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Objective Type D personality, a joint tendency toward negative affectivity and social inhibition, has been linked to adverse events in patients with heart disease, although with inconsistent findings. Here, we apply an individual patient-data meta-analysis to data from 19 prospective cohort studies (N = 11,151) to investigate the prediction of adverse outcomes by type D personality in patients with acquired cardiovascular disease. Method For each outcome (all-cause mortality, cardiac mortality, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, major adverse cardiac event, any adverse event), we estimated type D's prognostic influence and the moderation by age, sex, and disease type. Results In patients with cardiovascular disease, evidence for a type D effect in terms of the Bayes factor (BF) was strong for major adverse cardiac event (BF = 42.5; odds ratio [OR] = 1.14) and any adverse event (BF = 129.4; OR = 1.15). Evidence for the null hypothesis was found for all-cause mortality (BF = 45.9; OR = 1.03), cardiac mortality (BF = 23.7; OR = 0.99), and myocardial infarction (BF = 16.9; OR = 1.12), suggesting that type D had no effect on these outcomes. This evidence was similar in the subset of patients with coronary artery disease (CAD), but inconclusive for patients with heart failure (HF). Positive effects were found for negative affectivity on cardiac and all-cause mortality, with the latter being more pronounced in male than female patients. Conclusion Across 19 prospective cohort studies, type D predicts adverse events in patients with CAD, whereas evidence in patients with HF was inconclusive. In both patients with CAD and HF, we found evidence for a null effect of type D on cardiac and all-cause mortality.

BackgroundThe clinical value of the identification of mood disorders in patients with acute coronary syndrome (ACS) is well established. However, assessment based on DSM criteria presents some limitations. This study aimed to provide an innovative strategy for evaluating the spectrum of mood disturbances in ACS.MethodsA total of 288 patients with a first episode of ACS underwent interviews based on DSM-IV-TR criteria (major depressive disorder, minor depression, and dysthymia), Diagnostic Criteria for Psychosomatic Research-DCPR (demoralization and type A behavior), and the Clinical Interview for Depression-CID. Additional self-report inventories (psychological well-being and distress) were administered. A total of 100 consecutive patients who satisfied criteria for DSM-IV-TR depression or DCPR demoralization were enrolled in a randomized controlled trial on a sequential combination of cognitive-behavioral and well-being therapy (CBT/WBT) vs clinical management (CM) and reassessed up to 30-month post-intervention.ResultsA total of 29.9% of patients showed a DSM-IV-TR depressive syndrome. Inclusion of demoralization and type A identified psychological distress in 58% of the sample. According to CID, reactivity to social environment, fatigue, depressed mood, and somatic anxiety were the most common symptoms. Somatic symptoms were significantly associated with DSM-IV-TR depression (fatigue and changes of appetite), whereas environmental reactivity with demoralization. Both depression and demoralization were associated with higher distress and lower well-being. Unlike CM, CBT/WBT was significantly associated with decrease of guilt, pessimism, fatigue, and early insomnia (CID).ConclusionsThe findings indicate that standard psychiatric approach identifies only a narrow part of mood disturbances affecting ACS patients. A more articulated assessment unravels specific clinical configurations that may entail prognostic and therapeutic implications.

This pilot randomized controlled trial evaluates the preliminary efficacy of a 4-month well-being therapy (WBT) and lifestyle intervention among adults with type 2 diabetes and overweight/obesity.Fifty-eight patients were recruited from two outpatient clinics and randomized to receive the WBT-lifestyle intervention or the lifestyle intervention alone. Data were collected at baseline (T0), immediate postintervention (T1), 6-month follow-up (T2), and 12-month follow-up (T3). Primary efficacy outcomes included changes in weight, psychological distress, and well-being, whereas secondary efficacy outcomes included changes in lifestyle and physiological parameters.Compared with the lifestyle-alone intervention, the WBT-lifestyle intervention showed greater improvements in depression (p = .009, d = -0.6), hostility (p = .018, d = -0.6), and personal growth (p = .026, d = 0.5) at T1, in self-reported physical activity at T2 (p = .013, d = 0.7) and T3 (p = .040, d = 0.5), and in triglycerides (p = .019, d = -1.12) at T3. There were no differences between treatment groups in weight and other physiological parameters.These findings suggest that WBT may be a valuable addition to lifestyle interventions for improving short-term psychological outcomes and promoting long-term healthy changes in physical activity, with a potential impact on physiological outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT03609463.

This retrospective observational study investigated hospital staff requests for job fitness visits, addressed to occupational medicine. Specific objectives were to analyze: (1) health workers' requests, sociodemographic characteristics, psychiatric diagnoses, assigned doctor's fit notes, and (orthopedic, psychiatric) limitations; (2) associations between psychiatric diagnoses, sociodemographic (sex, age), and work-related (job, department) characteristics; (3) associations between the same psychiatric diagnoses/orthopedic limitations, fit notes, and/or psychiatric limitations. Data of St. Orsola-Malpighi Polyclinic health workers (N = 149; F = 73.8%; mean age = 48 ± 9.6 years), visited by both the occupational medicine physician and psychiatrist (January 2016-May 2019), were analyzed. 83.2% of the sample presented with at least one psychiatric diagnosis, including mood (47%), anxiety (13.4%), and anxious-depressive (10.7%) disorders. Significant differences between psychiatric diagnoses according to sex and fit notes (both p < 0.01) have been found, whereas no significant associations based on age and work-related characteristics have been observed. Analysis of frequencies of participants with the same psychiatric diagnosis (orthopedic limitation being equal), according to doctor's fit notes and psychiatric work limitations, showed a high heterogeneity of assignments. The current occupational medicine procedure for fit notes/job limitations assignments does not allow taking into consideration clinical factors possibly associated with more specific assignments. To standardize the procedure and translate the psychiatrist's clinical judgment into practice, further studies to test the usefulness of clinimetrics, which might represent a reliable approach in considering different fit notes and job limitations, are needed., International Journal of Environmental Research and Public Health, 19 (15), ISSN:1660-4601, ISSN:1661-7827

