Prevalence and Rapid Screen Method of Diagnostic Criteria for Psychosomatic Research Syndromes in Human Papillomavirus-Infected Patients.

INTRODUCTION: The early and rapid identification of psychosomatic symptoms is crucial to prevent harmful outcomes in patients with human papillomavirus (HPV) infection in busy comprehensive clinics. This study aimed to explore the prevalence and rapid screening method of the Diagnostic Criteria for Psychosomatic Research-revised (DCPR) syndromes in patients with HPV infection. METHODS: A total of 504 participants underwent a clinical assessment that included DCPR, Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), the Social Support Rating Scale (SSRS), the Simplified Coping Style Questionnaire (SCSQ), fear of disease, sociodemographic and clinical characteristics. The prevalence of DCPR syndromes and DSM-5 diagnoses were compared between the HPV-positive and negative patients using χ2 tests. We explored the rapid screen indicator through multiple logistic regression analyses of the participants' psychosocial factors, sociodemographic and clinical characteristics. RESULTS: The incidence of DCPR syndromes in HPV-positive patients (56.6%) was significantly greater than that in HPV-negative patients (17.3%) and DSM-5 diagnoses (8.5%) in the HPV-positive group. Health anxiety, irritable mood, type A behavior, and demoralization were the most common psychosomatic syndromes in HPV-positive patients. As the degree of fear increased from 0 to 5 to 10, the risk of DCPR increased from 1.27 (95% CI: 0.21-7.63) to 3.24 (score range: 1-5, 95% CI: 1.01-10.39) to 9.91 (score range: 6-10, 95% CI: 3.21-30.62) in the HPV-positive group. CONCLUSION: The degree of fear, as an independent risk factor, could be used to quickly screen outpatients with a high risk of DCPR syndrome among women with HPV infection.

Clinical Interviewing: An Essential but Neglected Method of Medicine.

Clinical interviewing is the basic method to understand how a person feels and what are the presenting complaints, obtain medical history, evaluate personal attitudes and behavior related to health and disease, give the patient information about diagnosis, prognosis, and treatment, and establish a bond between patient and physician that is crucial for shared decision making and self-management. However, the value of this basic skill is threatened by time pressures and emphasis on technology. Current health care trends privilege expensive tests and procedures and tag the time devoted to interaction with the patient as lacking cost-effectiveness. Instead, the time spent to inquire about problems and life setting may actually help to avoid further testing, procedures, and referrals. Moreover, the dialogue between patient and physician is an essential instrument to increase patient's motivation to engage in healthy behavior. The aim of this paper was to provide an overview of clinical interviewing and its optimal use in relation to style, flow and hypothesis testing, clinical domains, modifications according to settings and goals, and teaching. This review points to the primacy of interviewing in the clinical process. The quality of interviewing determines the quality of data that are collected and, eventually, of assessment and treatment. Thus, interviewing deserves more attention in educational training and more space in clinical encounters than it is currently receiving.

Type D Personality as a Risk Factor for Adverse Outcome in Patients With Cardiovascular Disease: An Individual Patient-Data Meta-analysis.

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.

An innovative approach to the assessment of mood disturbances in patients with acute coronary syndrome.

BACKGROUND: The 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. METHODS: A 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. RESULTS: A 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). CONCLUSIONS: The 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.

An intervention based on Well-Being Therapy to prevent alcohol use and other unhealthy lifestyle behaviors among students: a three-arm cluster randomized controlled trial.

Unhealthy lifestyle, such as alcohol use, and negative health outcomes have been associated with impairments in psychological well-being. The primary objective of the study was to test the efficacy of an intervention based on Well-Being Therapy to prevent or stem alcohol use, binge drinking and other unhealthy lifestyle among Italian adolescents in school settings. A three-arm cluster randomized controlled trial including three test periods (baseline, post-test, six-month follow-up) was implemented. Seven classes (144 students) were randomly assigned to receive well-being intervention (WBI), lifestyle intervention (LI), or no intervention (NI). Primary outcomes were alcohol use (AUDIT-C), binge drinking and other unhealthy lifestyle behaviors (i.e. unhealthy diet, physical inactivity, tobacco and cannabis smoking, poor sleep and Internet addiction). Linear mixed models and mixed-effects logistic regression were used to test the efficacy of WBI in comparison with LI and NI. At six-month follow-up, AUDIT-C total score increased more in NI in comparison with WBI (p = 0.044) and LI (p = 0.016), whereas the odds of being classified as at-risk drinker were lower in WBI (p = 0.038) and LI (p = 0.002), than NI. Only WBI showed a protective effect for cannabis use at post-test in comparison with NI (p = 0.003) and LI (p = 0.014). Sleep hours at night decreased more in NI than in LI (p = 0.027) at six months. Internet addiction decreased more in WBI (p = 0.002) and LI (p = 0.005) at post-test in comparison with NI. Although both interventions showed a positive impact on adolescent lifestyle, the positive effect of WBI on cannabis use underlines how this approach might be promising to stem adolescents' substance use.

