A Virtual Reality Cognitive Stimulation Program as an Effective Tool Against Residual/Prodromal Depressive Symptoms in Bipolar Disorders.

Background: Bipolar disorder (BD) is a severe psychiatric illness characterized by a chronic course and recurrent episodes, including residual depressive symptoms even during euthymic phases. These symptoms, although not meeting criteria for a depressive episode, are linked to relapse risk and impaired social functioning. This study aims to assess whether Virtual Reality Cognitive Remediation Training reduces depressive symptoms below the clinical threshold in individuals with BD. Methods: This post hoc analysis focuses on the secondary outcome (PHQ9) of a randomized-controlled trial. Participants were recruited from the Center of Liaison Psychiatry and Psychosomatics in Italy. The experimental group received Virtual Reality Cognitive Remediation, while the control group received standard treatment Results: Data from 39 individuals in the experimental group and 25 in the control group were analyzed. A greater reduction in PHQ-9 scores (>9) was observed in the experimental group (71.8% to 48.7%) compared to the control group. Significant improvements in total PHQ-9 scores and specific symptoms were noted in the experimental group compared to the control group. Conclusions: The study highlights the significant impact of virtual reality intervention on reducing depressive symptoms in bipolar disorder. This promising outcome underscores the potential preventive role of cognitive stimulation in relapse prevention. The intervention could offer valuable benefits for both treatment and prevention strategies in bipolar disorder.

Improving Social and Personal Rhythm Dysregulation in Young and Old Adults with Bipolar Disorder: Post-Hoc Analysis of a Feasibility Randomized Controlled Trial Using Virtual Reality-Based Intervention.

Introduction: Rehabilitative interventions employing technology play a crucial role in bipolar disorder (BD) treatment. The study aims to appraise the virtual reality (VR)-based cognitive remediation (CR) and the interpersonal rhythm approaches to treatment outcomes of BD across different age groups. Methods: Post-hoc analysis of a 12-week randomizedcontrolled cross-over feasibility trial involving people with mood disorders (BD, DSM-IV) aged 18-75 years old: thirty-nine exposed to the experimental VR-based CR vs 25 waiting list controls. People with BD relapse, epilepsy or severe eye diseases (due to the potential VR risks exposure) were excluded. Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) was used to measure the outcome. Results: Cases and controls did not statistically significantly differ in age and sex distributions. Personal rhythm scores improved over the study follow-up in the experimental vs the control group (APC = 8.7%; F = 111.9; p < 0.0001), both in young (18-45 years) (APC = 5.5%; F = 70.46; p < 0.0001) and, to a lesser extent, older (>46 years) adults (APC = 10.5%; F = 12.110; p = 0.002). Conclusions: This study observed improved synchronization of personal and social rhythms in individuals with BD after a virtual reality cognitive remediation intervention, particularly in social activity, daily activities, and chronotype, with greater benefits in the younger population.

Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care.

INTRODUCTION: Uncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to identify women with uUTIs in whom antibiotics can be withheld without influencing clinical outcomes. This pilot study aims to provide preliminary evidence on whether a POCT informed management of uUTI in women can safely reduce antibiotic use. METHODS AND ANALYSIS: This is an open-label two-arm parallel cluster-randomised controlled pilot trial. 20 general practices affiliated with the Bavarian Practice-Based Research Network (BayFoNet) in Germany were randomly assigned to deliver patient management based on POCTs or to provide usual care. POCTs consist of phase-contrast microscopy to detect bacteria and urinary dipsticks to detect erythrocytes in urine samples. In both arms, urine samples will be obtained at presentation for POCTs (intervention arm only) and microbiological analysis. Women will be followed-up for 28 days from enrolment using self-reported symptom diaries, telephone follow-up and a review of the electronic medical record. Primary outcomes are feasibility of patient enrolment and retention rates per site, which will be summarised by means and SDs, with corresponding confidence and prediction intervals. Secondary outcomes include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, number of recurrent and upper UTIs and re-consultations and diagnostic accuracy of POCTs versus urine culture as the reference standard. These outcomes will be explored at cluster-levels and individual-levels using descriptive statistics, two-sample hypothesis tests and mixed effects models or generalised estimation equations. ETHICS AND DISSEMINATION: The University of Würzburg institutional review board approved MicUTI on 16 December 2022 (protocol n. 109/22-sc). Study findings will be disseminated through peer-reviewed publications, conferences, reports addressed to clinicians and the local citizen's forums. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05667207.

