Search

Background Intrahepatic cholangiocarcinoma (ICC) is the second most common primitive liver cancer and is rising in incidence worldwide. Given its low survival and resectability rates, locoregional therapies such as Yttrium-90 transarterial radioembolization (Y-TARE) are increasingly being employed. This retrospective study aim was to confirm and update our previous results about overall survival (OR), safety, and efficacy of Y-TARE in patients with unresectable/recurrent ICC. Materials and Methods OS was evaluated as primary endpoint while radiological tumor response at 3 months, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, was considered as secondary endpoint. Results Over a total of 49 patients, the overall median survival was 16 months (27-41 months, 95% confidence interval [CI]) from Y-TARE procedure. A significantly longer survival was recorded in naive patients compared to patients previously submitted to any type of liver-directed treatment and radical surgery (18 vs 14 months, P =.015 and 28 vs 14 months, P =.001, respectively). Target lesion and overall objective response for RECIST 1.1 criteria were 64.6% and 52.1%, respectively. Low rates of postprocedural and late complications were recorded. Conclusions In unresectable and recurrent ICC, Y-TARE confirms its safety and its potential in increasing OS, especially in naive patients.

Background: The cutaneous manifestations of COVID-19 may be useful disease markers and prognostic indicators. Recently, postinfectious telogen effluvium and trichodynia have also been reported. Objective: To evaluate the presence of trichodynia and telogen effluvium in patients with COVID-19 and describe their characteristics in relation to the other signs and symptoms of the disease. Methods: Patients with a history of COVID-19 presenting to the clinics of a group of hair experts because of telogen effluvium and/or scalp symptoms were questioned about their hair signs and symptoms in relation to the severity of COVID-19 and associated symptoms. Results: Data from 128 patients were collected. Telogen effluvium was observed in 66.3% of the patients and trichodynia in 58.4%. Trichodynia was associated with telogen effluvium in 42.4% of the cases and anosmia and ageusia in 66.1% and 44.1% of the cases, respectively. In majority (62.5%) of the patients, the hair signs and symptoms started within the first month after COVID-19 diagnosis, and in 47.8% of the patients, these started after 12 weeks or more. Limitations: The recruitment of patients in specialized hair clinics, lack of a control group, and lack of recording of patient comorbidities. Conclusion: The severity of postviral telogen effluvium observed in patients with a history of COVID-19 infection may be influenced by COVID-19 severity. We identified early-onset (12 weeks) telogen effluvium.

(1) Background: The 'Living Better' web-based programme has shown short- and long-term benefits for body composition and psychological variables in obese patients with hypertension by promoting a healthier lifestyle. To further explore the potential of this programme, in this work we aimed to explore the possible effect of the patient's 'own doctor' appearing in the video content of the Living Better intervention. (2) Methods: A total of 132 patients were randomly assigned either to the experimental (EG, n = 70) or control (CG, n = 62) group (with a doctor the patient knew as 'their own' or an 'unknown doctor', respectively). The body mass index (BMI), motivation towards physical activity (PA), PA levels, motivation to change one's eating habits, adherence to the Mediterranean diet, and eating behaviour were all assessed and compared at baseline and post-intervention (12 weeks). (3) Results: The results of this study confirmed the positive effects of the Living Better programme on BMI and external eating style, with significant improvements in these variables in both groups. In addition, in the EG there was higher intrinsic motivation to change eating behaviour (mean difference of 0.9, 95% CI [0.1, 1.6], p = 0.032) and lower amotivation (mean difference of -0.6, 95% CI [-1.2, -0.1], p = 0.027) compared to the CG. (4) Conclusions: This study suggests that the presence of the patients' own doctor in the audiovisual content of the Living Better intervention did not have significant additional benefits in terms of BMI or external eating style. However, their presence did improve intrinsic motivation and amotivation related to eating habits.