Negative health outcomes in depressed cardiac patients are associated with both low and high psychological well-being dimensions.

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 < 0.05), higher autonomy (B = 0.070; p < 0.05) and lower personal growth (B = -0.073; p < 0.05) levels were associated with non-participation in S.P. Moreover, only among patients who did not join the program, those presenting with an impaired level of P.W.B. 'positive relations' dimension (i.e. below the 25th percentile) showed a worse cardiac prognosis (Log Rank: χ2(1) = 4.654; p = 0.031). Negative health outcomes in depressed cardiac patients, such as non-participation in S.P. and worse cardiac course, are associated with both high and low levels of certain P.W.B. dimensions. Psychotherapeutic approaches geared to a balance in P.W.B. dimensions could represent promising new additions to S.P. programs.

Promoting weight loss and psychological well-being in patients with obesity: A sequential combination of behavioural lifestyle intervention and well-being therapy.

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.

Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Clinimetric Criteria for Patient-Reported Outcome Measures.

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 clini-metric 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.

Kellner's Symptom Questionnaire, a Highly Sensitive Patient-Reported Outcome Measure: Systematic Review of Clinimetric Properties.

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.

Sequential Combination of Cognitive-Behavioral Treatment and Well-Being Therapy in Depressed Patients with Acute Coronary Syndromes: A Randomized Controlled Trial (TREATED-ACS Study).

INTRODUCTION: Randomized controlled trials (RCT) of psychotherapeutic interventions have addressed depression and demoralization associated with acute coronary syndromes (ACS). The present trial introduces psychological well-being, an increasingly recognized factor in cardiovascular health, as a therapeutic target. OBJECTIVE: This study was designed to determine whether the sequential combination of cognitive-behavioral therapy (CBT) and well-being therapy (WBT) may yield more favorable outcomes than an active control group (clinical management; CM) and to identify subgroups of patients at greater risk for cardiac negative outcomes. METHODS: This multicenter RCT comparedCBT/WBT sequential combination versus CM, with up to 30 months of follow-up. One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS) were randomized to CBT/WBT associated with lifestyle suggestions (n = 50) and CM (n = 50). The main outcome measures included: severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events. RESULTS: CBT/WBT sequential combination was associated with a significant improvement in depressive symptoms compared to CM. In both groups, the benefits persisted at follow-up, even though the differences faded. Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events. CONCLUSIONS: Addressing psychological well-being in the psychotherapeutic approach to ACS patients with depressive symptoms was found to entail important clinical benefits. It is argued that lifestyle changes geared toward cardiovascular health may be facilitated by a personalized approach that targets well-being.

A survey on lifestyle and awareness of the use of statins in a sample of cardiopathic patients.

Current guidelines highlight the importance of lifestyle modification in the treatment of hypercholesterolemia, in addition to lipid-lowering drugs. However, patients taking statins do not always follow the physician's prescriptions on lifestyle change.. The present research aims to understand the psychological characteristics associated with unhealthy lifestyle change/maintenance among cardiopathic patients treated with statins. 58 patients were enrolled and evaluated by both observer- (clinical distress, psychosomatic syndromes) and self-rated (lifestyle, subclinical distress, well-being) measures. Ad-hoc items were included to evaluate self-perceived lifestyle changes and awareness about cholesterol-lowering effects of statins. 55.4% of the patients had not changed their lifestyle since taking statins and felt less contented (p < 0.05); 10.7% were unaware of the cholesterol-lowering effects of these drugs. Minor depression was the most frequent diagnosis(8.9%). It was significantly associated with the absence of lifestyle modification(p < 0.05), even though all minor depressed patients were aware of the effects of statins. On the contrary, those who were unaware showed significantly lower well-being (positive relations [p <0.05]; purpose in life [p<0.001]). Minor depression and psychological well-being impairments should thus be assessed in patients taking statins in order to recognize potential psychological risk factors associated with maintenance of unhealthy behaviors. .