Acute Uncomplicated UTIs in Adults: Rapid Evidence Review.

An acute uncomplicated urinary tract infection (UTI) is a bacterial infection of the lower urinary tract with no sign of systemic illness or pyelonephritis in a noncatheterized, nonpregnant adult with no urologic abnormalities or immunocompromise. In women, a self-diagnosis of a UTI with the presence of typical symptoms (e.g., frequency, urgency, dysuria/burning sensation, nocturia, suprapubic pain), without vaginal discharge, is accurate enough to diagnose an uncomplicated UTI without further testing. Urine culture and susceptibility testing should be reserved for women with recurrent infection, treatment failure, history of resistant isolates, or atypical presentation to make a definitive diagnosis and guide antibiotic selection. First-line antibiotics include nitrofurantoin for five days, fosfomycin in a single dose, trimethoprim for three days, or trimethoprim/sulfamethoxazole for three days. Symptomatic treatment with nonsteroidal anti-inflammatory drugs and delayed antibiotics may be considered because the risk of complications is low. Increased fluids, intake of cranberry products, and methenamine hippurate can prevent recurrent infections. Antibiotic prophylaxis is also effective in preventing recurrence but has a risk of adverse effects and antimicrobial resistance. Men with lower UTI symptoms should always receive antibiotics, with urine culture and susceptibility results guiding the antibiotic choice. Clinicians should also consider the possibility of urethritis and prostatitis in men with UTI symptoms. First-line antibiotics for men with uncomplicated UTI include trimethoprim, trimethoprim/sulfamethoxazole, and nitrofurantoin for seven days. Uncomplicated UTIs in nonfrail women and men 65 years and older with no relevant comorbidities also necessitate a urine culture with susceptibility testing to adjust the antibiotic choice after initial empiric treatment; first-line antibiotics and treatment durations do not differ from those recommended for younger adults.

Identifying the Best Initial Oral Antibiotics for Adults with Community-Acquired Pneumonia: A Network Meta-Analysis.

BACKGROUND: The objective of this network meta-analysis was to compare rates of clinical response and mortality for empiric oral antibiotic regimens in adults with mild-moderate community-acquired pneumonia (CAP). METHODS: We searched PubMed, Cochrane, and the reference lists of systematic reviews and clinical guidelines. We included randomized trials of adults with radiologically confirmed mild to moderate CAP initially treated orally and reporting clinical cure or mortality. Abstracts and studies were reviewed in parallel for inclusion in the analysis and for data abstraction. We performed separate analyses by antibiotic medications and antibiotic classes and present the results through network diagrams and forest plots sorted by p-scores. We assessed the quality of each study using the Cochrane Risk of Bias framework, as well as global and local inconsistency. RESULTS: We identified 24 studies with 9361 patients: six at low risk of bias, six at unclear risk, and 12 at high risk. Nemonoxacin, levofloxacin, and telithromycin were most likely to achieve clinical response (p-score 0.79, 0.71, and 0.69 respectively), while penicillin and amoxicillin were least likely to achieve clinical response. Levofloxacin, nemonoxacin, azithromycin, and amoxicillin-clavulanate were most likely to be associated with lower mortality (p-score 0.85, 0.75, 0.74, and 0.68 respectively). By antibiotic class, quinolones and macrolides were most effective for clinical response (0.71 and 0.70 respectively), with amoxicillin-clavulanate plus macrolides and beta-lactams being less effective (p-score 0.11 and 0.22). Quinolones were most likely to be associated with lower mortality (0.63). All confidence intervals were broad and partially overlapping. CONCLUSION: We observed trends toward a better clinical response and lower mortality for quinolones as empiric antibiotics for CAP, but found no conclusive evidence of any antibiotic being clearly more effective than another. More trials are needed to inform guideline recommendations on the most effective antibiotic regimens for outpatients with mild to moderate CAP.

