Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia

Objective Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms. Methods A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses. Conclusions This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context

Happiness around the world: A combined etic-emic approach across 63 countries.

What does it mean to be happy? The vast majority of cross-cultural studies on happiness have employed a Western-origin, or "WEIRD" measure of happiness that conceptualizes it as a self-centered (or "independent"), high-arousal emotion. However, research from Eastern cultures, particularly Japan, conceptualizes happiness as including an interpersonal aspect emphasizing harmony and connectedness to others. Following a combined emic-etic approach (Cheung, van de Vijver & Leong, 2011), we assessed the cross-cultural applicability of a measure of independent happiness developed in the US (Subjective Happiness Scale; Lyubomirsky & Lepper, 1999) and a measure of interdependent happiness developed in Japan (Interdependent Happiness Scale; Hitokoto & Uchida, 2015), with data from 63 countries representing 7 sociocultural regions. Results indicate that the schema of independent happiness was more coherent in more WEIRD countries. In contrast, the coherence of interdependent happiness was unrelated to a country's "WEIRD-ness." Reliabilities of both happiness measures were lowest in African and Middle Eastern countries, suggesting these two conceptualizations of happiness may not be globally comprehensive. Overall, while the two measures had many similar correlates and properties, the self-focused concept of independent happiness is "WEIRD-er" than interdependent happiness, suggesting cross-cultural researchers should attend to both conceptualizations

LA DESVALORIZACIÓN DE LO FEMENINO EN UNA TAREA FICTICIA DE SELECCIÓN DE PERSONAL

Este trabajo utiliza la perspectiva de género para explicar resultados de estudios del mercado laboral. A partir de una lista de correos de la universidad Adolfo Ibáñez, se obtuvo una muestra de 229 participantes para el Experimento 1 y 94 para el Experimento 2. En ambos experimentos se manipuló la información que los participantes tenían acerca de atributos femeninos o masculinos de postulantes ficticios a un cargo laboral. Mientras que el Experimento 1 contenía diferencias en el tipo de postulante y diferencias en el tipo de cargo (típicamente femenino o masculino), el Experimento 2 tuvo como objetivo mostrar que al manipular los atributos asociados a género, independientemente del cargo, se podían producir resultados que implicaban claramente la desvalorización de los atributos femeninos. Nuestros resultados son consistentes con estudios anteriores que muestran cómo los atributos femeninos son socialmente más desvalorizados que los masculinos

Metodología para validar un instrumento de evaluación por competencias en estudiantes de Psicología

This paper presents a methodology to validate an instrument for the assessment of competencies associated to a psychology students’ profile. Using a quantitative non- experimental- correlational design, with the participation of the school of psychology faculty, a tool was developed based on a group of selected competencies. The validation process was conducted by applying the instrument to second year psychology students. Results demonstrate its validity and contribute to the research on the development and validation of instruments designed to determine whether teaching - learning strategies are achieving the proposed competencies in students’ education.Se presenta una metodología para validar una estrategia de evaluación por competencias asociadas al perfil de alumnos de psicología. Mediante un estudio cuantitativo de diseño no experimental-correlacional, con la participación del cuerpo docente de la carrera de psicología, se elaboró un instrumento con base en un grupo de competencias seleccionadas. El proceso de validación se llevó a cabo aplicándolo a estudiantes de segundo año de la carrera. Los resultados muestran su validez y contribuyen a la investigación en el diseño de estrategias para la elaboración y validación de instrumentos que permitan determinar si efectivamente las estrategias de enseñanza – aprendizaje están logrando las competencias propuestas en la formación de los alumnos

Metodología para validar un instrumento de evaluación por competencias en estudiantes de Psicología

This paper presents a methodology to validate an instrument for the assessment of competencies associated to a psychology students’ profile. Using a quantitative non- experimental- correlational design, with the participation of the school of psychology faculty, a tool was developed based on a group of selected competencies. The validation process was conducted by applying the instrument to second year psychology students. Results demonstrate its validity and contribute to the research on the development and validation of instruments designed to determine whether teaching - learning strategies are achieving the proposed competencies in students’ education.Se presenta una metodología para validar una estrategia de evaluación por competencias asociadas al perfil de alumnos de psicología. Mediante un estudio cuantitativo de diseño no experimental-correlacional, con la participación del cuerpo docente de la carrera de psicología, se elaboró un instrumento con base en un grupo de competencias seleccionadas. El proceso de validación se llevó a cabo aplicándolo a estudiantes de segundo año de la carrera. Los resultados muestran su validez y contribuyen a la investigación en el diseño de estrategias para la elaboración y validación de instrumentos que permitan determinar si efectivamente las estrategias de enseñanza – aprendizaje están logrando las competencias propuestas en la formación de los alumnos

Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia

Altres ajuts: This study has been co-financed with European Union ERDF funds. The project also counts on with the support from Swing Therapeutics, Inc., San Francisco, CA. Juan P. Sanabria-Mazo has a PFIS predoctoral contract from the ISCIII (FI20/00034). Jaime Navarrete has a postdoctoral contract awarded by CIBERESP (CB22/02/00052). Estíbaliz Royuela has a research contract linked to a project awarded by the Ministry of Education and Science (PID2020-117667RA-I00).Objective: Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms. Methods: A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses. Conclusions: This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context

Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer

Abstract Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer that presents as de novo metastatic disease in 20–30% of cases, with one-third of cases demonstrating HER2-positivity. There has been limited investigation into locoregional therapy utilization following HER2-directed systemic therapy for these patients, and their locoregional progression or recurrence (LRPR) and survival outcomes. Patients with de novo HER2-positive metastatic IBC (mIBC) were identified from an IRB-approved IBC registry at Dana-Farber Cancer Institute. Clinical, pathology, and treatment data were abstracted. Rates of LRPR, progression-free survival (PFS), overall survival (OS), and pathologic complete response (pCR) were determined. Seventy-eight patients diagnosed between 1998 and 2019 were identified. First-line systemic therapy comprised chemotherapy for most patients (97.4%) and HER2-directed therapy for all patients (trastuzumab [47.4%]; trastuzumab+pertuzumab [51.3%]; or trastuzumab emtansine [1.3%]). At a median follow-up of 2.7 years, the median PFS was 1.0 year, and the median OS was 4.6 years. The 1- and 2-year cumulative incidence of LRPR was 20.7% and 29.0%, respectively. Mastectomy was performed after systemic therapy in 41/78 patients (52.6%); 10 had a pCR (24.4%) and all were alive at last follow-up (1.3–8.9 years after surgery). Among 56 patients who were alive and LRPR-free at one year, 10 developed LRPR (surgery group = 1; no-surgery group = 9). In conclusion, patients with de novo HER2-positive mIBC who undergo surgery have favorable outcomes. More than half of patients received systemic and local therapy with good locoregional control and prolonged survival, suggesting a potential role for local therapy

Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia

Objective Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms. Methods A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses. Conclusions This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context.peerReviewe