Longitudinal Relationships Between Heart Failure Self-care and All-Cause Hospital Readmissions.

BACKGROUND: Many patients with heart failure (HF) are repeatedly hospitalized. Heart failure self-care may reduce readmission rates. Hospitalizations may also affect self-care. OBJECTIVE: The purpose of this secondary analysis was to test the hypotheses that better HF self-care is associated with a lower rate of all-cause readmissions and that readmissions motivate patients to improve their self-care. METHODS: This was a prospective cohort study of patients with HF (N = 400) who were enrolled during a stay at an urban teaching hospital between 2014 and 2016. The Self-Care of Heart Failure Index v6.2 was administered during the hospital stay, along with other questionnaires, and repeated at 6-month intervals after discharge. All-cause readmissions and deaths were ascertained for 24 months. RESULTS: A total of 333 (83.3%) were readmitted at least once, and 117 (29.3%) of the patients died during the follow-up period. A total of 1581 readmissions were ascertained. Higher Self-Care of Heart Failure Index Maintenance scores predicted more rather than fewer readmissions (adjusted hazard ratio, 1.09; 95% confidence interval, 1.01-1.17; P < .01). Conversely, more readmissions predicted higher Maintenance scores (b = 0.29; 95% confidence interval, 0.02-0.56; P < .05). CONCLUSIONS: These findings do not support the hypothesis that HF self-care maintenance or management helps to reduce the rate of all-cause readmissions, but they do suggest that the experience of multiple readmissions may help to motivate improvements in HF self-care.

Effects of Depression on Heart Failure Self-Care.

BACKGROUND: Depression has been identified as a barrier to effective heart failure self-care, but recent studies suggest that the relationship between depression and self-care is more complex than was previously believed. This study was designed to clarify the relationship between depression and self-care in hospitalized patients with HF. METHODS AND RESULTS: During hospitalization with a confirmed clinical diagnosis of HF, 400 patients completed a structured interview to diagnose Diagnostic and Statistical Manual, 5th edition (DSM-5) depressive disorders, the Patient Health Questionnaire (PHQ-9) depression questionnaire, the Self-Care of Heart Failure Index (SCHFI), and several psychosocial questionnaires. Multivariable models were fitted to each SCHFI scale; separate models were run with DSM-5 disorders and PHQ-9 depression scores. Higher PHQ-9 depression scores were independently associated with lower (worse) scores on the SCHFI Maintenance (P < .05), Management (P < .01), and Confidence (P < .01) scales. No independent associations with DSM-5 depressive disorders were detected. Measures of perceived stress, anxiety, and low perceived social support were also significantly associated with poor HF self-care. CONCLUSIONS: Patients with a combination of psychosocial problems, including symptoms of depression, stress, anxiety, and inadequate social support, may be more likely than other patients to display difficulties with HF self-care that can increase their risk for hospitalization. Research is needed on "broad-spectrum" psychosocial interventions for patients with HF self-care deficits.

Left Ventricular Dysfunction and Depression in Hospitalized Patients with Heart Failure.

OBJECTIVE: This study examined whether the severity of left ventricular systolic dysfunction is associated with depression in patients with heart failure (HF). Other factors were also studied to identify independent correlates of depression in HF. METHODS: The sample consisted of 400 hospitalized patients with HF. Left ventricular ejection fraction and other medical data were obtained from medical records. Depression and other psychosocial characteristics were assessed by an interview and questionnaires. Proportional odds models were used to test the relationships of these characteristics to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) depressive disorders, and analysis of covariance was used to test relationships with continuous measures of depression in secondary models. RESULTS: The models produced no evidence of an association between left ventricular ejection fraction and depression. The adjusted odds ratio (95% confidence interval) was 1.00 (0.98-1.01; p = .87) for depression diagnosis. Analysis of covariance estimates (standard errors) were -0.01 (0.02; p = .54) for the Hamilton Rating Scale for Depression and -0.01 (0.01; p = .59) for the Patient Health Questionnaire. The odds of depression were higher in African American patients and in those with high levels of anxiety or stress. Other characteristics that have been associated with depression in previous studies, including sex and age, were not consistently associated with depression in this study. CONCLUSIONS: There is no relationship between the severity of left ventricular systolic dysfunction and depression in hospitalized patients with HF. In contrast, African American patients and those with a high level of anxiety or perceived stress are more likely than other patients to have a comorbid depressive disorder.