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients’ subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini­metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

Balanced levels of Psychological Well-Being (PWB) can represent protective factors for human functioning. PWB has not been investigated among young adolescents who practice binge drinking (BD), a popular pattern of alcohol intake, defined as the consumption of five or more alcoholic units in one session. The negative impact of BD on psychophysical health has been extensively studied, but there is scarcity of studies investigating the influence of psychological variables on BD in early adolescence. The main aim of this study was to fill the gap in the literature, focusing on PWB as a new possible target of preventive interventions. One thousand six hundred and eighty-seven Italian adolescents completed questionnaires assessing BD, cannabis use, lifestyle, allostatic overload, subclinical psychological distress, problem-solving, and PWB. Binge drinkers represented 9% of the sample. Among them, 71%, 26%, and 3% binge drank monthly, weekly, and daily, respectively. Stress (higher frequency of stressful life events), psychological distress (higher hostility), and PWB dimensions (higher scores on positive relations and lower on purpose in life) were associated with BD. These new findings on unbalanced levels of PWB could represent the potential target of longitudinal studies aimed to implement specific preventive interventions among young adolescents. Implications for research and prevention are discussed.

Introduction: Patient-reported outcomes (PROs) are of increasing importance in clinical medicine. However, their evaluation by classic psychometric methods carries considerable limitations. The clinimetric approach provides a viable framework for their assessment. Objective: The aim of this paper was to provide a systematic review of clinimetric properties of the Symptom Questionnaire (SQ), a simple, self-rated instrument for the assessment of psychological symptoms (depression, anxiety, hostility, and somatization) and well-being (contentment, relaxation, friendliness, and physical well-being). Methods: The PRISMA guidelines were used. Electronic databases were searched from inception up to March 2019. Only original research articles, published in English, reporting data about the clinimetric properties of the SQ, were included. Results: A total of 284 studies was selected. The SQ has been used in populations of adults, adolescents, and older individuals. The scale significantly discriminated between subgroups of subjects in both clinical and nonclinical settings, and differentiated medical and psychiatric patients from healthy controls. In longitudinal studies and in controlled pharmacological and psychotherapy trials, it was highly sensitive to symptoms and well-being changes and discriminated between the effects of psychotropic drugs and placebo. Conclusions: The SQ is a highly sensitive clinimetric index. It may yield clinical information that similar scales would fail to provide and has a unique position among the PROs that are available. Its use in clinical trials is strongly recommended.

Behavioural lifestyle interventions focused on diet and physical activity are a cornerstone for the treatment of obesity. However, their effects vary substantially across individuals in terms of magnitude and durability. Personalized approaches that target psychological well-being may be promising to facilitate healthy behaviours and sustained weight loss. This preliminary study aimed to explore whether the sequential combination of behavioural lifestyle intervention (BLI) and well-being therapy (WBT) may result in more favourable outcomes than BLI alone in promoting weight loss (primary outcome) and improving psychological well-being, distress, dietary behaviours and physical activity (secondary outcomes). A total of 83 patients with obesity were randomly assigned to BLI/WBT (N = 38) or BLI group (N = 45). The BLI group received a 12-week behavioural weight loss programme, whereas the BLI/WBT group received the same programme followed by an additional 4-week WBT, adapted for group interventions. Data were collected at pretreatment (baseline, T1), at the end of BLI/WBT (T2), at 6-month (T3) and 12-month (T4) follow-ups. There was a significant weight loss in both treatment groups at T2, T3 and T4. The BLI/WBT group showed greater improvements in depressive symptoms at T3 and T4, in autonomy at T2, in personal growth at T4 and in global well-being at T4 compared with BLI group. WBT yielded no additional effect on weight loss. However, the secondary outcomes indicate that WBT may have enduring effects that reduce vulnerability to psychological distress in patients with obesity. In order to confirm these preliminary findings and explore whether a more intensive and individualized WBT can foster sustained weight loss, future studies are needed.

Introduction. Among patients affected by masked hypertension (MH), psychological variables have been poorly investigated. This research aimed to fill the gap in the literature and to investigate ill-being and well-being in patients with MH, compared with patients with essential hypertension (EH) and normotensive subjects (NS). Methods. 10 patients with MH, enrolled at the Division of Internal Medicine, Sant’Orsola Hospital (Bologna, Italy), were compared with 10 EH patients recruited at Bellaria Hospital (Bologna, Italy), and 10 NS, matched for age and sex. They were administered both observer- and self-rated measures. Results. 70% of MH patients showed ill-being (40% depression, 40% anxiety, 60% at least one psychosomatic syndrome). The most frequent causes of stress were loneliness (70%), work (60%), illness/bereavement (50%) and significant changes in life (50%). 40% of the patients developed allostatic overload (AO) as a consequence of stress. Compared with EH patients and NS, patients with MH reported a higher frequency of psychiatric diagnoses (p

