Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients.

INTRODUCTION: Patients with breast cancer (BC) cope with depression which is linked to functional limitations in survivorship and to physical symptoms. Pain and fatigue are prominent symptoms that affect the well-being of cancer survivors. Emotional processing has been associated with improved physical and psychological health in survivors. Art therapy is a form of psychotherapy that involves the use of visual art-making for expression and communication. It encourages emotional processing and has been linked to symptom reduction in patients with cancer. This protocol is designed to examine two mechanistic changes: emotional processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (heart rate variability and cytokine expression) through which an art therapy intervention may reduce depression, pain and fatigue. In addition, we will examine ethnocultural differences in the effect of art therapy in women from different ethnocultural backgrounds. METHODS AND ANALYSIS: A randomised controlled study with careful controls will randomise 240 patient with BC (50% Jewish and 50% Arab) to an 8-week group art therapy intervention or an 8-week Mandala colouring comparison group. This design will test the mechanisms of art therapy on the targeted outcomes beyond the effects of time with a group, focus on a task and engagement with art materials. We will examine two potential mechanisms: emotional processing and cholinergic anti-inflammatory processes; of the intervention effects on depression, pain and fatigue and compare these effects in Arab versus Jewish women. ETHICS AND DISSEMINATION: Participants will sign informed consent before participation and will be informed that they can leave the study at any point in time without effect on their medical treatment. The Helsinki committees of each participating hospital have approved the study. Data collected in this study will be published in peer-review journals, and we will use the platform of the study website (http://repat.haifa.ac.il/en/) for further dissemination to the general public. TRIAL REGISTRATION NUMBER: The study is registered in ClinicalTrials.gov: NCT03377816; Pre-results.

The Bodymind Model: A platform for studying the mechanisms of change induced by art therapy.

This paper introduces the Bodymind model of Art Therapy and delineates the processes through which it has salutary effects on individuals coping with a variety of health related challenges. The goal of this model is to articulate how activation, reorganization, growth and reintegration of the self can emerge from bodymind processes activated by art therapy. It provides a framework for the conduct of research that will test the key theoretical mechanisms through which art therapy benefits clients. We expect this model to be a spring board for discussion, debate and development of the profession of art therapy. Furthermore, we hope readers can use this model to conduct sound mechanistic studies. This paper can inform social scientists and medical professionals on the manner in which art making can contribute to health.

Negative affectivity, restriction of emotions, and site of metastases predict mortality in recurrent breast cancer.

OBJECTIVE: To assess whether negative affectivity and restriction of emotions predict survival time with recurrent breast cancer. METHODS: Thirty-two patients with recurrent breast cancer, diagnosed 6-19 months earlier and stabilized using surgical, medical and/or radiation therapies, were enrolled. Cox regression survival analyses, including initial severity of metastases (RR=4.3 [1.3-14.3]; p=0.02), were used to explore the association of psychological variables with survival. RESULTS: Low chronic anxiety in the context of low emotional constraint predicted low mortality (RR 0.07 [0.01-0.52]; p=0.007). However, patients with low chronic anxiety scores but with high constraint had higher mortality (RR=3.7 [1.2-11.5; p=0.02). High chronic anxiety, with or without high constraint, also predicted earlier death, as did high control of feelings. CONCLUSION: An integrated model of negative affectivity in the context of restriction of emotions appears to strengthen the prediction of survival based on severity of breast cancer metastases.

Can addressing family relationships improve outcomes in chronic disease? Report of the National Working Group on Family-Based Interventions in Chronic Disease.

The management of patients with chronic disease constitutes the largest single cost to the health care system in the United States. New approaches and methods are needed to reduce preventable complications and to enhance the health and well-being of patients with chronic disease and their families. Interventions that target the family setting in which disease management takes place have emerged as an alternative to traditional strategies that focus only on the individual patient or that consider the family only as a peripheral source of positive or negative social support. In this approach, the educational, relational, and personal needs of all family members are emphasized. Data reviewed by the National Working Group on Family-Based Interventions in Chronic Disease identified potential mechanisms by which the relational context of the family affects disease management and how characteristics of family relationships serve as risk or protective factors. In this paper we describe the major forms of family-based interventions, review the results of selected clinical trials, and present applications for clinical practice. The data suggest that approaches to the management of chronic disease should be expanded to include the broader relational context in which disease management takes place. Although it adds complexity to clinical intervention, this approach increases clinical flexibility, addresses the important players in disease management, and accounts for a significant number of risk and protective factors that affect outcome.

Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients.

