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      The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation

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          Abstract

          Background

          Coronary heart disease (CHD) is typically associated with many cardiovascular risk factors (e.g., elevated blood pressure), low health-related quality of life, depression, anxiety and psychological stress. Expressive writing (EW) has shown beneficial effects on such variables in both people from the community and in patients with a variety of chronic illnesses. However, no study to date has evaluated the physical and psychological effects of the expressive writing procedure on coronary patients referred to cardiac rehabilitation (CR).

          Methods

          The clinical effectiveness of a 2-week disease-related expressive writing procedure (writing about one's deepest thoughts and feelings regarding the experience with heart disease) compared with the standard writing task (writing about one's deepest thoughts and feelings about the most traumatic or negative event experienced in the life), a neutral writing condition (writing about the facts regarding heart disease and its treatment) and an empty control condition will be evaluated in a randomized controlled clinical trial (RCT) with repeated follow-up measurements at 3, 6 and 12 months after discharge from CR. The primary outcome is health-related quality of life (SF-12). Secondary outcome measures are depression (BDI-II), anxiety (BAI) and post-traumatic growth (PTGI). Furthermore, the study will explore the moderating effects of coping styles, type D personality, perceived emotional support and participants' evaluative ratings of the writing interventions on the main experimental effects in order to identify sub-groups of patients showing different results.

          Discussion

          The WRITTEN-HEART study aims to explore and expand the frontiers of the expressive writing research enterprise by investigating the feasibility, safety and clinical efficacy of brief and cost-effective expressive writing interventions in patients with CHD referred to CR.

          Trial registration

          ClinicalTrials.gov NCT01253486

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          Most cited references34

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          Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey.

          This study presents estimates of lifetime and 12-month prevalence of 14 DSM-III-R psychiatric disorders from the National Comorbidity Survey, the first survey to administer a structured psychiatric interview to a national probability sample in the United States. The DSM-III-R psychiatric disorders among persons aged 15 to 54 years in the noninstitutionalized civilian population of the United States were assessed with data collected by lay interviewers using a revised version of the Composite International Diagnostic Interview. Nearly 50% of respondents reported at least one lifetime disorder, and close to 30% reported at least one 12-month disorder. The most common disorders were major depressive episode, alcohol dependence, social phobia, and simple phobia. More than half of all lifetime disorders occurred in the 14% of the population who had a history of three or more comorbid disorders. These highly comorbid people also included the vast majority of people with severe disorders. Less than 40% of those with a lifetime disorder had ever received professional treatment, and less than 20% of those with a recent disorder had been in treatment during the past 12 months. Consistent with previous risk factor research, it was found that women had elevated rates of affective disorders and anxiety disorders, that men had elevated rates of substance use disorders and antisocial personality disorder, and that most disorders declined with age and with higher socioeconomic status. The prevalence of psychiatric disorders is greater than previously thought to be the case. Furthermore, this morbidity is more highly concentrated than previously recognized in roughly one sixth of the population who have a history of three or more comorbid disorders. This suggests that the causes and consequences of high comorbidity should be the focus of research attention. The majority of people with psychiatric disorders fail to obtain professional treatment. Even among people with a lifetime history of three or more comorbid disorders, the proportion who ever obtain specialty sector mental health treatment is less than 50%. These results argue for the importance of more outreach and more research on barriers to professional help-seeking.
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            Impact of Psychological Factors on the Pathogenesis of Cardiovascular Disease and Implications for Therapy

