eHealth-Integrated Psychosocial and Physical Interventions for Chronic Pain in Older Adults: Scoping Review.

BACKGROUND: Chronic noncancer pain (CNCP) is highly present among older adults, affecting their physical, psychological, and social functioning. A biopsychosocial multimodal approach to CNCP management is currently extensively suggested by international clinical practice guidelines. Recently, the growing development and application of eHealth within pain management has yielded encouraging results in terms of effectiveness and feasibility; however, its use among the older population remains underexamined. OBJECTIVE: The overall aim of this scoping review was to systematically map existing literature about eHealth multimodal interventions (including both physical and psychosocial components) targeting older adults with CNCP. METHODS: This review adhered to the JBI methodology, a protocol was a priori registered as a preprint on the medRxiv platform, and the results were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Four electronic databases (PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and PsycINFO) were systematically searched for relevant articles. Studies were included if they reported on multimodal interventions (including both physical and psychosocial components) delivered through any eHealth modality to an older population with any type of CNCP. Two reviewers selected the studies: first by screening titles and abstracts and second by screening full-text articles. The quality of the included studies was evaluated using the Quality Assessment Tool for Studies with Diverse Designs. The results of the studies were summarized narratively. RESULTS: A total of 9 studies (n=6, 67% published between 2021 and 2023) with quality rated as medium to high were included, of which 7 (78%) were randomized controlled trials (n=5, 71% were pilot and feasibility studies). All the included studies evaluated self-management interventions, most of them (n=7, 78%) specifically designed for older adults. The participants were aged between 65 and 75 years on average (mean 68.5, SD 3.5 y) and had been diagnosed with different types of CNCP (eg, osteoarthritis and chronic low back pain). Most of the included studies (5/9, 56%) involved the use of multiple eHealth modalities, with a higher use of web-based programs and video consulting. Only 1 (11%) of the 9 studies involved a virtual reality-based intervention. The evaluated interventions showed signs of effectiveness in the targeted biopsychosocial outcomes, and the participants' engagement and ratings of satisfaction were generally positive. However, several research gaps were identified and discussed. CONCLUSIONS: Overall, of late, there has been a growing interest in the potential that eHealth multimodal interventions offer in terms of improving pain, physical, and psychosocial outcomes in older adults with CNCP. However, existing literature on this topic still seems scarce and highly heterogeneous, with few proper randomized controlled trials, precluding robust conclusions. Several gaps emerged in terms of the older population considered and the lack of evaluation of comorbidities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1101/2023.07.27.23293235.

The prognostic role of fatigue, depression and anxiety on postoperative outcomes after pancreatectomy for pancreatic cancer. A prospective observational study (FAT-PRO study).

OBJECTIVES: This study aims to assess the prevalence of preoperative fatigue, depression and anxiety among patients undergoing pancreatic surgery for pancreatic cancer (PC), and possible relationship with postoperative outcomes. METHODS: Prospective data from 162 consecutive patients undergoing pancreatectomy for PC at a third-level referral centers for pancreatic surgery were collected. All patients preoperatively completed four questionnaires assessing depression (PHQ-9), anxiety (STAI-Y2), chronic illness fatigue (FACIT-F) and cancer therapy fatigue (FACT-G). RESULTS: Forty patients (25%) where in the first quartile for chronic illness (FACIT-F ≤34) and/or cancer therapy (FACT-G ≤78) fatigue, 26 patients (16%) met the criteria for major depression (PHQ-9 ≥10) and 34 patients (21%) had anxiety symptoms (STAI-Y2 ≥40). Cancer therapy fatigue was significantly associated with higher rates of morbidity (70% vs 49%), major morbidity (Clavien-Dindo ≥3) (28% vs 11%), post-pancreatectomy hemorrhage (18% vs 4%), pulmonary complications (20% vs 9%) and mortality (8% vs null) (all P ≤ 0.01). Major depression was associated with higher rates of post-pancreatectomy hemorrhage and readmission (23% vs 5%). Multivariable logistic regression analysis of preoperative factors confirmed diabetes (OR 2.71, 95%CI 1.01-7.20; P = 0.04), ASA score ≥3 (OR 4.12, 95%CI 1.52-11.21; P < 0.01) and cancer therapy fatigue (OR 2.95, 95%CI 1.01-8.74; P = 0.04) to be independent predictors of major morbidity. CONCLUSIONS: Higher levels of fatigue (in particular cancer therapy fatigue) strongly correlates with worse postoperative outcomes.