General practitioners' decision making managing uncomplicated urinary tract infections in women: a qualitative study.

BACKGROUND: To be effective, interventions aimed at increasing the appropriateness of antibiotic use in primary care should consider the perspectives of prescribing physicians. AIM: To explore the decision making of general practitioners (GPs) when managing uncomplicated urinary tract infections (uUTIs) in women. DESIGN & SETTING: A qualitative study using semi-structured interviews with 22 GPs in Bavaria and Baden-Württemberg (southern Germany). METHOD: Verbatim transcripts were analysed through inductive qualitative content analysis. RESULTS: We generated the following three main themes: factors facilitating the decision making; factors complicating the decision making; and consultation modalities. According to participants, following evidence-based recommendations makes the prescription decision smoother. GPs' and patients' prior experiences and beliefs guides decisions towards certain antibiotics, even if those experiences and beliefs contradict evidence-based recommendations. Patient expectations and demands also condition antibiotic prescribing, favouring it. Organisational constraints, such as time pressure, the day of the week (for example, before weekends), and a lower cost of antibiotics for patients than alternative treatments favour the decision to prescribe antibiotics. Diagnostic and prognostic uncertainty complicates decision making, as does scepticism towards evidence-based recommendations. Discordance within the patient-doctor relationship contributed to this complexity. Regarding consultation modalities, a more in-depth consultation and shared decision making were seen as helpful in this process. CONCLUSION: We identified different factors as intervening against or for a straightforward management decision when dealing with women with uUTIs. They reveal the complexity behind the GPs' decision making. Providing GPs with easy-to-apply guidance while removing economic constraints to allocate sufficient consultation time, and supporting shared decision making may help GPs appropriately manage uUTIs in women.

Expectations of general practitioners on a practice based research network in Germany- a qualitative study within the Bavarian Research Practice Network (BayFoNet).

BACKGROUND: Despite general practitioners' (GPs') key role in Germany`s primary health care, clinical research in general practice is scarce. Clinical research is mainly conducted at inpatient facilities, although their results are rarely transferable. German GPs have no extra time or funding for research, as well as limited research training. To support clinical research in German primary health care, practice-based research networks (PBRNs) are developed. As they will be based on an active involvement of GPs, we need more information on GPs` participation-readiness. The aim of this study was to explore facilitators and barriers to participation in the Bavarian Research Practice Network (BayFoNet) from the GPs`perspective before clinical trials will be performed. METHODS: We have performed semi-structured qualitative interviews with a purposive sample of 20 Bavarian GPs in 2022 under the application of the consolidated framework for implementation research (CFIR). Transcriptions were analysed according to Kuckartz` qualitative content analysis. The five domains of the CFIR framework served as initial deductive codes. RESULTS: N = 14 interviewees already agreed to participate in BayFoNet, whereas n = 6 interviewees opted not to participate in BayFoNet at the time of data collection. Main facilitators to conduct clinical research within BayFoNet were the motivation to contribute to evidence strength and quality in general practice, professional development and training of practice staff, as well as networking. Barriers for an active participation were bad experiences with previous clinical studies and lack of resources. CONCLUSIONS: PBRNS in Germany have to be promoted and the entire practice team has to be involved at an early stage of development. Professional training of general practice staff and a living network might enhance engagement. Participatory approaches could help to develop acceptable and feasible study designs. Furthermore, PBRNs should support patient recruitment and data collection in general practices and disseminate the results of their research projects regularly to maintain GPs` engagement. TRIAL REGISTRATION: DRKS00028805, NCT05667207.

[Twelve tips for a good medical consultation in primary care.] / Dodici suggerimenti per una buona consultazione medica nelle cure primarie.

