I2P - Artigos em Revistas Internacionais / Papers in International Journals

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  • ItemAcesso Aberto
    Development of a theory and evidence-based digital intervention tool for weight loss maintenance: The NoHoW Toolkit [preprint]
    (PsyArXiv Preprints, 2020-10-21) Marques, Marta; Matos, Marcela; Mattila, Elina; Encantado, Jorge; Duarte, Cristiana; Teixeira, Pedro; Stubbs, James; Sniehotta, Falko; Ermes, Miikka; Harjumaa, Marja; Leppänen, Juha; Välkkynen, Pasi; Silva, Marlene; Ferreira, Cláudia; Carvalho, Sérgio; Palmeira, Lara; Horgan, Graham; Lilienthal Heitmann, Berit; Evans, Elizabeth; Palmeira, António
    Background: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer promising means to delivering behaviour change approaches at low cost and on a wide scale. The NoHoW project was a European Commission H2020-funded project aimed to develop, test, and evaluate a digital Toolkit designed to promote successful long-term weight management. The Toolkit was tested in an 18-month large-scale international 2 x 2 factorial (motivation and self-regulation versus emotion regulation) randomised controlled trial, conducted in overweight/obese adults who lost ≥5% of their body weight in the preceding twelve months before enrolment into the intervention. Objective: This paper describes the development of the NoHoW Toolkit focusing on the logic models, content and specifications, and results from user testing. Methods: The Toolkit was developed using a systematic approach including (1) development of the theory-based logic models, (2) selection of behaviour change techniques, (3) translation of these techniques into a digital web-based app (NoHoW Toolkit components), (4) technical development, (5) user evaluation and refinement of the Toolkit. Results: The Toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers), with modules targeting weight, physical activity, and dietary behaviours. The final Toolkit was comprised of 34 sessions, distributed through 15 modules, providing active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full Toolkit (15 modules, 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Further, the Toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood and sleep. Conclusions: A systematic approach to the development of digital solutions based on theory, evidence, and user testing, may significantly contribute to the advancement of the science of behaviour change and improve current solutions for sustained weight management. Testing the Toolkit using a 2x2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.
  • PublicaçãoAcesso Aberto
    The Me and the Us of Emotions: a cluster-randomized controlled trial of the feasibility and efficacy of a compassion-based social– emotional learning program for children
    (Frontiers Media, 2023-11-01) Xavier, Ana; Vagos, Paula; Palmeira, Lara; Menezes, Paulo; Patrão, Bruno; Mendes, Sofia; Tavares, Marta
    There are well-established benefits of social and emotional learning (SEL) programs for children within educational contexts. Combining social–emotional skills and compassion abilities has been seldomly done, and it may be valuable at individual and societal levels, for resilient, empathetic, and inclusive societies. This study explored the feasibility and efficacy of a program designed to promote socioemotional and compassion skills in children attending the 3rd and 4th grades, by using in-class dynamics complemented with serious games. This program, named “The Me and the Us of Emotions,” is part of the Gulbenkian Knowledge Academies 2020 and consists of 10 group sessions embedded in the school curriculum. Using a cluster-randomized controlled trial design, school classes were allocated to intervention (classes, n = 8; children, n = 163) and control groups (classes, n = 6; children, n = 132). During the program, facilitators assessed adherence to the sessions’ plan, attendance, dosage (i.e., how many sessions were delivered), and participant responsiveness. Children completed self-report measures of social–emotional skills and emotional climate at pre-, post-intervention, 3-month, and 6-month follow-ups. Results indicate that the program is feasible, with high adherence, high attendance rate, and participant responsiveness. Results also indicate empathy, soothing, and drive feelings to change from pre-intervention to all other assessment moments, for the intervention group only. Moreover, cooperation and threat changed over time for participants in both the control and the intervention groups. The current study offers empirical support for the feasibility and utility of a compassion- based social–emotional learning program on promoting children’s empathy, and emotions of soothing and vitality in the school context. Thus, these findings contribute to recent research on the potential added value of compassion practices within an SEL program.
