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      Sustained Effects of a Mindfulness-Based Stress-Reduction Intervention in Type 2 Diabetic Patients : Design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-Study)

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          Abstract

          OBJECTIVE

          To determine whether a mindfulness-based stress reduction (MBSR) intervention is effective for reducing psychosocial distress (i.e., depression, psychosocial stress) and the progression of nephropathy (i.e., albuminuria) and for improving the subjective health status of patients with type 2 diabetes.

          RESEARCH DESIGN AND METHODS

          Patients with type 2 diabetes and microalbuminuria were randomized to a mindfulness-based intervention ( n = 53) or a treatment-as-usual control ( n = 57) group. The study is designed to investigate long-term outcomes over a period of 5 years. We present data up to the first year of follow-up (FU).

          RESULTS

          At FU, the MBSR group showed lower levels of depression ( d = 0.71) and improved health status ( d = 0.54) compared with the control group. No significant differences in albuminuria were found. Per-protocol analysis also showed higher stress reduction in the intervention group ( d = 0.64).

          CONCLUSIONS

          MBSR intervention achieved a prolonged reduction in psychosocial distress. The effects on albuminuria will be followed up further.

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          Most cited references10

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          The prevalence of comorbid depression in adults with diabetes: a meta-analysis.

          To estimate the odds and prevalence of clinically relevant depression in adults with type 1 or type 2 diabetes. Depression is associated with hyperglycemia and an increased risk for diabetic complications; relief of depression is associated with improved glycemic control. A more accurate estimate of depression prevalence than what is currently available is needed to gauge the potential impact of depression management in diabetes. MEDLINE and PsycINFO databases and published references were used to identify studies that reported the prevalence of depression in diabetes. Prevalence was calculated as an aggregate mean weighted by the combined number of subjects in the included studies. We used chi(2) statistics and odds ratios (ORs) to assess the rate and likelihood of depression as a function of type of diabetes, sex, subject source, depression assessment method, and study design. A total of 42 eligible studies were identified; 20 (48%) included a nondiabetic comparison group. In the controlled studies, the odds of depression in the diabetic group were twice that of the nondiabetic comparison group (OR = 2.0, 95% CI 1.8-2.2) and did not differ by sex, type of diabetes, subject source, or assessment method. The prevalence of comorbid depression was significantly higher in diabetic women (28%) than in diabetic men (18%), in uncontrolled (30%) than in controlled studies (21%), in clinical (32%) than in community (20%) samples, and when assessed by self-report questionnaires (31%) than by standardized diagnostic interviews (11%). The presence of diabetes doubles the odds of comorbid depression. Prevalence estimates are affected by several clinical and methodological variables that do not affect the stability of the ORs.
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            A mechanism converting psychosocial stress into mononuclear cell activation.

            Little is known about the mechanisms converting psychosocial stress into cellular dysfunction. Various genes, up-regulated in atherosclerosis but also by psychosocial stress, are controlled by the transcription factor nuclear factor kappaB (NF-kappaB). Therefore, NF-kappaB is a good candidate to convert psychosocial stress into cellular activation. Volunteers were subjected to a brief laboratory stress test and NF-kappaB activity was determined in peripheral blood mononuclear cells (PBMC), as a window into the body and because PBMC play a role in diseases such as atherosclerosis. In 17 of 19 volunteers, NF-kappaB was rapidly induced during stress exposure, in parallel with elevated levels of catecholamines and cortisol, and returned to basal levels within 60 min. To model this response, mice transgenic for a strictly NF-kappaB-controlled beta-globin transgene were stressed by immobilization. Immobilization resulted in increased beta-globin expression, which could be reduced in the presence of the alpha1-adrenergic inhibitor prazosin. To define the role of adrenergic stimulation in the up-regulation of NF-kappaB, THP-1 cells were induced with physiological amounts of catecholamines for 10 min. Only noradrenaline resulted in a dose- and time-dependent induction of NF-kappaB and NF-kappaB-dependent gene expression, which depended on pertussis-toxin-sensitive G protein-mediated phosphophatidylinositol 3-kinase, Ras/Raf, and mitogen-activated protein kinase activation. Induction was reduced by alpha(1)- and beta-adrenergic inhibitors. Thus, noradrenaline-dependent adrenergic stimulation results in activation of NF-kappaB in vitro and in vivo. Activation of NF-kappaB represents a downstream effector for the neuroendocrine response to stressful psychosocial events and links changes in the activity of the neuroendocrine axis to the cellular response.
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              The effects of mindfulness-based stress reduction therapy on mental health of adults with a chronic medical disease: a meta-analysis.

              The objective of this study was to examine the effectiveness of mindfulness-based stress reduction (MBSR) on depression, anxiety and psychological distress across populations with different chronic somatic diseases. A systematic review and meta-analysis were performed to examine the effects of MBSR on depression, anxiety, and psychological distress. The influence of quality of studies on the effects of MBSR was analyzed. Eight published, randomized controlled outcome studies were included. An overall effect size on depression of 0.26 was found, indicating a small effect of MBSR on depression. The effect size for anxiety was 0.47. However, quality of the studies was found to moderate this effect size. When the studies of lower quality were excluded, an effect size of 0.24 on anxiety was found. A small effect size (0.32) was also found for psychological distress. It can be concluded that MBSR has small effects on depression, anxiety and psychological distress in people with chronic somatic diseases. Integrating MBSR in behavioral therapy may enhance the efficacy of mindfulness based interventions. Copyright 2010 Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Diabetes Care
                Diabetes Care
                diacare
                dcare
                Diabetes Care
                Diabetes Care
                American Diabetes Association
                0149-5992
                1935-5548
                May 2012
                11 April 2012
                : 35
                : 5
                : 945-947
                Affiliations
                [1] 1Department of Medicine II and Psychosomatics, University of Heidelberg, Heidelberg, Germany
                [2] 2Department of Medicine I and Clinical Chemistry, University of Heidelberg, Heidelberg, Germany
                [3] 3Department of Psychosomatic Medicine and Psychotherapy, University of Hamburg-Eppendorf, Hamburg, Germany
                [4] 4Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany
                Author notes
                Corresponding author: Mechthild Hartmann, mechthild.hartmann@ 123456med.uni-heidelberg.de .

                M.H., S.K., and C.K. contributed equally to this study.

                Article
                1343
                10.2337/dc11-1343
                3329807
                22338101
                aade703e-3257-4fbc-86bc-a285b39e64e5
                © 2012 by the American Diabetes Association.

                Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

                History
                : 17 July 2011
                : 9 January 2012
                Categories
                Original Research
                Clinical Care/Education/Nutrition/Psychosocial Research

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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