Prevalence of depression in a cohort of 400 patients with pancreatic neoplasm attending day hospital for major surgery: Role on depression of psychosocial functioning and clinical factors.

OBJECTIVE: (1) To determine the prevalence and type of depressive symptoms at day-hospital clinical evaluation, before undergoing major surgery in patients diagnosed with pancreatic neoplasm. (2) To analyze the association between depression and sociodemographic, clinical, and psychosocial variables. (3) To understand how coping strategies, perceived social support, and self-efficacy might affect depressive symptoms in this cohort of patients. METHODS: Secondary data analysis collected during the baseline phase of a randomized controlled trial performed at the Pancreas Institute of the University Hospital of Verona, Italy, between June 2017 and June 2018. RESULTS: 18.5% of pancreatic patients had a PHQ-9 score ≥10 (cut-off). Depressed patients were basically more often female (p = 0.07), younger (p = 0.06), and married/with a partner (p = 0.02). Depression was associated to high trait anxiety (p < 0.01), the use of anxiolytics (p < 0.01), sleep-inducing drugs (p < 0.01), and painkillers (p < 0.01). Among psychosocial variables, depressed patients showed lower perceived self-efficacy (p < 0.01) and family and friends' social support (p < 0.01) and used significantly more often dysfunctional coping strategies (p < 0.01), compared to nondepressed. A logistic multivariate model using psychosocial variables as explanatory and depression as dependent was calculated and post hoc analyses were conducted to describe the contribution of each psychosocial variable on depression. CONCLUSIONS: Our study advocates the need for screening for distress and depression in cancer surgery units and recommends to strengthen patients' adaptive coping, social support, and sense of effectiveness in facing the challenges related to the medical condition and treatment process.

Does being accompanied make a difference in communication during breast cancer consultations? Results from a multi-centered randomized controlled trial.

OBJECTIVES: This study is based on a multi-centered RCT conducted on breast cancer patients during their first consultation with an oncologist. The main aim was to evaluate whether the introduction of a communication tool (i.e., the Question Prompt Sheet or Question Listing), with or without a companion, impacted the number of questions asked by patients during the consultation, and subsequent psychological and relational outcomes. METHODS: The sample consisted of 324 breast cancer patients who were randomly placed into one of the two intervention groups: Question Prompt Sheet or Question Listing. Before and after the consultation, patients completed a set of standardized instruments: Satisfaction with decisions made during the consultation (SWD), Shared Decision Making Questionnaire (SDMQ-9), Patient Enablement Instrument (PEI), Patient Health Questionnaire Depression scale (PHQ-9), General Health Questionnaire (GHQ-12). RESULTS: The results indicate that the number of questions asked during the consultation was higher when a Question Listing was provided and when the patient was unaccompanied. Unaccompanied patients asked more questions in both groups and had significantly lower scores than accompanied on the GHQ-12 and on the PHQ-9, indicating lower clinical symptomatology. CONCLUSIONS: Results are in contrast with previous literature, indicating that being unaccompanied help patients to interact more with the oncologist. Further studies are needed to evaluate how the presence or not of a companion really impacts breast cancer patients during their first consultation with an oncologist. TRIAL REGISTRATION: ClinicalTrials.gov NCT01510964.

From research to clinical practice: a systematic review of the implementation of psychological interventions for chronic headache in adults.