BACKGROUND: The medical risk factors associated with increased mortality in hemodialysis (HD) patients are well known, but the psychosocial factors that may affect outcome have not been clearly defined. One key psychosocial factor, depression, has been considered a predictor of mortality, but previous studies have provided equivocal results regarding the association. We sought to determine whether depressive affect is associated with mortality in a longitudinal study of end-stage renal disease (ESRD) patients treated with HD, using multiple assessments over time. METHODS: Two hundred ninety-five outpatients with ESRD treated with HD were recruited from three outpatient dialysis units in Washington D.C. to participate in a prospective cohort study with longitudinal follow-up. Patients were assessed every six months for up to two years using the Beck Depression Inventory (BDI), age, serum albumin concentration, Kt/V, and protein catabolic rate (PCR). A severity index, previously demonstrated to be a mortality marker, was used to grade medical comorbidity. The type of dialyzer with which the patient was treated was noted. Patient mortality status was tracked for a minimum of 20 and a maximum of 60 months after the first interview. Cox proportional hazards models, treating depression scores as time-varying covariates in a univariable analysis, and controlling for age, medical comorbidity, albumin concentration, and dialyzer type and site in multivariable models, were used to assess the relative mortality risk. RESULTS: The mean (+/- SD) age of our population at initial interview was 54.6 +/- 14.1 years. The mean PCR was 1.06 +/- 0.27 g/kg/day, and the mean Kt/V was 1.2 +/- 0.4 at baseline, suggesting that the patients were well nourished and dialyzed comparably to contemporary U.S. patients. The patients' mean BDI at enrollment was 11.4 +/- 8.1, in the range of mild depression. Patients' baseline level of depression was not a significant predictor of mortality at 38.6 months of follow-up. In contrast, when depression was treated as a time-varying covariate based on periodic follow-up assessments, the level of depressive affect was significantly associated with mortality in both single variable and multivariable analyses. CONCLUSIONS: Higher levels of depressive affect in ESRD patients treated with HD are associated with increased mortality. The effects of depression on patient survival are of the same order of magnitude as medical risk factors. Our findings using both controls for factors possibly confounded with depressive affect in patients with ESRD and time-varying covariate analyses may explain the inconsistent results of previous studies of depression and mortality in ESRD patients. Time-varying analyses in longitudinal studies may add power to defining and sensitivity to establishing the association of psychosocial factors and survival in ESRD patients. The mechanism underlying the relationship of depression and survival and the effect of interventions to improve depression in HD outpatients and general medical inpatients should be studied.

Bupropion sustained release versus paroxetine for the treatment of depression in the elderly.

BACKGROUND: Depression is a serious and widespread emotional disorder among the elderly. This study compared the efficacy and safety of bupropion sustained release (SR) with the selective serotonin reuptake inhibitor paroxetine in the treatment of major depression in elderly outpatients. METHOD: Elderly (> or = 60 years) outpatients with major depressive disorder (DSM-IV criteria) were evaluated in this 6-week multicenter, randomized, double-blind study comparing bupropion SR, 100-300 mg/day, and paroxetine, 10-40 mg/day. Efficacy was assessed by changes in scores on the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and the Clinical Global Impressions-Severity of Illness and -Improvement scales. Safety was assessed by monitoring adverse events, vital signs, and body weight. RESULTS: A total of 100 patients ranging in age from 60 to 88 years were randomly assigned to treatment with bupropion SR (N = 48) or paroxetine (N = 52). Measurements of efficacy were similar between the 2 treatment groups, with both groups showing improved scores on all depression rating scales. Headache, insomnia, dry mouth, agitation, dizziness, and nausea occurred in > 10% of patients in both groups; somnolence, diarrhea, constipation, and anorexia occurred in > 10% of patients in the paroxetine group. No statistically significant differences between groups in vital signs or weight were found. CONCLUSION: Both bupropion SR and paroxetine were safe and effective for the treatment of depression in the elderly. Because of its favorable side effect profile, bupropion SR may provide a safe and effective nonserotonergic treatment alternative that is well suited as an antidepressant for the elderly.

Interdialytic weight gain and survival in hemodialysis patients: effects of duration of ESRD and diabetes mellitus.

