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Mental health services need reliable and valid instruments to measure mental health recovery outcomes, and the only available one in Spanish is arduous. Adapting an instrument is more efficient than creating a new one as it enables international comparison research. The aim of this study was to conduct a cross-cultural adaptation of the 15-item Questionnaire about the Process of Recovery. Fifty-four participants engaged in a five-stage systematic and standardized process carried out from November 2019 to November 2020. Professional translators (n = 4) from the Translation Service Center for Foreign Languages of the Universidad de Alcalá participated in the direct translation, synthesis and back translation stages, and mental health professionals (n = 33) and service users (n = 17) from the Hospital Regional Universitario de Málaga and the Hospital Universitario Virgen de la Victoria in Andalucía (Spain), with an average of 19.2 (SD 12.86) years of experience in mental health, participated in the committee of experts and pilot debriefing stages. Additionally, legibility was assessed. Out of the 15-items of the questionnaire, three (20%) were equal amongst translations, three items (20%) of the back translations matched the original questionnaire and discrepancies identified were adapted accordingly. Seven items (46.7%) were approved online by experts and consensus of alternative translations was reached for the rest. The average time spent completing the questionnaire by service users during the face-to-face pilot was 4.12 min (SD 2.25). Internal consistency obtained was ω = 0.95 and α = 0.91. Debriefing findings reported the questionnaire as comprehensible (97.1%), adequate in wording (91.2%), formal in language (55.9%) and adequate in terms of length (100%). The questionnaire scored 65.53, 'normal' readability, on the Inflesz scale. The adapted instrument has conceptual, linguistic, cultural and metric equivalence to the original instrument.

WHAT IS KNOWN ON THE SUBJECT?: A relevant number of restraint prevention programmes have been developed internationally. In Spain, there is no harmonized policy to prevent the use of restraint. More studies are necessary to establish which programmes and components are necessary to prevent restraint. WHAT DOES THE PAPER ADD TO EXISTING KNOWLEDGE?: There was a significant decreasing trend in the total number of mechanical restraint hours during the implementation of the intervention. There was no significant decreasing trend in the number of mechanical restraint episodes. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Interventions at a regional level aimed at preventing mechanical restraint are feasible in the Spanish context. All components of the Six Core Strategies could be necessary to prevent episodes of mechanical restraint. ABSTRACT: Introduction Mechanical restraint (MR) is used in many countries, including Spain, where non-harmonized policies between autonomous communities exist. There is a lack of research about interventions at regional levels to reduce their use. Aim To analyse data on key outcomes during the implementation of a multicomponent intervention in Andalusia (Spain) to reduce the use of MR. Method Episodes in a period of 30 months in all wards (N = 20) were analysed. The intervention consisted of five strategies: (a) leadership, (b) analysis of the situation, (c) awareness training for the heads of the wards, (d) unified record of MR and (e) staff training. We analysed the monthly trend of restraint hours and restraint episodes/1,000 bed days using segmented regression. Results There were 206.32 restraint hours and 12.96 restraint episodes/1,000 bed days during the study period. A significant decreasing trend was observed in restraint hours (-1.79%, p < .001), but not in the number of restraint episodes (-0.45%; p = .149). Discussion The results coincide with other international studies; however, studies with better designs are required to evaluate the effectiveness of the intervention. Implications for Practice Interventions at a regional level aimed at preventing MR are feasible in the Spanish context.

Resumen Introduccion El objetivo del estudio fue analizar la tendencia en el porcentaje de hospitalizaciones psiquiatricas en poblacion mayor, asi como, estudiar las caracteristicas de la poblacion mayor ingresada en una unidad de hospitalizacion psiquiatrica. Material y metodos Se analizaron las tendencias en los porcentajes de altas de poblacion mayor a nivel nacional y de los porcentajes de ingresos de la Unidad de Hospitalizacion de Salud Mental (UHSM) del Hospital Regional Universitario de Malaga durante un periodo de al menos 18 anos mediante regresion segmentada. Para el estudio de las caracteristicas de la poblacion mayor ingresada se compararon todos los pacientes (n = 5.925) y los episodios de ingreso (n = 15.418) consecutivos entre los anos 1999 y 2017 en la UHSM. Resultados A nivel nacional hubo un incremento de las altas hospitalarias por trastorno mental en personas mayores con un significativo cambio de porcentaje anual medio del 2,0%. En la unidad de estudio esta poblacion fue en mayor medida de genero femenino, admitida de forma involuntaria y tuvo un tiempo de estancia mayor. Presentaron con mas frecuencia trastornos mentales de tipo organico y trastorno depresivo y con menor frecuencia esquizofrenia, trastornos por consumo de sustancias y trastornos de personalidad. Conclusiones Hubo una tendencia creciente en el porcentaje de personas mayores con hospitalizaciones psiquiatricas en el periodo de estudio. Estos resultados alertan sobre el aumento de admisiones de esta poblacion en las unidades de hospitalizacion de psiquiatria y la necesidad de adaptacion de estas unidades a las caracteristicas particulares de estos pacientes.

The early prediction of patients at risk may facilitate the efficient use of interventions that have been demonstrated to reduce readmissions. The aim of the study was to analyze variables during first admissions associated with further high use of an inpatient hospitalization psychiatric unit in Malaga, Spain. The risk of having three or more psychiatric admissions was analyzed in a sample of 1535 first-time admissions with multivariate Cox regression. In the multivariate model, the variables associated with the risk of high use were age at admission (p < 0.001), length of stay (p < 0.001), place of residence (p < 0.001), and previous history with mental health services (p < 0.001). The results suggest that there are several easily accessible characteristics at first admission that are potentially useful in detecting patients at risk.

Aims There is evidence that patients with schizophrenia spectrum disorders present higher mortality in comparison with the general population. The aim of this study was to analyse the causes of mortality and sociodemographic factors associated with mortality, standardised mortality ratios (SMRs), life expectancy and potential years of life lost (YLL) in patients with schizophrenia spectrum disorders in Spain. Methods The study included a cohort of patients from the Malaga Schizophrenia Case Register (1418 patients; 907 males; average age 42.31 years) who were followed up for a minimum of 10 years (median = 13.43). The factors associated with mortality were analysed with a survival analysis using Cox's proportional hazards regression model. Results The main causes of mortality in the cohort were circulatory disease (21.45%), cancer (17.09%) and suicide (13.09%). The SMR of the cohort was more than threefold that of the population of Malaga (3.19). The life expectancy at birth was 67.11 years old, which is more than 13 years shorter than that of the population of Malaga. The YLL was 20.74. The variables associated with a higher risk of mortality were age [adjusted hazard ratio (AHR) = 1.069, p < 0.001], male gender (AHR = 1.751, p < 0.001) and type of area of residence (p = 0.028; deprived urban zone v. non-deprived urban area, AHR = 1.460, p = 0.028). In addition, receiving welfare benefit status in comparison with employed status (AHR = 1.940, p = 0.008) was associated with increased mortality. Conclusions There is excess mortality in patients with schizophrenia spectrum disorders and also an association with age, gender, socioeconomic inequalities and receiving welfare benefits. Efforts directed towards improved living conditions could have a positive effect on reducing mortality.

