Anhedonic Depression Is Not Associated With Risk of Recurrent Major Adverse Cardiac Events and All-Cause Mortality in Acute Coronary Syndrome Patients.

BACKGROUND: Depression after acute coronary syndrome (ACS) is common and increases risks of adverse outcomes, but it remains unclear which depression features are most associated with major adverse cardiac events (MACE) and all-cause mortality (ACM). PURPOSE: To examine whether a subtype of depression characterized by anhedonia and major depressive disorder (MDD) predicts 1-year MACE/ACM occurrence in ACS patients compared to no MDD history. We also consider other depression features in the literature as predictors. METHODS: Patients (N = 1,087) presenting to a hospital with ACS completed a self-report measure of current depressive symptoms in-hospital and a diagnostic interview assessing MDD within 1 week post-hospitalization. MACE/ACM events were assessed at 1-, 6-, and 12-month follow-ups. Cox regression models were used to examine the association of the anhedonic depression subtype and MDD without anhedonia with time to MACE/ACM, adjusting for sociodemographic and clinical covariates. RESULTS: There were 142 MACE/ACM events over the 12-month follow-up. The 1-year MACE/ACM in patients with anhedonic depression, compared to those with no MDD, was somewhat higher in an age-adjusted model (hazard ratio [HR] = 1.63, p = .08), but was not significant after further covariate adjustment (HR = 1.24, p = .47). Of the additional depression features, moderate-to-severe self-reported depressive symptoms significantly predicted the risk of MACE/ACM, even in covariate-adjusted models (HR = 1.72, p = .04), but the continuous measure of self-reported depressive symptoms did not. CONCLUSION: The anhedonic depression subtype did not uniquely predict MACE/ACM as hypothesized. Moderate-to-severe levels of total self-reported depressive symptoms, however, may be associated with increased MACE/ACM risk, even after accounting for potential sociodemographic and clinical confounders.

Development and usability testing of the e-EXCELS tool to guide cancer survivorship follow-up care.

OBJECTIVE: The aim of this study is to describe a user-centered (e.g., cancer survivors and clinicians) development process of an eHealth tool designed to facilitate self-management of cancer survivorship follow-up care. METHODS: Guided by Cognitive-Social Health Information Processing (C-SHIP) model and informed by core self-management skills, we engaged in a user-centered design process. In phase I, we conducted in-depth interviews with survivors of breast (n = 33), prostate (n = 4), and colorectal (n = 6) cancers, and (n = 9) primary care providers to develop content and design of the web tool. Phase II utilized iterative user testing interviews (n = 9) to test the web-based tool prototype. Data from both phases were independently coded using a template/content analytic approach. RESULTS: The top 5 functions identified in phase I for the web-based platform included: (a) educational materials to learn and prepare for health encounters (80%); (b) questions for health providers (74%); (c) ability to track contact information of providers (67%); (d) provide general information (64%); and, (e) support information (62%). Users of the prototype reported patient burden, tool fatigue, introduction timing of the tool, relevance, and security/privacy as concerns in phase II. CONCLUSIONS: This study demonstrates the value of using a theoretically informed and user-centered design process to develop relevant and patient-centered eHealth resources to support cancer survivorship. A larger study is needed to establish the efficacy of this eHealth tool as an intervention to improve adherence to follow-up care guidelines.

Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

BACKGROUND: Breast, colorectal, and prostate cancer survivors are at increased risk for late and long-term effects post-treatment. The post-treatment phase of care is often poorly coordinated and survivors navigate follow-up care with minimal information or guidance from their healthcare team. This manuscript describes the Extended Cancer Education for Longer-term Survivors (EXCELS) in Primary Care protocol. EXCELS is a randomized controlled trial to test the efficacy of patient-level self-management educational strategies on adherence to preventative health service use and cancer survivorship follow-up guidelines. METHODS: The EXCELS trial compares four conditions: (1) EXCELS-website (e.g., a mobile-optimized technology platform); (2) EXCELS-health coaching; (3) EXCELS-website and health coaching; and (4) a print booklet. Approximately 480 breast, colorectal, and prostate survivors will be recruited through the New Jersey Primary Care Research Network (NJPCRN) and New Jersey State Cancer Registry (NJSCR). Eligible survivors (diagnosed stages 1-3) must have completed active treatment, access to a phone and a computer, smartphone or tablet with internet access, and be able to speak and read English. Patient assessments occur at baseline, 6, 12, and 18 months. The primary outcomes are increased engagement in preventive health services and monitoring for cancer recurrence and treatment-related late effects. DISCUSSION: The EXCELS trial is the first to test cancer survivorship educational self-management interventions for cancer survivors in a primary care context. Findings from this trial will inform successful implementation and engagement strategies for longer-term, post-treatment cancer survivors managed in primary care settings. TRIAL REGISTRATION: Registered August 1, 2017 at ClinicalTrials.gov , trial # NCT03233555.