BACKGROUND: Medical mortality determinants in end-stage renal disease (ESRD) patients treated with hemodialysis (HD) are well known. More recently, associations have been established between the dose of dialysis administered and patient survival. We showed in a prospective study that both dialyzer type and patient compliance with the dialysis prescription were independently associated with survival. Although several parameters of dialytic technique and patient compliance are associated with differential survival in patients with ESRD treated with HD, the association of interdialytic weight gain (IWG) with survival is unclear. No study has assessed the relationship between IWG and mortality in HD patients, controlled for multiple medical risk factors. The aim of our study was to determine whether IWG was associated with survival in patients with ESRD treated with HD, controlling for multiple medical and dialytic risk factors. METHODS: We prospectively conducted an observational, longitudinal, multicenter study of 283 urban HD patients to determine the relationship of IWG with several dialytic parameters and patient survival. Medical risk factors such as demographic indices and comorbid conditions were assessed. We studied Kt/V, the protein catabolic rate (PCR), serum albumin and anthropometric measurements, behavioral compliance indices, dialyzer characteristics, and serum electrolyte concentrations, and correlated these with IWG. In addition, the duration of dialysis was assessed in HD patients with and without diabetes mellitus. Cox proportional hazards models assessed the relative mortality risk of increased IWG, controlling for variations in medical comorbidity and other mortality determinants. RESULTS: The mean (+/- SD) age of our population was 54.6 +/- 14.1 years, and the mean time they were treated with HD was 30.4 +/- 46.9 months. The mean IWG was 1.54 +/- 0.71% dry wt/day. Correlations were found between increased IWG and younger age, and lower midarm circumference, and increased Kt/V, PCR, and serum potassium concentration. The mean follow-up period was 48.9 +/- 10.6 months. An increase in IWG was associated with a significantly increased relative mortality risk in diabetic ESRD patients treated with HD when variations in age, comorbidity, serum albumin concentration, and dialyzer type and site were controlled. There was, however, no association of increased mortality risk with increased IWG in the larger population of patients without diabetes. In further analyses, the increased mortality risk associated with increased IWG was found to be present only in patients with diabetes mellitus who had recently started HD therapy for ESRD. CONCLUSION: IWG is correlated with several nutritional and dialytic variables and with parameters that predict survival in HD patients. Increased IWG is independently associated with decreased survival of diabetic ESRD patients treated with HD, after adjusting for variation in other medical risk factors. The population of incident diabetic HD patients is particularly susceptible to increased risk associated with increased IWG. The mechanisms underlying these results are obscure, but IWG might be associated with poorer survival in this population if it were linked to worsened hypertension, cardiovascular stress, or poorer glycemic control. Interventions to improve compliance with IWG in incident diabetic HD patients are warranted.

Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients.

BACKGROUND: The medical risk factors associated with increased mortality in hemodialysis (HD) patients are well known, but the psychosocial factors that may affect outcome have not been clearly defined. Psychosocial factors could affect mortality through interaction with parents' nutrition or their compliance with the dialysis prescription. We conducted a prospective, longitudinal, multicenter study of urban HD patients to determine the contribution of compliance and psychosocial factors to patient survival. METHODS: Patients were assessed using indices of social support, patient's assessments of their well-being, including illness effects (IEQ), and satisfaction with life (SWLS), the Beck Depression Inventory (BDI), serum albumin concentration, Kt/V and protein catabolic rate (PCR). Behavioral compliance was measured three ways: percent time actually dialyzed per treatment compared to prescribed time (shortening behavior); percent sessions attended (skipping behavior) and total integrated time compliance (% TCOMP). A severity index, previously demonstrated to be a mortality marker, was used to grade medical comorbidity. The typed of dialyzer the patient was treated with was noted. A Cox proportional hazards model, controlling for age, medical comorbidity, albumin concentration and dialyzer type was used to assess relative mortality risk of variations in psychosocial factors and behavioral compliance. RESULTS: A total of 295 patients (60.8% of those eligible) agreed to participate. The mean ( +/- SD) age of our population was 54.6 +/- 14.1 year, mean PCR was 1.06 +/- 0.27 g/kg/day, and mean Kt/V 1.2 +/- 0.4, suggesting the patients were well nourished and adequately dialyzed. The patients' mean BDI was 11.4 +/- 8.1 (in the range of mild depression). Patients' SWLS was similar to that of a group of patients without chronic illness. After a 26 month mean follow-up period, higher levels of perceived social support, improved perception of the effects of illness and increased behavioral compliance were significantly associated with decreased relative mortality risk (0.8, 0.77, and 0.79, respectively), controlled for variations in patients' age, severity of illness, serum albumin concentration and dialyzer type. Variations in depression and Kt/V were not predictors of mortality during the observation period. CONCLUSIONS: Lower levels of social support, decreased behavioral compliance with the dialysis prescription, and increased negative perception of the effects of illness are independently associated with increased mortality in ESRD patients treated with HD. The effects are of the same order of magnitude as medical risk factors. Such effects may be attributable to a relationship between a patients' perception of social support and effects of illness and behavior, with other factors such as the provision of better medical care in patients with larger social networks. The mechanism underlying the relationship of psychosocial factors and compliance and survival, and the effect of interventions to improve perception of illness, and increase social support and compliance with the dialysis prescription in HD patients should be studied.