There are a large number of mobile applications that allow the monitoring of health status. The quality of the applications is only evaluated by users and not by standard criteria. This study aimed to examine depression-related applications in major mobile application stores and to analyze them using the rating scale tool Mobile Application Rating Scale (MARS). A search of digital applications for the control of symptoms and behavioral changes in depression was carried out in the two reference mobile operating systems, Apple (App Store) and Android (Play Store), by means of two reviewers with a blind methodology between September and October 2019 in stores from Spain and the United Kingdom. Eighteen applications from the Android Play Store and twelve from the App Store were included in this study. The quality of the applications was evaluated using the MARS scale from 1 (inadequate) to 5 (excellent). The average score of the applications based on the MARS was 3.67 ± 0.53. The sections with the highest scores were “Functionality” (4.51) and “Esthetics” (3.98) and the lowest “Application Subjective quality” (2.86) and “Information” (3.08). Mobile Health applications for the treatment of depression have great potential to influence the health status of users; however, applications come to the digital market without health control.

Achondroplasia, as the most common form of disproportionate short stature, potentially impacts the health-related quality of life (HRQOL) and functioning of people with this condition. Because there are no psychometrically validated patient-reported outcome (PRO) condition-specific instruments for achondroplasia, this study selected and tested available generic, disease-specific and under development questionnaires for possible use in multinational clinical research. A three-step approach was applied. First, a literature review and clinician/expert opinions were used to select relevant PRO questionnaires. Second, focus group discussions, including a group cognitive debriefing for piloting of the questionnaires with children/adolescents with achondroplasia and their parents, were performed in Spain and Germany. Third, a field-test study was conducted to test the psychometric properties of these instruments. Six questionnaires were identified as potentially relevant in children with achondroplasia. In each country, five focus groups including a cognitive debriefing were conducted, and the results narrowed the possibilities to three instruments as most appropriate to assess HRQOL (the generic PedsQL, the height-specific QoLISSY, and the achondroplasia-specific APLES). Results of the field study indicate the QoLISSY and the PedsQL questionnaires to be most appropriate for use in clinical research at this time. This selection study is a step forward in assessing the impact of achondroplasia on HRQOL. Of the instruments examined, the QoLISSY and the PedsQL both capture items relevant to children with achondroplasia and have met the psychometric validation criteria needed for use in research. The APLES instrument is a promising tool that should be revisited upon psychometric validation.

The Coercion Experience Scale (CES) is a questionnaire that evaluates the subjective experience of coercion during psychiatric hospitalization. This study aimed to assess a short version of the Coercion Experience Scale (CES-18) in a Spanish Sample (N = 114). Two authors independently selected the items, choosing those that could also be applied to the experience of coercion after the use of forced medication. Reliability was estimated using internal consistency coefficients. Internal validity was assessed by means of a factorial analysis based on the method of extraction of main components and using orthogonal rotation VARIMAX. Convergent and discriminatory validity was evaluated by correlation between the total score of the CES-18 with the original CES and a Visual Analogue Scale, The Davidson Trauma Scale and the Client Assessment of Treatment Scale. The CES-18 showed adequate internal consistency (Cronbach α = 0.940). Factor analysis resulted in a two-factor solution (Coercion and Humiliation and Fear) explaining 64.2% of the total variance. The correlation between the original CES and CES-18 was adequate (r = 0.968). The scores suggested good divergent and convergent validity. The Spanish language CES-18 demonstrated adequate psychometric proprieties in order to assess perceived coercion during psychiatric hospitalization.

BACKGROUND COVID-19 forced the implementation of restrictive measures in Spain, such as lockdown, home confinement, social distancing, and isolation. It is necessary to study whether limited access to basic services and decreased family and social support could have deleterious effects on cognition, quality of life, and mental health in vulnerable older people. OBJECTIVE This study aims to explore the impact of the COVID-19 outbreak on cognition in older adults with mild cognitive impairment or dementia as the main outcome and the quality of life, perceived health status, and depression as secondary outcomes and to analyze the association of living alone and a change in living arrangements with those outcomes and other variables related with the use of technology and health services. Likewise, this study aims to analyze the association of high and low technophilia with those variables, to explore the access and use of health care and social support services, and, finally, to explore the informative-, cognitive-, entertainment-, and socialization-related uses of information and communications technologies (ICTs) during the COVID-19 outbreak. METHODS This cohort study was conducted in Málaga (Spain). In total, 151 participants with mild cognitive impairment or mild dementia, from the SMART4MD (n=75, 49.7%) and TV-AssistDem (n=76, 50.3%) randomized clinical trials, were interviewed by telephone between May 11 and June 26, 2020. All participants had undergone 1-3 assessments (in 6-month intervals) on cognition, quality of life, and mood prior to the COVID-19 breakout. RESULTS The outbreak did not significantly impact the cognition, quality of life, and mood of our study population when making comparisons with baseline assessments prior to the outbreak. Perceived stress was reported as moderate during the outbreak. After correction for multiple comparisons, living alone, a change in living arrangements, and technophilia were not associated with negative mental health outcomes. However, being alone was nominally associated with self-perceived fear and depression, and higher technophilia with better quality of life, less boredom, perceived stress and depression, and also less calmness. Overall, health care and social support service access and utilization were high. The most used ICTs during the COVID-19 outbreak were the television for informative, cognitive, and entertainment-related uses and the smartphone for socialization. CONCLUSIONS Our findings show that the first months of the outbreak did not significantly impact the cognition, quality of life, perceived health status, and depression of our study population when making comparisons with baseline assessments prior to the outbreak. Living alone and low technophilia require further research to establish whether they are risk factors of mental health problems during lockdowns in vulnerable populations. Moreover, although ICTs have proven to be useful for informative-, cognitive-, entertainment-, and socialization-related uses during the pandemic, more evidence is needed to support these interventions. CLINICALTRIAL ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797 INTERNATIONAL REGISTERED REPORT RR2-10.2196/26431

Background The COVID-19 pandemic has led to worldwide implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine, and home confinement measures. Such restrictions on activities of daily life and separation from loved ones may lead to social isolation and loneliness with health-related consequences among community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, inadequate access to health care and social support services may aggravate chronic conditions. Home-based technological interventions have emerged for combating social isolation and loneliness, while simultaneously preventing the risk of virus exposure. Objective The aim of this cohort study is to explore, analyze, and determine the impact of social isolation on (1) cognition, quality of life, mood, technophilia, and perceived stress among community-dwelling older adults with mild cognitive impairment or mild dementia and on the caregiver burden; (2) access to and utilization of health and social care services; and (3) cognitive, social, and entertainment-related uses of information and communication technologies. Methods This study will be conducted in Málaga (Andalucía, Spain). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia and his/her informal caregiver, will be contacted by telephone. Potential respondents will be participants of the following clinical trials: support, monitoring, and reminder technology for mild dementia (n=100) and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (n=100). Results As of May 2021, a total of 153 participants have been enrolled and assessed during COVID-19 confinement, of whom 67 have been assessed at 6 months of enrollment. Changes in the mean values of the variables will be analyzed relative to baseline findings of previous studies with those during and after confinement, using repeated-measures analysis of variance or the nonparametric Friedman test, as appropriate. The performance of multivariate analysis of covariance (ANCOVA) to introduce potential covariates will also be considered. Values of 95% CI will be used. Conclusions If our hypothesis is accepted, these findings will demonstrate the negative impact of social isolation owing to COVID-19 confinement on cognition, quality of life, mood, and perceived stress among community-dwelling older adults with mild cognitive impairment and mild dementia, the impact on technophilia, caregiver burden, the access to and utilization of health and social care services, and the cognitive, social, and entertainment-related use of information and communication technologies during and after COVID-19 confinement. Trial Registration ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797 International Registered Report Identifier (IRRID) DERR1-10.2196/26431