Attention Deficit and Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder that often persists into adult-hood. The Italian situation regarding the clinical management of childhood ADHD shows some criticalities, despite the high preva-lence rate: diagnostic assessments are often inaccurate, protocols for transition from childcare services are almost non-existent and theItalian National Registry for ADHD in childhood was drawn up only in 2007, hence the first specialized services were created laterthan the rest of Europe. On the basis of these issues, we investigated the Italian situation with regard to disorders in adulthood, com-paring the different European operational models, assuming that these critical issues are reflected in the clinical management of thedisorder in adulthood. In fact, unlike other European countries, there are no official guidelines governing the clinical management ofthe disorder in adulthood and evidence-based pharmacotherapies, available in most European countries, are off-label or not allowedin Italy. The aim of the study is to evaluate the current state of knowledge and working method in relation to adult ADHD in the Ital-ian background and to identify the main evaluation and treatment pathways in Italian Mental Health Services. The study is also an at-tempt to clarify which services are operational on the Italian territory, with the aim of improving the quality of interventions for theclinical population. Three hundred thirty-eight services have been identified in all Italian Regions and Autonomous Provinces, includ-ing Mental Health Centres (CSM), Pathological Addition Services (SERD), Psychiatric Diagnosis and Treatment Services (SPDC). Anad-hoc survey with closed-ended questions was administered by telephone to each selected centre and the results were compared withthe European literature.

Attention Deficit and Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder that often persists into adulthood. The Italian situation regarding the clinical management of childhood ADHD shows some criticalities, despite the high prevalence rate: diagnostic assessments are often inaccurate, protocols for transition from childcare services are almost non-existent and the Italian National Registry for ADHD in childhood was drawn up only in 2007, hence the first specialized services were created later than the rest of Europe. On the basis of these issues, we investigated the Italian situation with regard to disorders in adulthood, comparing the different European operational models, assuming that these critical issues are reflected in the clinical management of the disorder in adulthood. In fact, unlike other European countries, there are no official guidelines governing the clinical management of the disorder in adulthood and evidence-based pharmacotherapies, available in most European countries, are off-label or not allowed in Italy. The aim of the study is to evaluate the current state of knowledge and working method in relation to adult ADHD in the Italian background and to identify the main evaluation and treatment pathways in Italian Mental Health Services. The study is also an attempt to clarify which services are operational on the Italian territory, with the aim of improving the quality of interventions for the clinical population. Three hundred thirty-eight services have been identified in all Italian Regions and Autonomous Provinces, including Mental Health Centres (CSM), Pathological Addition Services (SERD), Psychiatric Diagnosis and Treatment Services (SPDC). An ad-hoc survey with closed-ended questions was administered by telephone to each selected centre and the results were compared with the European literature.

Background: Few studies have investigated psychosocial characteristics and lifestyle behaviors of participants at programs for secondary prevention of colorectal cancer (CRC). This study aimed, through a comprehensive psychosomatic assessment based on clinimetric principles, to evaluate psychosocial characteristics and lifestyle behaviors in participants at CRC secondary prevention program, and to investigate the associations between these variables and endoscopic outcomes. Methods: In this cross-sectional study, the first 150 consecutive asymptomatic participants at the CRC prevention program who resulted positive to fecal occult blood test (FOBT) and were thus referred to colonoscopy, underwent a psychosomatic assessment including psychiatric diagnoses (DSM-5), psychosomatic syndromes (DCPR-R), psychological distress (SQ), psychological well-being (PWB-I) and lifestyle behaviors. Results: Whereas only 5.3% of the sample showed at least one DSM-5 diagnosis, 51.3% showed at least one DCPR syndrome, such as allostatic overload, alexithymia, Type A behavior, and demoralization. Patients affected by psychosomatic syndromes presented with significantly higher psychological distress, lower psychological well-being and unhealthy lifestyle behaviors, such as tobacco smoking and unhealthy diet, in comparison with patients without DCPR syndromes. Among endoscopic outcomes, the presence of adenomas was significantly associated with DCPR irritable mood. Conclusions: In a clinical context of secondary prevention addressing asymptomatic patients with a positive FOBT, a comprehensive psychosomatic assessment may provide relevant clinical information for those patients who present certain psychosomatic syndromes associated with high psychological distress, impaired psychological well-being, unhealthy lifestyle behaviors and colorectal precancerous lesions. The results of the present study indicate a road to the practice of “preventive” medicine at CRC screening program.

La Well-Being Therapy (WBT) e una strategia psicoterapeutica breve che incoraggia l’autosservazione del benessere psicologico per mezzo di un diario strutturato, di tecniche cognitivo-comportamentali per la ristrutturazione cognitiva di pensieri e/o comportamenti che interferiscono con il raggiungimento del benessere, e l’assegnazione di compiti a casa (ovvero, perseguendo esperienze ottimali). La WBT si fonda su un modello multidimensionale di benessere psicologico, che e stato originariamente sviluppato da Marie Jahoda, e il cui obiettivo e quello di raggiungere uno stato di eutimia. Un’importante caratteristica della terapia e l’autosservazione del benessere psicologico associata alla messa in atto di specifici compiti. Tale prospettiva e diversa da quella di interventi psicologici che vengono classificati come "positivi" ma che in realta si focalizzano sulla sofferenza. La WBT e stata validata in diversi studi randomizzati e controllati riguardanti la prevenzione delle ricadute nella depressione e il miglioramento dei livelli di guarigione nei disturbi affettivi. Un aspetto importante della WBT e l’assunzione che gli squilibri nei livelli di benessere e sofferenza possano variare da paziente a paziente e necessitino di strategie di valutazione specifiche. L’obiettivo di questo articolo e quello di fornire una rassegna aggiornata della WBT e di illustrare come le intuizioni cliniche ottenute con l’utilizzo della WBT possano svelare modalita di approccio innovative nell’ambito delle condizioni mediche. Viene inoltre presentato un caso clinico che esemplifica l’applicazione e il ruolo potenziale della WBT nel produrre cambiamenti nello stile di vita nella sindrome metabolica. Si sostiene che i cambiamenti nello stile di vita possono essere ottenuti solo attraverso un approccio personalizzato rivolto al benessere psicologico.

