The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India.

INTRODUCTION: Depression and diabetes are highly prevalent worldwide and often co-exist, worsening outcomes for each condition. Barriers to diagnosis and treatment are exacerbated in low and middle-income countries with limited health infrastructure and access to mental health treatment. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study tests the sustained effectiveness and cost-effectiveness of a multi-component care model for individuals with poorly-controlled diabetes and depression in diabetes clinics in India. MATERIALS AND METHODS: Adults with diabetes, depressive symptoms (Patient Health Questionnaire-9 score≥10), and ≥1 poorly-controlled cardiometabolic indicator (either HbA1c≥8.0%, SBP≥140mmHg, and/or LDL≥130mg/dl) were enrolled and randomized to the intervention or usual care. The intervention combined collaborative care, decision-support, and population health management. The primary outcome is the between-arm difference in the proportion of participants achieving combined depression response (≥50% reduction in Symptom Checklist score from baseline) AND one or more of: ≥0.5% reduction in HbA1c, ≥5mmHg reduction in SBP, or ≥10mg/dl reduction in LDL-c at 24months (12-month intervention; 12-month observational follow-up). Other outcomes include control of individual parameters, patient-centered measures (i.e. treatment satisfaction), and cost-effectiveness. RESULTS: The study trained seven care coordinators. Participant recruitment is complete - 940 adults were screened, with 483 eligible, and 404 randomized (196 to intervention; 208 to usual care). Randomization was balanced across clinic sites. CONCLUSIONS: The INDEPENDENT model aims to increase access to mental health care and improve depression and cardiometabolic disease outcomes among complex patients with diabetes by leveraging the care provided in diabetes clinics in India (clinicaltrials.gov number: NCT02022111).

Composite International Diagnostic Interview screening scales for DSM-IV anxiety and mood disorders.

BACKGROUND: Lack of coordination between screening studies for common mental disorders in primary care and community epidemiological samples impedes progress in clinical epidemiology. Short screening scales based on the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI), the diagnostic interview used in community epidemiological surveys throughout the world, were developed to address this problem. METHOD: Expert reviews and cognitive interviews generated CIDI screening scale (CIDI-SC) item pools for 30-day DSM-IV-TR major depressive episode (MDE), generalized anxiety disorder (GAD), panic disorder (PD) and bipolar disorder (BPD). These items were administered to 3058 unselected patients in 29 US primary care offices. Blinded SCID clinical reinterviews were administered to 206 of these patients, oversampling screened positives. RESULTS: Stepwise regression selected optimal screening items to predict clinical diagnoses. Excellent concordance [area under the receiver operating characteristic curve (AUC)] was found between continuous CIDI-SC and DSM-IV/SCID diagnoses of 30-day MDE (0.93), GAD (0.88), PD (0.90) and BPD (0.97), with only 9-38 questions needed to administer all scales. CIDI-SC versus SCID prevalence differences are insignificant at the optimal CIDI-SC diagnostic thresholds (χ2 1 = 0.0-2.9, p = 0.09-0.94). Individual-level diagnostic concordance at these thresholds is substantial (AUC 0.81-0.86, sensitivity 68.0-80.2%, specificity 90.1-98.8%). Likelihood ratio positive (LR+) exceeds 10 and LR- is 0.1 or less at informative thresholds for all diagnoses. CONCLUSIONS: CIDI-SC operating characteristics are equivalent (MDE, GAD) or superior (PD, BPD) to those of the best alternative screening scales. CIDI-SC results can be compared directly to general population CIDI survey results or used to target and streamline second-stage CIDIs.

Behavioural factors associated with symptom outcomes in a primary care-based depression prevention intervention trial.