Immunologic function and survival in hemodialysis patients.

BACKGROUND: Although the medical determinants of mortality in patients with end-stage renal disease (ESRD) treated with hemodialysis (HD) are well appreciated, the contribution of immunologic parameters to survival in such patients is unclear, especially when variations in age, medical comorbidity and nutrition are controlled. In addition, although dysregulation of cytokine metabolism has been appreciated in patients with ESRD, the association of these parameters with outcomes has not been established. Recently, the type of dialyzer used in patients' treatment has been associated with survival, but the mechanisms underlying these findings, including their immune effects, have not been established. We conducted a prospective, cross-sectional, observational multicenter study of urban HD patients to determine the contribution of immunological factors to patient survival. We hypothesized increased proinflammatory cytokines would be associated with increased mortality, and that improved immune function would be associated with survival. METHODS: Patients were assessed using demographic and anthropometric indices, Kt/V, protein catabolic rate (PCR) and immunologic variables including circulating cytokine [interleukin (IL)-1, IL-2, IL-4, IL-5, IL-6, IL-12, IL-13 and tumor necrosis factor (TNF)-alpha] levels, total hemolytic complement activity (CH50), and T cell number and function. A severity index, previously demonstrated to be a mortality marker, was used to grade medical comorbidity. A Cox proportional hazards model, controlling for patients' age, severity index, level of serum albumin concentration, dialyzer type and dialysis site was used to asses relative survival risk. RESULTS: Two hundred and thirty patients entered the study. The mean (+/- SD) age of the population was 54.4 +/- 14.2 years, mean serum albumin concentration was 3.86 +/- 0.47 g/dl, mean PCR was 1.1 +/- 0.28 g/kg/day, and mean Kt/V 1.2 +/- 0.3. Patients' serum albumin concentration was correlated with levels of Kt/V and PCR, and their circulating IL-13 and TNF-alpha levels, but negatively with their circulating IL-2 levels, T-cell number and T-cell antigen recall function. T-cell antigen recall function correlated negatively with PCR, but not Kt/V. There was no correlation of any other immune parameter and medical or demographic factor. Immune parameters, were all highly intercorrelated. Mean level of circulating cytokines in HD patients were in all cases greater than those of a normal control group. There were few differences in medical risk factors or immune parameters between patients treated with different types of dialyzers. After an almost three-year mean follow-up period, increased IL-1, TNF-alpha, IL-6, and IL-13 levels were significantly associated with increased relative mortality risk, while higher levels of IL-2, IL-4, IL-5, IL-12, T-cell number and function, and CH50 were associated with improved survival. The difference in survival between patients treated with unmodified cellulose dialyzers and modified or synthetic dialyzers approached the level of statistical significance, but there were no differences in levels of circulating cytokines between these two groups. CONCLUSIONS: Higher levels of circulating proinflammatory cytokines are associated with mortality, while immune parameters reflecting improved T-cell function are associated with survival in ESRD patients treated with HD, independent of other medical risk factors. These factors may serve as markers for outcome. The mechanism underlying the relationship of immune function and survival, and the effect of interventions to normalize immune function in HD patients should be studied.

Psychologic functioning, quality of life, and behavioral compliance in patients beginning hemodialysis.