Literature supports the positive effects of psychological well-being (P.W.B.) on health. However, most studies focused on the unitary construct of P.W.B., neglecting the different role played by distinct P.W.B. dimensions on health-related outcomes. The aim of this study was to determine whether unbalanced (i.e. low or high) levels of P.W.B. dimensions could differentially affect cardiac course after acute coronary syndrome (A.C.S.), in terms of participation in secondary prevention (S.P.) and/or survival. The sample included 136 depressed and/or demoralized A.C.S. patients referred for a S.P. program on lifestyle modification, in addition to routine cardiac visits provided by the hospital where they were admitted. Psychological assessment included validated interviews on depression and demoralization, Symptom Questionnaire and Psychological Well-Being scales. 100 patients joined the S.P. program, 36 did not. Logistic regression revealed that older age (B=0.051; p

Benzodiazepines (BZs) have been used broadly in gastroenterology, for instance in treating anxiety symptomatology associated with gastrointestinal (GI) illness, or in treating some underlying conditions (e.g., addressing alcohol dependence in liver disease), or in various diagnostic endoscopy procedures, and in preparation for surgery. It is known that anxiety and GI symptomatology/disorders frequently co-exist, with anxiety exacerbating GI disorders, and some GI symptoms provoking anxiety.

Prospective memory (PM) is essential in everyday life because it concerns the ability to remember to perform an intended action in the future. This ability could be influenced by poor sleep quality, the role of which, however, is still being debated. To examine the role of sleep quality in PM in depth, we decided to perform a retrospective naturalistic study examining different clinical populations with a primary sleep disorder or comorbid low sleep quality. If sleep is important for PM function, we could expect poor sleep to affect PM performance tasks both directly and indirectly. We examined a total of 3600 nights, recorded using actigraphy in participants belonging to the following groups: primary insomnia (731 nights), narcolepsy type 1 (1069 nights), attention deficit hyperactivity disorder (152 nights in children and 239 in adults), severe obesity (232 nights), essential hypertension (226 nights), menopause (143 nights), healthy controls (808 nights). In a naturalistic activity-based PM task, each participant originally wore an actigraph around the non-dominant wrist and was requested to push the event-marker button at two specific times of day: bedtime (activity 1) and get-up time (activity 2). Each clinical group showed significantly lower sleep quality in comparison to the control group. However, only narcolepsy type 1 patients presented a significantly impaired PM performance at get-up time, remembering to push the event-marker button around half the time compared not only to healthy controls but also to the other clinical groups. Overall, the present results seem to point to sleep quality having no effect on the efficiency of a naturalistic activity-based PM task. Moreover, the data indicated that narcolepsy type 1 patients may show a disease-specific cognitive deficit of PM.

Although the literature suggested that impaired psychological well-being (PWB) is associated with obesity, evidence on the role of PWB in weight outcomes is limited and inconclusive. This research aimed to investigate the joint role of PWB in achieving clinically significant weight loss (CWL; loss of 5% of the initial weight) through a comprehensive lifestyle intervention for obesity using a broad-based evaluation.This study is a prospective cohort of 96 patients with obesity attending a comprehensive lifestyle intervention for weight loss. Data on weight, lifestyle, PWB, and distress, were collected before and after the intervention.30.5% of the participants achieved CWL at the end of treatment. A more pronounced increase in autonomy (odds ratio = 0.80 [95%Unbalanced dimensions of PWB, in particular exceedingly high autonomy, may contribute to a poor weight loss outcome. This study paves the way for the addition of psychotherapeutic strategies geared to euthymia in comprehensive lifestyle intervention.Aunque la literatura sugiere que el deterioro del bienestar psicológico (BP) está asociado con obesidad, la evidencia sobre el papel del BP en el peso es limitada. Se investiga el papel del BP en el logro de pérdida de peso clínicamente significativa (PPCS; pérdida del 5% del peso inicial) a través de una intervención integral sobre el estilo de vida con respecto a la obesidad.Cohorte prospectiva de 96 pacientes con obesidad que asisten a una intervención integral sobre el estilo de vida para la pérdida de peso. Se recolectaron datos sobre peso, estilo de vida, BP y angustia, antes y después de la intervención.El 30,5% de los participantes lograron pérdida de peso al final del tratamiento. Mayor aumento de autonomía (razón de momios = 0,80 [Las dimensiones desequilibradas del BP, en particular la autonomía excesivamente alta, pueden contribuir a una pérdida de peso insuficiente. Se allana el camino para añadir estrategias psicoterapéuticas orientadas a la eutimia en la intervención integral en el estilo de vida.

Background The literature has outlined positive effects of cardiac rehabilitation (CR) on clinical psychological distress (DSM depression and anxiety) and quality of life (QoL). In cardiac settings, subclinical distress (subthreshold depressive and anxious symptomatology) and psychological well-being also showed relevant clinical implications. This research explored these psychological variables, their changes over time and cardiac course of CR patients. Methods Clinical and subclinical distress, QoL, and psychological well-being were assessed in 108 consecutive patients undergoing CR, at baseline and up to 12 months after the program's completion. Results Of all patients, 25.9 per cent showed high distress with a DSM diagnosis, 31.5 per cent high distress without a DSM diagnosis, and 42.6 per cent low distress. Comparing these subgroups, worse QoL and psychological well-being were significantly linked not only to clinical but also to subclinical distress. After CR completion, a significant reduction in DSM diagnoses was observed, whereas there were no positive effects on subclinical distress, QoL, and well-being, or when they initially occurred, they were not long lasting. Moreover, only the subgroup with high distress without a DSM diagnosis was at greater risk for adverse cardiac outcomes, showing worse scores on items of contentment. Conclusions These findings confirm data on clinical distress reduction after CR completion. However, a large amount of relevant subclinical distress remains and predicts adverse cardiac events.