Stress management in the workplace for employees with hypertension: a randomized controlled trial.

While behavioral interventions can improve blood pressure (BP) in individuals with hypertension, getting such services to people who could benefit remains difficult. Workplace programs have potential as dissemination vehicles. The objective is to evaluate the effectiveness of a standardized stress management program delivered in groups at the workplace for reducing BP compared with enhanced usual care. This randomized controlled trial studied 92 urban medical center employees with hypertension randomized into two groups. The intervention was a 10-week group workshop on cognitive-behavioral coping skills. Enhanced usual care included self-help materials for BP reduction and physician referral. Intervention group participants' systolic BP (SBP) decreased 7.5 mm Hg over controls between baseline and follow-up, from 149.1 (95% CI: 146.0-152.1) to 140.0 (95% CI: 134.7-145.2), p < .001. The differential change between intervention and enhanced usual care groups (Group × Time interaction) was 7.5 mm Hg (t = -2.05; p = .04). Diastolic BP reductions were not significantly different. Scores on measures of emotional exhaustion and depressive rumination showed significant improvements and correlated with reductions in SBP. There was no significant change in the usual care group. A standardized worksite group intervention produced clinically meaningful reductions in SBP in participants with hypertension.

Impact of Perceived Weight Stigma among Underserved Women on Doctor-Patient Relationships.

OBJECTIVE: To evaluate how perception of weight stigma among underserved women with obesity impacts doctor-patient relationships. METHODS: This study consisted of an interviewer-administered survey of 149 women with obesity (BMI ≥ 30 kg/m2) immediately after their physician visit at four Federally Qualified Health Centers. Perceptions of weight stigma and physician empathy were measured using the Stigma Situations in Health Care instrument and Consultation and Relational Empathy (CARE) measure, respectively. Associations of CARE and Stigma scores with BMI and patient characteristics were analyzed using Mantel-Haenszel chi-square test and ordinal logistic regression. RESULTS: The mean CARE score was 42.1 (sd 8.4; range 11.0-50.0) and mean Stigma score was 4.6 (sd 7.6; range 0-43.0). Each increase in BMI category was associated with almost 2-fold increased odds of higher perception of Stigma (OR, 1.90, 95% CI 1.30-2.78, p=0.001). BMI was not associated with CARE. However, for each increase in stigma category, the odds of lower CARE score doubled (OR, 0.52, 95% CI 0.36-0.75, p=0.0005). CONCLUSION: While BMI was not associated with perception of physician empathy, higher frequency of weight stigmatizing situations was negatively associated with perception of physician empathy. Reducing weight stigma in primary care could improve doctor-patient relationships and quality of care in patients with obesity.

Hispanic residential ethnic density and depression in post-acute coronary syndrome patients: Re-thinking the role of social support.