BACKGROUND: A randomized trial of a primary care-based intervention to prevent depression relapse resulted in improved adherence to long-term antidepressant medication and depression outcomes. We evaluated the effects of this intervention on behavioural processes and identified process predictors of improved depressive symptoms. METHOD: Patients at high risk for depression recurrence or relapse following successful acute phase treatment (N=386) were randomly assigned to receive a low intensity 12-month intervention or continued usual care. The intervention combined education about depression, shared decision-making regarding use of maintenance pharmacotherapy and cognitive-behavioural strategies to promote self-management. Baseline, 3, 6, 9 and 12-month interviews assessed patients' self-care practices, self-efficacy for managing depression and depressive symptoms. RESULTS: Intervention patients had significantly greater self-efficacy for managing depression (P<0.01) and were more likely to keep track of depressive symptoms (P<0.0001), monitor early warning signs (P<0.0001), and plan for coping with high risk situations (P<0.0001) at all time points compared to usual care control patients. Self-efficacy for managing depression (P<0.0001), keeping track of depressive symptoms (P=0.05), monitoring for early warning signs (P=0.01), engaging in pleasant activities (P<0.0001) and engaging in social activities (P<0.0001) positively predicted improvements in depression symptom scores. CONCLUSIONS: A brief intervention designed to target cognitive-behavioural factors and promote adherence to pharmacotherapy in order to prevent depression relapse was highly successful in changing several behaviours related to controlling depression. Improvements in self-efficacy and several self-management behaviours that were targets of the intervention were significantly related to improvements in depression outcome.

Psychiatric illness and subsequent traumatic brain injury: a case control study.

OBJECTIVE: To determine whether psychiatric illness is a risk factor for subsequent traumatic brain injury (TBI). METHODS: Case control study in a large staff model health maintenance organisation in western Washington State. Patients with TBI, determined by International classification of diseases, 9th revision, clinical modification (ICD-9-CM) diagnoses, were 1440 health plan members who had TBI diagnosed in 1993 and who had been enrolled in the previous year, during which no TBI was ascertained. Three health plan members were randomly selected as control subjects, matched by age, sex, and reference date. Psychiatric illness in the year before the TBI reference date was determined by using computerised records of ICD-9-CM diagnoses, psychiatric medication prescriptions, and utilisation of a psychiatric service. RESULTS: For those with a psychiatric diagnosis in the year before the reference date, the adjusted relative risk for TBI was 1.7 (95% confidence interval (CI) 1.4 to 2.0) compared with those without a psychiatric diagnosis. Patients who had filled a psychiatric medication prescription had an adjusted relative risk for TBI of 1.6 (95% CI 1.2 to 2.1) compared with those who had not filled a psychiatric medication prescription. Patients who had utilised psychiatric services had an adjusted relative risk for TBI of 1.3 (95% CI 1.0 to 1.6) compared with those who had not utilised psychiatric services. The adjusted relative risk for TBI for patients with psychiatric illness determined by any of the three psychiatric indicators was 1.6 (95% CI 1.4 to 1.9) compared with those without any psychiatric indicator. CONCLUSION: Psychiatric illness appears to be associated with an increased risk for TBI.

Status of minor depression or dysthymia in primary care following a randomized controlled treatment.

This report describes the rates of recovery and remission from minor depression or dysthymia in primary care patients three months after completing a randomized controlled treatment trial. The subjects were primary care patients who received > or =4 treatment sessions with Problem-Solving Treatment, paroxetine, or placebo and who completed an independent assessment 3 months after the study (201 with minor depression, 229 with dysthymia). The 17-item Hamilton Rating Scale for Depression (HAMD), semistructured questions about postintervention depression treatments, and baseline medical comorbidity, neuroticism, and social function were the primary measures. For minor depression 76% and for dysthymia 68% of subjects who were in remission at the end of the 11-week treatment trial were recovered (HAMD < or =6) three months after the treatment trial. Of patients who were not in remission at 11 weeks, for minor depression 37% and for dysthymia 31% went on to achieve remission at 25 weeks. The majority of patients chose not to use antidepressants or psychotherapy after the trial. Patients with minor depression that had greater baseline social function and lower neuroticism scores were more likely to be recovered. For patients with minor depression, these findings suggest a need for some matching of continuation and maintenance treatment to patient characteristics rather than uniform, automatic treatment recommendations. Because of the chronic, relapsing nature of dysthymia, practical improvements in encouraging effective continuation and maintenance phases of treatment are indicated.

Two-year effects of quality improvement programs on medication management for depression.