BACKGROUND: The recent pandemic has brought into sharper focus the need, long emphasised in the scientific literature, for a change in primary care that goes beyond the limits of the hyper-specialisation constitutive of Western health systems. While the direction of the cultural and organisational change that needs to be developed is well outlined, little is written about the competencies and values that physicians must acquire in order to shape a new and coherent organisation of services. The patient encounter is the frame in which these competencies take shape, and it is from this perspective that these competencies are examined here. OBJECTIVES: The aim of this narrative review of empirical studies and the multisciplinary literature is to provide primary care physicians with some tips for a good management of the medical consultation. These tips outline the competencies needed in general practice, rethought within the paradigm of complexity of care. RESULTS: The concepts, practices and values on which the 12 tips are based are: a) an attitude of attention to the complexity of care in which the patient's subjectivity can only be understood through an encounter with one's own subjectivity; b) the peculiar method of clinical reasoning in general practice, which includes the early generation of diagnostic hypotheses to be verified using simple and inexpensive tests, such as history taking and physical examination; these tests should have a high negative predictive value to rule out more serious conditions; c) the contextualisation of the working diagnosis (opposed to a definitive diagnosis) as a tool for dealing with complexity; d) the analysis of the evolution of scenarios as a tool for planning and choosing courses of action; e) the assessment of uncertainty in addition to that of measurable risk; f) the involvement of the patient and the use of the test of time as tools for managing uncertainty; g) the centrality of sharing the decision with the patient.

[Top 4 Research Studies of the month for Italian Primary Care Physicians: November 2023.] / La Top 4 di novembre 2023. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) Based on efficacy, safety, and cost, a regimen of terbinafine 250 mg once daily for 12 weeks, followed by a 12-week period of no therapy, and then a 4-week booster of terbinafine 250 mg is preferred for onychomycosis in adults for the outcome of complete cure at 1 year. 2) A high-quality randomized trial found that standard-course antibiotic therapy for children with uncomplicated urinary tract infection was superior to short-course therapy. However, the number needed to treat of 28 suggests that offering short-course therapy is not unreasonable, especially if there is good follow-up in the subsequent weeks. 3) An updated guideline of the American College of Physicians on screening of colorectal cancer adds 2 new recommendations. One is to consider not screening patients aged 45 to 49 years. The other recommendation is against screening using stool Dna, computed tomography colonography, capsule endoscopy, urine, or serum screening tests for colorectal cancer. 4) The US Preventive Services Task Force found additional evidence on the benefit of folic acid supplementation for preventing neural tube defects. Since the critical period starts at least 1 month before conception, the task force recommends a daily supplement of 0.4 mg to 0.8 mg folic acid for all women who plan to or could become pregnant.

[Focusing on patient-oriented evidence that matters: a practical approach to keeping up with new research.] / Evidenze mediche orientate al paziente: un approccio pratico per rimanere aggiornati sugli studi che vale la pena conoscere.

One of the challenges of medical practice, especially primary care because of its breadth, is keeping up with the latest research findings. As physicians, how can we select, among hundreds of thousands of research studies published each year, those worth knowing about? Since 1996, a group of American primary care physicians have been systematically reviewing over 100 journals every month to identify new Patient-Oriented Evidence that Matters (POEMs). To be a POEM, a research study must have the potential to change clinical practice by addressing hard, patient-oriented outcomes, such as mortality, intensity or duration of symptoms, or quality of life, as opposed to disease-oriented (surrogate) outcomes, such as laboratory parameters. In addition, it must be methodologically valid, i.e., reasonably free of bias, with its validity evaluated through objective criteria by experts in evidence-based medicine with no conflicts of interest with the industry. To be useful at the point of care, these studies must be easy to retrieve and require little work to review. Starting from this issue, a selection of POEMs most likely to change and improve Italian primary care practice will be published monthly in Recenti Progressi in Medicina as brief evidence summaries. In addition, yearly, we will present an article summarizing the 20 most important research studies for primary care of the previous year.

[The methodological and relational core competencies of General practice/Family medicine in Primary Care.] / Le competenze distintive metodologiche e relazionali del medico di medicina generale nelle cure primarie.