BACKGROUND: Psychological interventions have been proved to be effective in chronic headache (CH) in adults. Nevertheless, no data exist about their actual implementation into standard clinical settings. We aimed at critically depicting the current application of psychological interventions for CH into standard care exploring barriers and facilitators to their implementation. Secondarily, main outcomes of the most recent psychological interventions for CH in adults have been summarized. METHODS: We conducted a systematic review through PubMed and PsycINFO in the time range 2008-2018. A quality analysis according to the QATSDD tool and a narrative synthesis were performed. We integrated results by: contacting the corresponding author of each paper; exploring the website of the clinical centers cited in the papers. RESULTS: Of the 938 identified studies, 28 papers were selected, whose quality largely varied with an average %QATSDD quality score of 64.88%. Interventions included CBT (42.85%), multi-disciplinary treatments (22.43%), relaxation training (17.86%), biofeedback (7.14%), or other interventions (10.72%). Treatments duration (1 day-9 months) and intensity varied, with a prevalence of individual-basis implementation. The majority of the studies focused on all primary headaches; 4 studies focused on medication-overuse headache. Most of the studies suggest interventions as effective, with the reduction in frequency of attacks as the most reported outcome (46.43%). Studies were distributed in different countries, with a prevalent and balanced distribution in USA and Europe. Ten researches (35.71%) were performed in academic contexts, 11 (39.28%) in clinical settings, 7 (25%) in pain/headache centres. Interventions providers were professionals with certified experience. Most of the studies were funded with private or public funding. Two contacted authors answered to our e-mail survey, with only one intervention implemented in the routine clinical practice. Only in three out of the 16 available websites a reference to the implementation into the clinical setting was reported. CONCLUSION: Analysis of contextual barriers/facilitators and cost-effectiveness should be included in future studies, and contents regarding dissemination/implementation of interventions should be incorporated in the professional training of clinical scientists. This can help in filling the gap between the existing published research and treatments actually offered to people with CH.

Regulation of microRNAs in Satellite Cell Renewal, Muscle Function, Sarcopenia and the Role of Exercise.

Sarcopenia refers to a condition of progressive loss of skeletal muscle mass and function associated with a higher risk of falls and fractures in older adults. Musculoskeletal aging leads to reduced muscle mass and strength, affecting the quality of life in elderly people. In recent years, several studies contributed to improve the knowledge of the pathophysiological alterations that lead to skeletal muscle dysfunction; however, the molecular mechanisms underlying sarcopenia are still not fully understood. Muscle development and homeostasis require a fine gene expression modulation by mechanisms in which microRNAs (miRNAs) play a crucial role. miRNAs modulate key steps of skeletal myogenesis including satellite cells renewal, skeletal muscle plasticity, and regeneration. Here, we provide an overview of the general aspects of muscle regeneration and miRNAs role in skeletal mass homeostasis and plasticity with a special interest in their expression in sarcopenia and skeletal muscle adaptation to exercise in the elderly.

Perspectives and Experiences on eHealth Solutions for Coping With Chronic Pain: Qualitative Study Among Older People Living With Chronic Pain.

BACKGROUND: Chronic noncancer pain (CNCP) is a major health issue among the older population, affecting multiple aspects of individual functioning. Recently, the use of eHealth solutions has been proposed in supporting chronic pain self-management even among older adults, although some barriers have emerged. Few qualitative studies, with none conducted in Mediterranean countries, have explored older people's experiences and perceptions regarding the types of strategies used to cope with chronic pain and eHealth tools for chronic pain management. OBJECTIVE: This study's objectives were to explore the perspectives and experiences of older adults regarding the coping strategies used to manage chronic pain, the use of digital technologies in everyday life, and the potentiality and barriers in using those technologies for health and pain management. METHODS: A multimethod approach (ie, self-report questionnaires and a semistructured interview) has been adopted targeting older adults (ie, those who are aged 65 to 80 years and presenting different types of CNCP) who are attending a pain therapy center in Italy. Qualitative answers were analyzed using thematic analysis. RESULTS: Overall, participants reported using a variety of pain coping strategies; however, they showed an attitude of resignation to their CNCP condition. Nearly 70% (12/18) of the interviewees referred to using digital technologies for purposes related to health and pain management, mostly involving very basic management activities. The participants' opinions on the useful functions that need to be incorporated in eHealth tools for chronic pain management have been categorized into four themes: (1) specific pain self-management skills, (2) support in organizing various health-related aspects, (3) sharing experiences with others, and (4) increasing pain-related personal knowledge. Conversely, the following potential barriers to adopting eHealth tools emerged: (1) computer illiteracy, (2) negative effects or risks, (3) impersonal interaction, and (4) physical limitations. CONCLUSIONS: The use of eHealth solutions still seems low, often being accompanied by a perceived lack of digital skills or attitude among a sample of older adults from Italy with CNCP. Before introducing innovative eHealth solutions, it would be of primary importance to take action to enhance, on the one hand, self-efficacy in pain management and, on the other, the digital literacy level among older people.