Psychologic and demographic characteristics have been shown to correlate with behavioral compliance in studies of prevalent hemodialysis (HD) patients. Few data, however, exist on the psychologic characteristics or their relationship to compliance in patients initiating HD treatment, or incident patients. Our previous work with prevalent HD patients showed an interrelationship among social support, perception of the effects of illness, and depression measured by a standardized depression index and a cognitive depression index deleting somatic symptoms. To compare psychosocial and behavioral compliance parameters in incident and prevalent patients, 99 incident HD patients undergoing dialysis for less than 6 months were assessed by using a variety of questionnaires. The patients' mean standardized depression index score was in the range of mild depression. There was no difference in mean age, Karnofsky functional status, perception of effects of illness or standardized or cognitive depression scores between incident patients and 149 prevalent patients treated with HD for 6 to 246 months. Satisfaction with life scores and perception of sexual adjustment were better, but Kt/V (quantitative measure of the amount of dialysis provided) and protein catabolic rate were lower in incident than in prevalent patients. Social support and perception of illness scores correlated with depression measures in incident patients, findings that were similar to prevalent patients. Incident (as did prevalent) patients showed striking bivariate correlations between the psychosocial and depression variables, but fewer correlations between psychologic and compliance measures. Both standard compliance parameters, such as mean predialysis serum phosphorus and potassium concentration, and behavioral compliance were better in incident than in prevalent patients. Worsened sexual adjustment, functional status, and increased severity of illness were correlated with improved behavioral compliance in incident patients. Behavioral compliance styles correlated with different social support and severity of medical illness variables in incident and prevalent patients, when assessed by multiple linear regression analysis. These different patterns suggest the existence of different mechanisms of adaptation in the groups. Measures focused on increasing delivery of dialysis and enhancing social support in urban African-American patients starting HD therapy may be useful in improving compliance with the dialysis prescription, and indirectly improving survival.

Aspects of quality of life in hemodialysis patients.

The proper means of measuring quality of life in chronically ill patients is unclear. Because different measures may assess varied aspects of patients' experience and because they may be interrelated in different ways, the relationship between several of these quality-of-life measures, including indices of psychological well-being, social support, and severity of illness in ESRD patients treated with hemodialysis (HD), was prospectively assessed. In addition, it was determined whether patients' assessment of quality of life, along any dimension, was related to patient compliance in three urban HD units, in a population largely composed of African-American patients. Severity of illness scores correlated with both attendance and compliance with the dialysis prescription. Karnofsky scores correlated inversely with age, depression, social environment, and level of severity of illness, as expected, but not with behavioral compliance measures. Social support scores correlated with perception of illness, depression, satisfaction with life, and adjustment to illness scores, but not with behavioral or standard compliance measures. Perception of illness scores correlated with depression, social support, adjustment to illness, and satisfaction with life scores, but not with Karnofsky ratings, severity scores, or standard and/or behavioral compliance measures. Social environment scores correlated with almost all assessed variables, with the exception of anthropometric measurements, predialysis phosphorus levels, and behavioral compliance measures. Satisfaction with life scores (a global, subjective measure of quality of life) correlated with advancing age, level of social support, severity of illness, and the presence of a relationship, but were not correlated with Karnofsky scores. These data suggest that quality of life in patients treated with HD must be measured in several ways. The Psychological Adjustment to Illness Scale Social Environment score may be a useful, generalizable adjunct measure of quality of life in HD patients, in addition to the Satisfaction With Life Scale. Quality of life and perception of the effects of illness are not necessarily associated with functional ability in HD patients. These findings must be considered where making decisions about the discontinuation of HD treatment.

Behavioral compliance with dialysis prescription in hemodialysis patients.

The relationship between compliance and outcome is poorly understood, partially because there has been no gold standard for measuring compliance in hemodialysis patients. To investigate interrelationships between psychological, medical, and compliance factors, hemodialysis (HD) patients were studied with the Beck Depression Inventory, and a subset, the Cognitive Depression Index, the Perception of Illness Effects scale, and the Multidimensional Scale of Perceived Social Support. Behavioral compliance was measured in three ways: (1) percent time compliance (signifying "shortening behavior"); (2) percent attendance (signifying "skipping behavior) (3) percent total time compliance, assessing patients' time on dialysis normalized for prescribed time, including all shortenings and absences. Standard compliance indicators (predialysis serum potassium and phosphorus concentrations and interdialytic weight gain) were also analyzed. The patients' mean Beck Depression Inventory was in the range of mild depression. The prevalence of depression was 25.5%. Both depression indices correlated with Perception of Illness Effects scale scores. In general, social support was related to both measures of depression and perception of illness effects. Total time compliance was 95.8 +/- 5.0%. Younger patients were more likely to skip treatments compared with older patients. Time compliance comprised a wide spectrum, with most patients relatively compliant, whereas a small proportion received far less than their prescribed dialysis. Skipping and shortening behaviors did not correlate, suggesting that these constitute two separate types of noncompliant behaviors. Time compliance parameters did not correlate with potassium levels or interdialytic weight gain, but did correlate with phosphorus levels. Interrelationships between behavioral compliance measures and other parameters varied between units and patients of different gender. Finally, behavioral compliance patterns were stable over months in patients.(ABSTRACT TRUNCATED AT 250 WORDS)