BACKGROUND Considering the changing demographic trends in Europe, the rising prevalence of dementia, and the increasing demand, limited accessibility and finite resources for long-term healthcare and support services, developing active and assisted living technological solutions becomes necessary for the independent living of community-dwelling adults. The TV-AssistDem project aims to develop a TV-based assistive integrated service for people with mild cognitive impairment by conducting a feasibility study for prototype development and refinement. OBJECTIVE To identify (1) usability barriers and facilitators to implementation, (2) usage and clinical change from baseline and (3) user and caregiver satisfaction. METHODS A two-phased study was carried out between August 2018 and April 2019. PHASE I consisted of a one-time introduction to the TV-AssistDem functionalities at the users´ home environment for usability testing and clinical evaluation at baseline. PHASE II analyzed the usage of the service during a one-month intervention period. Completion of the System Usability Scale, clinical evaluation and assessment of satisfaction was carried out to conclude PHASE II. Participants: Two European countries: Biomedical Research Institute of Malaga (IBIMA) and the Romanian NGO Home Care Association (Îngrijiri La Domiciliu). Twelve dyads (N=24) formed by people with mild cognitive impairment and mild dementia and their informal caregivers, healthcare professionals (nurse and social worker) and technological developers. RESULTS Usability testing reported 72 issues, identifying implementation barriers and corresponding solutions, categorized into human (7) and technological axis (7); and implementation facilitators (4). The likelihood to recommend TV-AssistDem is “passive” and the prototype may be considered as “marginally acceptable”. For almost all services the usage analysis identified 3 very intensive users (more than twice the expected average), 5 normal users and 4 with almost no use of the system. The limited sample size did not provide statistically significant clinical data but the overall increase in clinical average values and delta values is a promising finding that will be validated during the randomized clinical trial which will cover a larger population (N=240) over a longer period of time (12 months). Dyads satisfaction reported TV-AssistDem to be user-friendly, innovative and interactive overall. CONCLUSIONS This user and caregiver centered study with healthcare professional participation tested the TV-AssistDem prototype as an important starting point in prototype refinement, intervention planning, adaptation and successful implementation demonstrating the technological viability for full trial commitment. CLINICALTRIAL NCT03653234 May 13, 2020 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12877-019-1267-z

Background: Quality of life (QoL) is affected even at early stages in older adults with cognitive impairment. The use of mobile health (mHealth) technology can offer support in daily life and improve the physical and mental health of older adults. However, a clarification of how mHealth technology can be used to support the QoL of older adults with cognitive impairment is needed. Objective: To investigate factors affecting mHealth technology use in relation to self-rated QoL among older adults with cognitive impairment. Methods: A cross-sectional research design was used to analyse mHealth technology use and QoL in 1,082 older participants. Baseline data were used from a multi-centered randomized controlled trial including QoL, measured by the Quality of Life in Alzheimer’s Disease (QoL-AD) Scale, as the outcome variable. Data were analyzed using logistic regression models. Results: Having moderately or high technical skills in using mHealth technology and using the internet via mHealth technology on a daily or weekly basis was associated with good to excellent QoL in older adults with cognitive impairment. Conclusions: The variation in technical skills and internet use among the participants can be interpreted as an obstacle for mHealth technology to support QoL. © The Author(s) 2021. CC BY 4.0© The Author(s) 2021Corresponding Author: Line Christiansen, Department of Health, Blekinge Institute of Technology, Valhallavägen 1, SE-371 79 Karlskrona, Sweden. Email: line.christiansen@bth.se

BACKGROUND The COVID-19 pandemic has led to worldwide implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine, and home confinement measures. Such restrictions on activities of daily life and separation from loved ones may lead to social isolation and loneliness with health-related consequences among community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, inadequate access to health care and social support services may aggravate chronic conditions. Home-based technological interventions have emerged for combating social isolation and loneliness, while simultaneously preventing the risk of virus exposure. OBJECTIVE The aim of this cohort study is to explore, analyze, and determine the impact of social isolation on (1) cognition, quality of life, mood, technophilia, and perceived stress among community-dwelling older adults with mild cognitive impairment or mild dementia and on the caregiver burden; (2) access to and utilization of health and social care services; and (3) cognitive, social, and entertainment-related uses of information and communication technologies. METHODS This study will be conducted in Málaga (Andalucía, Spain). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia and his/her informal caregiver, will be contacted by telephone. Potential respondents will be participants of the following clinical trials: support, monitoring, and reminder technology for mild dementia (n=100) and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (n=100). RESULTS As of May 2021, a total of 153 participants have been enrolled and assessed during COVID-19 confinement, of whom 67 have been assessed at 6 months of enrollment. Changes in the mean values of the variables will be analyzed relative to baseline findings of previous studies with those during and after confinement, using repeated-measures analysis of variance or the nonparametric Friedman test, as appropriate. The performance of multivariate analysis of covariance (ANCOVA) to introduce potential covariates will also be considered. Values of 95% CI will be used. CONCLUSIONS If our hypothesis is accepted, these findings will demonstrate the negative impact of social isolation owing to COVID-19 confinement on cognition, quality of life, mood, and perceived stress among community-dwelling older adults with mild cognitive impairment and mild dementia, the impact on technophilia, caregiver burden, the access to and utilization of health and social care services, and the cognitive, social, and entertainment-related use of information and communication technologies during and after COVID-19 confinement. CLINICALTRIAL ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/26431

Digital health interventions may improve different behaviours. However, the rapid proliferation of technological solutions often does not allow for a correct assessment of the quality of the tools. This study aims to review and assess the quality of the available mobile applications (apps) related to interventions for low back pain. Two reviewers search the official stores of Android (Play Store) and iOS (App Store) for localisation in Spain and the United Kingdom, in September 2019, searching for apps related to interventions for low back pain. Seventeen apps finally are included. The quality of the apps is measured using the Mobile App Rating Scale (MARS). The scores of each section and the final score of the apps are retrieved and the mean and standard deviation obtained. The average quality ranges between 2.83 and 4.57 (mean 3.82) on a scale from 1 (inadequate) to 5 (excellent). The best scores are found in functionality (4.7), followed by aesthetic content (mean 4.1). Information (2.93) and engagement (3.58) are the worst rated items. Apps generally have good overall quality, especially in terms of functionality and aesthetics. Engagement and information should be improved in most of the apps. Moreover, scientific evidence is necessary to support the use of applied health tools.