BACKGROUND: Significant underuse of evidence-based treatments for depression persists in primary care. We examined the effects of 2 primary care-based quality improvement (QI) programs on medication management for depression. METHODS: A total of 1356 patients with depressive symptoms (60% with depressive disorders and 40% with subthreshold depression) from 46 primary care practices in 6 nonacademic managed care organizations were enrolled in a randomized controlled trial of QI for depression. Clinics were randomized to usual care or to 1 of 2 QI programs that involved training of local experts who worked with patients' regular primary care providers (physicians and nurse practitioners) to improve care for depression. In the QI-medications program, depression nurse specialists provided patient education and assessment and followed up patients taking antidepressants for up to 12 months. In the QI-therapy program, depression nurse specialists provided patient education, assessment, and referral to study-trained psychotherapists. RESULTS: Participants enrolled in both QI programs had significantly higher rates of antidepressant use than those in the usual care group during the initial 6 months of the study (52% in the QI-medications group, 40% in the QI-therapy group, and 33% in the usual care group). Patients in the QI-medications group had higher rates of antidepressant use and a reduction in long-term use of minor tranquilizers for up to 2 years, compared with patients in the QI-therapy or usual care group. CONCLUSIONS: Quality improvement programs for depression in which mental health specialists collaborate with primary care providers can substantially increase rates of antidepressant treatment. Active follow-up by a depression nurse specialist in the QI-medications program was associated with longer-term increases in antidepressant use than in the QI model without such follow-up.

Stressful life events and impulsiveness in failed suicide.

The relationship of recent stressful life events with impulsiveness in triggering suicide attempts and how impulsiveness changes from one suicide attempt to another is unclear. This study used structured-interview tools and standardized measurements to examine the relationship between life stress and impulsiveness in a sample of patients who required hospitalization for a medically serious suicide attempt. After controlling for potentially confounding variables, the number of disrupted interpersonal relationships in the preceding year was a significant predictor of the impulsiveness of the suicide attempt, with three or more losses (but not other life stresses) associated with less impulsive attempts (T = 2.4, p = .02). Female gender (T = -1.98, p = .05) and lifetime DMS-III-R diagnoses (T = -2.45, p = .02) were significantly associated with more impulsive attempts. In 55 patients with at least two suicide attempts, impulsiveness, lethal intent, and communication of intent were significantly greater for the present compared to the prior attempt (p = 0.000). Certain stressful life events, gender, and total lifetime DSM-III-R diagnoses are associated with impulsiveness of failed suicide attempts; yet, impulsiveness is not necessarily consistent from one suicide attempt to another. This evidence supports and amplifies a stress-diathesis model of suicide behavior. Accordingly, efforts to increase personal resilience in individuals who have "failed suicide" may be more effective at preventing suicide morbidity than simple stress-reduction measures alone.

Cost-effectiveness of a collaborative care program for primary care patients with persistent depression.

OBJECTIVE: The authors evaluated the incremental cost-effectiveness of stepped collaborative care for patients with persistent depressive symptoms after usual primary care management. METHOD: Primary care patients initiating antidepressant treatment completed a standardized telephone assessment 6-8 weeks after the initial prescription. Those with persistent major depression or significant subthreshold depressive symptoms were randomly assigned to continued usual care or collaborative care. The collaborative care included systematic patient education, an initial visit with a consulting psychiatrist, 2-4 months of shared care by the psychiatrist and primary care physician, and monitoring of follow-up visits and adherence to medication regimen. Clinical outcomes were assessed through blinded telephone assessments at 1, 3, and 6 months. Health services utilization and costs were assessed through health plan claims and accounting data. RESULTS: Patients receiving collaborative care experienced a mean of 16.7 additional depression-free days over 6 months. The mean incremental cost of depression treatment in this program was $357. The additional cost was attributable to greater expenditures for antidepressant prescriptions and outpatient visits. No offsetting decrease in use of other health services was observed. The incremental cost-effectiveness was $21.44 per depression-free day. CONCLUSIONS: A stepped collaborative care program for depressed primary care patients led to substantial increases in treatment effectiveness and moderate increases in costs. These findings are consistent with those of other randomized trials. Improving outcomes of depression treatment in primary care requires investment of additional resources, but the return on this investment is comparable to that of many other widely accepted medical interventions.

A randomized effectiveness trial of collaborative care for patients with panic disorder in primary care.