            Recent studies provide clear and convincing evidence that psychosocial factors contribute significantly to the pathogenesis and expression of coronary artery disease (CAD). This evidence is composed largely of data relating CAD risk to 5 specific psychosocial domains: (1) depression, (2) anxiety, (3) personality factors and character traits, (4) social isolation, and (5) chronic life stress. Pathophysiological mechanisms underlying the relationship between these entities and CAD can be divided into behavioral mechanisms, whereby psychosocial conditions contribute to a higher frequency of adverse health behaviors, such as poor diet and smoking, and direct pathophysiological mechanisms, such as neuroendocrine and platelet activation. An extensive body of evidence from animal models (especially the cynomolgus monkey, Macaca fascicularis) reveals that chronic psychosocial stress can lead, probably via a mechanism involving excessive sympathetic nervous system activation, to exacerbation of coronary artery atherosclerosis as well as to transient endothelial dysfunction and even necrosis. Evidence from monkeys also indicates that psychosocial stress reliably induces ovarian dysfunction, hypercortisolemia, and excessive adrenergic activation in premenopausal females, leading to accelerated atherosclerosis. Also reviewed are data relating CAD to acute stress and individual differences in sympathetic nervous system responsivity. New technologies and research from animal models demonstrate that acute stress triggers myocardial ischemia, promotes arrhythmogenesis, stimulates platelet function, and increases blood viscosity through hemoconcentration. In the presence of underlying atherosclerosis (eg, in CAD patients), acute stress also causes coronary vasoconstriction. Recent data indicate that the foregoing effects result, at least in part, from the endothelial dysfunction and injury induced by acute stress. Hyperresponsivity of the sympathetic nervous system, manifested by exaggerated heart rate and blood pressure responses to psychological stimuli, is an intrinsic characteristic among some individuals. Current data link sympathetic nervous system hyperresponsivity to accelerated development of carotid atherosclerosis in human subjects and to exacerbated coronary and carotid atherosclerosis in monkeys. Thus far, intervention trials designed to reduce psychosocial stress have been limited in size and number. Specific suggestions to improve the assessment of behavioral interventions include more complete delineation of the physiological mechanisms by which such interventions might work; increased use of new, more convenient "alternative" end points for behavioral intervention trials; development of specifically targeted behavioral interventions (based on profiling of patient factors); and evaluation of previously developed models of predicting behavioral change. The importance of maximizing the efficacy of behavioral interventions is underscored by the recognition that psychosocial stresses tend to cluster together. When they do so, the resultant risk for cardiac events is often substantially elevated, equaling that associated with previously established risk factors for CAD, such as hypertension and hypercholesterolemia.
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              DS14: standard assessment of negative affectivity, social inhibition, and Type D personality.

              Type D personality-a joint tendency toward negative affectivity (NA) and social inhibition (SI)-is related to poor cardiac prognosis, but there is no standard for assessing Type D. This study reports on the Type D Scale-14 (DS14) as a standard measure of NA, SI, and Type D. The study included 3813 participants (2508 from the general population, 573 cardiac patients, 732 hypertension patients). They all filled out the DS14, containing 7-item NA and SI subscales; 275 subjects also completed the NEO-FFI, and 121 patients filled out the DS14 twice. Factor analysis of the DS14 yielded 2 dominant traits; all of the NA and SI items loaded between 0.62 to 0.82 on their corresponding factor (N = 3678). The NA scale covered dysphoria, worry, and irritability; the SI scale covered discomfort in social interactions, reticence, and lack of social poise. The NA and SI scales were internally consistent (alpha = 0.88/0.86; N = 3678), stable over a 3-month period (test-retest r = 0.72/0.82) and not dependent on mood and health status (N = 121). NA correlated positively with neuroticism (r = 0.68); SI correlated negatively with extraversion (r = -0.59/-0.65). Scale-level factor analysis confirmed the construct validity of the DS14 against the NEO-FFI. Using a cutoff of 10 (NA > or =10 and SI > or =10), 1027 subjects (28%) were classified as Type D, 21% in the general population versus 28% in coronary heart disease and 53% in hypertension (p < or = .001). Age, sex, and Type D (odds ratio, 3.98; 95% confidence interval, 3.2-4.6; p <.0001) were independently associated with cardiovascular morbidity. The DS14 is a brief, psychometrically sound measure of negative affectivity and social inhibition that could readily be incorporated in epidemiologic and clinical research.
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                Author and article information

                Journal
                Health Qual Life Outcomes
                Health and Quality of Life Outcomes
                BioMed Central
                1477-7525
                2011
                8 July 2011
                : 9
                : 51
                Affiliations
                [1 ]Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy
                [2 ]Department of Psychology, University of Bergamo, Bergamo, Italy
                [3 ]Department of Psychology, Catholic University of Milan, Milan, Italy
                Article
                1477-7525-9-51
                10.1186/1477-7525-9-51
                3151200
                21740564
                cc5ba521-09e7-4794-adc6-40b2d010c7f4
                Copyright ©2011 Manzoni et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 9 March 2011
                : 8 July 2011
                Categories
                Study Protocol

                Health & Social care
                Health & Social care

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