clinical needs. The other half of the subjects are assigned to care as usual. Evaluation.Subjects are independently assessed at baseline, 3 months, 6 months, 12 months, 18 months, and 24 months. The evaluation assesses the incremental cost-effectiveness of the intervention compared with care as usual. Specific outcomes examined include care for depression, depressive symptoms, health-related quality of life, satisfaction with depression care, health care costs, patient time costs, market and nonmarket productivity, and household income. Conclusions.The study blends methods from health services and clinical research in an effort to protect internal validity while maximizing the generalizability of results to diverse health care systems. We hope that this study will show the cost-effectiveness of a new model of care for late life depression that can be applied in a range of primary care settings.

Five-Year Impact of Quality Improvement for Depression Results of a Group-Level Randomized Controlled Trial

BACKGROUND Quality improvement (QI) programs for depressed primary care patients can improve health outcomes for 6 to 28 months; effects for longer than 28 months are unknown. OBJECTIVE To assess how QI for depression affects health outcomes, quality of care, and health outcome disparities at 57-month follow-up. DESIGN A group-level randomized controlled trial. SETTING Forty-six primary care practices in 6 managed care organizations. PATIENTS Of 1356 primary care patients who screened positive for depression and enrolled in the trial, 991 (73%, including 451 Latinos and African Americans) completed 57-month telephone follow-up. INTERVENTIONS Clinics were randomly assigned to usual care or to 1 of 2 QI programs supporting QI teams, provider training, nurse assessment, and patient education, plus resources to support medication management (QI-meds) or psychotherapy (QI-therapy) for 6 to 12 months. MAIN OUTCOME MEASURES Probable depressive disorder in the previous 6 months, mental health-related quality of life in the previous 30 days, primary care or mental health specialty visits, counseling or antidepressant medications in the previous 6 months, and unmet need, defined as depressed but not receiving appropriate care. RESULTS Combined QI-meds and QI-therapy, relative to usual care, reduced the percentage of participants with probable disorder at 5 years by 6.6 percentage points (P =.04). QI-therapy improved health outcomes and reduced unmet need for appropriate care among Latinos and African Americans combined but provided few long-term benefits among whites, reducing outcome disparities related to usual care (P =.04 for QI-ethnicity interaction for probable depressive disorder). CONCLUSIONS Programs for QI for depressed primary care patients implemented by managed care practices can improve health outcomes 5 years after implementation and reduce health outcome disparities by markedly improving health outcomes and unmet need for appropriate care among Latinos and African Americans relative to whites; thus, equity was improved in the long run.

Regular use of prescribed opioids: association with common psychiatric disorders.

Abstract Use of opioids for chronic non‐cancer pain is increasing, but the clinical epidemiology and standards of care for this practice are poorly defined. Psychiatric disorders are associated with increased physical symptoms and may be associated with opioid use. We performed a secondary analysis of cross‐sectional data from the Health Care for Communities (HCC) survey conducted in 1997–1998 (N=9279) to determine the association of psychiatric disorders and self‐reported regular use of prescribed opioids within the past year. Regular prescription opioid use was reported by 282 (3%) respondents. In unadjusted logistic regression models, respondents with common mental disorders in the past year (major depression, dysthymia, generalized anxiety disorder, or panic disorder) were more likely to report regular prescription opioid use than those without any of these disorders (OR=6.15, 95% CI=4.13, 9.14, P< 0.001). Respondents reporting problem drug use (OR=4.75, 95% CI=2.52, 8.94, P<0.001), or problem alcohol use (OR=1.89, 95% CI=1.03, 3.40, P=.041) reported higher rates of prescribed opioid use than those without problem use. In multivariate logistic regression models controlling for demographic and clinical variables, the presence of a common mental disorder remained a significant predictor of prescription opioid use (OR=3.15, 95% CI=1.69, 5.88, P<0.001), among individuals reporting low pain interference (N=8307); but not (OR=1.27, n.s.) among those reporting high pain interference (N=972). Depressive, anxiety and drug abuse disorders are associated with increased use of regular opioids in the general population. Depressive and anxiety disorders are more common and more strongly associated with prescribed opioid use than drug abuse disorders.