Moderators of Response to Cognitive Behavior Therapy for Major Depression in Patients With Heart Failure.

OBJECTIVE: Although cognitive behavior therapy (CBT) is efficacious for major depression in patients with heart failure (HF), approximately half of patients do not remit after CBT. To identify treatment moderators that may help guide treatment allocation strategies and serve as new treatment targets, we performed a secondary analysis of a randomized clinical trial. Based on evidence of their prognostic relevance, we evaluated whether clinical and activity characteristics moderate the effects of CBT. METHODS: Participants were randomized to enhanced usual care (UC) alone or CBT plus enhanced UC. The single-blinded outcomes were 6-month changes in Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9). Actigraphy was used to assess daily physical activity patterns. We performed analyses to identify the specific activity and clinical moderators of the effects of CBT in 94 adults (mean age = 58, 49% female) with HF and major depressive disorder. RESULTS: Patients benefited more from CBT (versus UC) if they had the following: more medically severe HF (i.e., a higher New York Heart Association class or a lower left ventricular ejection fraction), more stable activity patterns, wider active periods, and later evening settling times. These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). CONCLUSIONS: These findings suggest that increasing the cross-daily stability of activity patterns, and prolonging the daily active period, might help increase the efficacy of CBT. Given moderating effects of HF severity measures, research is also needed to clarify and address factors in patients with less severe HF that diminish the efficacy of CBT. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01028625.

Residual Symptoms After Treatment for Depression in Patients With Coronary Heart Disease.

OBJECTIVE: Depression is associated with an increased risk of mortality in patients with coronary heart disease (CHD). The risk may be reduced in patients who remit with adequate treatment, but few patients achieve complete remission. The purpose of this study was to identify the symptoms that persist despite aggressive treatment for depression in patients with CHD. METHODS: One hundred twenty-five patients with stable CHD who met the DSM-IV criteria for a moderate-to-severe major depressive episode completed treatment with cognitive behavior therapy, either alone or combined with an antidepressant, for up to 16 weeks. Depression symptoms were assessed at baseline and after 16 weeks of treatment. RESULTS: The M (SD) Beck Depression Inventory scores were 30.0 (8.6) at baseline and 8.3 (7.5) at 16 weeks. Seventy seven (61%) of the participants who completed treatment met remission criteria (Hamilton Rating Scale for Depression ≤7) at 16 weeks. Loss of energy and fatigue were the most common posttreatment symptoms both in remitters (n = 44, 57%; n = 34, 44.2%) and nonremitters (n = 42, 87.5%; n = 35, 72.9%). These symptoms were not predicted by baseline depression severity, anxiety, demographic, or medical variables including inflammatory markers or cardiac functioning or by medical events during depression treatment. CONCLUSIONS: Fatigue and loss of energy often persist in patients with CHD even after otherwise successful treatment for major depression. These residual symptoms may increase the risks of relapse and mortality. Development of effective interventions for these persistent symptoms is a priority for future research.

Cardiac Risk Markers and Response to Depression Treatment in Patients With Coronary Heart Disease.

BACKGROUND: Depression is associated with an increased risk of mortality in patients with coronary heart disease. There is evidence that this risk may be reduced in patients who respond to depression treatment. The purpose of this study was to determine whether cardiac risk markers predict poor response to depression treatment and, second, whether they improve with successful treatment. METHODS: One hundred fifty-seven patients with stable coronary heart disease who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for a moderate to severe major depressive episode were treated with cognitive behavior therapy, either alone or combined with an antidepressant, for up to 16 weeks. Depression, physical activity, sleep quality, thyroid hormones (total thyroxine [T4] and free T4), and inflammatory blood markers (C-reactive protein, interleukin-6, tumor necrosis factor) were assessed at baseline and after 16 weeks of treatment. RESULTS: The mean (SD) Beck Depression Inventory scores were 30.2 (8.5) at baseline and 8.5 (7.8) at 16 weeks. More than 50% of the participants met the criteria for depression remission (17-item Hamilton Rating Scale for Depression ≤ 7) at 16 weeks. Only free T4 thyroid hormone at baseline predicted poor response to depression treatment after adjustment for potential confounders (p = .004). Improvement in sleep quality (p = .012) and physical activity level (p = .041) correlated with improvement in depression. None of the inflammatory markers predicted posttreatment depression or changed with depression. CONCLUSIONS: Thyroid hormone (T4) level predicted depression treatment outcome, and improvement in depression correlated with improvement in sleep and physical activity. More detailed studies of thyroid function and objective assessments of sleep and physical activity in relation to depression improvement and cardiac outcomes are needed.