The side effects and risks associated with the medical intervention are defined as iatrogenesis. Adverse drug reactions, malpractice, medical error, and negligence constitute common iatrogenic complications. Examples of important syndromes induced by medications are asthma caused by beta-adrenoceptor antagonists, pulmonary fibrosis associated with cytotoxic agents, gastric bleeding and complications with anti-inflammatory agents, torsade de pointes tachycardia with various drugs, abnormal glucose homeostasis with thiazide and corticosteroids, and osteonecrosis of the jaw with bisphosphonates. In psychiatry, iatrogenesis has traditionally been concerned with medical complications of psychotropic drug treatment, such as tardive dyskinesia and insulin resistance with antipsychotic drugs, and cardiac and metabolic disturbances with antidepressant medications. The complications may occur due to direct toxicity, drug-drug interactions, intoxication, or withdrawal from psychotropic medications. In more recent years, attention has also been dedicated to the patient experience of negative effects of psychotherapy, including the interactions between pharmacotherapy and psychotherapy. As it happened with medical therapy, psychiatric treatment has mainly been assessed and evaluated as to its capacity to improve psychiatric symptomatology. Side effects have been conceptualized as the unavoidable drawbacks of any form of medical therapy. Little attention has been paid to the adverse psychological and behavioral effects of psychiatric treatment on psychopathology and illness course. In view of the insufficient body of knowledge on the iatrogenic effects of psychological therapies, we will only concentrate on the effects of psychotropic drug treatment. Many of the insights that have been gained in the past 25 years have originated in this journal.

OBJECTIVE: The role of depression and quality of life on clinical outcomes of congestive heart failure (CHF) is well recognised. However, there are fewer studies investigating the prognostic role of subclinical psychological distress and well-being impairments. The aims of this study were to evaluate clinical/subclinical psychological distress and well-being in CHF outpatients, and the influence of these psychological factors on adverse cardiac events (re-hospitalisation, cardiac death), at 4-year follow-up. DESIGN: Sixty-eight CHF outpatients underwent psychological assessment at baseline and, after 4 years, information about cardiac events was collected in 60 patients by means of clinical records. MAIN OUTCOME MEASURES: Psychological assessment included structured clinical interview for DSM (major/minor depression), Interview for diagnostic criteria for psychosomatic research (demoralisation), symptom questionnaire, psychological well-being scales. RESULTS: At follow-up, 39.7% of the baseline sample reported cardiovascular events (14 CHF-related re-hospitalisations and 13 cardiac deaths) and 5.9% other causes for death. Among the variables examined as potential risk factors for adverse cardiovascular outcomes, only hostility was significant, even after controlling for disease severity (hazard ratio = 2.38, 95%confidence interval: 1.04-5.45, p = .040). CONCLUSION: In outpatients with CHF, psychological assessment should include both clinical and subclinical distress such as hostility, in order to better address psychological risk factors for cardiac outcomes.

Objective Cardiac rehabilitation (CR) is considered the recommended secondary prevention treatment for cardiovascular diseases (CVD), in terms of health behaviours and, secondarily, better cardiac outcomes promotion. However, the role of psychiatric and psychosomatic distress on the efficacy of CR is unclear. This research aimed to evaluate the impact of CR on unhealthy behaviour modification and cardiac course, considering the moderating role of depression, anxiety, and psychosomatic syndromes. Design A longitudinal design between and within groups was employed. The assessment was repeated four times: at admission to CR (T1), at discharge (T2), 6 (T3) and 12 months following CR completion (T4). Method One hundred and eight patients undergoing CR versus 85 patients with CVD not referred to CR, underwent psychiatric, psychosomatic, and health behaviour assessment. The assessment included the Structured Clinical Interview for DSM-IV (depression and anxiety), the interview based on Diagnostic Criteria for Psychosomatic Research, GOSPEL Study questionnaire (health behaviours), Pittsburgh Sleep Quality Index, and 8-item Morisky Medication Adherence Scale. Results Cardiac rehabilitation was associated with maintenance of physical activity, improvement of behavioural aspects related to food consumption, stress management, and sleep quality. On the contrary, CR was not associated with weight loss, healthy diet, and medication adherence. Depression and psychosomatic syndromes seem to moderate the modification of specific health-related behaviours (physical activity, behavioural aspects of food consumption, stress management, and pharmacological adherence). Conclusion In CR settings, an integrated assessment including both psychiatric and psychosomatic syndromes is needed to address psychological factors associated with unhealthy behaviour modification. Statement of contribution What is already known on this subject? Cardiac rehabilitation (CR) is considered a class 1A treatment recommendation and the most cost-effective model of secondary prevention to reduce cardiovascular events. There is evidence about the association between psychological distress and both unhealthy behaviour and cardiac course. Depression and psychosomatic distress, such as type A behaviour and demoralization, are frequently associated with CVD course. However, the role of psychiatric and psychosomatic distress in CR is not well known. What does this study add? CR exerted a protective effect on physical activity and a positive effect on eating behaviour, stress management, and quality of sleep. CR did not show any particular effect on smoking, overweight/obesity, dietary habits, medication adherence, and patients’ 1-year survival. Findings from this study suggest the importance to consider specific psychological and psychosomatic aspects in affecting lifestyle.