Fostering quality of life in young adults living with multiple sclerosis: a pilot study of a co-created integrated intervention.

Introduction: Multiple sclerosis (MS) is generally diagnosed at an early age, making the acceptance of this chronic disease challenging. Research dedicated to young adults with MS (YawMS) is still limited. A biopsychosocial co-created intervention for YawMS integrating social, physical and psychological activities was developed (ESPRIMO intervention) in order to improve the quality of life (QoL) and well-being. This pre-post intervention assessment study examines the feasibility of the ESPRIMO intervention and its signal of efficacy. Methods: Inclusion criteria were: age 18-45 years, MS diagnosis, Expanded Disability Status Scale score < 3.5. After giving informed consent, YawMS completed a battery of questionnaires, which was repeated after the intervention. The battery included a bespoke feasibility scale, the COOP/WONCA charts, and the Short Form-12 Health Survey (SF-12). Results: Fifty-three YAwMS were enrolled and 43 (81.1%) completed the intervention. The majority of the sample positively rated the pleasantness, usefulness and feasibility of the intervention. A significant change in the COOP/WONCA "general QoL" chart (t = 3.65; p < 0.01) and SF-12 mental wellbeing component (t = -3.17; p < 0.01) was found. Discussion: ESPRIMO is an innovative intervention that is feasible; preliminary results show an improvement in QoL and mental wellbeing. Further studies are needed to test its efficacy and evaluate future implementation in health services.Clinical trial registration: ClinicalTrials.gov, NCT04431323.

Umbrella Systematic Review and Meta-Analysis: Physical Activity as an Effective Therapeutic Strategy for Improving Psychosocial Outcomes in Children and Adolescents.

OBJECTIVE: Physical activity (PA) interventions are part of many interdisciplinary programs for the management of children and adolescents with or without physical or psychological conditions or disabilities. Aiming to summarize the available evidence, we conducted an umbrella review of meta-analyses of PA interventions that included psychosocial outcomes in populations of children and adolescents. METHOD: Literature searches were conducted in PubMed, Cochrane Central, Web of Science, Medline, SPORTDiscus, and PsychInfo from January 1, 2010, to May 6, 2022. Meta-analyses of randomized and quasi-randomized studies investigating the efficacy of PA interventions for psychosocial outcomes in children and adolescents were included. Summary effects were recalculated using common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small study effects, and whether the results of the observed positive studies were greater than expected due to chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Quality was assessed using the AMSTAR 2 tool. This study is registered with the Open Science Framework, https://osf.io/ap8qu. RESULTS: A total of 112 studies from 18 meta-analyses generating 12 new meta-analyses comprising 21,232 children and adolescents in population groups including attention-deficit/hyperactivity disorder, cancer, cerebral palsy, chronic respiratory diseases, depression, neuromotor impairment, and obesity and in general populations were included. PA interventions were efficacious in reducing psychological symptoms in all meta-analyses across the different population groups using random-effects models. However, umbrella review criteria suggested a weak strength of association for this outcome, and GRADE credibility of evidence ranged from moderate to very low. For psychological well-being, 3 out of 5 meta-analyses identified significant effects, but the strength of these associations was weak, and GRADE credibility of evidence ranged from moderate to very low. Similarly, for social outcomes, meta-analyses reported a significant summary effect, but the strength of association was weak, and GRADE credibility of evidence ranged from moderate to very low. For self-esteem, one meta-analysis in children with obesity failed to show any effect. CONCLUSION: Even though existing meta-analyses suggested a beneficial effect of PA interventions on psychosocial outcomes across different population groups, the strength of associations was weak, and the credibility of evidence was variable depending on the target population, outcome, and condition or disability. Randomized studies of PA interventions in children and adolescents with and without different physical and psychological conditions or disabilities should always include psychosocial outcomes as an important dimension of social and mental health. STUDY PREREGISTRATION INFORMATION: Prenatal Maternal Infection and Adverse Neurodevelopment: A Structural Equation Modelling Approach to Downstream Environmental Hits; https://osf.io/; ap8qu.

Cross-sectional survey evaluating the psychological impact of the COVID-19 vaccination campaign in patients with cancer: The VACCINATE study.