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    Pre-service teachers’ views of their training: Key issues to sustain quality teacher education
    (Sciendo, 2014-01-01) Flores, Maria Assunção; Santos, Patrícia; Fernandes, Sandra; Pereira, Diana
    This paper draws upon data from a broader piece of research aimed at examining pre-service teachersí views of their initial teacher education within the context of a masterísdegree programme in teaching. The data were collected through questionnaires andwritten narratives at the beginning and at the end of the programme. In this paper, thedata arising from 47 narratives at the end of the programme are presented. Five categoriesemerged from the qualitative data: curriculum content, teaching practice, the role ofteacher educators, teaching and learning methods, the organisational aspects and struc-ture of the programme. Although the participants identified positive aspects of the initialteacher education programme, they also stress that there is room for improvement,especially with regard to a greater coherence of the curriculum and a better articulationof its different components. Implications of the findings for enhancing the quality ofinitial teacher education and the role of teachersí educators are discussed.
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    Improving the performance of student teams in project-based learning with Scrum
    (MDPI - Multidisciplinary Digital Publishing Institute, 2021-08-19) Fernandes, Sandra; Dinis-Carvalho, José; Ferreira-Oliveira, Ana Teresa
    The purpose of this paper is to analyze the effectiveness of Scrum for project and team management in PBL teams in higher education. To attain this goal, a study was carried out to analyze students’ perceptions about Scrum as an effective method for PBL teams. Based on two different editions of PBL that used the Scrum method with different characteristics in each approach, this paper aims to identify the best practices for effective team and project management and draw recommendations for successful use of scrum in PBL approaches. The authors used an exploratory case study carried out within an engineering program at the University of Minho, Portugal. The research design was based on an explorative quantitative and qualitative approach. Implementing Scrum in PBL teams helps students to keep the project running smoothly and draws greater awareness on how to manage the project and teams in a more effective way. Findings show that task assignment, performance monitoring, visual management and regular feedback were considered the main advantages of using Scrum in PBL teams, which had a positive impact on student performance. However, for the success of Scrum, students recognize the role of the Scrum Master and Project Owner as vital to guide the teams in a sustainable way. Research on the application of Scrum in Education is scarce and mostly exploratory. This paper is among the very few empirical studies consolidating knowledge on the implementation of Scrum approaches to improve learning in higher education. More specifically, it brings a valuable contribution on how to improve specifically team performance in PBL teams with the use of agile approaches such as Scrum.
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    Memory Impairments and Wellbeing in Breast Cancer Patients: A Systematic Review
    (MDPI - Multidisciplinary Digital Publishing Institute, 2023-11-07) Rodrigues, Pedro F. S.; Bártolo, Ana; Albuquerque, Pedro B.
    Breast cancer is one of the most diagnosed cancers among women. Its effects on the cognitive and wellbeing domains have been widely reported in the literature, although with inconsistent results. The central goal of this review was to identify, in women with breast cancer, the main memory impairments, as measured by objective and subjective tools and their relationship with wellbeing outcomes. The systematic literature search was conducted in the PubMed, Scopus, and ProQuest databases. The selected studies included 9 longitudinal and 10 cross-sectional studies. Although some studies included participants undergoing multimodal cancer therapies, most focused on chemotherapy’s effects (57.89%; n = 11). The pattern of results was mixed. However, studies suggested more consistently working memory deficits in breast cancer patients undergoing chemotherapy. In addition, some associations have been identified between objective memory outcomes (verbal memory) and wellbeing indicators, particularly depression and anxiety. The inconsistencies in the results could be justified by the heterogeneity of the research designs, objective and subjective measures, and sample characteristics. This review confirms that more empirical evidence is needed to understand memory impairments in women with breast cancer. An effort to increase the homogeneity of study methods should be made in future studies.
