The moderation of Mindfulness-based stress reduction effects by trait mindfulness: results from a randomized controlled trial

Mindfulness-based stress reduction (MBSR) has shown effectiveness for a variety of mental health conditions. However, it is not known for whom the intervention is most effective. In a randomized controlled trial (N = 30), we explored whether individuals with higher levels of pretreatment trait mindfulness would benefit more from MBSR intervention. Results demonstrated that relative to a control condition (n = 15), MBSR treatment (n = 15) had significant effects on several outcomes, including increased trait mindfulness, subjective well-being, and empathy measured at 2 and 12 months after treatment. However, relative to controls, MBSR participants with higher levels of pretreatment mindfulness showed a larger increase in mindfulness, subjective well-being, empathy, and hope, and larger declines in perceived stress up to 1 year after treatment.     

Effectiveness of a nurse-led multidisciplinary self-management program for patients with coronary heart disease in communities: A randomized controlled trial

ObjectiveTo examine the effectiveness of a nurse-led multidisciplinary self-management program (NMSP) on self-management behaviors, self-efficacy, health-related quality of life (HRQoL) and unplanned health service utilization (HSU) among Chinese patients with coronary heart disease (CHD) in communities.MethodsA randomized controlled trial with repeated measurements was used. A convenience sample of 144 participants was recruited from a community health center in China. All participants were randomly assigned to an intervention group (n = 72) in the newly developed NMSP or a control group (n = 72) in routine care. Outcome measurement was performed at baseline, 3 months and 6 months using Coronary Artery Disease Self-Management Scale (CADSs), Self-efficacy for Chronic Disease 6-item Scale (SECD6), and Short Form-12 health survey questionnaire (SF-12).ResultsOver the six months, the two groups reported significant differences in disease medical and emotional management of CADSs, confidence in symptom and disease management of SECD6, physical and mental component summary of SF-12, as well as emergency and outpatient visits of unplanned HSU.ConclusionsThe NMSP improves self-management behaviors, self-efficacy, HRQoL and reduces unplanned HSU among CHD patients in communities.Practice implicationsThis study provides an effective approach to empower CHD patients with emphasizing on collaboration support of health professionals in communities.     

Impact of a 1-year lifestyle modification program on plasma lipoprotein and PCSK9 concentrations in patients with coronary artery disease

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Economic,clinical, and quality-of-life outcomes associated with olanzapine treatment in mania. Results from a randomized controlled trial

INTRODUCTION: The objectives of this study were to determine the economic, clinical, and quality-of-life outcomes associated with olanzapine treatment in patients diagnosed with mania. METHODS: Patients with a diagnosis of bipolar I disorder with manic or mixed episodes were enrolled in a randomized controlled trial. The study design comprised a 3-week acute phase followed by a 49-week open label extension. In the open label extension, the use of lithium and fluoxetine was permitted for patients who experienced breakthrough symptoms. Clinical, economic, and quality-of-life outcomes of treatment were assessed. RESULTS: During the acute phase, olanzapine patients experienced a statistically significant greater mean improvement from baseline on the Y-MRS total score compared to the placebo patients. In the open label extension, patients experienced a statistically significant mean change of 11.8 units on the Y-MRS from the end of the acute phase. When compared to costs incurred in the previous 12 months of therapy, patients experienced savings of almost $900 per month during the 49 weeks of olanzapine therapy. These cost savings were largely driven by reductions in in-patient costs during the open label extension. Health-related quality of life improvements measured by the SF-36 were seen on several dimensions both in the 3-week acute phase as well as in the 49-week open label extension. CONCLUSION: From a clinical, economic, and quality-of-life outcomes standpoint, olanzapine had a significant impact in the treatment of mania, and could be considered a cost-effective treatment option for use in this population if these findings are extrapolated to non-clinical trial populations.     