Major Depression and Long-Term Survival of Patients With Heart Failure.

OBJECTIVES: Previous studies have found that depression predicts all-cause mortality in heart failure (HF), but little is known about its effect on long-term survival. This study examined the effects of depression on long-term survival in patients with HF. METHODS: Patients hospitalized with HF (n = 662) at an urban academic medical center were enrolled in a prospective cohort study between January 1994 and July 1999. Depression was assessed on a structured interview during the index hospitalization and on quarterly interviews for 1 year after discharge. Patients were classified at index as having Diagnostic and Statistical Manual, Fourth Edition major depressive disorder (n = 131), minor depression (n = 106), or no depression (n = 425). Clinical data and the National Death Index were used to identify date of death or last known contact through December 19, 2014, up to 20 years after the index hospitalization. The main outcome was time from enrollment to death from any cause. RESULTS: A total of 617 (94.1%) patients died during the follow-up period. Major depressive disorder was associated with higher all-cause mortality compared with no depression (adjusted hazard ratio = 1.64, 95% confidence interval = 1.27-2.11, p = .0001). This association was stronger than that of any of the established predictors of mortality that were included in the fully adjusted model. Patients with persistent or worsening depressive symptoms during the year after discharge were at greatest risk for death. The association between minor depression and survival was not significant. CONCLUSIONS: Major depression is an independent risk factor for all-cause mortality in patients with HF. Its effect persists for many years after the diagnosis of depression.

Nocturnal patterns of heart rate and the risk of mortality after acute myocardial infarction.

BACKGROUND: The purposes of this study were to identify nocturnal patterns of heart rate (HR) in depressed and nondepressed patients after an acute myocardial infarction (MI) and to determine which patterns, if any, are associated with all-cause mortality or recurrent infarction. METHODS: Functional data analysis and model-based clustering methods were used to identify nocturnal HR patterns in 245 depressed and 247 nondepressed patients with a recent MI. All-cause mortality and recurrent infarctions were ascertained over a median follow-up of 24 months. RESULTS: Three HR activity patterns were identified. In the first, HR gradually declined during the nighttime and increased the next morning. The second pattern was similar, but with a higher overall HR during the recording interval. The third showed almost no decrease in HR at night (ie, "nondipping"). All-cause mortality was higher among patients with pattern 3 than pattern 1 (P = .007), and the combined end point of recurrent MI or all-cause mortality was higher in pattern 3 than pattern 2 (P = .05). Patterns 2 and 3 were more common in the depressed than in the nondepressed patients. CONCLUSIONS: The nondipping nocturnal HR independently predicts all-cause mortality and recurrent MI. Future studies should examine the underlying causes of nondipping nocturnal HR and its association with depression and investigate the effects of treatment on survival.

Symptoms that remain after depression treatment in patients with coronary heart disease.

OBJECTIVE: Symptoms which commonly remain after treatment for major depression increase the risk of relapse and recurrence in medically well patients. The same symptoms predict major adverse cardiac events in observational studies of patients with coronary heart disease (CHD). The purpose of this study was to determine the prevalence and predictors of residual depression symptoms in depressed patients with CHD-. METHODS: Beck Depression Inventory-II data from two randomized clinical trials and an uncontrolled treatment study of depression in patients with CHD were combined to determine the prevalence and predictors of residual symptoms. RESULTS: Loss of energy, loss of pleasure, loss of interest, fatigue, and difficulty concentrating were the five most common residual symptoms in all three studies. They are also among the most common residual symptoms in medically well patients who are treated for depression. The severity of pre-treatment anxiety predicted the post-treatment persistence of all these symptoms except for loss of energy. CONCLUSIONS: The most common post-treatment residual symptoms found in this study of patients with coronary heart disease and comorbid major depression are the same as those that have been reported in previous studies of medically-well depressed patients. This suggests that they may be resistant to standard depression treatments across diverse patient populations. More effective treatments for these symptoms are needed.