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    Person‐Centred Planning in Centres of Activities for Inclusion
    (Cogitatio Press, 2023-11-08) Carvalhais, Lénia; Fernandes, Ana Rita; Almeida, Lígia
    Person‐centred planning includes the active social participation of individuals with intellectual and developmental disabilities (IDD) and is the fairest path towards assuring human rights and citizenship among people with IDD. Semi‐structured interviews were undertaken with four technicians from centres of activities in Portugal, four family members, and four adults with IDD to observe the best practices that facilitate/hinder the implementation of person‐centred interventions. Several discrepancies were identified regarding inclusive practices in centres of activities and capacity building, associated with the sense of mission, vision and perspective of technical structures, the bureaucratic weight that conditions the transition between intervention models, the participation and positioning of families regarding their representation of the centres, as well as the investment these centres make concerning effective and fair inclusion in surrounding communities. Still far from successful implementation, a person‐centred approach must be considered and include all participants’ perspectives to build robust and integral life projects.
  • PublicaçãoAcesso Restrito
    Life Design Counseling outcome and process: A case study with an adolescent
    (Elsevier, 2016-04) Cardoso, Paulo; Gonçalves, Miguel M.; Duarte, Maria Eduarda; Silva, Joana Ribeiro da; Alves, Daniela
    This article aims to explore the relationship between clients' narrative transformation and the promotion of vocational decidedness and career maturity in a mid-adolescent case of Life Design Counseling (LDC). To assess LDC outcomes the Vocational Certainty Scale and the Career Maturity Inventory — Form C were used before and after the intervention. To intensively analyze the process of LDC change two measures of narrative change were used: the Innovative Moments Coding System (IMCS), as a measure of innovation emergence, and the Return to the Problem Coding System (RPCS), as a measure of ambivalence towards change. The results show that the three LDC sessions produced a significant change in vocational certainty but not in career maturity. Findings confirm that the process of change, according to the IMCS, is similar to the one observed in previous studies with adults. Implications for future research and practice are discussed.
  • PublicaçãoAcesso Restrito
    Three narrative-based coding systems: Innovative moments, ambivalence and ambivalence resolution
    (Taylor and Francis Group; Routledge, 2017-01) Gonçalves, Miguel M.; Ribeiro, António P.; Mendes, Inês; Alves, Daniela; Silva, Joana Ribeiro da; Rosa, Catarina
    Narrative and dialogical perspectives suggest that personal meaning systems' flexibility is an important resource for change in psychotherapy. Drawn from these theoretical backgrounds, a research program focused on the identification of Innovative Moments (IMs)—exceptions to the inflexible meaning systems present in psychopathological suffering—has been carried out. For this purpose, three process-oriented coding systems were developed: The IMs Coding System, the Ambivalence Coding System, and the Ambivalence Resolution Coding System. They allow, respectively, for the study of change, ambivalence, and ambivalence resolution in therapy. This paper presents these coding systems, the main findings that resulted from their application to different samples and therapeutic models, the main current and future lines of research, as well as the clinical applications of this research program.
  • PublicaçãoAcesso Restrito
    What Can Therapists Learn from Coding Therapy Sessions? Interviewing Clinicians to Explore the Case of Innovative Moments Training
    (Taylor and Francis, 2023-09-01) Fernández-Navarro, Pablo; Silva, Joana Ribeiro da; Batista, João
    Innovative Moment Coding System (IMCS) has influenced their clinical practice. Participants, that worked both as researchers and therapists, were interviewed using a semi-structured script written for the current study. The interviews explored whether or not coding psychotherapy sessions (participants’ research experience with innovative moments; IMs) had impacted their clinical practice. A descriptive–interpretative qualitative approach was used to analyze the video recordings of the interviews. Four themes identified the effects of coding therapy sessions with IMs in therapists’ clinical practice: (1) increasing attention to clients’ change instances, (2) noticing clients’ development, (3) implementing strategies inspired by the IM model, and (4) identifying hindering situations. Results suggested that coding therapy sessions appears to bring benefits to practice, regardless of the participant’s theoretical orientation. We discuss how coding sessions may bring subtle but valuable additions to therapists’ everyday practice offering better attunement to clients’ micro-processes of change. In particular, IMCS categorization of such processes could present a useful form of feedback for therapist’s interventions or deliberate practice, further developing therapists’ sensitivity to the interplay between change and problem narratives (called double listening).