Comparing multifactorial lifestyle interventions and stress management in coronary risk reduction

The aim of this study was to compare the effects of residential multifactorial cardiac rehabilitation, outpatient multifactorial rehabilitation, stress management, and standard coronary rehabilitation, on cardiac risk reduction. Out of 144 eligible male patients recently treated with percantaneous transluminal coronary angiography (PTCA), coronary artery bypass graft (CABG), or acute myocardial infarction (AMI), 132 were randomized into this study. All interventions covered a 12-month active intervention, intense during the first months and subsequently leveled out. Main assessments were performed before randomization and after the intervention. Patients offered behavioral rehabilitation showed improved selfreported healthy diet habits and exercise frequency, and higher internal locus of control. Although blood lipids, exercise capacity, body mass, anxiety, depression, and Type A scores were changed in the expected direction, no significant difference emerged between active intervention and the standard care condition. Standard care of today appears to have great potential in particular if supplemented with some kind of stress management.     

Effect of clarithromycin treatment on Chlamydia pneumoniae in vascular tissue of patients with coronary artery disease: a randomized, double-blind, placebo-controlled trial

Several small clinical trials have indicated that antibiotic treatment of Chlamydia pneumoniae infection is associated with a better outcome in patients with coronary artery disease (CAD). It has not been demonstrated whether antibiotic treatment eradicates C. pneumoniae from vascular tissue. The aim of the present study was to assess the effect of clarithromycin on the presence of C. pneumoniae in the vascular tissue of patients with CAD. Patients who had CAD and who were waiting for coronary artery bypass graft surgery were enrolled in a randomized, double-blind, placebo-controlled trial. Patients were treated with clarithromycin at 500 mg or placebo once daily from the day of inclusion in the study until surgery. Several vascular tissue specimens were obtained during surgery. The presence of C. pneumoniae in vascular tissue specimens was examined by immunohistochemical staining (IHC) and two PCR assays. Chlamydia immunoglobulin G (IgG) titers were determined by an enzyme-linked immunosorbent assay at the time of inclusion in the study and 8 weeks after surgery. A total of 76 patients were included, and 180 vascular tissue specimens were obtained (80 specimens from the group treated with clarithromycin and 100 specimens from the group treated with placebo). Thirty-five patients received clarithromycin (mean duration, 27 days; standard deviation [SD], 12.2 days), and 41 patients received placebo (mean duration, 27 days; SD, 13.9 days). IHC detected the C. pneumoniae major outer membrane protein antigen in 73.8% of the specimens from the group treated with clarithromycin and 77.0% of the specimens from the group treated with placebo (P was not significant). Chlamydia lipopolysaccharide antigen was found in only one specimen from the group that received placebo. C. pneumoniae DNA was not detected in any specimen. Baseline Chlamydia-specific IgG titers were equally distributed in both groups and were not significantly different after treatment. There was no indication of an active C. pneumoniae infection in vascular tissue. Chlamydia-specific IgG titers remained unchanged throughout the study in both the antibiotic- and the placebo-treated patients.     

Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial

Highly stressed employees are subject to greater health risks, increased cost, and productivity losses than those with normal stress levels. To address this issue in an evidence-based manner, worksite stress management programs must be able to engage individuals as well as capture data on stress, health indices, work productivity, and health care costs. In this randomized controlled pilot, our primary objective was to evaluate the viability and proof of concept for two mind-body workplace stress reduction programs (one therapeutic yoga-based and the other mindfulness-based), in order to set the stage for larger cost-effectiveness trials. A second objective was to evaluate 2 delivery venues of the mindfulness-based intervention (online vs. in-person). Intention-to-treat principles and 2 (pre and post) × 3 (group) repeated-measures analysis of covariance procedures examined group differences over time on perceived stress and secondary measures to clarify which variables to include in future studies: sleep quality, mood, pain levels, work productivity, mindfulness, blood pressure, breathing rate, and heart rate variability (a measure of autonomic balance). Two hundred and thirty-nine employee volunteers were randomized into a therapeutic yoga worksite stress reduction program, 1 of 2 mindfulness-based programs, or a control group that participated only in assessment. Compared with the control group, the mind-body interventions showed significantly greater improvements on perceived stress, sleep quality, and the heart rhythm coherence ratio of heart rate variability. The two delivery venues for the mindfulness program produced basically equivalent results. Both the mindfulness-based and therapeutic yoga programs may provide viable and effective interventions to target high stress levels, sleep quality, and autonomic balance in employees.     