In this article, we examine three out of the seven distinctive values of General practice/family medicine (Gpfm), as proposed by World Organization of Family Doctors (Wonca) and recently translated into Italian: patient-centered care, continuity of care, and evidence-based care. We believe that these values can contribute to the ongoing debate on the reorganization of the primary care model and the reform of the core curriculum of Italian Gpfm. These three values are the basis of the distinctive methodological and relational competencies of Gpfm. In this contribution, we analyze them through the lens of epistemology of complexity, aiming to highlight the unique aspects of this method and relationship, thus identifying the necessary competencies for Gpfm. The thought and method of care - the first and third values - are analyzed considering that the framework in which Gpfm operates leads to significant modifications of the clinical method. While it certainly encompasses elements of the traditional clinical method, they are executed at different paces and with different objectives, employing distinct strategies. For instance, the epidemiological context with a high prevalence of symptomatic distress but low prevalence of "true" disease needs the early generation of diagnostic hypotheses. These hypotheses are then tested using verbal and physical examinations as exclusion tests with high predictive power. The aim is to arrive at diagnoses that are not exhaustive, yet operational and contextualized. Furthermore, the uncertainty inherent in Gpfm requires the utilization of contextual knowledge related to the patient's environment, negotiation with the patient about the tolerable threshold of decisional uncertainty, their involvement - which increases with greater uncertainty - and the use of the test of time within an organizational and relational protective network. Complex thinking enables reflection on the second value - the relationship - by assigning the physician's subjectivity a place as precious as that of the patient, which is already historically established. Thus, both the physician and patient, as subjects, exist on the same ontological plane but differ methodologically due to their distinct roles. Adopting an epistemology of complexity in Gpfm allows each variable of the system - subjects, context, method, clinical aspects - to regain significance. This approach favours a genuine science in service of humanity.

[Top 5 Research Studies of the month for Italian Primary Care Physicians: October 2023.] / La Top 5 di ottobre 2023. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a selection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. Amoxicillin is no more likely to cause a rash than any other antibiotic in children with infectious mononucleosis. According to a good quality systematic review and network meta-analysis, only a small number of randomized controlled trials, disappointing in overall quality, suggest that for managing neuropsychiatric symptoms in adults with dementia, risperidone has the best balance of effectiveness and adverse effects. In a rigorously conducted double-blind randomized controlled trial, adults with acute low back or neck pain treated with opioids had no benefit in pain relief as those treated with placebo. In a large study of more than 21,000 participants aged 60 to 84 years, taking 60,000 IU vitamin D each month slightly reduced their likelihood of experiencing a major cardiovascular event (number needed to treat = 172 over 5 years). A single screening colonoscopy had higher rates of participation than 5 years of fecal occult blood testing in a high-quality study in which patients were offered free screening with these two methods (84% vs 73%; p<0.001).

Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study.

INTRODUCTION: General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients. METHODS AND ANALYSIS: The BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points. ETHICS AND DISSEMINATION: Research ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients. TRIAL REGISTRATION NUMBERS: DRKS00028805, NCT05667207.

Impact of the COVID-19 pandemic on people in need of care or support: protocol for a SARS-CoV-2 registry.