The role of psychosocial stress in the development of essential hypertension has attracted increasing attention in the last decades, even though research findings have been often inconclusive. We specifically investigated allostatic overload (AO) in hypertensive patients using a clinimetric approach. Allostatic overload was assessed by a semi-structured research interview based on clinimetric criteria in 80 consecutive outpatients with essential hypertension (46.3 % females; mean age 62.18 ± 8.59 years; age range 47–74 years) and 80 normotensive matched controls. Three clinical interviews and two self-rating questionnaires for assessing psychological distress and well-being were also administered. Cardiac variables were collected. AO was present in 26 (32.5 %) of the hypertensive patients based on clinical interviewing, and in only 6 normotensive controls (p < .001). Hypertensive patients with AO had significantly higher levels of psychological distress than those without. Further, patients with AO displayed significantly lower levels of well-being and quality of life (p < .001). A significantly greater prevalence of psychosomatic syndromes was found to be associated with the presence of AO (p < .05), whereas no significant association was detected as to psychiatric diagnoses. Significantly greater cardiovascular risk was found among hypertensive patients reporting AO compared to those without (p < .05). The results of this study support the clinical relevance of a psychological assessment of hypertensive patients, with important implications for the non-pharmacological management of hypertension.

The relationship between anxiety and cardiovascular disease (CVD) has been known and well-documented for decades. Though more attention has been paid to the relationship between depression and CVD, the evidence of the relationship between anxiety and CVD has been growing. For instance, Goodwin et al. (2009) documented that anxiety disorders are strongly and significantly associated with CVD among adults in the USA. Frasure-Smith and Lesperance (2008), among others, found that, not just depression but also anxiety predicted a greater risk of major adverse cardiac events such as cardiac death, myocardial infarction, or cardiac arrest in patients with stable coronary artery disease. Less attention has been paid to the possible benefits of anxiolytic medications, such as benzodiazepines (BZs), for patients with CVD and anxiety or possible full-blown anxiety disorder.

Purpose: There are several clinical areas where psychological well-being may play an important role: the assessment of the dynamic balance between ill-being and well-being; reduction of incidence, prevention of recurrence and achievement of full recovery in psychiatric disorders such as depression; patient’s satisfaction and perceived change after treatment. The aim of this article is to discuss the clinical role of Well-Being Therapy (WBT). Materials and methods: A critical review of the literature concerned with psychological well-being and its treatment was performed. WBT is a short-term psychotherapeutic strategy that emphasizes self-observation of psychological well-being, with the use of a structured diary, cognitive restructuring of interfering thoughts and/or behaviors through cognitive behavioral techniques, and homework assignments (i.e. pursuing optimal experiences). WBT is based on a multidimensional model of psychological well-being that was originally developed by Marie Jahoda and it is aimed at achieving a state of euthymia. Results: WBT has been validated in a number of randomized controlled trials. The sequential combination of cognitive behavior therapy (CBT) and WBT has mainly characterized its use so far. Illustration of a clinical case exemplifies its application and the potential role of psychological well-being in the clinical process. Conclusions: Even though more randomized controlled trials concerned with WBT are needed, consideration of psychological well-being may unravel innovative approaches to the prevention, assessment and treatment of mood and anxiety disorders.

Objective Psychiatric morbidity is quite common in vasovagal syncope (VVS), but findings are sometimes contradictory. Among patients with suspected VVS, up to 40% has a negative response to Head-Up Tilt test (HUT), the cause of syncope remaining unexplained (US). The authors evaluated and compared the psychological and psychosomatic profile in patients with positive (VVS) and negative HUT (US). Method A consecutive series of 67 patients with suspected VVS underwent HUT: 45 patients had a positive HUT, 22 negative. They were evaluated by means of observer- and self-rated measures. Results Of the total sample, 95.5% had at least one Diagnostic and Statistical Manual of Mental Disorders diagnosis or one psychosomatic syndrome, such as specific and social phobias, illness denial and demoralization. Comparing VVS and US patients, no statistical differences on diagnoses' frequencies were found. However, the US group had significantly poorer health habits, lower levels of well-being and higher psychological distress. They also reported to be more anxious, depressed and hostile. VVS patients were significantly more blood and social phobic than US patients. Conclusion Despite similar and remarkable observer-rated psychopathology, US patients reported higher self-perceived psychological distress than VVS patients. Psychological evaluation of patients undergoing HUT should incorporate both clinical and subclinical methods to better address syncope management.

Aiming to verify which is the most effective screening approach for sleep disorders between the serial (first step: sleep self-report measure; second step only in case of positive outcome at the first: objective tool) and parallel (unique step, with the concurrent use of sleep self-report measure and objective tool), a first secondary analysis of previously collected data (study 1) was carried out examining primary insomniacs (PI) and healthy controls (HC). Aiming to verify the implementation of such approaches in clinical populations presenting high comorbidity with sleep disorder, an additional secondary analysis (study 2) was carried out, investigating hypertensive patients (HP) and severe obese patients (SOP). 84 HC and 47 PI were examined in study 1, while 36 SOP, and 30 HP in study 2. All participants originally underwent actigraphic recordings for seven consecutive days, using the Actiwatch device (objective tool). At the end of the recording week, participants filled the Mini Sleep Questionnaire (sleep self-report measure). As regards the study 1, the parallel and serial approaches allowed to correctly identify the 97.87% and 55.32% of PI, respectively. With reference to the study 2, the 36.11% and 80.56% of SOP were identified as positive at the serial and parallel approaches, respectively, while the corresponding percentages of HP were 30% and 70%. Study 1 showed that parallel screening approach is the most effective in PI, allowing to correctly identifying almost the entirety of these patients. Study 2 highlighted that serial screening approach is more useful in SOP and HP, identifying a percentage of positive patients overall in line with the documented comorbidity with sleep disorder in these clinical populations.