A randomized trial of coronary artery bypass surgery. Survival of patients with a low ejection fraction

The Coronary Artery Surgery Study (CASS) was designed to compare medical and surgical treatment of selected patients with chronic, stable coronary artery disease. This report concerns a subset of patients with reduced ventricular function. Of 780 patients randomly assigned to medical or surgical treatment, 160 had ejection fractions above 0.34 but below 0.50 at base line and have been followed for an average of seven years. Eighty-two patients were assigned to medical therapy, and 78 to surgery; the two groups were comparable at base line with regard to prognostically important variables. At seven years, 84 per cent of patients in the surgical group were alive, as compared with 70 per cent of the medical group (P = 0.01). Nearly half the patients with impaired ventricular function had triple-vessel disease at entry; at seven years, observed survival in this group was 88 and 65 per cent for those assigned to surgical and medical treatment, respectively (P = 0.009). Survival of patients with single-vessel or double-vessel disease was similar in the two treatment groups. We conclude that patients with triple-vessel disease and ejection fractions higher than 0.34 but lower than 0.50 appear to have improved seven-year survival with elective bypass surgery.     

Effects of a lifestyle-related risk factor modification intervention on lifestyle changes among patients with coronary artery disease in Nepal

ObjectiveTo investigate the effect of a lifestyle-related risk factor modification intervention on coronary artery disease (CAD) patients’ lifestyle changes.MethodA randomized controlled study was conducted in Nepal. A total of 224 CAD patients (112 in each study group) were included at baseline, and 196 patients (98 in each group) completed the one-month follow-up. Patients in the intervention group (IG) received nurse-led intervention in addition to the usual care. Face-to face and telephone interview was conducted using standard questionnaires to collect data on lifestyle-related risk factors; smoking, alcohol consumption, diet, body mass index, stress, adherence to medical therapy, and physical activity. General linear model repeated measure analysis was used to analyse the effects of the intervention.ResultsBased on self-reported data we found significant improvement in lifestyle-related risk factor habits in the IG compared with the usual care group with respect to diet (p < 0.001), physical activity (p < 0.001), medication adherence (p < 0.001) and stress (p < 0.001) at one-month follow-up.ConclusionLifestyle-related risk factor modification intervention can positively influence health risk habits, even when it is less intensive but supplemented with information leaflets.Practical implicationsNurse-led one-time intervention may successfully deliver counselling to improve healthy lifestyle among underserved CAD patients.     

A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients

OBJECTIVE: The objective of this study was to assess the effects of participation in a mindfulness meditation-based stress reduction program on mood disturbance and symptoms of stress in cancer outpatients. METHODS: A randomized, wait-list controlled design was used. A convenience sample of eligible cancer patients enrolled after giving informed consent and were randomly assigned to either an immediate treatment condition or a wait-list control condition. Patients completed the Profile of Mood States and the Symptoms of Stress Inventory both before and after the intervention. The intervention consisted of a weekly meditation group lasting 1.5 hours for 7 weeks plus home meditation practice. RESULTS: Ninety patients (mean age, 51 years) completed the study. The group was heterogeneous in type and stage of cancer. Patients' mean preintervention scores on dependent measures were equivalent between groups. After the intervention, patients in the treatment group had significantly lower scores on Total Mood Disturbance and subscales of Depression, Anxiety, Anger, and Confusion and more Vigor than control subjects. The treatment group also had fewer overall Symptoms of Stress; fewer Cardiopulmonary and Gastrointestinal symptoms; less Emotional Irritability, Depression, and Cognitive Disorganization; and fewer Habitual Patterns of stress. Overall reduction in Total Mood Disturbance was 65%, with a 31% reduction in Symptoms of Stress. CONCLUSIONS: This program was effective in decreasing mood disturbance and stress symptoms in both male and female patients with a wide variety of cancer diagnoses, stages of illness, and ages. cancer, stress, mood, intervention, mindfulness.     

Induction of autologous graft-versus-host disease: results of a randomized prospective clinical trial in patients with poor risk lymphoma.