INTRODUCTION: People in need of care or support are severely affected by the COVID-19 pandemic. We lack valid data of long-term assessments. We present a register study to detect the physical and psychosocial impact of the COVID-19 pandemic on people in need of care or support in Bavaria, Germany. To describe the persons' life conditions comprehensively, we assess the perspectives and needs of the respective care teams too. Results will serve as evidence-based source to manage the pandemic and long-term prevention strategies. METHODS AND ANALYSIS: The 'Bavarian ambulatory COVID-19 Monitor' is a multicentre registry including a purposive sample of up to 1000 patient-participants across three study sites in Bavaria. The study group consists of 600 people in need of care with a positive SARS-CoV-2 PCR test. Control group 1 comprises 200 people in need of care with a negative SARS-CoV-2 PCR test, while control group 2 comprises 200 people with a positive SARS-CoV-2 PCR test but are not in need of care. We assess the clinical course of infection, psychosocial aspects and care needs using validated measures. Follow-up is every 6 months for up to 3 years. Additionally, we assess up to 400 people linked to these patient-participants (caregivers, general practitioners (GPs)) for their health and needs. Main analyses are stratified by level of care I-V (I=minor/V=most severe impairment of independence), inpatient/outpatient care setting, sex and age. We use descriptive and inferential statistics to analyse cross-sectional data and changes over time. In qualitative interviews with 60 stakeholders (people in need of care, caregivers, GPs, politicians), we explore interface problems of different functional logics, of everyday and professional perspectives. ETHICS AND DISSEMINATION: The Institutional Review Board of the University Hospital LMU Munich (#20-860) and the study sites (Universities of Wurzburg and Erlangen) approved the protocol. We disseminate the results by peer-reviewed publications, international conferences, governmental reports, etc.

The effects of primary care monitoring strategies on COVID-19 related hospitalisation and mortality: a retrospective electronic medical records review in a northern Italian province, the MAGMA study.

BACKGROUND: Most symptomatic SARS-CoV-2 infections produce mild to moderate symptoms. Although most patients are managed in the outpatient setting, little is known about the effect of general practitioners' (GP) management strategies on the outcomes of COVID-19 outpatients in Italy. OBJECTIVES: Describe the management of Italian GPs of SARS-CoV-2 infected adult patients and explore whether GP active care and monitoring are associated with reducing hospitalisation and death. METHODS: Retrospective observational study of SARS-CoV-2 infected adult outpatients managed by GPs in Modena (Italy) from March 2020 to April 2021. Information on management and monitoring strategies, patients' socio-demographic characteristics, comorbidities, and outcomes (hospitalisation and death due to COVID-19) were retrieved through an electronic medical record review and analysed descriptively and through multiple logistic regression. RESULTS: Out of the 5340 patients from 46 GPs included in the study, 3014 (56%) received remote monitoring, and 840 (16%) had at least one home visit. More than 85% of severe or critical patients were actively monitored (73% daily) and 52% were visited at home. Changes over time in patients' therapeutic management were observed in concordance with the guidelines' release. Active daily remote monitoring and home visits were strongly associated with reduced hospitalisation rate (OR 0.52, 95% CI 0.33-0.80 and OR 0.50, 95% CI 0.33-0.78 respectively). CONCLUSION: GPs effectively managed an increasing number of outpatients during the first waves of the pandemic. Active monitoring and home visits were associated with reduced hospitalisation in COVID-19 outpatients.

Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies.

BACKGROUND: Cognitive Remediation (CR) programs are effective for the treatment of mental diseases; in recent years, Virtual Reality (VR) rehabilitation tools are increasingly used. This study aimed to systematically review and meta-analyze the published randomized controlled trials that used fully immersive VR tools for CR programs in psychiatric rehabilitation. We also wanted to map currently published CR/VR interventions, their methods components, and their evidence base, including the framework of the development intervention of CR in fully immersive VR. METHODS: Level 1 of evidence. This study followed the PRISMA extension for Scoping Reviews and Systematic Review. Three electronic databases (Pubmed, Cochrane Library, Embase) were systematically searched, and studies were included if they met the eligibility criteria: only randomized clinical trials, only studies with fully immersive VR, and only CR for the adult population with mental disorders. RESULTS: We found 4905 (database) plus 7 (manual/citation searching articles) eligible studies. According to inclusion criteria, 11 studies were finally reviewed. Of these, nine included patients with mild cognitive impairment, one with schizophrenia, and one with mild dementia. Most studies used an ecological scenario, with improvement across all cognitive domains. Although eight studies showed significant efficacy of CR/VR, the interventions' development was poorly described, and few details were given on the interventions' components. CONCLUSIONS: Although CR/VR seems to be effective in clinical and feasibility outcomes, the interventions and their components are not clearly described. This limits the understanding of the effectiveness and undermines their real-world implementation and the establishment of a gold standard for fully immersive VR/CR.