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    Mother–infant bonding in the first nine months postpartum: the role of mother’s attachment style and psychological flexibility
    (Taylor and Francis Group; Routledge, 2023-07-31) Vagos, Paula; Mateus, Vera; Silva, Joana Ribeiro da; Araújo, Vânia; Xavier, Ana; Palmeira, Lara
    Introduction Mother’s bond to the infant in the postpartum period plays an important role in the subsequent mother–infant relationship and the infant’s socio-emotional functioning. Several maternal characteristics, such as attachment style and psychological flexibility, may contribute to the quality of mother–infant bonding, though literature examining these variables is still scarce. The present study aimed to examine the impact of mother’s attachment on mother–infant bonding in the first month postpartum and the mediating role of psychological flexibility on that association. Methods Participants were 226 mothers of an infant up to 9 months old, who reported on their own attachment style (in terms of anxiety, comfort with proximity, trust in others), psychological flexibility (in terms of openness to experience, behavioural awareness, valued action) and mother–infant bonding. Results Results showed that mother’s attachment anxiety predicted a bond with the infant directly and indirectly via mother’s psychological flexibility, specifically through behavioural awareness and valued action. Trust in others had an impact on mother–infant bonding through behavioural awareness, whereas comfort with proximity influenced mother–infant bond indirectly, via valued action. Finally, mothers’ civil status, schooling and number of children were relevant to better understand the variance of our mediating and dependent variables. Discussion Our findings highlight the importance of mother’s attachment and psychological flexibility in promoting the quality of mother–infant bonding, which can inform future intervention programmes targeting modifiable factors, such as psychological flexibility, to promote early positive parent–infant relationships, particularly for single, first-time mothers, with higher levels of education.
  • PublicaçãoAcesso Restrito
    Engaging students in learning: findings from a study of project-led education
    (Taylor and Francis, 2014-01) Fernandes, Sandra; Mesquita, Diana; Flores, Maria Assunção; Lima, Rui M.
    This paper reports on findings from a three-year study of project-based learning implemented in the first year of the Industrial Engineering and Management programme, at the University of Minho, Portugal. This particular model was inspired on project-led education (PLE), following Powell and Weenk's [2003. Project-Led Engineering Education. Utrecht: Lemma] work. It aims to analyse students’ perceptions of PLE as a learning device and its implications for faculty and students’ role in teaching and learning. Data collection took place in two phases through individual surveys and focus groups to students. Findings suggest the importance of PLE as a device to enhance meaningful learning and provide evidence from students that it helps to increase their engagement in learning. Implications of PLE for faculty and students role in teaching and learning will be discussed in the paper.
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    Students’ views of assessment in project-led engineering education: findings from a case study in Portugal
    (Taylor and Francis Group; Routledge, 2012-03) Fernandes, Sandra; Flores, Maria Assunção; Lima, Rui Manuel
    According to the demands of the Bologna process, new educational methods and strategies are needed in order to enhance student-centred learning. Project work is one of those approaches. This paper aims to evaluate the impact of project-led education (PLE) on students’ learning processes and outcomes, within the context of a first-year engineering programme. It explores students’ perceptions about assessment procedures and processes. Data collection was based on individual surveys at the end and the beginning of each PLE edition and through focus groups, after a period of six months. Findings are presented according to emerging themes from the data analysis, focusing mainly on students’ perspectives of learning and assessment, the role of formative and summative assessments in PLE and their impact on learning. Implications for improving assessment practices are discussed.