Introduction: Online interventions have long been shown to be an effective means to promote a healthy lifestyle, thereby helping to control body weight and blood pressure figures. Likewise, using video modeling is also considered an effective way to guide patients through behavioral interventions. Nonetheless, to the best of our knowledge, this study is the first to analyze how the presence of patients' "own doctor" in the audiovisual content of a web-based lifestyle program (" Living Better" ) aimed at promoting regular physical exercise and healthy eating behavior, compared with an "unknown doctor," influences the outcomes of adults with obesity and hypertension., Materials and Methods: A total of 132 patients were randomly assigned either to the experimental ( n = 70) or control ( n = 62) group ("own doctor" or "unknown doctor", respectively). The body mass index, systolic and diastolic blood pressure, number of antihypertensive drugs used, physical activity level, and quality of life was assessed and compared at baseline and post-intervention (12 weeks)., Results: The intention-to-treat analysis showed intragroup significant improvements in both groups in terms of the body mass index (control group: mean difference -0.3, 95% CI [-0.5, -0.1], p = 0.002; experimental group: -0.4 [-0.6, -0.2], p < 0.001) and systolic blood pressure (control group: -2.3 [-4.4, -0.2], p = 0.029; experimental group: -3.6 [-5.5, -1.6], p < 0.001). In addition, there were also significant improvements in the experimental group for the diastolic blood pressure (-2.5 [-3.7, -1.2], p < 0.001), physical activity (479 [9, 949], p = 0.046), and quality of life (5.2 [2.3, 8.2], p = 0.001). However, when comparing the experimental with the control group, no between-group significant differences were found in these variables., Conclusions: This study suggests that the presence of patients' "own doctor" in the audiovisual content of a web-based intervention, aimed at promoting a healthy lifestyle among adults with obesity and hypertension, do not show significant additional benefits over the efficacy of e-counseling., Trial Registration: ClinicalTrials.gov NCT04426877. First Posted: 11/06/2020. https://clinicaltrials.gov/ct2/show/NCT04426877., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Múzquiz-Barberá, Ruiz-Cortés, Herrero, Vara, Escrivá-Martínez, Baños, Rodilla and Lisón.)

The presence of meaning in life (PML) and the search for meaning in life (SML) are crucial when facing difficult times. Although several theoretical frameworks have tried to explain the dynamics of meaning in life during adversity, empirical evidence about interactions among both constructs using longitudinal designs is scarce. This study examined the trajectories of both PML and SML during the COVID-19 lockdown period in Spain. In total, 220 adults fulfilled an online survey during two periods: a strict and a relaxed lockdown period. Latent growth models showed that both PML and SML declined slightly during the strict lockdown, but they reached a plateau during the relaxed lockdown. Results also showed that age and having a partner predicted higher PML and lower SML at baseline, whereas being male predicted higher scores on PML. PML and SML were negatively associated at baseline, higher SML at baseline was related to a steeper decreasing PML slope during the strict lockdown, and the PML and SML slopes in the relaxed lockdown period were negatively related. This study contributes to better understanding longitudinal fluctuations of meaning in life in situations of adversity., (© The Author(s) 2022.)

