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.

Key psychosocial issues in medical care.

OBJECTIVE: The aim of this review is to illustrate an innovative framework for assessing the psychosocial aspects of medical disorders within the biopsychosocial model. It is based on clinimetrics, the science of clinical measurements. It may overcome the limitations of DSM-5 in identifying highly individualized responses at the experiential, behavioral, and interpersonal levels. METHOD: A critical review of the clinimetric formulations of the biopsychosocial model in the setting of medical disease was performed. References were identified through searches from PubMed for English articles on human subjects published from January 1982 to October 2023. RESULTS: Clinimetric methods of classification have been found to deserve special attention in four major areas: allostatic load (the cumulative cost of fluctuating and heightened neural or neuroendocrine responses to environmental stressors); health attitudes and behavior; persistent somatization; demoralization and irritable mood. This type of assessment, integrated with traditional psychiatric nosography, may disclose pathophysiological links and provide clinical characterizations that demarcate major prognostic and therapeutic differences among patients who otherwise seem deceptively similar because they have the same medical diagnosis. It may be of value in a number of medical situations, such as: high level of disability or compromised quality of life in relation to what is expected by disease status; delayed or partial recovery; insufficient participation in self-management and/or rehabilitation; failure to resume healthy role after convalescence; unhealthy lifestyle; high attendance of medical facilities disproportionate to detectable disease; lack of treatment adherence; illness denial. CONCLUSIONS: The clinimetric approach to the assessment of key psychosocial variables may lead to unique individual profiles, that take into account both biology and biography. It may offer new opportunities for integrating psychosocial and medical perspectives.

Illness Denial in Medical Disorders: A Systematic Review.

INTRODUCTION: Illness denial pertains to medical patients who do not acknowledge the presence or severity of their disease or the need of treatment. OBJECTIVE: This systematic review was performed to clarify the clinical role and manifestations of illness denial, its impact on health attitudes and behavior, as well as on short- and long-term outcomes in patients with medical disorders. METHODS: The systematic search according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines was conducted on PubMed, Scopus, and Web of Science. RESULTS: The initial search yielded a total of 14,098 articles; 176 studies met the criteria for inclusion. Illness denial appeared to be a relatively common condition affecting a wide spectrum of health attitudes and behavior. In some cases, it may help a person cope with various stages of illness and treatment. In other situations, it may determine delay in seeking treatment, impaired adherence, and reduced self-management, leading to adverse outcomes. The Diagnostic Criteria for Psychosomatic Research (DCPR) were found to set a useful severity threshold for the condition. An important clinical distinction can also be made based on the DCPR for illness denial, which require the assessment of whether the patient has been provided with an adequate appraisal of the medical situation. CONCLUSIONS: This systematic review indicates that patients with medical disorders experience and express illness denial in many forms and with varying degrees of severity. The findings suggest the need for a multidimensional assessment and provide challenging insights into the management of medical disorders.

Allostatic Load and Endocrine Disorders.

The building of life stress, well expressed by the concept of allostatic load, plays an important part in all phases of endocrine illness. Allostatic load refers to the cumulative burden of both stressful life events and chronic stress. When environmental challenges exceed the individual ability to cope, allostatic overload ensues. Assessment of allostatic load/overload by clinical measurements including indices and rating scales, in addition to biomarkers, offers a characterization of the person's psychosocial environment that is missing from current formulations. Consideration of allostatic load in endocrinology may shed light on a number of clinical issues: interpretation of abnormal hormone values that lack explanations; coping with the various phases of illness; maladaptive illness behavior; response to treatment; presence of residual symptoms; health-damaging lifestyle habits. Addressing allostatic load calls for innovative models of endocrine outpatients with multidisciplinary organization of care, extended time for the interview, focus on rehabilitation. We provide an overview on the mechanisms of allostatic load, how it can be assessed, its potential role in endocrine disturbances, and how its consideration may lead to a needed innovation in patient care.

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.

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.

Staging of unipolar depression: systematic review and discussion of clinical implications.