Background: Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. Objective: This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). Methods: A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. Results: A moderate decrease was detected in PHQ-9 scores from HLP (beta=-3.05; P=.01) and MP (beta=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. Conclusions: The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions., This study was financed by the Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness with the PI13/01171 grant (Efficacy and cost-effectiveness of the low-intensity psychological interventions applied by ICTs for the treatment of depression in primary care: a controlled trial). The authors would like to thank the Institut d'Investigacio Sanitaria de les Illes Balears (IdiSBa) for the assistance received on statistical analysis queries.

Despite the robust body of work on cognitive aspects of bipolar disorder (BD), a clear profile of associated impairments in impulsivity, decision-making and risk-taking from studies that use behavioural measures has yet to be established. A systematic review, across four electronic databases (PsycINFO, MEDLINE/PubMed, ScienceDirect and Scopus), of literature published between January 1999 and December 2018 was carried out in accordance with the PRISMA statement. The protocol was registered on PROSPERO (CRD42018114684). A fixed-effect and random-effects meta-analysis using the Hedges' g (ES) estimate was performed. The analysis revealed significant impairment in BD individuals with medium effect sizes in various aspects of impulsivity – response inhibition (ES = 0.49; p < 0.0001), delay of gratification (ES = 0.54; p < 0.0001) and inattention (ES = 0.49; p < 0.0001) – and in decision-making (ES = 0.61, p = 0.0002), but no significant impairment in risk-taking behaviour (ES = 0.41; p = 0.0598). Furthermore, we found significant heterogeneity between studies for decision-making and risk-taking behaviour but not for impulsivity. Impaired risk-taking behaviour was significant in a subgroup of BD-I and euthymic individuals (ES = 0.92; p < 0.0001) with no significant heterogeneity. A stratification analysis revealed comparable results in euthymic and non-euthymic individuals for impulsivity. Our findings suggest that behaviour impulsivity is elevated in all phases of BD, representing a core and clinically relevant feature that persists beyond mood symptoms. More studies about decision-making and risk-taking are necessary to establish if they are impaired in BD and to analyze the role of mood state.

Background The public health emergency of coronavirus disease (COVID-19) is rapidly evolving worldwide; some countries, including Spain, have implemented restrictive measures. Populations that are vulnerable to this outbreak and its physical and mental health effects include community-dwelling older adults with mild cognitive impairment or mild dementia. Telehealth is a potential tool to deliver health care and decrease exposure risk. Objective The aims of this study were to explore the impact of confinement on the health and well-being of community-dwelling older adults with mild cognitive impairment or mild dementia, to provide television-based and telephone-based health and social support, and to study the effects of a television-based assistive integrated technology, TV-AssistDem (TeleVision-based ASSistive Integrated Service to supporT European adults living with mild DEMentia or mild cognitive impairment). Methods A telephone-based survey was administered in Spain to 93 participants in the TV-AssistDem clinical trial from March 25 to April 6, 2020. Results Of the respondents, 60/93 (65%) were women. The mean age was 73.34 (SD 6.07), and 69/93 (74%) lived accompanied. Lockdown measures forced 17/93 respondents (18%) to change their living arrangements. Health status was found to be optimal in 89/93 respondents (96%), with no COVID-19 symptoms. Grocery and pharmacy outings were performed by family members of 68/93 participants (73%); 57 (61%) reported overall well-being, and 65 (70%) maintained their sleep quality. However, participants living alone reported greater negative feelings and more sleeping problems. Regarding leisure activities, 53/93 respondents (57%) took walks, 32 (35%) played memory games, 55 (60%) watched television, and 91 (98%) telephoned relatives. 58/93 (64%) respondents reported accessing moderate or too much COVID-19 information, 89 (97%) received it from television, and 56 (62%) stated that their understanding of the information was extreme. 39/93 (39%) respondents had contacted health and social services, while 29 (31%) requested information regarding these services during the telephone call. There were no significant differences in health and well-being between the intervention and control groups. Respondents with TV-AssistDem performed more memory exercises (24/93, 52% vs 8/93, 17.4%; P Conclusions Our findings suggest that during COVID-19 confinement, the physical and mental health and well-being was optimal for the majority of our vulnerable population. However, those living alone reported greater negative psychological effects and sleeping problems. Measures adopted to address the negative experiences of confinement included keeping informed about the situation, accessing health and social services, having a support network that prevents risk of exposure to COVID-19 and guarantees food and medical supplies, a daily routine with maintained sleeping habits and leisure activities, staying physically and mentally active with cognitive stimulation exercises, and ensuring social connectedness using technology. Television sets were preferred technological devices to access COVID-19 information, watch television as a recreational activity, and perform memory exercises as an intellectual activity. Television-based telehealth support using TV-AssistDem demonstrated potential for cognitive stimulation. Trial Registration ClinicalTrials.gov NCT03653234; https://clinicaltrials.gov/ct2/show/NCT03653234

BACKGROUND There are a large number of mobile applications that allow monitoring of health status. The quality of the applications is only evaluated by users and not by standard criteria. OBJECTIVE To examine depression-related applications in major mobile application stores and analyse them using the rating scale tool MARS. METHODS A search of digital applications for the control of symptoms and behavioral changes in depression was carried out in the two reference mobile operating systems Apple (App Store) and Android (Play Store) by means of two independent reviewers between September and October 2019. The search was performed on the two operating systems in the regions of Spain and the United Kingdom. Eighteen applications from the Android Play Store and twelve from the App Store were included in this study. The quality of the applications was evaluated using the MARS scale. Descriptive statistics (mean and standard deviation) were applied for the values of each section and the final score of the applications. RESULTS The average score of the applications ranged from 2.38 to 4.6 (3.67 ± 0.53) applying the MARS scale, ranging from 1 (inadequate) to 5 (excellent). The sections with the highest scores were Functionality (4.51) and Esthetics (3.98) and those with the lowest App Subjective quality (2.86) and Information (3.08). CONCLUSIONS MHealth apps (such as apps for the treatment of depression) have great potential to influence in the health status of users. Apps come to the digital market from mobile app stores without any kind of health control.