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    Knowledge, concerns and attitudes towards plastic pollution: An empirical study of public perceptions in Portugal
    (Elsevier, 2023-10) Miguel, Isabel; Santos, Ana; Venâncio, Cátia; Oliveira, Miguel
    While the harmful effects of different types of plastic particles have been increasingly reported, studies on public perceptions and behaviors related to plastic pollution may be considered limited. The present study aims to assess the general public's knowledge, awareness, and concern about plastic pollution in different environmental compartments (air, water, and soil) and assess recycling behaviors. For this, a large representative sample was considered (over 1000 participants), composed of members of different genders, levels of education, and age groups. Overall, the results showed that participants were aware of plastic pollution in many environmental compartments, although they reported being more concerned about the marine and land environments than the air. Participants' levels of concern about the plastic problem were influenced by age and level of education, with older participants and those with lower educational levels attributing less importance to recycling as a means of tackling the plastic problem. Women are more likely to adopt plastic alternatives and engage in recycling practices than men. Data allowed the identification of priority sociodemographic characteristics of communities that should be targeted in education and awareness-raising activities.
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    Ethical and Political Constellations: Fichte, Schlegel and Hegel on Kantian Peace
    (Routledge, 2024-01) Jesus, Paulo Renato
    The reception of the Kantian essay on Perpetual Peace by Fichte, Schlegel and Hegel gives rise to a contrastive constellation of ethical, juridical and political ideas revolving around the idea of freedom, and the relationship between rights and duties within a constitutional State. In his review of the Kantian essay, Fichte (1796, Werke I, 3: 221-228; SW 08: 427-436) emphasizes the rational foundation of Kant’s Hauptidee, thus endorsing also the metaphysical status of the historical process through which Republican Constitutions are generated; for the progressive fulfillment of peace would testify both to the rational essence of Right and to the unfolding of the inexorable ends of Nature. The imperative of peace reveals the “supreme question of right” which concerns the purely rational condition of possibility of a community of free beings, i.e., the very possibility of humanity-as-community, encompassing necessarily the law of coexistence or compatibility of all possible free beings that relies on the reciprocal capacity of free self-limitation of freedom. Such capacity belongs to the people alone, and therefore it entails also the capacity to judge, without rebellion, how rightfully freedom is realized; hence, the proposition of creating a new institution, the Ephorat. In a nutshell, according to Fichte, peace and right are one and the same process of self-ordering freedom. Unsurprisingly enough, F. Schlegel accepts the equation that conjoins freedom and republicanism, and draws the logical conclusion that the true definitive article of perpetual peace would be the practically necessary political imperative of “universal and perfect republicanism” (1796, Versuch über den Begriff des Republikanismus, in Ausgabe 07: 11-25). Grounded in “primordial freedom,” source of individuality and independence, the Hegelian idea of State cannot surrender any degree of internal and external sovereignty. Consequently, the actualization of the individuality of the State implies negation, and thereby requires the continuous creation of the enemy and the continuous readiness to wage war against the enemy. Only the dialectical power of war does avoid vegetative and feminine stagnation, and by the same token it guarantees the protection and development of the State’s individuality. Peace must always be overcome by the “ethical moment” of war in which patriotic courage signifies a “universal duty” and a “formal virtue” consisting of self-sacrifice and self-abandonment or self-alignment with the universal (Grundlinien der PR, §§. 259, 324-327).
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    Herméneutique et incarnation du soi : principes de la génération de sens
    (Funes, 2019) Jesus, Paulo Renato
    Between the passibility of the flesh and narrative self-understanding, every human self unfolds itself as a semiotic artwork at once affective and creative. Contrary to an all-powerful and all-encompassing vision of hermeneutics as free self-generation of meaning, this article presents an attempt to identify the field of mediations that produce the intelligible relationship of oneself to oneself within intersubjective movements of meaning. In this way, the contributions of narrative and developmental psychology, phenomenology of memory and hermeneutics of the self are put into dialogue for mapping the symbolic space where a vulnerable living flesh becomes a storied self among selves. The vulnerability of the living flesh is metaphorically called naked skin exposed to traumatic events that require the invention of passages through effective signs, capable of opening new possible bodies and worlds.