Background: Chronic medical illnesses significantly and negatively affect the quality of life of individuals who suffer them and represent one of the most important challenges faced by healthcare providers and policy-makers due to its rising prevalence and high rates of comorbidity. Compassion-based interventions delivered over the Internet may be a useful approach to facilitate illness management and improve the quality of life of individuals with chronic medical conditions., Objectives: The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Internet Attachment-Based Compassion Therapy (iABCT) to improve the quality of life and well-being of patients with chronic medical illnesses., Method: A two-arm, parallel-group, randomized controlled trial (RCT) will be carried out, with three assessment points (baseline, 3-month, and 6-month) under two conditions: intervention group and control group (waiting list). The primary outcomes include the quality of life on the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Pemberton Happiness Index (PHI). Secondary outcomes, such as compassion, self-care behaviors, illness interference, self-criticism, symptomatology, attachment styles, social support, and illness perception, will be considered. Moreover, an assessment on satisfaction and usability will be carried out. A total of 68 participants as minimum will be recruited (34 per arm). Intent-to-treat mixed-model analyses without any ad hoc imputations will be conducted., Conclusions: Findings of this study will provide new insights into the potential of self-applied compassion-based interventions (CBI) delivered online in the context of chronic medical illnesses, considering aspects of their implementation (e.g., facilitators, barriers) and mechanisms of change., Trial Registration: The study is registered under Clinicaltrials.gov (NCT04809610) and it is currently in the participant recruitment phase., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Martínez-Sanchis et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: The aim of this study was to assess the immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibody titers after the primary regimen of 2 doses., Methods: Patients with RA with no seroconversion after 2 doses of SARS-CoV-2 vaccine and who received a third dose of either an mRNA or vector-based vaccine were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity, and T cell responses were assessed after the third dose., Results: A total of 21 nonresponder patients were included. At the time of vaccination, 29% were receiving glucocorticoids and 85% biologic disease-modifying antirheumatic drugs (including 6 taking abatacept [ABA] and 4 taking rituximab [RTX]). The majority (95%) received the BNT162b2 vaccine and only one of them received the ChAdOx1 nCoV-19 vaccine. After the third dose, 91% of the patients presented detectable anti-SARS-CoV-2 IgG and 76% showed neutralizing activity. Compared to other treatments, ABA and RTX were associated with the absence of neutralizing activity in 4 out of 5 (80%) patients and lower titers of neutralizing antibodies (median 3, IQR 0-20 vs 8, IQR 4-128; P = 0.20). Specific T cell response was detected in 41% of all patients after the second dose, increasing to 71% after the third dose. The use of ABA was associated with a lower frequency of T cell response (33% vs 87%, P = 0.03)., Conclusion: In this RA cohort, 91% of patients who failed to seroconvert after 2 doses of SARS-CoV-2 vaccine presented detectable anti-SARS-CoV-2 IgG after a third dose. The use of ABA was associated with a lower frequency of specific T cell response., (Copyright © 2022 by the Journal of Rheumatology.)

Background: Patients with chronic disease represent an at-risk group in the face of the COVID-19 crisis as they need to regularly monitor their lifestyle and emotional management. Coping with the illness becomes a challenge due to supply problems and lack of access to health care facilities. It is expected these limitations, along with lockdown and social distancing measures, have affected the routine disease management of these patients, being more pronounced in low- and middle-income countries with a flawed health care system., Objectives: The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Adhera® MejoraCare Digital Program, an mHealth intervention aimed at improving the quality of life of patients with chronic diseases during the COVID-19 outbreak in Paraguay., Method: A two-arm randomized controlled trial will be carried out, with repeated measures (baseline, 1-month, 3-month, 6-month, and 12-month) under two conditions: Adhera® MejoraCare Digital Program or waiting list. The primary outcome is a change in the quality of life on the EuroQol 5-Dimensions 3-Levels Questionnaire (EQ-5D-3L). Other secondary outcomes, as the effect on anxiety and health empowerment, will be considered. All participants must be 18 years of age or older and meet the criteria for chronic disease. A total of 96 participants will be recruited (48 per arm)., Conclusions: It is expected that the Adhera® MejoraCare Digital Program will show significant improvements in quality of life and emotional distress compared to the waiting list condition. Additionally, it is hypothesized that this intervention will be positively evaluated by the participants in terms of usability and satisfaction. The findings will provide new insights into the viability and efficacy of mHealth solutions for chronic disease management in developing countries and in times of pandemic., Trial Registration: ClinicalTrials.gov NCT04659746., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Escrivá-Martínez et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The study aimed to analyze the longitudinal change in mental health during the third wave of COVID-19 infections in Spain. Negative (e.g., emotional distress) and positive (e.g., positive functioning variables) outcomes were analyzed. Protective factors (e.g., resilience) as predictors of psychological adjustment (i.e., positive mental health, openness to the future, and low burden due to COVID-19) after ten months of the pandemic were also examined. The sample consisted of 164 participants, and self-reported questionnaires were administered at the beginning of the lockdown (March 2020), at the end of the lockdown (June 2020), and during the third wave (January 2021). Linear mixed models showed that individuals' emotional distress increased, and positive functioning variables (i.e., meaning in life, gratitude, resilience, and life satisfaction) decreased over time, but an increase was observed in some dimensions of posttraumatic growth. Regression analyses showed that resilience scores at all three data collection time points were significant predictors of positive mental health, openness to the future, and burden during the third wave. Mediation analyses showed that positive mental health and openness to the future were mediators of the effect of resilience on burden. The prolonged situation of the COVID-19 crisis had an important impact on positive and negative mental health. However, resilience may help to build up resources that can act as a buffer against adverse psychological effects., Competing Interests: Conflict of interestOn behalf of all the authors, the corresponding author states that there are no conflicts of interest., (© The Author(s) 2022.)