Treatment of depression and inadequate self-care in patients with heart failure: One-year outcomes of a randomized controlled trial.

OBJECTIVE: Both depression and inadequate self-care are common in patients with heart failure. This secondary analysis examines the one-year outcomes of a randomized controlled trial of a sequential approach to treating these problems. METHODS: Patients with heart failure and major depression were randomly assigned to usual care (n = 70) or to cognitive behavior therapy (n = 69). All patients received a heart failure self-care intervention starting 8 weeks after randomization. Patient-reported outcomes were assessed at Weeks 8, 16, 32, and 52. Data on hospital admissions and deaths were also obtained. RESULTS: One year after randomization, Beck Depression Inventory (BDI-II) scores were - 4.9 (95% C.I., -8.9 to -0.9; p < .05) points lower in the cognitive therapy than the usual care arm, and Kansas City Cardiomyopathy scores were 8.3 (95% C.I., 1.9 to 14.7; p < .05) points higher. There were no differences on the Self-Care of Heart Failure Index or in hospitalizations or deaths. CONCLUSIONS: The superiority of cognitive behavior therapy relative to usual care for major depression in patients with heart failure persisted for at least one year. Cognitive behavior therapy did not increase patients' ability to benefit from a heart failure self-care intervention, but it did improve HF-related quality of life during the follow-up period. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02997865.

Outcomes of a tailored self-care intervention for patients with heart failure and major depression: A secondary analysis of a randomized controlled trial.

BACKGROUND: Depression is a recognized barrier to heart failure self-care, but there has been little research on interventions to improve heart failure self-care in depressed patients. OBJECTIVES: To investigate the outcomes of an individually tailored self-care intervention for patients with heart failure and major depression, and to determine whether the adequacy of self-care at baseline, the severity of depression or anxiety, or other factors affect the outcomes of this intervention. DESIGN: Secondary analysis of data from a pre-registered randomized controlled trial (NCT02997865). METHODS: Outpatients with heart failure and comorbid major depression (n = 139) were randomly assigned to cognitive behavior therapy or usual care for depression. In addition, an experienced cardiac nurse provided the tailored self-care intervention to all patients in both arms of the trial starting eight weeks after randomization. Weekly self-care intervention sessions were held between Weeks 8 and 16; the frequency was tapered to biweekly or monthly between Weeks 17 and 32. The Self-Care of Heart Failure Index (v6.2) was used to assess self-care outcomes, with scores ≥70 on each of its three scales (Maintenance, Management, and Confidence) being consistent with adequate self-care. The Week 16 Maintenance scale score was the primary outcome for this analysis. RESULTS: At baseline, 107 (77%) of the patients scored in the inadequate self-care range on the Maintenance scale. Between Weeks 8 and 16, Maintenance scores improved more in patients with initially inadequate than initially adequate self-care (11.9 vs. 3.2 points, p = .003). Sixty-six (48%) of the patients with initially inadequate Maintenance scores achieved scores in the adequate range by Week 32 (p < .0001). Covariate-adjusted predictors of better Maintenance outcomes included adequate Maintenance at baseline (p < .0001), higher anxiety at baseline (p < .05), and higher dosages of the self-care intervention (p < .0001). Neither treatment with cognitive behavior therapy nor less severe major depression predicted better self-care outcomes. CONCLUSIONS: Depressed patients with inadequate heart failure self-care are able to achieve clinically significant improvements in self-care with the help of an individually tailored self-care intervention. Further refinement and testing are needed to increase the intervention's potential for clinical implementation.

Influence of Neighborhood Conditions on Recurrent Hospital Readmissions in Patients with Heart Failure: A Cohort Study.