Methodological Recommendations for Trials of Psychological Interventions.

Recent years have seen major developments in psychotherapy research that suggest the need to address critical methodological issues. These recommendations, developed by an international group of researchers, do not replace those for randomized controlled trials, but rather supplement strategies that need to be taken into account when considering psychological treatments. The limitations of traditional taxonomy and assessment methods are outlined, with suggestions for consideration of staging methods. Active psychotherapy control groups are recommended, and adaptive and dismantling study designs offer important opportunities. The treatments that are used, and particularly their specific ingredients, need to be described in detail for both the experimental and the control groups. Assessment should be performed blind before and after treatment and at long-term follow-up. A combination of observer- and self-rated measures is recommended. Side effects of psychotherapy should be evaluated using appropriate methods. Finally, the number of participants who deteriorate after treatment should be noted according to the methods that were used to define response or remission.

The clinical role of well-being therapy.

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.

The Clinical Inadequacy of the Placebo Model and the Development of an Alternative Conceptual Framework.

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.

Sex dependent risk factors for mortality after myocardial infarction: individual patient data meta-analysis.

BACKGROUND: Although a number of risk factors are known to predict mortality within the first years after myocardial infarction, little is known about interactions between risk factors, whereas these could contribute to accurate differentiation of patients with higher and lower risk for mortality. This study explored the effect of interactions of risk factors on all-cause mortality in patients with myocardial infarction based on individual patient data meta-analysis. METHODS: Prospective data for 10,512 patients hospitalized for myocardial infarction were derived from 16 observational studies (MINDMAPS). Baseline measures included a broad set of risk factors for mortality such as age, sex, heart failure, diabetes, depression, and smoking. All two-way and three-way interactions of these risk factors were included in Lasso regression analyses to predict time-to-event related all-cause mortality. The effect of selected interactions was investigated with multilevel Cox regression models. RESULTS: Lasso regression selected five two-way interactions, of which four included sex. The addition of these interactions to multilevel Cox models suggested differential risk patterns for males and females. Younger women (age<50) had a higher risk for all-cause mortality than men in the same age group (HR 0.7 vs. 0.4), while men had a higher risk than women if they had depression (HR 1.4 vs. 1.1) or a low left ventricular ejection fraction (HR 1.7 vs. 1.3). Predictive accuracy of the Cox model was better for men than for women (area under the curves: 0.770 vs. 0.754). CONCLUSIONS: Interactions of well-known risk factors for all-cause mortality after myocardial infarction suggested important sex differences. This study gives rise to a further exploration of prediction models to improve risk assessment for men and women after myocardial infarction.

Attention-Deficit/Hyperactivity Disorder and Unhealthy Lifestyle in Adolescence: Unforeseen Role of Allostatic Overload and Psychological Well-Being.

Unhealthy lifestyle behaviors (ULBs) are common in early adolescence and could be worsened by Attention-Deficit/Hyperactivity Disorder (ADHD), as well as by specific psychosocial factors, such as stress and unbalanced (i.e., too high or low scores of) psychological well-being (PWB) dimensions. This multi-center study aimed to evaluate how interactions between ADHD symptoms and psychosocial factors associated with ULBs (i.e., Allostatic Overload and multidimensional Psychological Well-Being), considered as moderators, could affect the adoption of ULBs during adolescence. A total of 440 fourteen-year-old adolescents were recruited from six upper secondary schools in Bologna and Rome (Italy) and completed self-report questionnaires on ULBs, ADHD, and psychosocial factors. Relations between ADHD symptomatology and specific ULBs (i.e., impaired sleep, problematic Internet use) were moderated by variables deemed as "negative" (i.e., Allostatic Overload) or "positive" (i.e., PWB dimensions of Self-Acceptance, Personal Growth, Positive Relations, Purpose in Life, Environmental Mastery): when the "negative" moderator is absent and the levels of the "positive" moderators are higher, ULBs decrease among students with lower ADHD symptomatology but increase among students with more severe ADHD. Based on ADHD severity, interventions should aim at promoting a state of euthymia, which consists in balanced PWB dimensions and reflects the optimal level of well-being to fulfill one's own potential and self-realization.