Staging has been increasingly used in unipolar depression since its introduction in the nineties. Several models are available, but their differential features and implications are not completely clear. We systematically reviewed: (a) staging models of longitudinal development of unipolar depression; (b) staging models of treatment-resistant unipolar depression; (c) their applications. MEDLINE, PsycINFO, EMBASE, and Web of Science were examined according to PRISMA guidelines from inception to December 2021. Search terms were: 'stage/staging', combined using the Boolean 'AND' operator with 'psychiatric disorder/mental disorder/depressive/mood disorder'. A total of 169 studies were identified for inclusion: 18 described staging models or applications, 151 described treatment-resistant staging models or applications. Staging models of longitudinal development were found to play a key role in formulating sequential treatment, with particular reference to the use of psychotherapy after pharmacotherapy. Staging methods based on treatment resistance played a crucial role in setting entry criteria for randomized clinical trials and neurobiological investigations. Staging is part of clinimetrics, the science of clinical measurements, and its role can be enhanced by its association with other clinimetric strategies, such as repeated assessments, organization of problematic areas, and evaluation of phenomena that may affect responsiveness. In research, it may allow to identify more homogeneous populations in terms of treatment history that may diminish the likelihood of spurious results in comparisons. In clinical practice, the use of staging in a clinimetric perspective allows clinicians to make full use of the information that is available for an individual patient at a specific time.

The Clinical Science of Euthymia: A Conceptual Map.

Euthymia is a trans-diagnostic construct characterized by lack of mood disturbances; presence of positive affect; balance of psychological well-being dimensions, flexibility, consistency, and resistance to stress. The aim of this critical review is to draw a conceptual map of euthymia. Relationships with other constructs, continuum between euthymia and dysthymia with discomfort as an intermediate area, associations with lifestyle, clinimetric assessment, role of psychotherapeutic interventions, establishment of therapeutic targets, and neurobiological mechanisms are discussed. The model is based on the bipolar nature of well-being dimensions. Euthymia means using allostasis optimally and maintaining a healthy balance that promotes positive aspects of brain and body health through health-promoting behaviors. It may provide a framework for a renewed definition of recovery, for measuring treatment outcome and for targeting interventions, including the sequential administration of therapeutic components. Clinical assessment requires a clinimetric approach encompassing a broad range of aspects, such as allostatic load and lifestyle behaviors, all interacting with each other and contributing to the euthymia/dysthymia balance. Clinimetric indices for assessing euthymia (the Clinical Interview for Euthymia and the Euthymia Scale) and related constructs (the Clinical Interview for Dysthymia and the Semi-Structured Interview for the Diagnostic Criteria for Psychosomatic Research) are presented here. Well-Being Therapy, a psychotherapeutic strategy specifically aimed at pursuing euthymia, relies on self-observation of well-being episodes using a structured diary as a distinct therapeutic ingredient. The clinical science of euthymia may unravel innovative approaches to assessment and treatment of psychiatric and medical disorders, according to a unitary conceptual framework.

Benzodiazepines: it's time to return to the evidence.

SUMMARY: We propose that discussions of benzodiazepines in the current psychiatric literature have become negatively biased and have strayed from the scientific evidence base. We advocate returning to the evidence in discussing benzodiazepines and adhering to clear definitions and conceptual rigour in commentary about them.

When Anxiety and Depression Coexist: The Role of Differential Diagnosis Using Clinimetric Criteria.

Depressive and anxiety disorders are frequently associated. Depression may be a complication of anxiety and anxiety can complicate depression. The nature of their relationship has been a source of controversy. Reviews generally base their conclusions on randomized controlled trials and meta-analyses that refer to the average patient and often clash with the variety of clinical presentations that may occur when anxiety and depression coexist. The aim of this review was to examine the literature according to profiling of subgroups of patients based on clinimetric criteria, in line with the recently developed concept of medicine-based evidence. We critically reviewed the literature pertaining to the specific presentations of anxiety and depression, outlining the advantages and disadvantages of each treatment approach. The following prototypic cases were presented: depression secondary to an active anxiety disorder, depression in patients with anxiety disorders under treatment, anxious depression, anxiety as a residual component of depression, and demoralization secondary to anxiety disorder. We argue that the selection of treatment when anxiety and depression coexist should take into account the modalities of presentation and be filtered by clinical judgment. Very different indications may ensue when the literature is examined according to this perspective.

Prodromal Symptoms in Depression: A Systematic Review.