The aim of this research was to investigate the relationships between creativity, subclinical bipolar disorder symptomatology, and psychological well-being. The study method was of descriptive, correlational type. Significant tests were performed using multivariate regression analysis. Students of the 4th grade of 6 different Italian colleges (N = 329) completed voluntarily the test of divergent feelings (TDF) included in the creative assessment packet (CAP), the Temperament Evaluation of Memphis, Paris, Pisa and San Diego—Autoquestionnaire (TEMPS-A), and the psychological well-being scale (PWB). Significant positive correlations between creativity and bipolar disorder vulnerability, especially hyperthymia, were found. Creativity was, instead, poorly associated to psychological well-being subscales, except autonomy and personal growth. In addition, although multivariate regression showed that creativity was not a significant predictor of almost all the psychological well-being subscales, it did show a significant association with personal growth. On the contrary, bipolar disorder vulnerability, in particular hyperthymia, was found to significantly predict all psychological well-being scales, except personal growth. These results improve knowledge on the mutual association of creativity, psychological well-being, and bipolar vulnerability, giving a theoretical framework in which situate these constructs.

Placebo effects are often attributed to clinical interactions and contextual factors that affect expectations of the patient about the treatment and result in symptom changes. The prevailing conceptualization consists of an undifferentiated placebo response that needs to be minimized in controlled investigations and maximized in clinical practice. However, treatment outcome is the cumulative result of the interaction of several classes of variables with a selected treatment: living conditions (housing, nutrition, work environment, social support), patient characteristics (age, sex, genetics, general health conditions, personality, well-being), illness features and previous therapeutic experience, self-management, and treatment setting (physician's attitude and attention, illness behavior). Such variables may be therapeutic or countertherapeutic, and are unlikely to be simply additive. In certain patients their interactive combination may lead to clinical improvement, whereas in other cases it may produce no effect, and, in a third group, it may lead to worsening of the condition. Maximizing patients' expectations does not necessarily result in sustained effects and, in due course, may actually lead to worsening of the condition (violation of expectations). In this paper, we outline a multifactorial conceptual model that may have implications for the design of clinical trials as well as for clinical practice, with special reference to psychopharmacology and psychotherapy. The effects of drug treatment may be potentiated by specific nonpharmacological treatment strategies, and this synergism may disclose significant differences against placebo. Medical outcomes may be unsatisfactory not because technical interventions are missing, but because our conceptual models and thinking are inadequate.

The precipitating role of emotional stress in the development of congestive heart failure (CHF) is a long-standing clinical observation. We employed new clinimetric criteria for the assessment of allostatic overload (AO) in a sample of CHF patients, with regard to its associations with psychological distress and health status. Allostatic overload was assessed by a semi-structured interview based on clinimetric criteria in 70 consecutive outpatients with CHF. One observer-rated scale and two self-rating questionnaires for psychological distress were administered. Cardiac variables were also collected at intake. Twenty-three patients (32.9%) were classified as having AO according to clinimetric criteria. Significant differences were found with regard to gender, with women being more likely to report AO than men (23.5% versus 57.9%). Patients with AO presented significantly higher levels of psychological distress (based on scales administered) compared with those who did not. Among cardiac risk factors, hyperglycaemia was found to be significantly associated with the presence of AO. The use of the clinimetric criteria provides a global index for identifying distress that might adversely influence the course and progression of CHF. It may be of use in clinical practice, leading to therapeutic suggestions such as lifestyle modifications and psychotherapy to help patients deal with their difficulties.

HART) [7] , on depressed patients after CAD, found that the effect of sertraline was greater in patients with severe and recurrent depression. It is also true that, in cardiac settings, mild depressive symptoms are sufficient to enhance cardiovascular risk even in the absence of major depressive disorder [8–11] . Antidepressant treatment could thus be successful in terms of cardiac prognosis only in the subgroup of cardiac patients with more severe depression, but not in those with milder depression at equally elevated cardiac risk. It has been suggested that selective serotonin reuptake inhibitors (SSRIs) might ameliorate the adverse effect of depression on cardiovascular disease through the inhibition of platelet aggregation, even independently of changes in depression [12] . This potential benefit, however, is counteracted by recognized adverse cardiovascular side effects [13–15] . In particular, the use of SSRIs such as citalopram and escitalopram is associated with cases of arrhythmias and prolonged QTc interval on electrocardiogram in patients lacking cardiovascular disorders [16] . Licht et al. [17] found that all antidepressants, including SSRIs, have a lowering effect on cardiac vagal control that has been found to be associated with increased blood pressure and other metabolic abnormalities, such as unfavorable lipid profiles and high glucose levels [18] . A significant relationship between depression and cardiac morbidity has been documented [1] . The identification of depression as an unfavorable marker of the clinical course in coronary artery disease (CAD) in the 1990s [2– 4] generated the hope of improving the prognosis of cardiovascular disease with treatment of depression. This hope, however, has not survived the test of time. In a Cochrane review on randomized controlled clinical trials (RCTs) of any length of treatment and any length of follow-up [5] , psychological and pharmacological interventions have shown a small yet clinically meaningful effect on depression outcomes in CAD patients. However, no beneficial effects on the reduction of mortality rates and cardiac events have been found. Indeed, in some cases, treatment of depression was found to entail negative physical consequences. There are several potential explanations, involving drugs and psychotherapy, which account for this phenomenon.