Improving depression care for older, minority patients in primary care

Objective:Few older minorities receive adequate treatment of depression in primary care. This study examines whether a collaborative care model for depression in primary care is as effective in older minorities as it is in nonminority elderly patients in improving depression treatment and outcomes. Study Design:A multisite randomized clinical trial of 1801 older adults comparing collaborative care for depression with treatment as usual in primary care. Twelve percent of the sample were black (n = 222), 8% were Latino (n = 138), and 3% (n = 53) were from other minority groups. We compared the 3 largest ethnic groups (non-Latino white, black, and Latino) on depression severity, quality of life, and mental health service use at baseline, 3, 6, and 12 months after randomization to collaborative care or usual care. Principal Findings:Compared with care as usual, collaborative care significantly improved rates and outcomes of depression care in older adults from ethnic minority groups and in older whites. At 12 months, intervention patients from ethnic minorities (blacks and Latinos) had significantly greater rates of depression care for both antidepressant medication and psychotherapy, lower depression severity, and less health-related functional impairment than usual care participants (64%, 95% confidence interval [CI] 55–72 versus 45%, CI 36–55, P = 0.003 for antidepressant medication; 37%, CI 28–47 versus 13%, CI 6–19, P = 0.002 for psychotherapy; mean = 0.9, CI 0.8–1.1 versus mean = 1.4, CI 1.3–1.5, P < 0.001 for depression severity, range 0–4; mean = 3.7, CI 3.2–4.1, versus mean = 4.7, CI 4.3–5.1, P < 0.0001 for functional impairment, range 0–10). Conclusions:Collaborative Care is significantly more effective than usual care for depressed older adults, regardless of their ethnicity. Intervention effects in ethnic minority participants were similar to those observed in whites.

Stigma and depression among primary care patients

We assessed stigma affecting employment, health insurance, and friendships in 1,187 depressed patients from 46 U.S. primary care clinics. We compared stigma associated with depression, HIV, diabetes, and hypertension. Finally, we examined the association of depression-related stigma with health services use and unmet need for mental health care during a 6-month follow-up. We found that 67% of depressed primary care patients expected depression related stigma to have a negative effect on employment, 59% on health insurance, and 24% on friendships. Stigma associated with depression was greater than for hypertension or diabetes but not HIV. Younger men reported less stigma affecting employment. Women had more employment-related stigma but this was somewhat mitigated by social support. Other factors associated with stigma included ethnicity (associated with health insurance stigma) and number of chronic medical conditions (associated with health insurance and friendship related stigma). Stigma was not associated with service use, but individuals with stigma concerns related to friendships reported greater unmet mental health care needs. In summary, stigma was common in depressed primary care patients and related to age, gender, ethnicity, social support and chronic medical conditions. The relationship between stigma and service use deserves further study in diverse settings and populations.

Depression and Diabetes: A Potentially Lethal Combination

ObjectiveTo assess whether Medicare fee-for-service beneficiaries with depression and diabetes had a higher mortality rate over a 2-year period compared with beneficiaries with diabetes alone.DesignEvidence of depression was based on a physician diagnosis or self-reported prescription of an antidepressant in the year prior to screening, or a score of ≥3 on the Patient Health Questionnaire two-item questionnaire. Mortality was assessed bi-monthly by checking Medicare claims and eligibility files or from information from telephone contact with the participant’s family. Cox proportional hazard regression models were used to calculate adjusted hazard ratios of death in depressed versus nondepressed beneficiaries with diabetes.ParticipantsA total of 10,704 beneficiaries with diabetes enrolled in a disease management program were surveyed with a health assessment questionnaire and followed over a two-year period. Main ResultsComorbid depression in Medicare beneficiaries with diabetes participating in a disease management program was associated with an increased risk for all-cause mortality over a two-year period of approximately 36% to 38%, depending on the definition of depression that was used. No significant increase in rates of cause-specific mortality from macrovascular disease were found in depressed versus nondepressed beneficiaries.ConclusionAmong a large Medicare cohort of fee-for-service beneficiaries with diabetes, comorbid depression was associated with an increase in all-cause mortality over a two-year period. Future research will be required to determine whether the increase in mortality associated with depression is due to potential behavioral mediators (i.e., smoking, poor adherence to diet) or physiologic abnormalities (i.e., hypothalamic-pituitary axis dysregulation) associated with depression.