BACKGROUND: Effectiveness studies have tested interventions to improve quality of care for depression in primary care, but none, to our knowledge, have been completed for panic disorder (PD) in this setting. This study sought to test the clinical effectiveness of PD pharmacotherapy embedded in a disease management framework of "collaborative care" (CC). METHODS: One hundred fifteen patients with PD from 3 primary care clinics were randomized to CC or "usual care" (UC). Patients in CC (n = 57) received educational videotapes and pamphlets; pharmacotherapy with the selective serotonin reuptake inhibitor paroxetine; 2 psychiatrist visits and 2 telephone calls in the first 8 weeks; and up to 5 telephone calls between 3 and 12 months' follow-up. Usual care patients (n = 58) were treated by their primary care physician. Telephone assessments of panic, anxiety sensitivity, depression, and disability variables were performed at 3, 6, 9, and 12 months' follow-up. Adequacy of pharmacotherapy was assessed with an algorithm based on a review of efficacy studies. RESULTS: Patients in CC were more likely to receive adequate (type, dose, duration) medication and more likely to adhere to this medication at 3 and 6 months. Random regression analyses showed that CC patients improved significantly more over time compared with UC patients on anxiety, depression, and disability measures, with the greatest effects at 3 and 6 months. CONCLUSIONS: Compared with UC, CC interventions significantly improved both quality of care and clinical and functional outcomes in primary care PD patients. Clinical differences were greatest in the first 6 months, corresponding to the greater quality of care and the greater intensity of intervention.

Prospective study of the natural history of infectious mononucleosis caused by Epstein-Barr virus.

BACKGROUND: Knowledge regarding the clinical characteristics and natural history of acute infectious mononucleosis is based largely on older, often retrospective, studies without systematic follow-up. Differences in diagnosis, methodology, or treatment between historical and current practice might affect an understanding of this illness. METHODS: Using a prospective case series design, we enrolled 150 persons with an acute illness serologically confirmed as Epstein-Barr virus infection. The goal of the study was to assess symptoms, physical examination findings, laboratory tests, and functional status measures during the acute presentation and 1, 2, and 6 months later. RESULTS: Acutely, infectious mononucleosis was characterized by the symptoms of sore throat and fatigue and substantial functional impairment. Objective physical and laboratory examination findings included pharyngitis and cervical lymphadenopathy, a moderate absolute and atypical lymphocytosis, and mildly elevated transaminase levels. The traditional signs of fever and splenomegaly were relatively uncommon. By 1 month, most symptoms and signs and all laboratory tests had returned to normal. Fatigue, cervical lymphadenopathy, pharyngitis, and functional health status improved more slowly. CONCLUSIONS: In contemporary practice most of the classical illness features of infectious mononucleosis are observed. Symptoms, signs, and poor functioning might be protracted in some patients.

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.

Improving depression care: barriers, solutions, and research needs.

Potential solutions for barriers to improved organization of care of depressive illness were identified. These included (1) aligning efforts to improve depression care with broader strategies for improving care of other chronic conditions; (2) increasing the availability of depression case management services in primary care; (3) developing registries and reminder systems to ensure active follow-up of depressed patients; (4) achieving agreement on how depression outcomes should be measured to provide outcomes-based performance standards; (5) providing greater support from mental health specialists for management of depressed patients by primary care providers; (6) campaigns to reduce the stigma associated with treatment of depressive illness; (7) increased dissemination of interventions that activate and empower patients managing a depressive illness; (8) redefining the lack of time of primary care providers for high-quality depression care as issues in organization of care and provider training; and (9) development of incentives (organizational or financial) for high-quality depression care. Research needs were identified according to what has been learned to date. Identified research needs included: studies of approaches to organization of case management, research in new populations (e.g., new diagnostic groups, rural populations, the disadvantaged, the elderly, and those with chronic medical illnesses), research on stepped care and relapse prevention strategies, evaluation of the societal benefits of improved depression care, and multisite trials and meta-analytic approaches that can provide adequate statistical power to assess societal benefits of improved care.

Somatic complaints among pregnant women cared for in obstetrics: normal pregnancy or depressive and anxiety symptom amplification revisited?