Background Implantable cardioverter defibrillator (ICD) is a key treatment option for both primary and secondary prevention of sudden cardiac death. Despite this, there is a growing number of studies showing that ICD is often associated with post-implantation deleterious psychosocial effects, even in the absence of medical complications. Knowledge about the predictive role of pre-ICD psychological profile is scant. The present research aims to describe patients' pre-ICD psychological profile, focusing on acute and chronic distress, such as anxiety, depression, type D personality, psychosomatic syndromes and allostatic overload (AO), and to evaluate if these psychological variables could affect ICD outcomes and survival. Methods 117 consecutive patients (74.4% males; mean age=63.1±13.7years) underwent psychological assessment prior to ICD implantation. Data on ICD-related complications and death were collected up to 26months after the intervention. Results At baseline, 36.8% of the sample had anxiety and 17.9% depression. Among psychosomatic syndromes, psychological factors affecting medical conditions were the most frequent (37.6%). 12.8% presented with type D personality, whereas 16.2% showed moderate AO and 4.3% severe AO. 25.6% of the patients had post-ICD complications and 6% died. Severe AO was the only predictor of survival. Conclusion Our findings show that a reliable evaluation of stress and the inability to cope with it (allostatic overload) may help to identify patients at higher risk of post-ICD complications and death. Such sensitive index, more than traditional psychiatric diagnostic criteria, may help the physician to identify easily manifestations of distress and clinically relevant information, which could affect medical illness outcomes.

Patients with cyclothymic disorder were assessed for presence of psychosomatic syndromes in a recent treatment trial comparing clinical management (CM) to sequential combination of cognitive-behavioral therapy and well-being therapy (CBT/WBT) in which demoralization was found to be the most common syndrome. Demoralization is a psychological state characterized by helplessness, hopelessness, sense of failure and a feeling of inability to cope and may represent a heightened suggestibility to encouragement. Hypothesizing that comorbid demoralization in such patients may prove to be a predictor of increased treatment response, secondary analyses, specifically analyses of variance for repeated measures and contrast analyses, were performed separately for the two treatment groups to compare the mean scores of outcome measures in different assessment times with comorbid demoralization as the between-subjects factor and assessment times as within-subject factors. Among patients in the CM group, a significant time by comorbid demoralization interaction was found at the 2-year follow-up, where demoralized cyclothymic patients showed a significantly greater reduction in mood symptomatology than nondemoralized ones (p < 0.05). Jerome Frank had proposed that common psychotherapeutic elements such as providing a healing setting and encouragement, and instilling hopes and expectations of improvement into the patient, acted positively on demoralized patients. Such nonspecific ingredients provide lessening of isolation and the basis for therapeutic alliance, both considered by some as mechanisms of change. Evaluating the presence of demoralization may help identify those patients with a heightened suggestibility to nonspecific elements of treatment.

Heavy episodic alcohol consumption or binge drinking (BD) is highly prevalent among adolescents in Europe. Young BD is associated with a range of negative health and social outcomes and its causes could be referred to greater positive alcohol expectancies or low self-efficacy and personality characteristics. Moreover, it is likely that some adolescents drink because they want to reduce negative emotions or deal with stress. Little is known on the relationship between BD and specific well-being impairments, whereas it seems that meaning in life, a concept similar to psychological well-being, do not characterize such population. We recruited 679 consecutive students who completed the Psychosocial Index and the Alcohol Use Disorder Identification Test (AUDIT). Among the recruited students, 337 consume alcohol and 161 report BD. Significant differences have been highlighted among three groups (no drinkers, drinkers and bingers) concerning stress and environmental mastery. Both higher scores of stress and lower levels of environmental mastery are associated with BD. These preliminary data show that BD is highly represented and the novelty of this study refers to the evaluation of binge drinking phenomenon in adolescents, through validated and reliable methods in the field of clinimetrics.

Summary Aims: The role of type A behaviour in cardiovascular disease is controversial and most of the research is based on self-rating scales. The aim of this study was to assess the prevalence of type A behaviour in cardiology and in other medical settings using reliable interview methods that reflect its original description. Methods: A sample of 1398 consecutive medical patients (198 with heart transplantation, 153 with a myocardial infarction, 190 with functional gastrointestinal disorders, 104 with cancer, 545 with skin disorders and 208 referred for psychiatric consultation) was administered the Structured Clinical Interview for the DSM-IV and the Structured Interview for the Diagnostic Criteria for Psychosomatic Research (DCPR) which identifies 12 clusters, including type A behaviour. Results: A cardiac condition was present in 366 patients. There was a significant difference in the prevalence of type A behaviour in cardiovascular disease (36.1%) compared with other medical disorders (10.8%). Type A behaviour frequently occurred together with psychiatric and psychosomatic disturbances, particularly irritable mood, even though in the majority of cases it was not associated with DSM-IV diagnoses. Among cardiac patients, those with type A behaviour were less depressed, demoralised and worried about their illness. Conclusions: Type A behaviour was found to occur in about a third of cases of patients with cardiovascular disease. Only in a limited number of cases was it associated with depression. It has a lifestyle connotation that may have important clinical consequences as to stress vulnerability and illness behaviour.

BackgroundThe classification of psychological distress and illness behavior in the setting of medical disease is still controversial. Current psychiatric nosology does not seem to cover the spectrum of disturbances. The aim of this investigation was to assess whether the joint use of DSM-IV categories and the Diagnostic Criteria for Psychosomatic Research (DCPR), that provide identification of syndromes related to somatization, abnormal illness behavior, irritable mood, type A behavior, demoralization and alexithymia, could yield subtyping of psychosocial variables in the medically ill.MethodA cross-sectional assessment using both DSM-IV and the DCPR was conducted in eight medical centers in the Italian Health System. Data were submitted to cluster analysis. Participants were consecutive medical out-patients and in-patients for whom a psychiatric consultation was requested. A total of 1700 subjects met eligibility criteria and 1560 agreed to participate.ResultsThree clusters were identified: non-specific psychological distress, irritability and affective disturbances with somatization.ConclusionsTwo-step cluster analysis revealed clusters that were found to occur across clinical settings. The findings indicate the need of expanding clinical assessment in the medically ill to include the various manifestations of somatization, illness behavior and subclinical distress encompassed by the DCPR.