Psychological interventions have been shown to be beneficial in mitigating stress related to COVID-19 confinement. According to theories of restorative environments, exposure to natural surroundings has positive effects on well-being and stress through its restorative qualities. With 360° video-based Virtual Reality (VR), people can be exposed to nature and so better manage the consequences associated with mobility restrictions during confinement. The main aim of this pilot study was to examine whether a 360° video-based VR intervention composed of five 13-minute sessions (once a day) has positive effects on affect, well-being, and stress. The sample was made up of 10 participants (4 men and 6 women; age : M = 46.5, SD = 11.7) who were confined at home (voluntarily or not) during the COVID-19 pandemic. Participants were instructed to watch a 360° video each day (of a "beach" or "lake" environment) using their smartphone and VR glasses sent to them by mail. Participants responded with several self-reports before and/or after each session (emotions and sense of presence) and before and/or after the intervention (affect, well-being, perceived stress, perceived restorativeness of nature, and the usefulness and acceptability of the intervention). Results showed a tendency to improve positive (e.g., happiness) and negative (e.g., anxiousness) emotions and experience a high sense of presence after each session. Moreover, perceived restorative qualities of the environment and their cognitive and behavioral effects were high. A significant decrease in negative affect was found after the intervention. Usefulness and acceptability were also high. This is the first study to show that an affordable and accessible technology can be used to overcome the negative consequences of confinement and counteract its harmful psychological effects., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2022 Jaime Navarrete et al.)

‘Living Better’, a self-administered web-based intervention, designed to facilitate lifestyle changes, has already shown positive short- and medium-term health benefits in patients with an obesity−hypertension phenotype. The objectives of this study were: (1) to examine the long-term (3-year) evolution of a group of hypertensive overweight or obese patients who had already followed the ‘Living Better’ program; (2) to analyze the effects of completing this program a second time (reintervention) during the COVID-19 pandemic. A quasi-experimental design was used. We recruited 29 individuals from the 105 who had participated in our first study. We assessed and compared their systolic and diastolic blood pressure (SBP and DBP), body mass index (BMI), eating behavior, and physical activity (PA) level (reported as METs-min/week), at Time 0 (first intervention follow-up), Time 1 (before the reintervention), and Time 2 (post-reintervention). Our results showed significant improvements between Time 1 and Time 2 in SBP (−4.7 (−8.7 to −0.7); p = 0.017), DBP (−3.5 (−6.2 to −0.8); p = 0.009), BMI (−0.7 (−1.0 to −0.4); p < 0.001), emotional eating (−2.8 (−5.1 to −0.5); p = 0.012), external eating (−1.1 (−2.1 to −0.1); p = 0.039), and PA (Time 1: 2308 ± 2266; Time 2: 3203 ± 3314; p = 0.030, Z = −2.17). Statistical analysis showed no significant differences in SPB, DBP, BMI, and eating behavior between Time 0 and Time 1 (p > 0.24). Implementation of the ‘Living Better’ program maintained positive long-term (3-year) health benefits in patients with an obesity−hypertension phenotype. Moreover, a reintervention with this program during the COVID-19 pandemic produced significant improvements in blood pressure, BMI, eating behavior, and PA.

The prevalence of mental disorders continues to increase, especially with the advent of the COVID-19 pandemic. Although we have evidence-based psychological treatments to address these conditions, most people encounter some barriers to receiving this help (e.g., stigma, geographical or time limitations). Digital mental health interventions (e.g., Internet-based interventions, smartphone apps, mixed realities -virtual and augmented reality) provide an opportunity to improve accessibility to these treatments. This article summarizes the main contributions of the different types of digital mental health solutions. It analyzes their limitations (e.g., drop-out rates, lack of engagement, lack of personalization, lack of cultural adaptations) and showcases the latest sophisticated and innovative technological advances under the umbrella of precision medicine (e.g., digital phenotyping, chatbots, or conversational agents). Finally, future challenges related to the need for real world implementation of these interventions, the use of predictive methodology, and hybrid models of care in clinical practice, among others, are discussed.