The results of blood or marrow transplantation in patients with chemorefractory aggressive lymphoma, that is, those not responding to conventional-dose chemotherapy at the time of transplant, have been poor. The relapse rate has been high after autologous bone marrow transplant, whereas allogeneic transplantation has been associated with excessive transplant-related toxicity. Administration of cyclosporine after autologous transplantation can induce an autoreactive syndrome that resembles graft-versus-host disease (GVHD). This syndrome, named autologous graft-versus-host disease, has clear antitumor activity in animal models that can be enhanced by the addition of cytokines such as gamma-interferon and interleukin-2. A randomized, prospective study was conducted to evaluate the antitumor effect of autologous graft-versus-host disease induced with cyclosporine, and augmented by the administration of gamma-interferon and interleukin-2 in patients with chemorefractory Hodgkin and aggressive non-Hodgkin lymphomas. Fifty-one patients were randomized, 24 to the autologous GVHD induction arm, and 27 to the noninduction arm after autologous transplant using mobilized peripheral blood stem cell (PBSC) grafts. There were no differences in treatment-related mortality, overall and event-free survival (OS, EFS) between both groups; however, in the induction arm, GVHD developed only in 4 patients. The administration of oral cyclosporine followed by interleukin-2 and gamma-interferon is generally not well tolerated, and does not appear to be an effective method to induce autologous GVHD in patients receiving autologous PBSC grafts.     

Effects of mindfulness-based stress reduction on emotional experience and expression: a randomized controlled trial

Objectives: Mindfulness‐based stress reduction (MBSR) has been found to reduce psychological distress and improve psychological adjustment in medical, psychiatric, and nonclinical samples. We examined its effects on several processes, attitudes, and behavior patterns related to emotion regulation. Design: Fifty‐six adults were randomly assigned to MBSR or to a waiting list (WL). Results: Compared with WL completers (n = 21), MBSR completers (n = 20) reported significantly greater increases in trait mindfulness and decreases in absent‐mindedness, greater increases in self‐compassion, and decreases in fear of emotions, suppression of anger, aggressive anger expression, worry, and difficulties regulating emotions. The WL group subsequently received MBSR, and the two groups combined showed significant changes on all of these variables from pre‐MBSR to post‐MBSR, and on all except the 2 anger variables from pre‐test to 2‐month follow‐up, as well as significant reductions in rumination. Conclusion: An 8‐week mindfulness training program might increase mindful awareness in daily life and have beneficial impact on clinically relevant emotion regulation processes. © 2011 Wiley Periodicals, Inc. J Clin Psychol 68:1–15, 2011.     

Statins and cardiovascular outcomes in elderly and younger patients with coronary artery disease: a post hoc analysis of the GREACE study

Introduction

The effect of cardiovascular disease (CVD) prevention measures aimed at elderly patients requires further evidence. We investigated the effect of statin treatment (targeted to achieve guideline goals) on CVD outcomes in different age groups to determine whether statins are more beneficial in the elderly.

Material and methods

The primary endpoint of this post hoc analysis of the GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) study (n = 1,600 patients with established coronary heart disease (CHD), mean follow-up 3 years) was the absolute and relative CVD event (a composite of death, myocardial infarction, revascularization, unstable angina, heart failure and stroke) risk reduction in age quartiles (each n = 200). Patients on “structured care” with atorvastatin (n = 800) followed up by the university clinic and treated to lipid goal were compared with the corresponding quartiles on “usual care” (n = 800) followed up by specialists or general practitioners of the patient''s choice outside the hospital.

Results

In the elderly (mean age 69 ±4 and 70 ±3 years in the “structured” and “usual care”, respectively) the absolute CVD event reduction between “structured” and “usual care” was 16.5% (p < 0.0001), while in the younger patients (mean age 51 ±3 years and 52 ±3 years in the “structured” and “usual care”, respectively) this was 8.5% (p = 0.016); relative risk reduction (RRR) 60% (p < 0.0001) vs. 42% respectively (p = 0.001). The elderly had higher rates of chronic kidney disease and higher uric acid levels, plus an increased prevalence of diabetes, metabolic syndrome and non-alcoholic fatty liver disease. These factors might contribute to the increased CVD risk in older patients.

Conclusions

All age groups benefited from statin treatment, but the elderly on “structured care” had a greater absolute and relative CVD risk reduction than the younger patients when compared with the corresponding patients assigned to “usual care”. These findings suggest that we should not deprive older patients of CVD prevention treatment and lipid target achievement.     