PURPOSE: This study examined how certain aspects of residential neighborhood conditions (ie, observed built environment, census-based area-level poverty, and perceived disorder) affect readmission in urban patients with heart failure. METHODS: A total of 400 patients with heart failure who were discharged alive from an urban-university teaching hospital were enrolled. Data were collected about readmissions during a 2-year follow-up. The impact of residential neighborhood conditions on readmissions was examined with adjustment for 7 blocks of covariates: 1) patient demographic characteristics; 2) comorbidities; 3) clinical characteristics; 4) depression; 5) perceived stress; 6) health behaviors; and 7) hospitalization characteristics. RESULTS: A total of 83.3% of participants were readmitted. Participants from high-poverty census tracts (≥20%) were at increased risk of readmission compared with those from census tracts with <10% poverty (hazard ratio [HR]: 1.53; 95% confidence interval: 1.03-2.27; P < .05) when adjusted for demographic characteristics. None of the built environmental or perceived neighborhood conditions were associated with the risk of readmission. The poverty-related risk of readmission was reduced to nonsignificance after including diabetes (HR: 1.33) and hypertension (HR: 1.35) in the models. CONCLUSIONS: The effect of high poverty is partly explained by high rates of hypertension and diabetes in these areas. Improving diabetes and blood pressure control or structural aspects of impoverished areas may help reduce hospital readmissions.

Depression and Hospital Readmissions in Patients with Heart Failure.

Depression increases the risk of mortality in patients with heart failure (HF). Less is known about whether depression predicts multiple readmissions or whether multiple hospitalizations worsen depression in patients with HF. This study aimed to test the hypotheses that depression predicts multiple readmissions in patients hospitalized with HF, and conversely that multiple readmissions predict persistent or worsening depression. All-cause readmissions were ascertained over a 2-year follow-up of a cohort of 400 patients hospitalized with HF. The Patient Health Questionnaire-9 was used to assess depression at index and 3-month intervals. At enrollment in the study, 21% of the patients were mildly depressed and 22% were severely depressed. Higher Patient Health Questionnaire-9 depression scores predicted a higher rate of readmissions (adjusted hazard ratio 1.02, 95% confidence interval 1.00 to 1.04, p = 0.03). The readmission rate was higher in those who were severely depressed than in those without depression (p = 0.0003), but it did not differ between patients who were mildly depressed and patients without depression. Multiple readmissions did not predict persistent or worsening depression, but younger patients in higher New York Heart Association classes were more depressed than other patients. Depression is an independent risk factor for multiple all-cause readmissions in patients hospitalized with HF. Severe depression is a treatable psychiatric co-morbidity that warrants ongoing clinical attention in patients with HF.

Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial.

BACKGROUND: Major depression and inadequate self-care are common in patients with heart failure (HF). Little is known about how to intervene when both problems are present. This study examined the efficacy of a sequential approach to treating these problems. METHODS: Stepped Care for Depression in HF was a single-site, single-blind, randomized controlled trial of cognitive behavior therapy (CBT) versus usual care (UC) for major depression in patients with HF. The intensive phase of the CBT intervention lasted between 8 and 16 weeks, depending upon the rate of improvement in depression. All participants received a tailored HF self-care intervention that began 8 weeks after randomization. The intensive phase of the self-care intervention ended at 16 weeks post-randomization. The coprimary outcome measures were the Beck Depression Inventory (version 2) and the Maintenance scale of the Self-Care of HF Index (v6.2) at week 16. RESULTS: One hundred thirty-nine patients with HF and major depression were enrolled; 70 were randomized to UC and 69 to CBT. At week 16, the patients in the CBT arm scored 4.0 points ([95% CI, -7.3 to -0.8]; P=0.02) lower on the Beck Depression Inventory, version 2 than those in the usual care arm. Mean scores on the Self-Care of HF Index Maintenance scale were not significantly different between the groups ([95% CI, -6.5 to 1.5]; P=0.22). CONCLUSIONS: CBT is more effective than usual care for major depression in patients with HF. However, initiating CBT before starting a tailored HF self-care intervention does not increase the benefit of the self-care intervention. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02997865.

Psychosocial Syndemics and Multimorbidity in Patients with Heart Failure †.