INTRODUCTION: Appraisal of prodromal symptoms of unipolar depression may complement the traditional cross-sectional approach and provide a longitudinal perspective, according to a staging model of the illness. OBJECTIVE: To provide an updated systematic review of clinical studies concerned with prodromal symptoms of unipolar depression, according to PRISMA guidelines. METHODS: Keyword searches were conducted in PubMed, Scopus, and Web of Science. Longitudinal studies on prodromal symptoms and signs in adult patients primarily diagnosed with unipolar depression were selected. Findings were examined separately according to study design (i.e., retrospective or prospective). RESULTS: Twenty-five studies met the criteria for inclusion in this systematic review. Findings indicate that a distinct prodromal symptomatology - commonly characterized by anxiety, tension, irritability, and somatic complaints - exists before the onset of unipolar depression. The duration of the prodromal phase was highly variable across studies, ranging from less than a month to several years. Prodromal symptoms profile and duration were consistent within individuals across depressive episodes. There was a close relationship between prodromal and residual symptoms of the same depressive episode. CONCLUSIONS: The present systematic review addresses an important, and yet relatively neglected, clinical issue that deserves further investigation and may be of immediate practical value. The findings provide challenging insights into the pathogenesis and course of unipolar depression, which may result in more timely and effective treatment of recurrences. The definition of a prodromal phase in depression would benefit from the joint use of symptom identification, biomarkers, and neuroimaging.

Allostatic Load and Its Impact on Health: A Systematic Review.

INTRODUCTION: Allostatic load refers to the cumulative burden of chronic stress and life events. It involves the interaction of different physiological systems at varying degrees of activity. When environmental challenges exceed the individual ability to cope, then allostatic overload ensues. Allostatic load is identified by the use of biomarkers and clinical criteria. OBJECTIVE: To summarize the current knowledge on allostatic load and overload and its clinical implications based on a systematic review of the literature. METHODS: PubMed, PsycINFO, Web of Science, and the Cochrane Library were searched from inception to December 2019. A manual search of the literature was also performed, and reference lists of the retrieved articles were examined.We considered only studies in which allostatic load or overload were adequately described and assessed in either clinical or non-clinical adult populations. RESULTS: A total of 267 original investigations were included. They encompassed general population studies, as well as clinical studies on consequences of allostatic load/overload on both physical and mental health across a variety of settings. CONCLUSIONS: The findings indicate that allostatic load and overload are associated with poorer health outcomes. Assessment of allostatic load provides support to the understanding of psychosocial determinants of health and lifestyle medicine. An integrated approach that includes both biological markers and clinimetric criteria is recommended.

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.

When the Label Does Not Match the Content of a Trial: "Well-Being Therapy" in Posttraumatic Stress Disorder: Commentary on Radstaak et al. (2020).

Radstaak, Hüning, and Bohlmeijer (2020) reported on a randomized controlled trial (RCT) of well-being therapy (WBT) compared to treatment as usual (TAU) in the treatment of residual posttraumatic stress disorder (PTSD) symptoms. No significant differences emerged between treatment conditions. However, our view is that what the authors labeled as WBT did not match the manualized psychotherapeutic strategy, and what was defined as TAU was actually an active control group. Further methodological limitations hinder the interpretation of results and make it difficult to draw conclusions from the study. Radstaak et al. (2020) deserve credit for addressing the vexing and neglected problem of residual symptoms in PTSD. However, the role of WBT in PTSD treatment still needs to be explored via an effectively designed RCT. Given that WBT does not require exposure to a patient's index traumatic event as a means of alleviating PTSD symptoms, WBT may represent a promising alternative to current treatments of PTSD.

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.

The Hamilton Rating Scales for Depression: A Critical Review of Clinimetric Properties of Different Versions.

The format of the original Hamilton Rating Scale for Depression (HAM-D) was unstructured: only general instructions were provided for rating individual items. Over the years, a number of modified versions of the HAM-D have been proposed. They differ not only in the number of items, but also in modalities of administration. Structured versions, including item definitions, anchor points and semi-structured or structured interview questions, were developed. This comprehensive review was conducted to examine the clinimetric properties of the different versions of the HAM-D. The aim was to identify the HAM-D versions that best display the clinimetric properties of reliability, validity, and sensitivity to change. The search was conducted on MEDLINE, Scopus, Web of Science, and PubMed, and yielded a total of 35,473 citations, but only the most representative studies were included. The structured versions of the HAM-D were found to display the highest inter-rater and test-retest reliability. The Clinical Interview for Depression and the 6-item HAM-D showed the highest sensitivity in differentiating active treatment from placebo. The findings indicate that the HAM-D is a valid and sensitive clinimetric index, which should not be discarded in view of obsolete and not clinically relevant psychometric criteria. The HAM-D, however, requires an informed use: unstructured forms should be avoided and the type of HAM-D version that is selected should be specified in the registration of the study protocol and in the methods of the trial.

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.