JMIR Research Protocols最新文献

{"title":"Genetic, Epidemiological, and Clinical Risk Factors for Perinatal Anxiety and Depression in Dubai: Protocol for a 2-Point Prospective Observational Study.","authors":"Zenab Yusuf Tambawala, Nusrat Khan, Shabnam Saquib, Jeyaseelan Lakshmanan, William Atiomo","doi":"10.2196/68346","DOIUrl":"10.2196/68346","url":null,"abstract":"<p><strong>Background: </strong>Perinatal anxiety and depression can significantly impact maternal well-being, infant development, and mother-child bonding. There is a relative lack of research on the overall burden of and risk factors for perinatal and postpartum depression and anxiety in the Middle Eastern region.</p><p><strong>Objective: </strong>We aimed to investigate genetic, epidemiological, and clinical risk factors for anxiety and depression in antenatal and postnatal mothers.</p><p><strong>Methods: </strong>This study is a 2-point, cross-sectional, observational study of pregnant women at a tertiary care hospital in Dubai, United Arab Emirates. We will evaluate the point prevalence of depression and anxiety with the Edinburgh Postnatal Depression Scale, the Generalized Anxiety Disorder 7 scale, and the Holmes-Rahe Stress Inventory and analyze the risk factors in affected and unaffected women. The women will be evaluated with structured interviews, initially in the antenatal period (between 20 to 26 weeks) and again in the postnatal period (between 6 weeks to 6 months after delivery). Whole-genome sequencing will be conducted to comprehensively map genomes and detect variants associated with depression and anxiety after the initial interview. Social factors such as family characteristics and partner support, as well as lifestyle factors such as exercise, vitamin D intake, and obstetric factors, along with intrapartum and neonatal events affecting maternal mental health, will also be assessed.</p><p><strong>Results: </strong>We will assess the prevalence of depression, anxiety, stress, and risk factors in the antenatal and postnatal period between July 2025 and June 2026 at Dubai Hospital. The association of genetic, social, and demographic risk factors with depression and anxiety will be compared in women who screen positive for depression and anxiety and those who screen negative.</p><p><strong>Conclusions: </strong>This research aims to identify genetic variants associated with perinatal anxiety and depression in Middle Eastern women and to develop a comprehensive risk assessment tool for identifying women at high risk for perinatal anxiety and depression.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/68346.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68346"},"PeriodicalIF":1.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12076025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pain Assessment Tools for Infants, Children, and Adolescents With Cancer: Protocol for a Scoping Review.","authors":"Mika Hirata, Noyuri Yamaji, Shotaro Iwamoto, Ayaka Hasegawa, Mitsuru Miyachi, Takashi Yamaguchi, Daisuke Hasegawa, Erika Ota, Nobuyuki Yotani","doi":"10.2196/66614","DOIUrl":"10.2196/66614","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pain management in children with cancer may be inadequate due to poor pain assessment, and evaluation using suitable tools is necessary. Despite the availability of many pain assessment scales, few studies have summarized the existing assessment tools, making it challenging to select a suitable scale.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This scoping review aims to map existing pain assessment tools for children with cancer and provide a comprehensive overview of pediatric cancer-related pain screening and assessment tools.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The scoping review will be conducted according to the guidelines by the Joanna Briggs Institute and reported following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) framework. Electronic databases, including PubMed, CINAHL, CENTRAL, ICHUSHI (Japan Medical Abstracts Society), and Embase, will be searched to identify eligible studies, without date or language restrictions. We defined the eligibility criteria based on the PCC (Population, Concept, and Context) format. Studies that focused on assessment tools for evaluating pain in children (aged 0-18 years) with cancer in a hospital or at home will be included. Although there are no restrictions on study design, protocols and conference abstracts will be excluded. Two or more reviewers will select studies by reviewing the full text of relevant articles identified by titles and abstracts, and disagreements will be resolved through discussion. Two or more reviewers will extract predefined data items, including characteristics of included studies (eg, author name, title of publication, year of publication, purpose of study, study setting, study population, outline of the assessment tool, study design, and findings) and the characteristics of assessment tools (eg, types of tools, target population, assessor, validity, instructions, precautions, and advantages and disadvantages of the tools). Pain assessment tools will be summarized in tabular format and described in a narrative synthesis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Through electronic database searches on November 20, 2023, we identified 3748 articles. This review will provide a comprehensive overview of pain assessment tools. The final report is planned for submission to a peer-reviewed journal in 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This scoping review is the first comprehensive effort to map existing tools on pediatric cancer-related pain assessment tools for infants, children, and adolescents aged &lt;18 years, according to developmental stages. Based on the findings of this study, we will discuss future clinical and research implications for pain assessment and management in children with cancer. The findings are expected to enhance pain management practices in children with cancer and inform health care providers, policy makers, and other stakeholders.