COVID-19 pandemic-related confinement may be a fruitful opportunity to use individual resources to deal with it or experience psychological functioning changes. This study aimed to analyze the evolution of different psychological variables during the first coronavirus wave to identify the different psychological response clusters, as well as to keep a follow-up on the changes among these clusters. The sample included 459 Spanish residents (77.8% female, M age  = 35.21 years, SD age  = 13.00). Participants completed several online self-reported questionnaires to assess positive functioning variables (MLQ, Steger et al. in J Loss Trauma 13(6):511-527, 2006. 10.1080/15325020802173660; GQ-6, McCullough et al. in J Person Soc Psychol 82:112-127, 2002. 10.1037/0022-3514.82.1.112; CD-RISC, Campbell-Sills and Stein in J Traum Stress 20(6):1019-1028, 2007. 10.1002/jts.20271; CLS-H, Chiesi et al. in BMC Psychol 8(1):1-9, 2020. 10.1186/s40359-020-0386-9; SWLS; Diener et al. in J Person Assess, 49(1), 71-75, 1985), emotional distress (PHQ-2, Kroenke et al. in Med Care 41(11):1284-1292, 2003. 10.1097/01.MLR.0000093487.78664.3C; GAD-2, Kroenke et al. in Ann Internal Med 146(5):317-325, 2007. 10.7326/0003-4819-146-5-200703060-00004; PANAS, Watson et al. in J Person Soc Psychol 47:1063-1070, 1988; Perceived Stress, ad hoc), and post-traumatic growth (PTGI-SF; Cann et al. in Anxiety Stress Coping 23(2):127-137, 2010. 10.1080/10615800903094273), four times throughout the 3 months of the confinement. Linear mixed models showed that the scores on positive functioning variables worsened from the beginning of the confinement, while emotional distress and personal strength improved by the end of the state of alarm. Clustering analyses revealed four different patterns of psychological response: "Survival", "Resurgent", "Resilient", and "Thriving" individuals. Four different profiles were identified during mandatory confinement and most participants remained in the same cluster. The "Resilient" cluster gathered the largest number of individuals (30-37%). We conclude that both the heterogeneity of psychological profiles and analysis of positive functioning variables, emotional distress, and post-traumatic growth must be considered to better understand the response to prolonged adverse situations., Supplementary Information: The online version contains supplementary material available at 10.1007/s10902-021-00469-z., Competing Interests: Conflict of interestAll authors declare that they have no conflict of interest., (© The Author(s) 2021.)