Heart failure (HF) is a common cause of hospitalization and mortality in older adults. HF is almost always embedded within a larger pattern of multimorbidity, yet many studies exclude patients with complex psychiatric and medical comorbidities or cognitive impairment. This has left significant gaps in research on the problems and treatment of patients with HF. In addition, HF is only one of multiple challenges facing patients with multimorbidity, stressful socioeconomic circumstances, and psychosocial problems. The purpose of this study is to identify combinations of comorbidities and health disparities that may affect HF outcomes and require different mixtures of medical, psychological, and social services to address. The syndemics framework has yielded important insights into other disorders such as HIV/AIDS, but it has not been applied to the complex psychosocial problems of patients with HF. The multimorbidity framework is an alternative approach for investigating the effects of multiple comorbidities on health outcomes. The specific aims are: (1) to determine the coprevalence of psychiatric and medical comorbidities in patients with HF (n = 535); (2) to determine whether coprevalent comorbidities have synergistic effects on readmissions, mortality, self-care, and global health; (3) to identify vulnerable subpopulations of patients with HF who have high coprevalences of syndemic comorbidities; (4) to determine the extent to which syndemic comorbidities explain adverse HF outcomes in vulnerable subgroups of patients with HF; and (5) to determine the effects of multimorbidity on readmissions, mortality, self-care, and global health.

Effect of omega-3 fatty acids on heart rate variability in depressed patients with coronary heart disease.

OBJECTIVE: To determine whether omega-3 fatty acid (FA) increases the natural log of very low frequency (lnVLF) power, an index of heart rate variability (HRV), and reduces 24-hour heart rate (HR) in depressed patients with coronary heart disease (CHD). Low intake of omega-3 FAs is associated with depression and with low HRV, and all three are associated with an increased risk of death in patients with CHD. METHODS: Thirty-six depressed patients with CHD randomized to receive 50 mg of sertraline and 2 g of omega-3/day, and 36 randomized to sertraline and a placebo, had 24-hour HRV measured at baseline and after 10 weeks of treatment. RESULTS: There was a significant treatment × time interaction for covariate adjusted lnVLF (p = .009), for mean 24-hour HR (p = .03), and for 1-minute resting HR (p = .02). The interaction was not significant for three other measures of HRV. LnVLF did not change over time in the omega-3 arm but decreased in the placebo arm (p = .002), suggesting that omega-3 may have prevented or slowed deterioration in cardiac autonomic function. CONCLUSIONS: The effects of omega-3 FAs on lnVLF and HR, although modest, were detected after only 10 weeks of treatment with 2 g per day of omega-3. Whether a longer course of treatment or a higher dose of omega-3 would further decrease HR, improve other indices of HRV, or reduce mortality in depressed CHD patients should be investigated.

Antidepressant use in patients with heart failure.

OBJECTIVE: There is little evidence that antidepressants are efficacious for depression in patients with heart failure (HF), and equivocal evidence that they are safe. This study identified characteristics that are associated with antidepressant use in hospitalized patients with HF. METHOD: Logistic regression models were used to identify independent correlates of antidepressant use in 400 patients hospitalized with HF between 2014 and 2016. The measure of depression in the primary analysis was a DSM-5 diagnosis based on a structured interview; this was replaced by a PHQ-9 depression score in a secondary analysis. RESULTS: In the primary analysis, there were positive associations between antidepressant use and white race, younger age, unemployment, non-ischemic HF, number of other prescribed medications, current minor depression, history of major depression, and functional impairment. In the secondary analysis, there were positive associations with white race, unemployment, number of other prescribed medications, and functional impairment; the effect of current severity of depression differed between patients with vs. without a history of major depression. CONCLUSIONS: Current depression is only one of several factors that influence the use of antidepressant medications in patients with HF. Further research is needed to ensure that these agents are being used appropriately in this patient population.

Multivariable models in biobehavioral research.

OBJECTIVE: To review contemporary multivariable modeling and statistical reporting practices in psychosomatic and behavioral medicine research. METHODS: A random sample of 40 original research articles involving multivariable models was obtained from the 2005 volumes of four of the leading psychosomatic and behavioral medicine research journals. A random comparison sample was obtained from the 2005 volumes of four of the leading general medical and psychiatric journals. Multivariable modeling and reporting practices were systematically coded. The evaluation focused primarily on issues raised in 2004 Statistical Corner article by Babyak. RESULTS: Deficiencies were found in a large proportion of the articles published in psychosomatic and behavioral medicine journals. The single most common problem was a lack of clear information, or any information at all, about important aspects of the statistical methods. Other frequent problems included post hoc selection of variables, lack of clear rationales and well-specified roles for selected variables, inadequate information about models as a whole (e.g., goodness of fit), failure to test model assumptions, and lack of model validation. Overfitting of multivariable models was the exception rather than the rule, but still a significant problem. CONCLUSIONS: There is room for improvement in the use and reporting of multivariable models in psychosomatic and behavioral medicine research journals. These problems can be overcome by adopting best statistical practices, such as those recommended by Psychosomatic Medicine's statistical guidelines and by authoritative guidebooks on statistical reporting practices.