BACKGROUND: The ethnic density hypothesis suggests that ethnic density confers greater social support and consequently protects against depressive symptoms in ethnic minority individuals. However, the potential benefits of ethnic density have not been examined in individuals who are facing a specific and salient life stressor. AIMS: We examined the degree to which the effects of Hispanic ethnic density on depressive symptoms are explained by socioeconomic resources and social support. METHODS: Patients with acute coronary syndrome (ACS, N = 472) completed the Beck Depression Inventory (BDI) and measures of demographics, ACS clinical factors and perceived social support. Neighborhood characteristics, including median income, number of single parent households and Hispanic ethnic density, were extracted from the American Community Survey Census (2005-2009) for each patient using his or her geocoded address. RESULTS: In a linear regression analysis adjusted for demographic and clinical factors, Hispanic ethnic density was positively associated with depressive symptoms (ß = .09, standard error (SE) = .04, p = .03). However, Hispanic density was no longer a significant predictor of depressive symptoms when neighborhood characteristics were controlled. The relationship of Hispanic density on depressive symptoms was moderated by nativity status. Among US-born patients with ACS, there was a significant positive relationship between Hispanic density and depressive symptoms and social support significantly mediated this effect. There was no observed effect of Hispanic density to depressive symptoms for foreign-born ACS patients. CONCLUSION: Although previous research suggests that ethnic density may be protective against depression, our data suggest that among patients with ACS, living in a community with a high concentration of Hispanic individuals is associated with constrained social and economic resources that are themselves associated with greater depressive symptoms. These data add to a growing body of literature on the effects of racial or ethnic segregation on health outcomes.

Women weigh in: obese African American and White women's perspectives on physicians' roles in weight management.

BACKGROUND: There is little qualitative research on the type of weight loss counseling patients prefer from their physicians and whether preferences differ by race. METHODS: This qualitative study used semistructured, in-depth interviews of 33 moderately to severely obese white and African American women to elucidate and compare their perceptions regarding their primary care physician's approach to weight loss counseling. Data were analyzed using a grounded theory approach and a series of immersion/crystallization cycles. RESULTS: White and African American women seemed to internalize weight stigma differently. African American participants spoke about their pride and positive body image, whereas white women more frequently expressed self-deprecation and feelings of depression. Despite these differences, both groups of women desired similar physician interactions and weight management counseling, including (1) giving specific weight loss advice and individualized plans for weight management; (2) addressing weight in an empathetic, compassionate, nonjudgmental, and respectful manner; and (3) providing encouragement to foster self-motivation for weight loss. CONCLUSION: While both African American and white women desired specific strategies from physicians in weight management, some white women may first need assistance in overcoming their stigma, depression, and low self-esteem before attempting weight loss.

Association of acute coronary syndrome-induced posttraumatic stress disorder symptoms with self-reported sleep.

BACKGROUND: Symptoms of posttraumatic stress disorder (PTSD) after acute coronary syndrome (ACS) are associated with recurrent ACS events and mortality. Poor sleep may be a mechanism, but the association between PTSD and sleep after ACS is unknown. PURPOSE: This study aims to estimate the association between ACS-induced PTSD symptoms and self-reported sleep. METHODS: ACS-induced PTSD symptoms were assessed 1-month post-ACS in 188 adults using the Impact of Events Scale-Revised. Sleep was assessed using the Pittsburgh Sleep Quality Index. Linear and logistic regression models were used to determine whether PTSD symptoms were associated with self-reported sleep, independent of sociodemographic and clinical covariates. RESULTS: In adjusted models, ACS-induced PTSD symptoms were associated with worse overall sleep (ß = 0.22, p = 0.003) and greater impairment in six of seven components of sleep (all p values <0.05). CONCLUSIONS: ACS-induced PTSD symptoms may be associated with poor sleep, which may explain why PTSD confers increased cardiovascular risk after ACS.

A randomized controlled trial of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy.

PURPOSE: To testthe relative effectiveness of a mindfulness-based stress reduction program (MBSR) compared with a nutrition education intervention (NEP) and usual care (UC) in women with newly diagnosed early-stage breast cancer (BrCA)undergoing radiotherapy. METHODS: Datawere available from a randomized controlled trialof 172 women, 20 to 65 years old, with stage I or II BrCA. Data from women completing the 8-week MBSR program plus 3 additional sessions focuses on special needs associated with BrCA were compared to women receiving attention control NEP and UC. Follow-up was performed at 3 post-intervention points: 4 months, and 1 and 2 years. Standardized, validated self-administered questionnaires were used to assess psychosocial variables. Descriptive analyses compared women by randomization assignment. Regression analyses, incorporating both intention-to-treat and post hoc multivariable approaches, were used to control for potential confounding variables. RESULTS: A subset of 120 women underwent radiotherapy; 77 completed treatment prior to the study, and 40 had radiotherapy during the MBSR intervention. Women who actively received radiotherapy (art) while participating in the MBSR intervention (MBSR-art) experienced a significant (P < .05) improvement in 16 psychosocial variables compared with the NEP-art, UC-art, or both at 4 months. These included health-related, BrCA-specific quality of life and psychosocial coping, which were the primary outcomes, and secondary measures, including meaningfulness, helplessness, cognitive avoidance, depression, paranoid ideation, hostility, anxiety, global severity, anxious preoccupation, and emotional control. CONCLUSIONS: MBSR appears to facilitate psychosocial adjustment in BrCA patients receiving radiotherapy, suggesting applicability for MBSR as adjunctive therapy in oncological practice.