Background: The current COVID-19 coronavirus pandemic is an emergency on a global scale, with huge swathes of the population required to remain indoors for prolonged periods to tackle the virus. In this new context, individuals' health-promoting routines are under greater strain, contributing to poorer mental and physical health. Additionally, individuals are required to keep up to date with latest health guidelines about the virus, which may be confusing in an age of social-media disinformation and shifting guidelines. To tackle these factors, we developed Elena+, a smartphone-based and conversational agent (CA) delivered pandemic lifestyle care intervention. Methods: Elena+ utilizes varied intervention components to deliver a psychoeducation-focused coaching program on the topics of: COVID-19 information, physical activity, mental health (anxiety, loneliness, mental resources), sleep and diet and nutrition. Over 43 subtopics, a CA guides individuals through content and tracks progress over time, such as changes in health outcome assessments per topic, alongside user-set behavioral intentions and user-reported actual behaviors. Ratings of the usage experience, social demographics and the user profile are also captured. Elena+ is available for public download on iOS and Android devices in English, European Spanish and Latin American Spanish with future languages and launch countries planned, and no limits on planned recruitment. Panel data methods will be used to track user progress over time in subsequent analyses. The Elena+ intervention is open-source under the Apache 2 license (MobileCoach software) and the Creative Commons 4.0 license CC BY-NC-SA (intervention logic and content), allowing future collaborations; such as cultural adaptions, integration of new sensor-related features or the development of new topics. Discussion: Digital health applications offer a low-cost and scalable route to meet challenges to public health. As Elena+ was developed by an international and interdisciplinary team in a short time frame to meet the COVID-19 pandemic, empirical data are required to discern how effective such solutions can be in meeting real world, emergent health crises. Additionally, clustering Elena+ users based on characteristics and usage behaviors could help public health practitioners understand how population-level digital health interventions can reach at-risk and sub-populations., Competing Interests: JO, PS, AA, DR, CB, OK, EF, FW, and TK are affiliated with the Centre for Digital Health Interventions www.c4dhi.org, a joint initiative of the Department of Management, Technology and Economics at ETH Zurich and the Institute of Technology Management at the University of St. Gallen, which was funded in part by the Swiss health insurer CSS Versicherung. EF and TK are also cofounders of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, neither CSS nor Pathmate Technologies are involved in the Elena+ project or this article. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer AR declared a past co-authorship with several of the authors AS and RB to the handling editor., (Copyright © 2021 Ollier, Neff, Dworschak, Sejdiji, Santhanam, Keller, Xiao, Asisof, Rüegger, Bérubé, Hilfiker Tomas, Neff, Yao, Alattas, Varela-Mato, Pitkethly, Vara, Herrero, Baños, Parada, Agatheswaran, Villalobos, Keller, Chan, Mishra, Jacobson, Stanger, He, von Wyl, Weidt, Haug, Schaub, Kleim, Barth, Witt, Scholz, Fleisch, Wangenheim, Car, Müller-Riemenschneider, Hauser-Ulrich, Asomoza, Salamanca-Sanabria, Mair and Kowatsch.)

Background : The adverse consequences of the COVID-19 pandemic on mental health have been widely studied in recent months. However, few studies have examined the protective psychological factors that may explain how individuals are coping with the COVID-19 pandemic and its forced confinements. Objective : This study analyzes the impact of confinement due to the COVID-19 pandemic on positive functioning variables (resilience, meaning of life, gratitude, compassion, life satisfaction), emotional distress (depression, anxiety, perceived stress, affect), and posttraumatic growth (PTG). The impact was measured during and after the first month of strict and obligatory confinement in Spain. Methods : The sample was composed of 438 Spanish residents (78.3% women) between the ages of 18 and 68 ( M = 35.68; SD  = 13.19) during the first stage (first two weeks) of confinement. The sample was reduced to 197 participants during the second stage (fifth week) of confinement. Several online self-reported questionnaires were administered to assess positive functioning variables, emotional distress, and PTG. Results : Women, youths, individuals without a partner, with lower monetary incomes, or diagnosed with a mental disorder or chronic illness experienced lower scores in positive functioning variables and greater emotional distress during the first stage of confinement. Linear mixed models showed that scores on positive functioning variables, emotional distress, and PTG worsened in the second stage of confinement. Nevertheless, a structural equations model showed that increases in positive functioning variables in the second stage were associated with increases in life satisfaction ( R 2   = .450) and related to decreases in emotional distress ( R 2   = .186), leading in turn to increases in PTG ( R 2   = .061). Conclusions : Individuals could experience PTG during strict and mandatory confinement. The increase in PTG during this adverse event was indirectly associated with increases in positive functioning variables (i.e. gratitude, presence of meaning, resilience), through improvements in life satisfaction and emotional distress., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Background: Depression is one of the world's major health problems. Due to its high prevalence, it constitutes the first cause of disability among the Americas, where only a very low percentage of the population receives the adequate evidence-based psychological treatment. Internet-Based Interventions (IBIs) are a great alternative to reduce the treatment gap for mental disorders. Although there are several studies in low-and middle-income countries proving IBIs' feasibility and acceptability, there is still little evidence of the effectiveness in diverse social and cultural contexts such as Latin America., Methods: Two studies will be described: Study 1 is focused on the cultural adaptation of a cognitive-behavioral IBI Smiling is Fun (Botella et al. 2012, 2015) for Ecuadorian population with depression based on the procedure by Salamanca-Sanabria et al. (2018). Study 2 describes the design of a randomized controlled trial to test the preliminary efficacy of the culturally adapted intervention in a Public Health Care setting. A total of 153 patients with mild to moderate degree of depression as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.) and the Patient Health Questionnaire-9 (PHQ-9) will be randomly assigned to either an IBI group using only automated support by the system; an IBI group including also minimal human support; or a waiting list group. The primary outcome (depression) and secondary outcomes (e.g., anxiety, affect, quality of life) will be collected at baseline, 3, 6 and 12 months. Mixed-model analyses with no ad hoc imputations will be conducted., Discussion: This paper is pioneering in exploring the role of an Internet-based culturally adapted intervention for depression in a public care context in Ecuador. Results obtained will offer new insights into the viability and effectiveness of digital technologies for the psychological treatment of mental illnesses in developing countries., Competing Interests: The authors declare that they have no conflict of interests., (© 2020 The Authors.)

