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      The LIFE-Adult-Study: objectives and design of a population-based cohort study with 10,000 deeply phenotyped adults in Germany

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      BMC Public Health
      BioMed Central
      Cohort study, Epidemiology, Population based, Diseases of civilization

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          Abstract

          Background

          The LIFE-Adult-Study is a population-based cohort study, which has recently completed the baseline examination of 10,000 randomly selected participants from Leipzig, a major city with 550,000 inhabitants in the east of Germany. It is the first study of this kind and size in an urban population in the eastern part of Germany. The study is conducted by the Leipzig Research Centre for Civilization Diseases (LIFE). Our objective is to investigate prevalences, early onset markers, genetic predispositions, and the role of lifestyle factors of major civilization diseases, with primary focus on metabolic and vascular diseases, heart function, cognitive impairment, brain function, depression, sleep disorders and vigilance dysregulation, retinal and optic nerve degeneration, and allergies.

          Methods/design

          The study covers a main age range from 40-79 years with particular deep phenotyping in elderly participants above the age of 60. The baseline examination was conducted from August 2011 to November 2014. All participants underwent an extensive core assessment programme (5-6 h) including structured interviews, questionnaires, physical examinations, and biospecimen collection. Participants over 60 underwent two additional assessment programmes (3-4 h each) on two separate visits including deeper cognitive testing, brain magnetic resonance imaging, diagnostic interviews for depression, and electroencephalography.

          Discussion

          The participation rate was 33 %. The assessment programme was accepted well and completely passed by almost all participants. Biomarker analyses have already been performed in all participants. Genotype, transcriptome and metabolome analyses have been conducted in subgroups. The first follow-up examination will commence in 2016.

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          Most cited references53

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          The Inventory of Depressive Symptomatology (IDS): psychometric properties.

          The psychometric properties of the 28- and 30-item versions of the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C) and Self-Report (IDS-SR) are reported in a total of 434 (28-item) and 337 (30-item) adult out-patients with current major depressive disorder and 118 adult euthymic subjects (15 remitted depressed and 103 normal controls). Cronbach's alpha ranged from 0.92 to 0.94 for the total sample and from 0.76 to 0.82 for those with current depression. Item total correlations, as well as several tests of concurrent and discriminant validity are reported. Factor analysis revealed three dimensions (cognitive/mood, anxiety/arousal and vegetative) for each scale. Analysis of sensitivity to change in symptom severity in an open-label trial of fluoxetine (N = 58) showed that the IDS-C and IDS-SR were highly related to the 17-item Hamilton Rating Scale for Depression. Given the more complete item coverage, satisfactory psychometric properties, and high correlations with the above standard ratings, the 30-item IDS-C and IDS-SR can be used to evaluate depressive symptom severity. The availability of similar item content for clinician-rated and self-reported versions allows more direct evaluations of these two perspectives.
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            Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial.

            Depression and low perceived social support (LPSS) after myocardial infarction (MI) are associated with higher morbidity and mortality, but little is known about whether this excess risk can be reduced through treatment. To determine whether mortality and recurrent infarction are reduced by treatment of depression and LPSS with cognitive behavior therapy (CBT), supplemented with a selective serotonin reuptake inhibitor (SSRI) antidepressant when indicated, in patients enrolled within 28 days after MI. Randomized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients (1084 women, 1397 men) enrolled from 8 clinical centers. Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression (HRSD); LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI). Random allocation was to usual medical care or CBT-based psychosocial intervention. Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months, plus group therapy when feasible, with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50% reduction in Beck Depression Inventory scores after 5 weeks. Composite primary end point of death or recurrent MI; secondary outcomes included change in HRSD (for depression) or ESSI scores (for LPSS) at 6 months. Improvement in psychosocial outcomes at 6 months favored treatment: mean (SD) change in HRSD score, -10.1 (7.8) in the depression and psychosocial intervention group vs -8.4 (7.7) in the depression and usual care group (P<.001); mean (SD) change in ESSI score, 5.1 (5.9) in the LPSS and psychosocial intervention group vs 3.4 (6.0) in the LPSS and usual care group (P<.001). After an average follow-up of 29 months, there was no significant difference in event-free survival between usual care (75.9%) and psychosocial intervention (75.8%). There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups (depression, LPSS, and depression and LPSS patients). The intervention did not increase event-free survival. The intervention improved depression and social isolation, although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients.
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              Epidemiology of insomnia, depression, and anxiety.