The COVID-19 pandemic has profoundly impacted on cancer patients' psychological well-being and clinical status. We assessed the levels of anxiety, depression, and distress and the attitude towards COVID-19 vaccination in cancer patients, accepting vaccination at the Verona University Hospital and Camposampiero Hospital in the Veneto region. Self-reported questionnaires were administered to patients undergoing COVID-19 vaccination between March and May 2021 (first and second dose). Twenty-seven items were investigated: i) demographics/clinical characteristics; ii) anxiety, depression, and distress (Hospital Anxiety and Depression Scale-HADS-and Distress Thermometer-DT); iii) four specific items regarding awareness about infection risks, interference with anticancer treatments, and vaccine side effects. Sixty-two and 57% of the patients who accepted to be vaccinated responded to the survey in the two participating Hospitals, respectively. Mean age was 63 years (SD: 12 years; range 19-94 years), women were slightly more prevalent (57.6%), most participants were married (70%), and either worker or retired (60%). Borderline and clinical levels of anxiety were recorded in 14% and 10% of respondents; borderline and clinical levels of depression in 14% and 8%; and moderate and severe distress levels in 33% and 9%. Overall, there was high confidence that vaccination would reduce the risk of contracting COVID-19 (70%), which would make patients feel less worried about contracting the infection (60%). Fear that vaccine-related side effects would interfere with anticancer treatment and/or global health status was low (10% and 9% for items 3 and 4, respectively) and significantly associated with baseline levels of anxiety, depression, and distress at multivariate analysis. Results did not differ between the Verona and Camposampiero cohorts. During the COVID-19 vaccination campaign, adult cancer patients demonstrated high levels of confidence towards vaccination; baseline levels of anxiety, depression, and distress were the only significant predictors of reduced confidence.

[The role of music therapy in impaired hearing recovery. A survey among professionals working with deaf children and between users]. / Il ruolo della musicoterapia nel recupero del deficit uditivo. Un'indagine tra i professionisti che lavorano con bambini sordi e tra i fruitori.

In this study, two groups are interviewed: the first study includes a sample of 60 physicians and health providers in the field of deafness, whose opinion on music therapy is collected by a specific questionnaire; the second involves 8 parents of deaf children attending music therapy lessons, who are asked to give an evaluation on the effect of music therapy, based on the experience of their children. Results show that health professionals know very little about the rehabilitative effectiveness of music therapy, whereas the parents of deaf children give a positive evaluation on the psychological, behavioral and linguistic benefits that music therapy gives to their deaf children.

e-Health Interventions Targeting Pain-Related Psychological Variables in Fibromyalgia: A Systematic Review.

There is growing evidence to support the potential benefit of e-Health interventions targeting psychosocial outcomes and/or pain-related psychological variables for chronic pain conditions, including fibromyalgia syndrome (FMS). This systematic review aims at providing an in-depth description of the available e-Health psychological and/or multicomponent interventions for patients with FMS. Searches were made in PubMed, Cochrane, Web of Science, and PsycINFO up to 15 May 2023, finally including twenty-six articles. The quality of the included articles was medium-high (average quality assessment score of 77.1%). 50% of studies were randomized controlled trials (RCTs) (n = 13), and the majority of them focused exclusively on adult patients with FMS (n = 23) who were predominantly female. Four categories of e-Health modalities were identified: web-based (n = 19), mobile application (m-Health) (n = 3), virtual reality (VR) (n = 2), and video consulting (n = 2). Interventions were mainly based on the cognitive behavioral therapy (CBT) approach (n = 14) and mostly involved contact with a healthcare professional through different digital tools. Overall, a growing number of psychological and multicomponent interventions have been created and delivered using digital tools in the context of FMS, showing their potentiality for improving psychosocial outcomes and pain-related psychological variables. However, some digital tools resulted as underrepresented, and the literature on this topic appears highly heterogeneous precluding robust conclusions.

"INTEGRO INTEGRated Psychotherapeutic InterventiOn" on the Management of Chronic Pain in Patients with Fibromyalgia: The Role of the Therapeutic Relationship.