Introduction  The aim of this study was to determine if the combined use of curcumin and platelet-rich plasma (PRP) improves the axonal regeneration process in acutely repaired nerve injuries. Materials and Methods  The right sciatic nerves of 32 Holtzman albino rats were transected and immediately repaired. Four treatments were randomly allocated: (1) nerve repair only; (2) nerve repair + local PRP; (3) nerve repair + intraperitoneal curcumin; and (4) nerve repair + local PRP + intraperitoneal curcumin. Clinical (estimation of sciatic functional index) and electrophysiological outcomes were assessed 4 and 12 weeks after surgery, and histologic evaluations performed 12 weeks after surgery. Results  Group IV (PRP + curcumin) resulted in significantly better outcomes across all the evaluation parameters, compared with the other three groups ( p  < 0.05). Additionally, when used as single adjuvants, both the curcumin (group III) and PRP (group II) groups showed significant improvement over the control group ( p  < 0.05). No significant differences were found between PRP and curcumin when used as sole adjuvants. Conclusion  The combined administration of curcumin + PRP as adjuvants to nerve repair could enhance axonal regeneration in terms of clinical, electrophysiological, and histological parameters in a rat model of acute sciatic nerve injury., Competing Interests: Conflict of Interest None declared., (Society of Indian Hand Surgery & Microsurgeons. All rights reserved.)

Background: Infertility is estimated to affect 15% of couples of reproductive age. Weight management problems (being obese or overweight) are among the problems that produce infertility, both in women seeking spontaneous pregnancy and in those undergoing assisted reproduction techniques. Over the last few decades, the prevalence of obesity has increased alarmingly in our society and is now considered one of the most important public health problems. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. In other population groups, it has been shown that Internet-based interventions are just as effective as traditional ones, and these cover a larger population with a good cost-benefit ratio. However, to the best of our knowledge, no studies so far have analysed any specific online interventions for this group of infertile women. Thus, the objective of this project will be to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment. Methods : This will be a randomised controlled clinical trial conducted in 94 women which will compare a self-administered Internet-based intervention promoting a healthy lifestyle in terms of diet and exercise ( n = 47) to a control group that will receive standard medical care. The online program will comprise nine modules, will last for 3 months, and will be monitored every 3 months after the intervention until the final follow-up at 12 months. The main outcome will be the spontaneous pregnancy rate. Secondary outcomes will include changes in body composition, dietary and physical exercise habits, glycaemic profiles, lipid profiles, hormonal profiles, and patient quality of life related to their fertility problems. The data analysis will be done on an intention-to-treat basis. Discussion : The aim of this study is to increase our knowledge of the effectiveness of online interventions specifically adapted to infertile women who are overweight or obese in the promotion of healthy lifestyles.