Posttraumatic stress and myocardial infarction risk perceptions in hospitalized acute coronary syndrome patients.

Posttraumatic stress disorder (PTSD) is related to acute coronary syndrome (ACS; i.e., myocardial infarction or unstable angina) recurrence and poor post-ACS adherence to medical advice. Since risk perceptions are a primary motivator of adherence behaviors, we assessed the relationship of probable PTSD to ACS risk perceptions in hospitalized ACS patients (n = 420). Participants completed a brief PTSD screen 3-7 days post-ACS, and rated their 1-year ACS recurrence risk relative to other men or women their age. Most participants exhibited optimistic bias (mean recurrence risk estimate between "average" and "below average"). Further, participants who screened positive for current PTSD (n = 15) showed significantly greater optimistic bias than those who screened negative (p < 0.05), after adjustment for demographics, ACS severity, medical comorbidities, depression, and self-confidence in their ability to control their heart disease. Clinicians should be aware that psychosocial factors, and PTSD in particular, may be associated with poor adherence to medical advice due to exaggerated optimistic bias in recurrence risk perceptions.

Widowhood and mortality: a meta-analysis and meta-regression.

The study of spousal bereavement and mortality has long been a major topic of interest for social scientists, but much remains unknown with respect to important moderating factors, such as age, follow-up duration, and geographic region. The present study examines these factors using meta-analysis. Keyword searches were conducted in multiple electronic databases, supplemented by extensive iterative hand searches. We extracted 1,377 mortality risk estimates from 123 publications, providing data on more than 500 million persons. Compared with married people, widowers had a mean hazard ratio (HR) of 1.23 (95% confidence interval (CI), 1.19-1.28) among HRs adjusted for age and additional covariates and a high subjective quality score. The mean HR was higher for men (HR, 1.27; 95% CI, 1.19-1.35) than for women (HR, 1.15; 95% CI, 1.08-1.22). A significant interaction effect was found between gender and mean age, with HRs decreasing more rapidly for men than for women as age increased. Other significant predictors of HR magnitude included sample size, geographic region, level of statistical adjustment, and study quality.

Obese women's barriers to mammography and pap smear: the possible role of personality.

Obese women are at increased risk of developing and dying from cancer, but are less likely than nonobese women to receive cancer screening examinations. Our qualitative study explores obese women's barriers to Pap smears and mammograms in greater depth than previous research. We also seek to understand why some obese women undergo screening whereas others do not. A purposive sample of moderately to severely obese women over age 40 was recruited from community-based organizations, health clinics, and retail establishments. Semi-structured in-depth interviews (N = 33) informed by the Theory of Care-Seeking Behavior and three prior focus groups of obese women (N = 18) were recorded and transcribed. Qualitative analysis was iterative, using a grounded theory approach involving a series of immersion/crystallization cycles. Participants verified many barriers to cervical and breast cancer screening previously identified in the general population, including fear, modesty, competing demands, and low perceived risk. Participants also highlighted several weight-related barriers, including insensitive comments about weight and equipment and gowns that could not accommodate them. Comparison of participants who were up-to-date with both Pap smears and mammograms with those not up-to-date with either screening showed no discernable differences in these barriers, however. Instead, we found that the participants who followed through on their cancer screenings may share certain personality traits, such as conscientiousness or self-regulatory ability, that allow them to complete difficult or feared tasks. Our research therefore suggests that personality may act as an important mediator in health behavior, and should be taken into account in future theoretical models and health behavior interventions, particularly for obese women.

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial.

The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.

Music for surgical abortion care study: a randomized controlled pilot study.