Fibromyalgia (FM) is a chronic disease characterized by a heterogeneous set of physical and psychological conditions. The chronic experience of disability felt by patients and the impact on quality of life (QoL) of the disease may worsen the cognitive reappraisal ability and contribute to maintaining an altered pain modulation mechanism. This paper presents the study protocol of an INTEGRated psychotherapeutic interventiOn on the management of chronic pain in patients with fibromyalgia (INTEGRO). The aim of the study is to investigate the efficacy of an integrated psychotherapeutic intervention focused on pain management on QoL and pain perception, in a pilot sample of 45 FM patients with idiopathic chronic pain. The contribution of perceived therapeutic relationship (alliance) and physiological attunement, in both the patient and therapist, will be considered as possible mediators of intervention efficacy. Attachment dimensions, traumatic experiences, difficulties in emotion regulation, mindfulness attitude and psychophysiological profile will also be considered as covariates. The objectives are to evaluate longitudinally if patients will experience an increase in QoL perception (primary endpoint), pain-managing self-efficacy and emotion-regulation abilities as well as a reduction in pain intensity (secondary endpoints), considering the mediating role of perceived therapeutic alliance and physiological attunement in both the patient and therapist.

Italian validation of the Clinical Outcomes in Routine Evaluation-10 (CORE-10): a short measure for routine outcome monitoring in clinical practice.

The customization of the intervention using patient feedback is an evidence-based practice aimed at the continuous evaluation, during treatment, of the patient's change at a clinical level. There are few easy-to-use tools for common assessment of psychological distress, designed to be used for screening and during treatment to monitor progress. The Clinical Outcomes in Routine Evaluation-10 (CORE-10) is definitely one of them. Thus, the aim of the present study was to examine the psychometric properties of the Italian version of the CORE-10. A sample of 548 participants (females, N=463, 84.5%; mean age 23.29±7.21 years) was recruited in the study and filled out a battery of measures. The internal validity of the CORE-10 was investigated through a confirmatory factor analysis which evidenced a good fit to the data, suggesting a unidimensional factorial structure of the measure. Further, the scale had a good internal reliability and was significantly associated with other measures of distress, interpersonal problems, well-being, and insecure attachment. Finally, it showed excellent diagnostic accuracy, as well as intrinsic and post-test diagnostics. Given its validity and reliability, the CORE-10 may be adopted by Italian-speaking psychotherapists and researchers to evaluate the outcomes of mental health interventions as well as to track the session-to-session changes over time in psychological distress among patients.

Preoperative Anxiety in Patients with Pancreatic Cancer: What Contributes to Anxiety Levels in Patients Waiting for Surgical Intervention.

Pancreatic cancer is one of the most lethal malignancies. Currently, the only treatment is surgical resection, which contributes to significant preoperative anxiety, reducing quality of life and worsening surgical outcomes. To date, no standard preventive or therapeutic methods have been established for preoperative anxiety in pancreatic patients. This observational study aims to identify which patients' socio-demographic, clinical and psychological characteristics contribute more to preoperative anxiety and to identify which are their preoperative concerns. Preoperative anxiety was assessed the day before surgery in 104 selected cancer patients undergoing similar pancreatic major surgery, by administering the STAI-S (State-Trait Anxiety Inventory Form) and the APAIS (Amsterdam Preoperative Anxiety and Information Scale). Our data suggest that patients with high STAI-S showed higher levels of APAIS and that major concerns were related to surgical aspects. Among psychological characteristics, depressive symptoms and trait anxiety appeared as risk factors for the development of preoperative anxiety. Findings support the utility of planning a specific psychological screening to identify patients who need more help, with the aim of offering support and preventing the development of state anxiety and surgery worries in the preoperative phase. This highlights also the importance of good communication by the surgeon on specific aspects related to the operation.

Clinical phenotypes and quality of life to define post-COVID-19 syndrome: a cluster analysis of the multinational, prospective ORCHESTRA cohort.