Family mediators and moderators of treatment outcomes among youths with poorly controlled type 1 diabetes: results from a randomized controlled trial

OBJECTIVE: To determine whether multisystemic therapy (MST) improved family relationships among youths with poorly controlled type 1 diabetes and whether these changes mediated MST effects on health outcomes. The moderating effect of family demographics on study outcomes was also assessed. METHODS: A randomized controlled trial was conducted with 127 youths. Changes in general family relationships and caregiver support for diabetes care from baseline to treatment completion were assessed. Structural equation modeling (SEM) was used to test whether changes in family relations mediated improvements in frequency of blood glucose testing (BGT) and metabolic control. RESULTS: MST increased support for diabetes care from both primary and secondary caregivers in two-parent but not in single-parent families. However, MST had the strongest effects on BGT and metabolic control in single-parent families. SEM did not support family relations as the mediator of improved BGT or metabolic control. Rather, MST had a direct effect on BGT for all participants. BGT mediated improvements in metabolic control among single-parent families. CONCLUSIONS: MST improved family relationships for youths with diabetes in two-parent but not in single-parent families. Objective outcomes related to diabetes were strongest for single-parent families. Other processes such as increased parental monitoring may have been responsible for improved health outcomes among these families.     

Spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle change intervention to improve patient low-density lipoprotein cholesterol

This study evaluated spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle intervention to reduce patient low-density lipoprotein cholesterol and improve patient health behaviors. Participants were 251 spouses of patients from the Durham Veterans Affairs Medical Center randomized to intervention or usual care. The intervention comprised 9 monthly telephone calls to patients and spouses. Outcomes were assessed at baseline, 6 and 11 months. At 11 months, there were no differences in spouse outcomes between intervention and usual care groups for moderate intensity physical activity (i.e., frequency, duration) or dietary intake (i.e., total calories, total fat, percentage of calories from total fat, saturated fat, percentage of calories from saturated fat, cholesterol, fiber). To improve spouse outcomes, couple interventions may need to include spouse behavior change goals and reciprocal support between patients and spouses and consider the need for improvement in spouse outcomes.     

Carotid artery stenting in patients with symptomatic coronary artery disease

Carotid artery stenting has been accepted as a potential alternative to carotid endarterectomy in patients with significant carotid artery stenosis. The objective of this study was to evaluate the feasibility, safety and long-term outcome of percutaneous stenting of carotid artery stenosis in patients with coexisting symptomatic coronary disease. Between May 1996 and May 1999, we performed carotid artery stenting at 48 lesions in 36 patients with carotid stenosis of 60% and symptomatic coronary artery stenosis. Twenty-one patients (58%) had neurologic symptoms. Carotid stenting was performed in 43 internal, 2 external and 3 common carotid lesions. We used Wallstent in 46 lesions, Palmaz stent in 2 lesions and Microstent II in 1 lesion. Staged or combined coronary intervention was performed in 18 patients (50%) and staged coronary artery bypass surgery was performed in 6 patients (17%). In the other 12 patients (33%), medical treatments were performed. Carotid stenting was successful in all lesions. Simultaneous bilateral carotid stenting was performed in 11 patients (31%). One major and 1 minor stroke developed during the procedure. There were no deaths during the procedures and within 30 days post-procedure. During the follow-up of 14 +/- 7 (3 to 40) months, there were no deaths or neurological events. On follow-up (6 +/- 1 months) angiography and/or duplex sonography of 44 eligible lesions in 32 patients, there were 2 cases of asymptomatic restenosis (4.5%) which developed in Palmaz stents implanted at the external carotid artery and the common carotid artery, respectively. In conclusion, carotid artery stenting in patients with coexistent carotid and coronary artery disease is feasible, safe and shows favorable follow-up outcomes.     

Adjuvant intraperitoneal cisplatin therapy in patients with operated gastric carcinoma: results of a randomized trial

In a multicenter trial the efficacy of intraperitoneal administration of cisplatin after radical or palliative resection of gastric carcinoma with respect to overall survival was investigated. In 64 randomised patients, patients treated with intraperitoneal perfusion did not show a benefit in the overall survival after a median follow-up of 18 months.