Despite the extensive research documenting the significance of medically unexplained somatic symptoms in primary care patients, few studies have examined somatic symptoms as a predictor of depressive and anxiety disorders among pregnant women cared for in Obstetrics. We utilized the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PHQ) to assess current depressive and anxiety disorders and self-reported somatic symptoms among 186 women receiving prenatal care. We examined the bivariate relationships between depressive and anxiety disorders and mean number of somatic symptoms. Linear regression analyses assessed the unique association between maternal depression, anxiety and somatic symptoms, while controlling for selected demographics and maternal medical risk. Twenty three percent (N=43) of women met screening criteria for depressive and/or anxiety disorders. Women with depression and/or anxiety were significantly more likely to report somatic symptoms (mean=7.1, SD=2.6) compared to women without depression or anxiety (mean=5.0, SD=2.6) [t(df)=4.54(184), P<.001]. This association persisted in multivariate models. Our findings suggest that antenatal depressive and anxiety disorders are associated with an amplification of physical symptoms of pregnancy. Eliciting and tracking somatic symptoms during prenatal visits could potentially improve detection of depressive and anxiety disorders in the obstetrical sector.

Collaborative interventions for physically injured trauma survivors: a pilot randomized effectiveness trial.

Posttraumatic behavioral and emotional disturbances occur frequently among physically injured hospitalized trauma survivors. This investigation was a pilot randomized effectiveness trial of a 4-month collaborative care intervention for injured motor vehicle crash and assault victims. As surgical inpatients, intervention subjects (N=16) were assigned to a trauma support specialist who provided counseling, consulted with surgical and primary care providers, and attempted postdischarge care coordination. Control subjects (N=18) received usual posttraumatic care. For all participants, posttraumatic stress disorder (PTSD) and depressive symptoms, episodic alcohol intoxication, and functional limitations were evaluated during the hospitalization and 1 and 4 months postinjury. Study logs and field notes revealed that over 75% of intervention activity occurred in the first month after the trauma. One-month post-trauma intervention subjects when compared to controls demonstrated statistically significant decreases in PTSD symptoms as well as a reduction in depressive symptoms. However, at the 4-month assessment, intervention subjects evidenced no significant improvements in PTSD and depressive symptoms, episodic alcohol intoxication, or functional limitations. Future larger scale trials of stepped collaborative care interventions for physically injured trauma survivors are recommended.

Rethinking practitioner roles in chronic illness: the specialist, primary care physician, and the practice nurse.

In this article, we describe an evidence-based stepped care approach to improving the care of chronic illness in organized health care systems. We review the common principles that have been found to improve the management and outcomes of patients with major depression, asthma, diabetes, and congestive heart failure. These population-based methods to improve care of chronic illness require reorganizing the roles of specialists, primary care physicians, and nurses.

Medical symptoms without identified pathology: relationship to psychiatric disorders, childhood and adult trauma, and personality traits.

Community studies have shown that stressful life events, psychological distress, and depressive and anxiety disorders are associated with 1) a range of medical symptoms without identified pathology, 2) increased health care utilization, and 3) increased costs. In both primary care and medical specialty samples, patients who have syndromes with ill-defined pathologic mechanisms (such as the irritable bowel syndrome and fibromyalgia) have been shown to have significantly higher rates of anxiety and depressive disorders than do patients with comparable, well-defined medical diseases and similar symptoms. Other studies show that after adjustment for severity of medical illness, patients with depression or anxiety and comorbid medical disease have significantly more medical symptoms without identified pathology than do patients with a similar medical disease alone. Both childhood maltreatment and psychological trauma in adulthood have been associated with increased vulnerability to psychiatric illness and more medical symptoms. The substantial functional impairment, distress, and costs associated with medical symptoms without identified pathology suggest that research studies promoting a better understanding of the biopsychosocial cause of these symptoms may yield pragmatic, cost-effective approaches to treatment in medical settings.

Treatment of dysthymia and minor depression in primary care: a randomized trial in patients aged 18 to 59 years.