              This study used empirically validated insomnia diagnostic criteria to compare depression and anxiety in people with insomnia and people not having insomnia. We also explored which specific sleep variables were significantly related to depression and anxiety. Finally, we compared depression and anxiety in (1) different insomnia types, (2) Caucasians and African Americans, and (3) genders. All analyses controlled for health variables, demographics, organic sleep disorders, and symptoms of organic sleep disorders. Cross-sectional and retrospective. Community-based sample (N=772) of at least 50 men and 50 women in each 10-year age bracket from 20 to more than 89 years old. Self-report measures of health, sleep, depression, and anxiety. People with insomnia had greater depression and anxiety levels than people not having insomnia and were 9.82 and 17.35 times as likely to have clinically significant depression and anxiety, respectively. Increased insomnia frequency was related to increased depression and anxiety, and increased number of awakenings was also related to increased depression. These were the only 2 sleep variables significantly related to depression and anxiety. People with combined insomnia (ie, both onset and maintenance insomnia) had greater depression than did people with onset, maintenance, or mixed insomnia. There were no differences between other insomnia types. African Americans were 3.43 and 4.8 times more likely to have clinically significant depression and anxiety than Caucasians, respectively. Women had higher levels of depression than men. These results reaffirm the close relationship of insomnia, depression, and anxiety, after rigorously controlling for other potential explanations for the relationship.
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                Author and article information

                Contributors
                +49 341 9716100 , markus.loeffler@imise.uni-leipzig.de
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                22 July 2015
                22 July 2015
                2015
                : 15
                : 691
                Affiliations
                [ ]LIFE - Leipzig Research Centre for Civilization Diseases, University of Leipzig, Leipzig, Germany
                [ ]Institute for Medical Informatics, Statistics, and Epidemiology (IMISE), University of Leipzig, Haertelstrasse 16-18, 04107 Leipzig, Germany
                [ ]Department of Sport and Exercise Psychology, University of Leipzig, Leipzig, Germany
                [ ]Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany
                [ ]Clinic of Cognitive Neurology, University of Leipzig, Leipzig, Germany
                [ ]Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig, Leipzig, Germany
                [ ]Department of Internal Medicine/Cardiology, Leipzig Heart Centre, Leipzig, Germany
                [ ]Interdisciplinary Centre for Bioinformatics, University of Leipzig, Leipzig, Germany
                [ ]Department of Psychosomatic Medicine and Psychotherapy, Universal Medical Centre Mainz, Mainz, Germany
                [ ]Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, Leipzig, Germany
                [ ]Department of Medical Psychology and Medical Sociology, University of Leipzig, Leipzig, Germany
                [ ]Department of Cardiology-Angiology, University of Leipzig, Leipzig, Germany
                [ ]Department of Psychiatry and Psychotherapy, University of Leipzig, Leipzig, Germany
                [ ]Clinical Trial Centre Leipzig - Coordinating Centre for Clinical Trials, University of Leipzig, Leipzig, Germany
                [ ]Department of Electrophysiology, Leipzig Heart Centre, Leipzig, Germany
                [ ]Clinic of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany
                [ ]Interdisciplinary Centre for Clinical Research (IZKF), University of Leipzig, Leipzig, Germany
                [ ]Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany
                [ ]Department of Pediatric Cardiology, Leipzig Heart Centre, Leipzig, Germany
                [ ]Department of Radiology, University of Leipzig, Leipzig, Germany
                [ ]Department of Ophthalmology, University of Leipzig, Leipzig, Germany
                [ ]Department of Dermatology, Venereology and Allergology, University of Leipzig, Leipzig, Germany
                [ ]Medical Department, Division of Endocrinology and Nephrology, University of Leipzig, Leipzig, Germany
                Article
                1983
                10.1186/s12889-015-1983-z
                4509697
                26197779
                530610f7-a926-481c-a9f1-2974bf06e1e6
                © Loeffler et al. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 18 June 2015
                : 26 June 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Public health
                cohort study,epidemiology,population based,diseases of civilization
                Public health
                cohort study, epidemiology, population based, diseases of civilization

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