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered repo","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66614"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Effectiveness of Community-Delivered Hearing Rehabilitation and Health Education Intervention on Social Isolation and Functioning Among Chinese Adults With Hearing Impairment: Protocol for Randomized Controlled Trial.","authors":"Jiamin Gao, Yuying Zhang, Xiaqing Jiang, Zhenjing Fu, Haochen Jiang","doi":"10.2196/64115","DOIUrl":"10.2196/64115","url":null,"abstract":"<p><strong>Background: </strong>Hearing impairment (HI) is a common sensory deficit with considerable impacts on social well-being (SWB) in adults. Evidence on the effectiveness of auditory rehabilitation and hearing health education in the social domain of health for individuals with HI is scarce.</p><p><strong>Objective: </strong>This study aims to test the feasibility and efficacy of providing free hearing aids or a combined offline and online hearing health education intervention on social isolation and functioning among Chinese adults with HI.</p><p><strong>Methods: </strong>This study is a 3-arm, single-blinded, randomized controlled trial (RCT) with a follow-up at 24 months after the baseline study. A total of 435 participants aged 18 years and older with some degree of HI will be recruited and randomly assigned to 2 intervention groups and 1 control group. Free hearing-aid provision, as well as a hearing health education program that is combined with online and offline lessons, will be implemented in 2 intervention groups, respectively. The control group will not receive any intervention. The primary outcomes include social isolation and functioning in society. The secondary outcomes include social engagement, a sense of mastery, self-efficacy, psychological resilience, chronic diseases, life satisfaction, hearing health literacy, and hearing care usage.</p><p><strong>Results: </strong>Participants were recruited for hearing tests in September 2022, during which baseline results were collected through in-person interviews. Follow-up interviews were conducted in September 2024. The primary analysis will use ANOVA, linear mixed-effects modeling, structural equation modeling, and cost-effectiveness analysis.</p><p><strong>Conclusions: </strong>The findings of this study will provide evidence for the impact and cost-effectiveness of a community-based auditory or hearing health education intervention on SWB among Chinese adults with HI, which may contribute to promoting hearing health and reducing adverse health consequences in an aging society.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2200062148; https://www.chictr.org.cn/showproj.html?proj=174741.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64115.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64115"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gamification in mHealth Apps for Rehabilitation: Protocol for a Scoping Review.","authors":"Jacqueline Dawson, Randall Nee, Christian Ramirez, Sharlene Reyes, David Sanchez, Tulsi Sukhadia, Andrew Bartlett","doi":"10.2196/63600","DOIUrl":"10.2196/63600","url":null,"abstract":"<p><strong>Background: </strong>The use of gamification in physical therapy mobile health interventions has increased rapidly in recent years, particularly with self-management of exercise in a home environment. Prior research has focused broadly on digital exergames, such as virtual reality or video games, or specifically on single concerns, such as stroke or musculoskeletal rehabilitation.</p><p><strong>Objective: </strong>This scoping review aims to identify studies that have implemented gamification in rehabilitative interventions through mobile apps to treat all conditions addressed by physical therapists. Characteristics related to the rehabilitative process, gamification elements, and patient-related outcomes will be examined.</p><p><strong>Methods: </strong>A literature search will be conducted on the following databases: MEDLINE (Ovid), Embase, CINAHL, PeDRO, Scopus, and Web of Science. Study inclusion criteria will be based on the PICO (Population, Intervention, Comparison, Outcome) framework, with publications describing the use of a gamified mobile app in a movement-based intervention in any area of physical therapy included. The reporting of results will adhere to PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). A narrative synthesis of included publications will be performed.</p><p><strong>Results: </strong>Database searches were completed in May 2024 and yielded 2148 publications, with an additional 49 records identified through manual searching of references. Title and abstract screening, full-text screening, and data extraction are expected to be completed by April 2025. The review is expected to be completed by September 2025.</p><p><strong>Conclusions: </strong>Findings from this scoping review will provide evidence on gamified mobile apps to assist physical rehabilitation professionals with decision-making on remote interventions. Understanding game elements used in rehabilitative mobile apps may enhance patient engagement and adherence, which may ultimately improve patient-related outcomes.</p><p><strong>Trial registration: </strong>Open Science Framework fz9nq; https://osf.io/fz9nq.