BACKGROUND The public health emergency of coronavirus disease (COVID-19) is rapidly evolving worldwide; some countries, including Spain, have implemented restrictive measures. Populations that are vulnerable to this outbreak and its physical and mental health effects include community-dwelling older adults with mild cognitive impairment or mild dementia. Telehealth is a potential tool to deliver health care and decrease exposure risk. OBJECTIVE The aims of this study were to explore the impact of confinement on the health and well-being of community-dwelling older adults with mild cognitive impairment or mild dementia, to provide television-based and telephone-based health and social support, and to study the effects of a television-based assistive integrated technology, TV-AssistDem (TeleVision-based ASSistive Integrated Service to supporT European adults living with mild DEMentia or mild cognitive impairment). METHODS A telephone-based survey was administered in Spain to 93 participants in the TV-AssistDem clinical trial from March 25 to April 6, 2020. RESULTS Of the respondents, 60/93 (65%) were women. The mean age was 73.34 (SD 6.07), and 69/93 (74%) lived accompanied. Lockdown measures forced 17/93 respondents (18%) to change their living arrangements. Health status was found to be optimal in 89/93 respondents (96%), with no COVID-19 symptoms. Grocery and pharmacy outings were performed by family members of 68/93 participants (73%); 57 (61%) reported overall well-being, and 65 (70%) maintained their sleep quality. However, participants living alone reported greater negative feelings and more sleeping problems. Regarding leisure activities, 53/93 respondents (57%) took walks, 32 (35%) played memory games, 55 (60%) watched television, and 91 (98%) telephoned relatives. 58/93 (64%) respondents reported accessing moderate or too much COVID-19 information, 89 (97%) received it from television, and 56 (62%) stated that their understanding of the information was extreme. 39/93 (39%) respondents had contacted health and social services, while 29 (31%) requested information regarding these services during the telephone call. There were no significant differences in health and well-being between the intervention and control groups. Respondents with TV-AssistDem performed more memory exercises (24/93, 52% vs 8/93, 17.4%; P CONCLUSIONS Our findings suggest that during COVID-19 confinement, the physical and mental health and well-being was optimal for the majority of our vulnerable population. However, those living alone reported greater negative psychological effects and sleeping problems. Measures adopted to address the negative experiences of confinement included keeping informed about the situation, accessing health and social services, having a support network that prevents risk of exposure to COVID-19 and guarantees food and medical supplies, a daily routine with maintained sleeping habits and leisure activities, staying physically and mentally active with cognitive stimulation exercises, and ensuring social connectedness using technology. Television sets were preferred technological devices to access COVID-19 information, watch television as a recreational activity, and perform memory exercises as an intellectual activity. Television-based telehealth support using TV-AssistDem demonstrated potential for cognitive stimulation. CLINICALTRIAL ClinicalTrials.gov NCT03653234; https://clinicaltrials.gov/ct2/show/NCT03653234

Objetivos: Las personas que sufren esquizofrenia tienen un riesgo de mortalidad dos o tres veces superior al de la población general. El exceso de mortalidad se debe un 60% a causas naturales principalmente a enfermedades cardiovasculares, y en un 40% a accidentes o suicidio. El objetivo de este estudio es comprobar si los usuarios con esquizofrenia y un trastorno por uso de tabaco comórbido presentaban diferencias significativas en cuanto a riesgo metabólico frente a los no fumadores. Material y Métodos: Estudio prospectivo de 491 usuarios con diagnóstico de esquizofrenia paranoide incluidos en el programa de hábitos saludables. Se recogieron datos demográficos, uso de tabaco, datos antropométricos, tensión arterial, y se realizó una analítica sanguínea para observar niveles de triglicéridos, colesterol total, HDL y LDL. Se realiza análisis estadístico descriptivo junto a medidas de asociación entre tabaco y el síndrome metabólico. Resultados y Conclusiones: 185 pacientes fumaban diariamente en la muestra (37,7%), siendo la mayoría del sexo masculino (70%). Los valores antropométricos y analíticos no se diferenciaban de manera significativa entre el grupo de no fumadores y el grupo de fumadores. Los datos descriptivos se mostrarán en la Tabla 1. En nuestro estudio, la prevalencia de síndrome metabólico era 4,14 veces superior en el grupo de fumadores que en el de no fumadores. Los resultados eran estadísticamente significativos (p = 0,043). Se encontró una correlación positiva entre el uso de tabaco diario y la presencia de síndrome metabólico (r = 0.97, p = 0,031). Aunque el uso de tabaco no se incluye entre los criterios de síndrome metabólico en las clasificaciones actuales, su uso aumenta el riesgo de padecerlo. El tratamiento específico de la adicción al tabaco puede ayudar a disminuir el riesgo cardiovascular de estos pacientes, así como reducir el riesgo de padecer patología tumoral y enfermedad obstructiva crónica2.

Background Information and communication technologies are promising tools to increase the quality of life of people with dementia or mild cognitive impairment and that of their caregivers. However, there are barriers to their use associated with sociodemographic factors and negative attitudes, as well as inadequate knowledge about technologies. Objective The aim of this study was to analyze technophilia (attitudes toward new technologies) and the use of smartphones and tablets along with associated factors in people with dementia/mild cognitive impairment and their caregivers. Methods Data from the first visit of the Support Monitoring and Reminder for Mild Dementia (SMART4MD) randomized multicenter clinical trial were used for this analysis. Data were obtained from two European countries, Spain and Sweden, and from three centers: Consorci Sanitari de Terrassa (Catalonia, Spain), Servicio Andaluz de Salud (Andalusia, Spain), and the Blekinge Institute of Technology (Sweden). Participants with a score between 20 and 28 in the Mini Mental State Examination, with memory problems (for more than 6 months), and who were over the age of 55 years were included in the study, along with their caregivers. The bivariate Chi square and Mann-Whitney tests, and multivariate linear and logistic regression models were used for statistical analysis. Results A total of 1086 dyads were included (N=2172). Overall, 299 (27.53%) of people with dementia/mild cognitive impairment had a diagnosis of dementia. In addition, 588 (54.14%) of people with dementia/mild cognitive impairment reported using a smartphone almost every day, and 106 (9.76%) used specific apps or software to support their memory. Among the caregivers, 839 (77.26%) used smartphones and tablets almost every day, and 181 (16.67%) used specific apps or software to support their memory. The people with dementia/mild cognitive impairment showed a lower level of technophilia in comparison to that of their caregivers after adjusting for confounders (B=0.074, P=.02) with differences in technology enthusiasm (B=0.360, P Conclusions Technophilia was associated with a better quality of life and sociodemographic variables in people with dementia/mild cognitive impairment and caregivers, suggesting potential barriers for technological interventions. People with dementia/mild cognitive impairment frequently use smartphones and tablets, but the use of specific apps or software to support memory is limited. Interventions using these technologies are needed to overcome barriers in this population related to sociodemographic characteristics and the lack of enthusiasm for new technologies. Trial Registration ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699

Background: A large number of low-intensity Internet-based interventions (IBIs) for the treatment of depression have emerged in Primary Care, most of them focused on decreasing negative emotions. However, recent studies have highlighted the importance of addressing positive affect (PA) as well. This study is a secondary analysis of a randomized control trial. We examine the role of an IBI focused on promoting PA in patients with depression in Primary Care (PC). The specific objectives were to explore the profile of the patients who benefit the most and to analyze the change mechanisms that predict a significantly greater improvement in positive functioning measures. Methods: 56 patients were included. Measures of depression, affect, well-being, health-related quality of life, and health status were administered. Results: Participants who benefited the most were those who had lower incomes and education levels and worse mental health scores and well-being at baseline (7.9%&ndash, 39.5% of explained variance). Improvements in depression severity and PA were significant predictors of long-term change in well-being, F (3,55) = 17.78, p &lt, 0.001, R2 = 47.8%. Conclusions: This study highlights the importance of implementing IBIs in PC and the relevance of PA as a key target in Major Depressive Disorder treatment.