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    Maternal mental health in refugees and migrants: a comprehensive systematic review
    (Springer, 2023-08-17) Almeida, Lígia Moreira; Moutinho, Ana Raquel; Siciliano, Florência; Leite, Jorge; Caldas, José Peixoto
    The first years of motherhood are often difficult for women, requiring large emotional and biophysical adjustments and increased health risks that may combine with social disadvantage and psychosocial conditions towards decreased maternal wellbeing. Those outcomes are usually worse in vulnerable populations, as refugee and migrants. Comprehending mothers’ needs regarding mental health and psychological well-being must be prioritized. A systematic review using MEDLINE, EBSCO, and SCOPUS databases was carried out, searching for population-based studies published between 2012 and 2022 reporting on maternal mental health in displaced populations. A total of 2881 articles were retrieved; 35 publications met the inclusion criteria, being included in the final evaluation. Displaced women tend to be at higher risks of maternal mental distress, due to life stressors, isolation, intrapersonal and background characteristics, mental health stigma, discrimination, and barriers in accessing adequate healthcare. Refugee and asylum-seekers are at the most vulnerable positions. Postpartum depression is the most assessed condition regarding mental health but is manifestly insufficient for public health systems in assuring an adequate state of maternal well-being. Maternal mental healthcare must be patient-centered, more accessible, and available to both native and displaced mothers. PROSPERO Registration Number: CRD42022335343.
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    Non-pharmacological treatment-related changes of molecular biomarkers in major depressive disorder: A systematic review and meta-analysisTagedEnd
    (Elsevier, 2023-01-24) Irwin, Courtney L.; Coelho, Patrícia S.; Kluwe-Schiavon, Bruno; Silva-Fernandes, Anabela; Gonçalves, Óscar F.; Leite, Jorge; Carvalho, Sandra
    Background: Major depressive disorder (MDD) is a serious mood disorder and leading cause of disability. Despite treatment advances, approximately 30% of individuals with MDD do not achieve adequate clinical response. Better understanding the biological mechanism(s) underlying clinical response to specific psychopharmacological interventions may help fine tune treatments in order to further modulate their underlying mechanisms of action. However, little is known regarding the effect of non-pharmacological treatments (NPTs) on candidate molecular biomarker levels in MDD. This review aims to identify molecular biomarkers that may elucidate NPT response for MDD. Methods: We performed a systematic review and a multilevel linear mixed-effects meta-analyses, and a metaregression. Searches were performed in PubMed, Scopus, and PsycINFO in October 2020 and July 2021. Results: From 1387 retrieved articles, 17 and six studies were included in the systematic review and meta-analyses, respectively. Although there was little consensus associating molecular biomarker levels with symptomology and/or treatment response, brain metabolites accessed via molecular biomarker-focused neuroimaging techniques may provide promising information on whether an individual with MDD would respond positively to NPTs. Furthermore, non-invasive brain stimulation interventions significantly increased the expression of neurotrophic factors (NTFs) compared to sham/placebo, regardless of add-on pharmacological treatment. Conclusions: NTFs are candidate biomarkers to fine-tune NIBS for MDD treatment.