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%-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 < 0.001, R 2 = 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: Therapeutic alliance (TA) between the patient and therapist has been related to positive therapeutic outcomes. Because Internet-based interventions are increasingly being implemented, a tool is needed to measure the TA with Internet-based self-guided programs. The Working Alliance Inventory for online interventions (WAI-TECH-SF) was adapted based on the WAI Short Form (Hatcher & Gillaspy, 2006). The objectives of this study were: (1) to analyse the psychometric properties of the WAI-TECH-SF; (2) to explore the differences in the WAI-TECH-SF scores according to different categories of the sample; and (3) to analyse whether the WAI-TECH-SF can predict therapeutic outcomes and satisfaction with the treatment., Methods: 193 patients diagnosed with depression were included and received blended Cognitive-Behavioural Therapy. Measures of preferences, satisfaction, and credibility about the treatment, TA with the online program, depressive symptoms, and satisfaction with the treatment were administered., Results: An exploratory factor analysis revealed a one-dimensional structure with adequate internal consistency. Linear regression analyses showed that the WAI-TECH-SF predicted changes in depressive symptoms and satisfaction with the treatment., Conclusions: WAI-TECH-SF is a reliable questionnaire to assess the TA between the patient and the online program, which is associated with positive therapeutic outcomes and satisfaction with the treatment.

Recently, the prevalence of childhood obesity has increased alarmingly. Interventions combining eating habits, physical activity (PA), behavioral components, and family support have been shown to be effective, although variables such as self-efficacy beliefs and motivation seem to be important in achieving stable changes. Information and communication technologies (ICTs) can provide additional resources to traditional treatments. The objective is to analyze the efficacy of two treatments: a cognitive and behavioral treatment (CBT) focused on the promotion of healthy eating and PA habits, and this CBT intervention supported by a web platform (ETIOBE). Forty-seven obese children were randomized to these two conditions. Anthropometrical measures were evaluated before and after treatment and at follow-up. Self-efficacy and motivation questionnaires were filled out in the first and last intervention sessions. Mixed ANOVAs were performed for all variables. Simple mediation analyses were conducted to test whether the effect of condition on the post-intervention anthropometrical variable scores were mediated by self-efficacy. Results revealed that both treatments produced an improvement in the anthropometrical variables. CBT-E participants showed more PA self-efficacy as the treatment progressed and lower BMIz, lower fat mass, and higher lean mass. These results suggest that ICT help to improve the effects of childhood obesity interventions.

Background: Given the rise of internet-based treatments as an effective therapeutic tool for psychological disorders, it is necessary to carry out research that examines clients' experiences with this type of intervention. The qualitative methodology has been found to be useful for analyzing clients' perceptions in terms of facilitators and barriers, acceptability, and negative effects of internet-based treatments. However, a lack of integration of these primary studies has prevented their findings from being applied to new research and in clinical practice., Objective: The objective of this paper is to describe the protocol for a metasynthesis of qualitative studies exploring the experiences of clients who underwent an internet-based treatment., Methods: Elliot and Timulak's metasynthesis approach will be used to review and synthesize qualitative studies related to client experiences in terms of the barriers and facilitators they perceived when undergoing internet-based treatment. For each search string, the features in the Sample, Phenomenon of Interest, Design, Evaluation, Research type (SPIDER) tool will be considered. Electronic databases (PubMed, PsycINFO, and Web of Science) will be searched. Two independent reviewers will analyze the material in order to determine whether the eligibility criteria are fulfilled. Findings will make it possible to create a hierarchy of domains in terms of their relevance across all the primary studies. The data obtained from primary studies will be cross-analyzed using descriptive and interpretative procedures., Results: The search strategy is currently being conducted. First results are expected to be submitted for publication in 2019., Conclusions: We will develop conceptual framework of the barriers and facilitators perceived by clients and propose their implications and recommendations for clinical practice, research, and training., Trial Registration: PROSPERO CRD42018079894; https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=79894 (Archived by WebCite at http://www.webcitation.org/73C6OtlS7)., International Registered Report Identifier (irrid): PRR1-10.2196/9722., (©Javier Fernández-Álvarez, Amanda Díaz-García, Mª Dolores Vara, Guadalupe Molinari, Desirée Colombo, Giuseppe Riva, Rosa M Baños, Cristina Botella. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.11.2018.)

Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting., Methods: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm)., Discussion: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression., Trial Registration: ClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.