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63600"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144007085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of Using Resting Heart Rate and Step Counts From Patient-Held Sensors During Clinical Assessment of Medical Emergencies (FUSE): Protocol for Prospective Observational Study in European Hospitals.","authors":"Jack Barrington, Christian Subbe, John Kellett, Erika Frischknecht Christensen, Mikkel Brabrand, Prabath Nanayakkara, Jelmer Alsma","doi":"10.2196/55975","DOIUrl":"10.2196/55975","url":null,"abstract":"<p><strong>Background: </strong>Abnormalities of vital signs are quantified by comparison with normal ranges, which are those observed in resting healthy populations. It might be more appropriate to compare the vital sign values of an individual in distress with their own usual values recorded when they were stable and well. Sensors from smartwatches or smartphones might make this possible at scale, but the proportion of patients using them is not known.</p><p><strong>Objective: </strong>This study aimed to assess the feasibility of using heart rate and mobility data from patients' own wearable sensors as part of clinical assessments at the time of presentation to hospitals with medical emergencies, and to quantify the difference between heart rate and the change in daily steps taken by the patient on admission to acute care compared with the previously recorded values at home.</p><p><strong>Methods: </strong>This is an international, multicenter observational study using the flashmob research design. The study will recruit patients aged 18 years and older who present to emergency departments, acute medical departments, or ambulatory emergency care with an acute medical complaint. Main end points of the study include the proportion of patients assessed for an acute complaint who use wearable devices to record vital signs. The study will describe the population that uses devices that collect vital signs in terms of sex, age group, digital literacy, and the severity of illness on presentation (as measured by a standard set of vital signs and frailty). Trends in heart rate and step counts measured in the month before presentation to acute care services will be reported according to discharge or admission status. Data will be collected during a pilot phase and during a single week in centers across Europe.</p><p><strong>Results: </strong>The study has been registered and passed the required approvals in the Netherlands Medical Ethics Committee (MEC-2022-0795) and the United Kingdom Integrated Research Application System (IRAS 321129). Based on the results of a pilot study performed at a single site in the United Kingdom, a flashmob study has been concluded in hospitals throughout Europe in May 2024 and reported in 2025.</p><p><strong>Conclusions: </strong>With the increasing availability of consumer held devices able to record medically relevant information this study will provide information about the availability of these data for clinical use in a number of European settings.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/55975.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e55975"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mobile Health-Based Motivational Interviewing to Promote SARS-CoV-2 Vaccination in Rural Adults: Protocol for a Pilot Randomized Controlled Trial.","authors":"Ashlea Braun, Sarah Corcoran, Khue Tu Doan, Cameron Jernigan, Cate Moriasi, Michael Businelle, Thanh Bui","doi":"10.2196/64010","DOIUrl":"10.2196/64010","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Despite documented effectiveness, the public health impact of vaccinations is severely limited by misperceptions, hesitancy, and poor acceptance. Messaging from health care providers has not yet been optimized to overcome these barriers and has not been tailored to groups that face health disparities, such as rural Americans. Because vaccines have become controversial, as illustrated by the public response to the SARS-CoV-2 vaccines, traditional approaches that use persuasive education or advice to change perspectives are unlikely to have long-term effects and may even be counterproductive. Alternatively, motivational interviewing (MI) is a conversational approach to address modifiable behavior and its empathic nature can be useful when navigating challenging topics. Although MI has been found to be efficacious in improving vaccination rates among children and adolescents, it is unknown whether MI can reduce vaccine hesitancy and health disparities among underserved rural adults. Further, the ideal mode of delivery for MI is unknown, especially \"dose,\" \"intensity,\" and integration with mobile health (mHealth). Therefore, it is essential to investigate the efficacy of MI in promoting vaccine uptake in rural populations to reduce health disparities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to develop and evaluate the feasibility, acceptability, and preliminary efficacy of our mHealth-based MI intervention to diminish SARS-CoV-2 vaccine hesitancy (MOTIVACC).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This pilot study uses mixed methods. A 2-phase study will be conducted: convening a community advisory panel to understand barriers and facilitators to vaccination and mHealth uptake among adults (phase 1, n=16-20), and a pilot 3-group single-blind randomized controlled trial (RCT) for 8 weeks (phase 2, N=60). In the RCT, we recruit adults who have received no previous dose of the COVID-19 vaccine and randomize them into one of three arms: standard MI (SMI; n=20), intensive MI (IMI; n=20), or mHealth-based MOTIVACC (n=20). The primary RCT outcomes are positive change in vaccine hesitancy and intention to obtain the vaccines, measured on Likert scales. The secondary RCT outcome is the actual vaccine receipt.