OBJECTIVE: The researchers evaluated the effectiveness of paroxetine and Problem-Solving Treatment for Primary Care (PST-PC) for patients with minor depression or dysthymia. STUDY DESIGN: This was an 11-week randomized placebo-controlled trial conducted in primary care practices in 2 communities (Lebanon, NH, and Seattle, Wash). Paroxetine (n=80) or placebo (n=81) therapy was started at 10 mg per day and increased to a maximum 40 mg per day, or PST-PC was provided (n=80). There were 6 scheduled visits for all treatment conditions. POPULATION: A total of 241 primary care patients with minor depression (n=114) or dysthymia (n=127) were included. Of these, 191 patients (79.3%) completed all treatment visits. OUTCOMES: Depressive symptoms were measured using the 20-item Hopkins Depression Scale (HSCL-D-20). Remission was scored on the Hamilton Depression Rating Scale (HDRS) as less than or equal to 6 at 11 weeks. Functional status was measured with the physical health component (PHC) and mental health component (MHC) of the 36-item Medical Outcomes Study Short Form. RESULTS: All treatment conditions showed a significant decline in depressive symptoms over the 11-week period. There were no significant differences between the interventions or by diagnosis. For dysthymia the remission rate for paroxetine (80%) and PST-PC (57%) was significantly higher than for placebo (44%, P=.008). The remission rate was high for minor depression (64%) and similar for each treatment group. For the MHC there were significant outcome differences related to baseline level for paroxetine compared with placebo. For the PHC there were no significant differences between the treatment groups. CONCLUSIONS: For dysthymia, paroxetine and PST-PC improved remission compared with placebo plus nonspecific clinical management. Results varied for the other outcomes measured. For minor depression, the 3 interventions were equally effective; general clinical management (watchful waiting) is an appropriate treatment option.

The association between depressive symptoms and health status in patients with chronic pulmonary disease.

This study evaluated the association between depressive symptoms and health related quality of life (HRQoL) in patients with chronic pulmonary disease using both general and disease-specific HRQoL measures. A cross-sectional analysis of HRQoL measures completed by patients enrolled in the Department of Veteran Affairs Ambulatory Care Quality Improvement Project. 1252 patients with chronic pulmonary disease screened positive for emotional distress and returned the Hopkins Symptom Checklist-20 (SCL-20). 733 of 1252 had a score of 1.75 or greater on the SCL-20 indicating significant depressive symptoms. Depressive symptoms were associated with statistically significantly worse general and pulmonary health as reflected by lower scores on all sub-scales of both the Medical Outcomes Short Form-36 and the Seattle Obstructive Lung Disease Questionnaire. In fact, 11% to 18% of the variance in physical function sub-scales was attributed to depressive symptoms alone. Patients with chronic pulmonary disease and depressive symptoms reported significantly more impaired functioning and worse health status when compared to those patients without depressive symptoms. Because there are highly effective treatments for depression, selective screening of patients with chronic pulmonary disease for depression may identify a group that could potentially benefit from treatment interventions.

A randomized trial of relapse prevention of depression in primary care.

BACKGROUND: Despite high rates of relapse and recurrence, few primary care patients with recurrent or chronic depression are receiving continuation and maintenance-phase treatment. We hypothesized that a relapse prevention intervention would improve adherence to antidepressant medication and improve depression outcomes in high-risk patients compared with usual primary care. METHODS: Three hundred eighty-six patients with recurrent major depression or dysthymia who had largely recovered after 8 weeks of antidepressant treatment by their primary care physicians were randomized to a relapse prevention program (n = 194) or usual primary care (n = 192). Patients in the intervention group received 2 primary care visits with a depression specialist and 3 telephone visits over a 1-year period aimed at enhancing adherence to antidepressant medication, recognition of prodromal symptoms, monitoring of symptoms, and development of a written relapse prevention plan. Follow-up assessments were completed at 3, 6, 9, and 12 months by a telephone survey team blinded to randomization status. RESULTS: Those in the intervention group had significantly greater adherence to adequate dosage of antidepressant medication for 90 days or more within the first and second 6-month periods and were significantly more likely to refill medication prescriptions during the 12-month follow-up compared with usual care controls. Intervention patients had significantly fewer depressive symptoms, but not fewer episodes of relapse/recurrence over the 12-month follow-up period. CONCLUSIONS: A relapse prevention program targeted to primary care patients with a high risk of relapse/recurrence who had largely recovered after antidepressant treatment significantly improved antidepressant adherence and depressive symptom outcomes.