Background People with severe mental disorders (SMDs) suffer problems of obesity, a sedentary life, and poor physical condition, mainly due to low levels of physical activity. Self‐efficacy (SE) and social support (SS) are important components that influence participation in physical activity. Methods This study adapted a scale to assess SE and SS in promoting physical activity in Spanish people with SMDs, as well as provide preliminary evidence of its validity. One hundred Spanish patients (23% female) with SMDs, between 26 and 61 years old, completed the SE/SS assessment for SMD (SE/SS‐ASMD). Results The instrument seemed to capture a four‐factor structure in people with SMDs. Due to the lack of a gold standard, the scale was related to other instruments with which it might be expected to show a correlation, such as those for physical activity and its quality; however, the levels of correlation found were low (≈0.3). The Internal consistency (Cronbach's α) for the SE‐ASMD, SS‐ASMD staff, SS‐ASMD peers, and SS‐ASMD family scales were 0.76, 0.76, 0.80, and 0.80, respectively. Conclusions The psychometric analysis of the SE/SS‐ASMD supported its suitability as a new tool for researchers in the area of physical activity among people with SMDs., This study adapted a scale to assess SE and SS in promoting physical activity in Spanish people with SMDs, as well as provide preliminary evidence of its validity.

BACKGROUND Information and communication technologies are promising tools to increase the quality of life of people with dementia or mild cognitive impairment and that of their caregivers. However, there are barriers to their use associated with sociodemographic factors and negative attitudes, as well as inadequate knowledge about technologies. OBJECTIVE The aim of this study was to analyze technophilia (attitudes toward new technologies) and the use of smartphones and tablets along with associated factors in people with dementia/mild cognitive impairment and their caregivers. METHODS Data from the first visit of the Support Monitoring and Reminder for Mild Dementia (SMART4MD) randomized multicenter clinical trial were used for this analysis. Data were obtained from two European countries, Spain and Sweden, and from three centers: Consorci Sanitari de Terrassa (Catalonia, Spain), Servicio Andaluz de Salud (Andalusia, Spain), and the Blekinge Institute of Technology (Sweden). Participants with a score between 20 and 28 in the Mini Mental State Examination, with memory problems (for more than 6 months), and who were over the age of 55 years were included in the study, along with their caregivers. The bivariate Chi square and Mann-Whitney tests, and multivariate linear and logistic regression models were used for statistical analysis. RESULTS A total of 1086 dyads were included (N=2172). Overall, 299 (27.53%) of people with dementia/mild cognitive impairment had a diagnosis of dementia. In addition, 588 (54.14%) of people with dementia/mild cognitive impairment reported using a smartphone almost every day, and 106 (9.76%) used specific apps or software to support their memory. Among the caregivers, 839 (77.26%) used smartphones and tablets almost every day, and 181 (16.67%) used specific apps or software to support their memory. The people with dementia/mild cognitive impairment showed a lower level of technophilia in comparison to that of their caregivers after adjusting for confounders (B=0.074, P=.02) with differences in technology enthusiasm (B=0.360, PP=.37). Technophilia was associated with lower age (B=–0.009, P=.004), male gender (B=–0.160, PP=.01), living arrangement (living with children vs single; B=–2.538, P=.01), country of residence (Sweden vs Spain; B=0.256, PPPP=.04) and better quality of life (B=0.348, P CONCLUSIONS Technophilia was associated with a better quality of life and sociodemographic variables in people with dementia/mild cognitive impairment and caregivers, suggesting potential barriers for technological interventions. People with dementia/mild cognitive impairment frequently use smartphones and tablets, but the use of specific apps or software to support memory is limited. Interventions using these technologies are needed to overcome barriers in this population related to sociodemographic characteristics and the lack of enthusiasm for new technologies. CLINICALTRIAL ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699

BACKGROUND Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months’ follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS A moderate decrease was detected in PHQ-9 scores from HLP (β=–3.05; P=.01) and MP (β=–3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. CLINICALTRIAL ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12888-015-0475-0

BACKGROUND There are several mobile health (mHealth) apps in mobile app stores. These apps enter the business-to-customer market with limited controls. Both, apps that users use autonomously and those designed to be recommended by practitioners require an end-user validation to minimize the risk of using apps that are ineffective or harmful. Prior studies have reviewed the most relevant aspects in a tool designed for assessing mHealth app quality, and different options have been developed for this purpose. However, the psychometric properties of the mHealth quality measurement tools, that is, the validity and reliability of the tools for their purpose, also need to be studied. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) initiative has developed tools for selecting the most suitable measurement instrument for health outcomes, and one of the main fields of study was their psychometric properties. OBJECTIVE This study aims to address and psychometrically analyze, following the COSMIN guideline, the quality of the tools that are used to measure the quality of mHealth apps. METHODS From February 1, 2019, to December 31, 2019, 2 reviewers searched PubMed and Embase databases, identifying mHealth app quality measurement tools and all the validation studies associated with each of them. For inclusion, the studies had to be meant to validate a tool designed to assess mHealth apps. Studies that used these tools for the assessment of mHealth apps but did not include any psychometric validation were excluded. The measurement tools were analyzed according to the 10 psychometric properties described in the COSMIN guideline. The dimensions and items analyzed in each tool were also analyzed. RESULTS The initial search showed 3372 articles. Only 10 finally met the inclusion criteria and were chosen for analysis in this review, analyzing 8 measurement tools. Of these tools, 4 validated ≥5 psychometric properties defined in the COSMIN guideline. Although some of the tools only measure the usability dimension, other tools provide information such as engagement, esthetics, or functionality. Furthermore, 2 measurement tools, Mobile App Rating Scale and mHealth Apps Usability Questionnaire, have a user version, as well as a professional version. CONCLUSIONS The Health Information Technology Usability Evaluation Scale and the Measurement Scales for Perceived Usefulness and Perceived Ease of Use were the most validated tools, but they were very focused on usability. The Mobile App Rating Scale showed a moderate number of validated psychometric properties, measures a significant number of quality dimensions, and has been validated in a large number of mHealth apps, and its use is widespread. It is suggested that the continuation of the validation of this tool in other psychometric properties could provide an appropriate option for evaluating the quality of mHealth apps.

BACKGROUND Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual’s ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments. OBJECTIVE A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination. METHODS A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads—split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information. RESULTS Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit. CONCLUSIONS This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group’s relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field. CLINICALTRIAL ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13711

Background: Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual’s ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments. Objective: A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination. Methods: A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads—split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information. Results: Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit. Conclusions: This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group’s relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field. Trial Registration: ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699 International Registered Report Identifier (IRRID): DERR1-10.2196/13711

The newer atypical antipsychotic agents (AAPs) represent an attractive therapeutic option for a wide range of psychotic disorders, including schizophrenia and bipolar mania, because of the reduced risk of disabling extrapyramidal symptoms. However, their growing use has raised questions about their tolerability over the endocrine, metabolic, and cardiovascular axes. Indeed, atypical antipsychotic drugs are associated, to differing extents, with mild elevation of aminotransferases related to weight gain, AAP-induced metabolic syndrome, and nonalcoholic fatty liver disease. Although the hepatic safety of new AAPs seems improved over that of chlorpromazine, they can occasionally cause idiosyncratic liver injury with varying phenotypes and, rarely, lead to acute liver failure. However, AAPs are a group of heterogeneous, chemically unrelated compounds with distinct pharmacological and pharmacokinetic properties and substantially different safety profiles, which precludes the notion of a class effect for hepatotoxicity risk and highlights the need for an individualized therapeutic approach. We discuss the current evidence on the hepatotoxicity potential of AAPs, the emerging underlying mechanisms, and the limitations inherent to this group of drugs for both establishing a proper causality assessment and developing strategies for risk management.