BACKGROUND: The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. STUDY DESIGN: We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. RESULTS: In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; p<.05). Both groups reported similarly high satisfaction scores. There were no group differences in pain. CONCLUSIONS: Music as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain.

Posttraumatic stress due to an acute coronary syndrome increases risk of 42-month major adverse cardiac events and all-cause mortality.

Approximately 15% of patients with acute coronary syndromes (ACS) develop posttraumatic stress disorder (PTSD) due to their ACS event. We assessed whether ACS-induced PTSD symptoms increase risk for major adverse cardiac events (MACE) and all-cause mortality (ACM) in an observational cohort study of 247 patients (aged 25-93 years; 45% women) hospitalized for an ACS at one of 3 academic medical centers in New York and Connecticut between November 2003 and June 2005. Within 1 week of admission, patient demographics, Global Registry of Acute Coronary Events risk score, Charlson comorbidity index, left ventricular ejection fraction, and depression status were obtained. At 1-month follow-up, ACS-induced PTSD symptoms were assessed with the Impact of Events Scale-Revised. The primary endpoint was combined MACE (hospitalization for myocardial infarction, unstable angina or urgent/emergency coronary revascularization procedures) and ACM, which were actively surveyed for 42 months after index event. Thirty-six (15%) patients had elevated intrusion symptoms, 32 (13%) elevated avoidance symptoms, and 21 (9%) elevated hyperarousal symptoms. Study physicians adjudicated 21 MACEs and 15 deaths during the follow-up period. In unadjusted Cox proportional hazards regression analyses, and analyses adjusted for sex, age, clinical characteristics and depression, high intrusion symptoms were associated with the primary endpoint (adjusted hazard ratio, 3.38; 95% confidence interval, 1.27-9.02; p = .015). Avoidance and hyperarousal symptoms were not associated with the primary endpoint. The presence of intrusion symptoms is a strong and independent predictor of elevated risk for MACE and ACM, and should be considered in the risk stratification of ACS patients.

Association between social isolation and left ventricular mass.

BACKGROUND: Social isolation is associated with progression of cardiovascular disease, with the most socially isolated patients being at increased risk. Increased left ventricular mass is a predictor of cardiovascular morbidity and mortality. It is not yet clear whether social isolation is a determinant of increased left ventricular mass. METHODS: We performed a cross-sectional study of Northern Manhattan Study participants who were free of clinical cardiovascular disease and had obtained transthoracic echocardiograms (n=2021) and a baseline questionnaire on social habits. Social isolation was defined as the lack of friendship networks (knowing fewer than 3 people well enough to visit within their homes). Echocardiographic left ventricular mass was indexed to height(2.7), analyzed as a continuous variable and compared between exposure groups. RESULTS: The prevalence of social isolation was 13.5%. The average left ventricular mass was significantly higher (50.2 gm/m(2.7)) in those who were, as compared with those who were not (47.6 gm/m(2.7)), socially isolated (P<.05). Higher prevalence of social isolation was found among those less educated, uninsured, or unemployed. There were no significant race-ethnic differences in the prevalence of social isolation. In multivariate analysis, there was a trend toward an association between social isolation and increased left ventricular mass in the total cohort (P=.09). Among Hispanics, social isolation was significantly associated with greater left ventricular mass. Hispanics who were socially isolated averaged 3.9 gm/ht(2.7) higher left ventricular mass compared with those not socially isolated (P=.002). This relationship was not present among non-Hispanic blacks or whites. CONCLUSION: In this urban tri-ethnic cohort, social isolation was prevalent and associated with indices of low socioeconomic status. Hispanics who were socially isolated had a greater risk for increased left ventricular mass.

Association of anhedonia with recurrent major adverse cardiac events and mortality 1 year after acute coronary syndrome.