Background: Lack of specific definitions of clinical characteristics, disease severity, and risk and preventive factors of post-COVID-19 syndrome (PCS) severely impacts research and discovery of new preventive and therapeutics drugs. Methods: This prospective multicenter cohort study was conducted from February 2020 to June 2022 in 5 countries, enrolling SARS-CoV-2 out- and in-patients followed at 3-, 6-, and 12-month from diagnosis, with assessment of clinical and biochemical features, antibody (Ab) response, Variant of Concern (VoC), and physical and mental quality of life (QoL). Outcome of interest was identification of risk and protective factors of PCS by clinical phenotype, setting, severity of disease, treatment, and vaccination status. We used SF-36 questionnaire to assess evolution in QoL index during follow-up and unsupervised machine learning algorithms (principal component analysis, PCA) to explore symptom clusters. Severity of PCS was defined by clinical phenotype and QoL. We also used generalized linear models to analyse the impact of PCS on QoL and associated risk and preventive factors. CT registration number: NCT05097677. Findings: Among 1796 patients enrolled, 1030 (57%) suffered from at least one symptom at 12-month. PCA identified 4 clinical phenotypes: chronic fatigue-like syndrome (CFs: fatigue, headache and memory loss, 757 patients, 42%), respiratory syndrome (REs: cough and dyspnoea, 502, 23%); chronic pain syndrome (CPs: arthralgia and myalgia, 399, 22%); and neurosensorial syndrome (NSs: alteration in taste and smell, 197, 11%). Determinants of clinical phenotypes were different (all comparisons p < 0.05): being female increased risk of CPs, NSs, and CFs; chronic pulmonary diseases of REs; neurological symptoms at SARS-CoV-2 diagnosis of REs, NSs, and CFs; oxygen therapy of CFs and REs; and gastrointestinal symptoms at SARS-CoV-2 diagnosis of CFs. Early treatment of SARS-CoV-2 infection with monoclonal Ab (all clinical phenotypes), corticosteroids therapy for mild/severe cases (NSs), and SARS-CoV-2 vaccination (CPs) were less likely to be associated to PCS (all comparisons p < 0.05). Highest reduction in QoL was detected in REs and CPs (43.57 and 43.86 vs 57.32 in PCS-negative controls, p < 0.001). Female sex (p < 0.001), gastrointestinal symptoms (p = 0.034) and renal complications (p = 0.002) during the acute infection were likely to increase risk of severe PCS (QoL <50). Vaccination and early treatment with monoclonal Ab reduced the risk of severe PCS (p = 0.01 and p = 0.03, respectively). Interpretation: Our study provides new evidence suggesting that PCS can be classified by clinical phenotypes with different impact on QoL, underlying possible different pathogenic mechanisms. We identified factors associated to each clinical phenotype and to severe PCS. These results might help in designing pathogenesis studies and in selecting high-risk patients for inclusion in therapeutic and management clinical trials. Funding: The study received funding from the Horizon 2020 ORCHESTRA project, grant 101016167; from the Netherlands Organisation for Health Research and Development (ZonMw), grant 10430012010023; from Inserm, REACTing (REsearch & ACtion emergING infectious diseases) consortium and the French Ministry of Health, grant PHRC 20-0424.

Promoting participatory research in chronicity: The ESPRIMO biopsychosocial intervention for young adults with multiple sclerosis.

Background: Co-creation allows to develop tailored interventions in chronicity and to increase patients' engagement. Considering the interacting nature of physical, psychological, and social domains in multiple sclerosis (MS), a biopsychosocial approach to care is crucial. Aims: This paper aims to present (i) an example of a co-creation process in the context of chronic diseases (ii) preferences and perspectives of young adults with multiple sclerosis (YawMS; aged 18-45) and healthcare professionals (HCPs) on the relevance, objectives, and modalities of a biopsychosocial intervention (named ESPRIMO) and on strategies/barriers to participation. Methods: A participatory mixed-method approach in three consecutive steps was implemented: online surveys with YawMS (n = 121) and HCPs (n = 43), online focus groups (FGs) with YawMS, consultation with an advisory board (AB) composed by YawMS, HCPs and researchers. For the survey, descriptive statistics and inductive content analysis have been used for quantitative and qualitative analysis, respectively. FGs and AB were used to deepen the understanding of the survey's results. Results: An integrated intervention is extremely relevant according to the perspectives of the main stakeholders. Helping disease acceptance, providing stress management strategies, and supporting emotional expression emerged as the most relevant psychological objectives according to participants. Having tangible benefits, being tailored, and fostering interpersonal relationships emerged as the main preferred characteristics of physical activity. Preferences emerged on the modalities and timing of the intervention, with a venue unrelated to the disease strongly supported. Both HCPs and YawMS highlighted as the most valuable advantages of conducting the intervention online the increased accessibility, while the main limit was the restriction to social interaction (recognized as already limited during the COVID-19 pandemic). Accessibility and lack of time resulted as the main barriers to participation. Conclusion: The co-creation process gave valuable information on preferences and perspectives of main stakeholders on objectives, modalities, and strategies to improve participation which has been used in the design of the ESPRIMO biopsychosocial intervention. Those results might inform future intervention development in the field of chronicity. The current paper outlined a co-creation methodology which might be replicated in future research on other conditions of vulnerability.

Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial.

BACKGROUND: Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. METHODS AND ANALYSIS: A parallel-group randomized controlled trial will assess the feasibility, acceptability, and efficacy of a mindfulness and compassion-focused programme on frontline nurses who had been working during the COVID-19 pandemic. Seventy-two participants will be recruited from Verona University Hospital Trust (Veneto Region, north-east Italy) and will be divided equally into an intervention group and a control group. Primary outcome will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS). Secondary outcomes will be measured by the Cynicism and Professional Efficacy subscales of the MBI-GS, the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder (GAD-7), the Insomnia Severity Index (ISI), the Impact of Stressful Events (IES-R), the Perceived Stress Scale (PSS), the Five Facet Mindfulness Questionnaire (FFMQ), and the Forms of Self-Criticising/attacking and Self-Reassuring Scale (FSCRS). DISCUSSION: The study aims to fill a gap in the literature and present a scientifically validated intervention for those healthcare professionals most exposed to the stressful conditions of working during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT05308537.

Training in communication and emotion handling skills for students attending medical school: Relationship with empathy, emotional intelligence, and attachment style.

OBJECTIVE: To describe the Emoty-Com training, its impact on medical students' attitudes towards doctors' emotions and to explore the association between students' empathy, emotional intelligence (EI), and attachment style (AS) with post-training performance scores. METHODS: The 16-hour Emoty-Com training was delivered to all second-year medical students of Verona and Milan (Italy) Universities. At pre-training, students filled out three questionnaires assessing empathy, AS and EI and responded to three questions on attitudes towards doctors' emotions in the doctor-patient encounter. The same three questions and a final evaluation test were proposed at post-training. RESULTS: 264 students participated in the study. The training reduced students' worry about managing emotions during doctor-patient relationships. Gender was associated with specific subscales of empathy, EI, and AS. Final performance scores were associated with students' attitudes towards emotions but not with empathy, EI, and AS. CONCLUSION: The Emoty-Com training increased students' self-efficacy in handling their own emotions during consultations. Students' performance scores were related to their attitude towards doctors' emotions in clinical encounters. PRACTICE IMPLICATIONS: The Emoty-Com training suggests ways to teach and evaluate emotion-handling skills for medical students. Possible links between empathy, EI, AS, and the attitudes towards doctors' emotions during the years of education are highlighted.

Bipolar Spectrum Symptoms in Patients with Fibromyalgia: A Dimensional Psychometric Evaluation of 120 Patients.

BACKGROUND: Fibromyalgia Syndrome (FMS) is characterized by chronic widespread pain, fatigue, unrefreshing sleep and cognitive dysfunction. Depressive and manic symptoms are often reported in FMS patients' history. The aim of this study was to evaluate the prevalence of bipolar spectrum symptoms (BSS) and to correlate these with quality of life (QoL) scores and antidepressant treatment. METHODS: From October 2017 to July 2018, a battery of QoL questionnaires (FIQ, PSQI and SF-12) was administered to 120 FMS patients after a clinical examination. The MOODS-SR lifetime questionnaire was then remotely administered to the patients included in the study. RESULTS: The presence of depressive and manic lifetime symptoms was found, in line with the results of the available literature. A correlation was found between the history of depressive symptoms and the severity of FIQ and SF-12 scores. Despite a low statistical strength, a trend toward a correlation between a history of manic symptoms and SNRI treatment was detected. CONCLUSIONS: The correlation between the MOOD-depressive domains and poor QoL is in line with the available literature. Further studies are needed to corroborate these findings and to elucidate the relationship between manic symptoms and SNRI treatment.