Resumen Introduccion La hiperprolactinemia iatrogenica (HPRLi) se ha descrito con mas frecuencia con algunos antipsicoticos, dependiendo de su capacidad de bloqueo de los receptores de dopamina D2. Existe gran heterogeneidad de la practica clinica y posiblemente falta de concienciacion sobre este problema entre los medicos. Dada la elevada frecuencia con la que los pacientes con enfermedad mental grave reciben antipsicoticos de forma prolongada, se precisa vigilar posibles riesgos en su salud fisica. La HPRLi y sus sintomas pueden pasar desapercibidos si no se investigan rutinariamente. Metodologia Se realiza una revision profunda de la literatura para elaborar un consenso multidisciplinario con psiquiatras junto a otros especialistas (de Endocrinologia, Medicina Interna y Oncologia) con el fin de consensuar los riesgos clinicos y los metodos de deteccion mas adecuados de la HPRLi de acuerdo con los distintos niveles de evidencia cientifica ( I - IV) . Resultados Los sintomas a corto plazo incluyen amenorrea, galactorrea y disfuncion sexual (descenso del deseo y disfuncion erectil por hipogonadismo secundario). A medio-largo plazo y relacionado con la disminucion de estrogenos, se pueden inducir baja masa osea (osteopenia y osteoporosis), hipogonadismo, menopausia precoz, incremento del riesgo de algunos tipos de cancer (mama y endometrio), aumento del riesgo cardiovascular, alteraciones en la inmunidad, dislipidemia y disfuncion cognitiva, entre otros. La peticion de niveles de PRL deberia realizarse al inicio del tratamiento en todos los pacientes que reciben antipsicoticos, aunque no se observen sintomas precoces (amenorrea, galactorrea) por el riesgo de subestimar otros sintomas que pueden aparecen a medio plazo. Se aconseja determinar tambien niveles de FSL, LH, testosterona y vitamina D. Se recomienda explorar rutinariamente la funcion sexual, ya que puede ser un sintoma mal tolerado que podria conducir al abandono del tratamiento. Se propone un especial cuidado en ninos y adolescentes, asi como en pacientes con PRL > 50 ng/ml (intensidad moderada), revisando periodicamente si existe hipogonadismo o disfuncion sexual. En los pacientes con PRL > 150 ng/ml debe descartarse siempre un prolactinoma radiologicamente y se debe prestar especial atencion a posibles antecedentes de cancer de mama o endometrio. Se aconseja realizar densitometrias en varones >50 anos y en mujeres con amenorrea > 6 meses o menopausia precoz para detectar osteoporosis y evitar riesgo de fracturas por fragilidad.

This systematic review summarizes the most recent evidence from randomized controlled trials (RCTs) considering the effectiveness of physical therapy interventions (aerobic exercises, strength exercises, relaxation training, basic body awareness exercises, or a combination of these) within the multidisciplinary management of schizophrenia. Two authors searched PubMed, PsycINFO, EMBASE, Web of Science, Physiotherapy Evidence Database (PEDro), and the Cochrane Library considering RCTs published from July 1, 2011-October 1, 2014. Thirteen RCTs representing 549 participants met the inclusion criteria. Overall, the results demonstrate that aerobic exercise significantly reduces psychiatric symptoms, potentially improves mental and physical quality of life and reduces metabolic risk and weight. Specifically, yoga reduces psychiatric symptoms, whilst Tai-chi and progressive muscle relaxation may also have benefits to patients. Two RCTs reported on adverse events. No adverse event was observed supporting the notion that physical therapy is safe in people with schizophrenia. There was considerable heterogeneity in the design, implementation and outcomes in the included studies precluding a meaningful meta-analysis. In general, the quality of physical therapy RCTS is improving and current research demonstrates that physical therapy approaches are valuable interventions and can help improve the psychiatric, physical and quality of life of people with schizophrenia.

Background Physical fitness is a crucial variable in people with severe mental illness as these people could be more independent and improve their job opportunities. The present study compared the physical fitness of physically active and inactive people with severe mental illness. Methods Physical fitness was evaluated in sixty-two people with severe mental illness using 11 physical tests that include strength, flexibility, balance and aerobic condition. Significant differences were found between both groups in muscle strength (handgrip test) and balance (single leg balance test and functional reach) with better performance in the group of physically active people. Results The results of the present study suggest that physical fitness (strength and balance) is higher in people with severe mental illness who practise regular physical activity that those who are inactive people. Conclusions Physical active people may have a reduced risk of falls and fractures due to their higher levels of physical fitness.

Objective:This systematic review presents evidence regarding factors that may influence the patient’s subjective experience of an episode of mechanical restraint, seclusion, or forced administration of medication.Method:Two authors searched CINAHL, PubMed, SCOPUS, Web of Science, and Psych-Info, considering published studies between 1 January 1992 and 1 February 2016. Based on the inclusion criteria and methodological quality, 34 studies were selected, reporting a total sample of 1,869 participants.Results:The results showed that the provision of information, contact and interaction with staff, and adequate communication with professionals are factors that influence the subjective experience of these measures. Humane treatment, respect, and staff support are also associated with a better experience, and debriefing is an important procedure/technique to reduce the emotional impact of these measures. Likewise, the quality of the working and physical environment and some individual and treatment variables were related to the experience of these measures. There are different results in relation to the most frequently associated experiences and, despite some data that indicate positive experiences, the evidence shows such experiences to be predominantly negative and frequently with adverse consequences. It seems that patients find forced medication and seclusion to be more tolerable than mechanical restraint and combined measures.Conclusions:It appears that the role of the staff and the environmental conditions, which are potentially modifiable, affect the subjective experience of these measures. There was considerable heterogeneity among studies in terms of coercive measures experienced by participants and study designs.

Anti-psychotic medication has emerged as the primary medical treatment for people with severe mental illness, despite the great risks involved in the use of this medication. In addition, this population suffers from problems of obesity, sedentary lifestyle and poor physical fitness, which is aggravated by the use of this type of medication. The objective of this study is to explore the influence of the most commonly used antipsychotics in this population (Olanzapine and Risperidone) on physical activity and the physical fitness of people with severe mental illness. Sixty-two people between 26 and 61 years of age with severe mental illness were assessed. All participants were evaluated with a battery of 11 physical tests to assess their physical fitness and with the IPAQ-short version questionnaire to determine their level of physical activity. The doses of Risperidone and Olanzapine were also evaluated in all participants. Significant differences were found for physical activity, with higher levels reported in those patients with severe mental illness who did not take any of these medications. Regarding physical fitness, significant differences were only found for the consumption of Risperidone, with better physical fitness levels seen in patients who did not consume this medication; on the other hand, for the consumption of Olanzapine, differences were found in muscular strength, balance and aerobic condition with better values in non-Olanzapine consumers compared with Olanzapine consumers.