History of depression and survival after acute myocardial infarction.

OBJECTIVE: To compare survival in post-myocardial (MI) participants from the Enhancing Recovery In Coronary Heart Disease (ENRICHD) clinical trial with a first episode of major depression (MD) and those with recurrent MD, which is a risk factor for mortality after acute MI. Recent reports suggest that the level of risk may depend on whether the comorbid MD is a first or a recurrent episode. METHODS: Survival was compared over a median of 29 months in 370 patients with an initial episode of MD, 550 with recurrent MD, and 408 who were free of depression. RESULTS: After adjusting for an all-cause mortality risk score, initial Beck Depression Inventory score, and the use of selective serotonin reuptake inhibitor antidepressants, patients with a first episode of MD had poorer survival (18.4% all-cause mortality) than those with recurrent MD (11.8%) (hazard ratio (HR) = 1.4; 95% Confidence Interval (CI) = 1.0-2.0; p = .05). Both first depression (HR = 3.1; 95% CI = 1.6-6.1; p = .001) and recurrent MD (HR = 2.2; 95% CI = 1.1-4.4; p = .03) had significantly poorer survival than did the nondepressed patients (3.4%). A secondary analysis of deaths classified as probably due to a cardiovascular cause resulted in similar HRs, but the difference between depression groups was not significant. CONCLUSIONS: Both initial and recurrent episodes of MD predict shorter survival after acute MI, but initial MD episodes are more strongly predictive than recurrent episodes. Exploratory analyses suggest that this cannot be explained by more severe heart disease at index, poorer response to depression treatment, or a higher risk of cerebrovascular disease in patients with initial MD episodes.

Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial.

CONTEXT: Studies of depressed psychiatric patients have shown that antidepressant efficacy can be increased by augmentation with omega-3 fatty acids. OBJECTIVE: To determine whether omega-3 improves the response to sertraline in patients with major depression and coronary heart disease (CHD). DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial. Between May 2005 and December 2008, 122 patients in St Louis, Missouri, with major depression and CHD were randomized. INTERVENTIONS: After a 2-week run-in period, all patients were given 50 mg/d of sertraline and randomized in double-blind fashion to receive 2 g/d of omega-3 acid ethyl esters (930 mg of eicosapentaenoic acid [EPA] and 750 mg of docosahexaenoic acid [DHA]) (n=62) or to corn oil placebo capsules (n=60) for 10 weeks. MAIN OUTCOME MEASURES: Scores on the Beck Depression Inventory (BDI-II) and the Hamilton Rating Scale for Depression (HAM-D). RESULTS: Adherence to the medication regimen was 97% or more in both groups for both medications. There were no differences in weekly BDI-II scores (treatment x time interaction = 0.02; 95% confidence interval [CI], -0.33 to 0.36; t(112) = 0.11; P = .91), pre-post BDI-II scores (placebo, 14.8 vs omega-3, 16.1; 95% difference-in-means CI, -4.5 to 2.0; t(116) = -0.77; P = .44), or HAM-D scores (placebo, 9.4 vs omega-3, 9.3; 95% difference-in-means CI, -2.2 to 2.4; t(115) = 0.12; P = .90). The groups did not differ on predefined indicators of depression remission (BDI-II < or = 8: placebo, 27.4% vs omega-3, 28.3%; odds ratio [OR], 0.96; 95% CI, 0.43-2.15; t(113) = -0.11; P = .91) or response (> 50% reduction in BDI-II from baseline: placebo, 49.0% vs omega-3, 47.7%; OR, 1.06; 95% CI, 0.51-2.19; t(112) = 0.15; P = .88). CONCLUSIONS: Treatment of patients with CHD and major depression with sertraline and omega-3 fatty acids did not result in superior depression outcomes at 10 weeks, compared with sertraline and placebo. Whether higher doses of omega-3 or sertraline, a different ratio of EPA to DHA, longer treatment, or omega-3 monotherapy can improve depression in patients with CHD remains to be determined. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00116857.