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    Digitalized transcranial electrical stimulation: a consensus statement
    (Elsevier, 2022-09-05) Brunoni, André R; Ekhtiari, Hamed; Antal, Andrea; Auvichayapat, Paradee; Baeken, Chris; Benseñor, Isabela M; Bikson, Marom; Boggio, Paulo; Borroni, Barbara; Brighina, Filippo; Brunelin, Erome; Carvalho, Sandra; Caumo, Wolnei; Ciechanski, Patrick; Charvet, Leigh; Clark, Vincent P; Kadosh, Roi Cohen; Cotelli, Maria; Datta, Abhishek; Deng, Zhi-De; Raedt, Rudi De; Ridder, Dirk De; Fitzgerald, Paul B; Floel, Agnes; Frohlich, Flavio; George, Mark S; Ghobadi-Azbari, Peyman; Goerigk, Stephan; Hamilton, Roy H; Jaberzadeh, Shapour J; Hoy, Kate; Kidgell, Dawson J; Zonoozi, Arash Khojasteh; Kirton, Adam; Laureys, Steven; Lavidor, Michal; Lee, Kiwon; Leite, Jorge; Lisanby, Sarah H; Loo, Colleen; Martin, Donel M; Miniussi, Carlo; Mondino, Marine; Monte-Silva, Katia; Morales-Quezada, Leon; Nitsche, Michael A; Okano, Alexandre H; Oliveira, Claudia S; Onarheim, Balder; Pacheco-Barrios, Kevin; Padberg, Frank; Nakamura-Palacios, Ester M; Palm, Ulrich; Paulus, Walter; Plewnia, Christian; Priori, Alberto; Rajji, Tarek K; Razza, Lais B; Rehn, Erik M; Ruffini, Giuliov; Schellhorn, Klaus; Zare-Bidoky, Mehran; Simis, Marcel; Skorupinski, Pawel; Suen, Paulo; Thibaut, Aurore; Valiengo, Leandro C L; Vanderhasselt, Marie-Anne; Vanneste, Sven; Venkatasubramanian, Ganesan; Violante, Ines R; Wexler, Anna; Woods, Adam J; Fregni, Felipe
    Objective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES. Methods: We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Results: The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/ threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity. Conclusions: Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. Significance: We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.
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    Speed of Processing (SoP) Training Plus α-tACS in people with mild cognitive impairment: a double blind, parallel, placebo controlled trial study protocol
    (Frontiers, 2022-07-14) Leite, Jorge; Gonçalves, Óscar F.; Carvalho, Sandra
    Several cognitive training programs, alone or in combination with non-invasive brain stimulation have been tested in order to ameliorate age-related cognitive impairments, such as the ones found in Mild Cognitive Impairment (MCI). However, the effects of Cognitive Training (CT)—combined or not—with several forms of non-invasive brain stimulation have been modest at most. We aim to assess if Speed of Processing (SoP) training combined with alpha transcranial alternating current stimulation (a-tACS) is able to increase speed of processing as assessed by the Useful Field of View (UFOV), when comparing to SoP training or active a-tACS alone. Moreover, we want to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning by using the NIH EXAMINER. We also want to test the mechanisms underlying these interventions, namely brain connectivity and coherence as assessed by electroencephalography (EEG). To that purpose, our proposal is to enroll 327 elders diagnosed with MCI in a double-blinded, parallel randomized clinical trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in people with MCI. Participants will perform an intervention that will last for 15 sessions. For the first 3 weeks, participants will receive nine sessions of the intervention, and then will receive two sessions per week (i.e., booster) for the following 3 weeks. They will then be assessed at 1, 3, and 6 months after the intervention has ended. This will allow us to detect the immediate, and long-term effects of the interventions, as well as to probe the mechanisms underlying its effects.
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    Editorial: Optimization strategies for pain management with neuromodulation
    (Frontiers, 2022-09-15) Pacheco-Barrios, Kevin; Carvalho, Sandra; Leite, Jorge; Caumo, Wolnei; Fregni, Felipe
    Chronic pain is a high-priority global health issue due to its high prevalence, impact on quality of life, and cost (1). In most cases, chronic pain is challenging to manage, and the existing treatment modalities have reported frequent and severe adverse events, including gastritis (2), cardiovascular complications [...]