Background Quality of life of people with severe mental illness may be decrease by the high occurrence of metabolic and cardiovascular diseases. Physical fitness emerges as a modifying factor in this population through physical activity and this modification could influence in the quality of life of this population. The aim of the present study is to determine the contribution of physical fitness to the quality of life of people with severe mental illness. Methods In the current study, a physiotherapist and an occupational therapist assessed 62 people with severe mental illness. Physical fitness was measured with a range of 11 fitness tests that covered flexibility, strength, balance, and endurance. To assess quality of life the EQ-5D-3 L scale was used, which measures five dimensions (mobility, self-care, usual activities, pain-discomfort, and anxiety-depression). Results Significant correlations are presented between the quality of life and primary variables of physical fitness (balance, endurance, and upper limb strength). Endurance explained 22.9% of the variance of the quality of life in people with severe mental illness. Functional reach added another 36.2% variance to the prediction of quality of life. Conclusions The results of the present study suggest that some variables of physical fitness are associated with quality of life in people with severe mental illness. The improvement in physical fitness of this population should be a primary objective. Trial registration ClinicalTrials.gov Identifier: NCT02413164 “retrospective registered” Registered Febr 2017.

Borderline personality disorder (BOR) is determined by environmental and genetic factors, and characterized by affective instability and impulsivity, diagnostic symptoms also observed in manic phases of bipolar disorder (BIP). Up to 20% of BIP patients show comorbidity with BOR. This report describes the first case–control genome-wide association study (GWAS) of BOR, performed in one of the largest BOR patient samples worldwide. The focus of our analysis was (i) to detect genes and gene sets involved in BOR and (ii) to investigate the genetic overlap with BIP. As there is considerable genetic overlap between BIP, major depression (MDD) and schizophrenia (SCZ) and a high comorbidity of BOR and MDD, we also analyzed the genetic overlap of BOR with SCZ and MDD. GWAS, gene-based tests and gene-set analyses were performed in 998 BOR patients and 1545 controls. Linkage disequilibrium score regression was used to detect the genetic overlap between BOR and these disorders. Single marker analysis revealed no significant association after correction for multiple testing. Gene-based analysis yielded two significant genes: DPYD (P=4.42 × 10−7) and PKP4 (P=8.67 × 10−7); and gene-set analysis yielded a significant finding for exocytosis (GO:0006887, PFDR=0.019; FDR, false discovery rate). Prior studies have implicated DPYD, PKP4 and exocytosis in BIP and SCZ. The most notable finding of the present study was the genetic overlap of BOR with BIP (rg=0.28 [P=2.99 × 10−3]), SCZ (rg=0.34 [P=4.37 × 10−5]) and MDD (rg=0.57 [P=1.04 × 10−3]). We believe our study is the first to demonstrate that BOR overlaps with BIP, MDD and SCZ on the genetic level. Whether this is confined to transdiagnostic clinical symptoms should be examined in future studies.

Background: A 12-week, double-blind, parallel, multi-center randomized controlled trial in 316 adult patients with major depressive disorder (MDD) was conducted to evaluate the effectiveness of pharmacogenetic (PGx) testing for drug therapy guidance. Methods: Patients with a CGI-S ≥ 4 and requiring antidepressant medication de novo or changes in their medication regime were recruited at 18 Spanish public hospitals, genotyped with a commercial PGx panel (Neuropharmagen®), and randomized to PGx-guided treatment (n = 155) or treatment as usual (TAU, control group, n = 161), using a computer-generated random list that locked or unlocked psychiatrist access to the results of the PGx panel depending on group allocation. The primary endpoint was the proportion of patients achieving a sustained response (Patient Global Impression of Improvement, PGI-I ≤ 2) within the 12-week follow-up. Patients and interviewers collecting the PGI-I ratings were blinded to group allocation. Between-group differences were evaluated using χ2-test or t-test, as per data type. Results: Two hundred eighty patients were available for analysis at the end of the 12-week follow-up (PGx n = 136, TAU n = 144). A difference in sustained response within the study period (primary outcome) was not observed (38.5% vs 34.4%, p = 0.4735; OR = 1.19 [95%CI 0.74-1.92]), but the PGx-guided treatment group had a higher responder rate compared to TAU at 12 weeks (47.8% vs 36.1%, p = 0.0476; OR = 1.62 [95%CI 1.00-2.61]), and this difference increased after removing subjects in the PGx-guided group when clinicians explicitly reported not to follow the test recommendations (51.3% vs 36.1%, p = 0.0135; OR = 1.86 [95%CI 1.13-3.05]). Effects were more consistent in patients with 1–3 failed drug trials. In subjects reporting side effects burden at baseline, odds of achieving a better tolerability (Frequency, Intensity and Burden of Side Effects Rating Burden subscore ≤2) were higher in the PGx-guided group than in controls at 6 weeks and maintained at 12 weeks (68.5% vs 51.4%, p = 0.0260; OR = 2.06 [95%CI 1.09-3.89]). Conclusions: PGx-guided treatment resulted in significant improvement of MDD patient’s response at 12 weeks, dependent on the number of previously failed medication trials, but not on sustained response during the study period. Burden of side effects was also significantly reduced., This work was supported by the Spanish Centre for Industrial Technological Development (Centro para el Desarrollo Tecnológico Industrial, CDTI; IDI-20130958) and the Spanish Ministry of Economy and Competitiveness PTQ-11-05076; PTQ- 11-04914; INC-FPGS-2011-2223; INC-FPGS-2011-2224. The funding agency had no role in the development of the study design, collection of data, manuscript development, or the decision to submit this manuscript for publication. The study also received funding support from private investors (Mr. Luis Sánchez-Lafuente and Mr. Sergi Audivert) as well as from Almirall SA (Barcelona, Spain). AB-Biotics as sponsor participated in the design, analysis and interpretation of the study

Purpose There is still limited information on what type of measures are most efficient to reduce coercion. The aim of this study was to determine if the introduction of a new regulatory protocol in a specific psychiatric ward in Andalusia (Spain) contributed to reducing the use of mechanical restraint. Design and Methods The study included a comparison of two time periods: 2005 (one year before the implementation of the new regulatory protocol) and 2012, in all hospitalized patients (N = 1,094). The study also analyzes with logistic regression the variables related to a shorter duration of mechanical restraint. Findings Mechanical restraint rate per year was reduced, not significantly, from 18.2% to 15.1%. The average duration of each mechanical restraint episode was significantly reduced from 27.91 to 15.33 hr. The following variables have been associated with a shorter period of coercion: being female and the year of restraint (2012). Practice Implications Specific plans are required, including different interventions, in order to achieve marked reduction in the use of coercive measures.