CONTEXT: Depression consistently predicts recurrent events and mortality in patients with acute coronary syndrome (ACS), but it has 2 core diagnostic criteria with distinct biological correlates-depressed mood and anhedonia (loss of pleasure or interest). OBJECTIVE: To determine if depressed mood and/or anhedonia predict 1-year medical outcomes for patients with ACS. DESIGN: Observational cohort study of post-ACS patients hospitalized between May 2003 and June 2005. Within 1 week of admission, patients underwent a structured psychiatric interview assessing clinically impairing depressed mood, anhedonia, and major depressive episode (MDE). Also assessed were the Global Registry of Acute Coronary Events risk score, Charlson comorbidity index, left ventricular ejection fraction, antidepressant use, and depressive symptom severity using the Beck Depression Inventory. SETTING: Cardiac units of 3 university hospitals in New York and Connecticut. PARTICIPANTS: Consecutive sample of 453 patients with ACS (age, 25-93 years; 42% women). MAIN OUTCOMES MEASURES: All-cause mortality (ACM) and documented major adverse cardiac events (MACEs)-myocardial infarction, hospitalization for unstable angina, or urgent/emergency coronary revascularization)-actively surveyed for 1 year after admission. RESULTS: There were 67 events (16 deaths and 51 MACEs; 14.8%): 108 (24%) and 77 (17%) patients had anhedonia and depressed mood, respectively. Controlling for sex, age, and medical covariates, anhedonia (adjusted hazard ratio, 1.58; 95% confidence interval, 1.16-2.14; P < .01) was a significant predictor of combined MACE and ACM, but depressed mood was not. Anhedonia continued to significantly predict outcomes (P < .05) when additionally controlling for MDE diagnosis or depressive symptom severity. Findings were confirmed using depressed mood and anhedonia subscores from the Beck Depression Inventory in place of clinician interview ratings. CONCLUSIONS: Anhedonia identifies risk of MACE and ACM beyond that of established medical prognostic indicators, including MDE and depressive symptom severity. Correlates of anhedonia may add to the understanding of the link between depression and heart disease.

Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial.

BACKGROUND: Depressive symptoms are an established predictor of mortality and major adverse cardiac events (defined as nonfatal myocardial infarction or hospitalization for unstable angina or urgent/emergency revascularizations) in patients with acute coronary syndrome (ACS). This study was conducted to determine the acceptability and efficacy of enhanced depression treatment in patients with ACS. METHODS: A 3-month observation period to identify patients with ACS and persistent depressive symptoms was followed by a 6-month randomized controlled trial. From January 1, 2005, through February 29, 2008, 237 patients with ACS from 5 hospitals were enrolled, including 157 persistently depressed patients randomized to intervention (initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach; 80 patients) or usual care (77 patients) and 80 nondepressed patients who underwent observational evaluation. The primary outcome was patient satisfaction with depression care. Secondary outcomes were depressive symptom changes (assessed with the Beck Depression Inventory), major adverse cardiac events, and death. RESULTS: At the end of the trial, the proportion of patients who were satisfied with their depression care was higher in the intervention group (54% of 80) than in the usual care group (19% of 77) (odds ratio, 5.4; 95% confidence interval [CI], 2.2-12.9 [P < .001]). The Beck Depression Inventory score decreased significantly more (t(155) = 2.85 [P = .005]) for intervention patients (change, -5.7; 95% CI, -7.6 to -3.8; df = 155) than for usual care patients (change, -1.9; 95% CI, -3.8 to -0.1; df = 155); the depression effect size was 0.59 of the standard deviation. At the end of the trial, 3 intervention patients and 10 usual care patients had experienced major adverse cardiac events (4% and 13%, respectively; log-rank test, chi(2)(1) = 3.93 [P = .047]), as well as 5 nondepressed patients (6%) (for the intervention vs nondepressed cohort, chi(2)(1) = 0.48 [P = .49]). CONCLUSION: Enhanced depression care for patients with ACS was associated with greater satisfaction, a greater reduction in depressive symptoms, and a promising improvement in prognosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00158054.

Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: the Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) trial.

OBJECTIVE: To present the design of a multicenter, randomized trial testing the effects of stress reduction treatment (SRT) on the prevalence of shock-treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. METHODS: New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the last 6 months (n = 304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour Holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6, 12, and 24 months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), antitachycardia pacing events, medication changes, hospitalizations, deaths, and quality of life. RESULTS: Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock-treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on laboratory stress-induced and 24-hour arrhythmogenic electrophysiological indices from pre to post treatment, and both quality of life and measures of anger across the 2 years of the study. CONCLUSIONS: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial is the first large-scale, randomized, clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia-provoked shock and improve quality of life.