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Phase 1 of this study was approved by the ethics committees of both the University of Oklahoma and Oklahoma State University in July 2022, and was completed in June 2023. Phase 2 of this study was approved by the ethics committee at the University of Oklahoma in April 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This randomized trial will evaluate the preliminary efficacy of MI for targeting SARS-CoV-2 vaccine hesitancy, as well as compare traditional MI versus mHealth-based MI. This will provide pivotal data on scalable strategies to assist in navigating vaccine hesitancy, including in rural populations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT05977192; https://clini","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64010"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study.","authors":"Gianvincenzo Zuccotti, Paolo Osvaldo Agnelli, Lucia Labati, Erika Cordaro, Davide Braghieri, Simone Balconi, Marco Xodo, Fabrizio Losurdo, Cesare Celeste Federico Berra, Roberto Franco Enrico Pedretti, Paolo Fiorina, Sergio Maria De Pasquale, Valeria Calcaterra","doi":"10.2196/65229","DOIUrl":"10.2196/65229","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Early detection of vital sign changes is key to recognizing patient deterioration promptly, enabling timely interventions and potentially preventing adverse outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;In this study, vital parameters (heart rate, respiratory rate, oxygen saturation, and blood pressure) will be measured using the Comestai app to confirm the accuracy of photoplethysmography methods compared to standard clinical practice devices, analyzing a large and diverse population. In addition, the app will facilitate big data collection to enhance the algorithm's performance in measuring hemoglobin, glycated hemoglobin, and total cholesterol.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A total of 3000 participants will be consecutively enrolled to achieve the objectives of this study. In all patients, personal data, medical condition, and treatment overview will be recorded. The \"by face\" method for remote photoplethysmography vital sign data collection involves recording participants' faces using the front camera of a mobile device (iOS or Android) for approximately 1.5 minutes. Simultaneously, vital signs will be continuously collected for about 1.5 minutes using the reference devices alongside data collected via the Comestai app; biochemical results will also be recorded. The accuracy of the app measurements compared to the reference devices and standard tests will be assessed for all parameters. CIs will be calculated using the bootstrap method. The proposed approach's effectiveness will be evaluated using various quality criteria, including the mean error, SD, mean absolute error, root mean square error, and mean absolute percentage error. The correlation between measurements obtained using the app and reference devices and standard tests will be evaluated using the Pearson correlation coefficient. Agreement between pairs of measurements (app vs reference devices and standard tests) will be represented using Bland-Altman plots. Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and likelihood ratios will be calculated to determine the ability of the new app to accurately measure vital signs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection began in June 2024. As of March 25, 2025, we have recruited 1200 participants. The outcomes of the study are expected at the end of 2025. The analysis plan involves verifying and validating the parameters collected from mobile devices via the app, reference devices, and prescheduled blood tests, along with patient demographic data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Our study will enhance and support the accuracy of data on vital sign detection through PPG, also introducing measurements of biochemical risk indicators. The evaluation of a large population will allow for continuous improvement in the performance and accuracy of artificial intelligence algorithms, reducing errors. Expanding research on mobile health solutions like Comestai can supp","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65229"},"PeriodicalIF":1.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Tai Chi Therapy on Fatigue and Cognitive Function in Individuals With Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.","authors":"Bin Wang, Xiaodong Zhang, Ping Lu, Pingping Sun, Tianxiang He","doi":"10.2196/65958","DOIUrl":"https://doi.org/10.2196/65958","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Chronic fatigue syndrome (CFS) is a psychosomatic disorder characterized by persistent fatigue, primarily involving physical and mental exhaustion, with greater emphasis on the latter. This leads to a deterioration in concentration and memory. These symptoms affect cognitive functions, including attention and memory, to varying degrees. Previous research has shown that Tai Chi can help reduce fatigue in individuals with CFS. However, the relationship between alleviating CFS-related fatigue through Tai Chi and its impact on cognitive functions remains unclear. The effects of Tai Chi on cognitive functions in individuals with CFS have not been clinically validated, and its efficacy and safety have yet to be examined through large-scale randomized controlled trials. Therefore, this protocol outlines a pilot randomized, parallel, single-blind clinical trial designed to evaluate the impact of Tai Chi therapy on fatigue and cognitive functions in individuals with CFS, using both subjective and objective assessments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This pilot study aims to explore the preliminary efficacy and safety of Tai Chi in reducing fatigue and improving cognitive function in patients with CFS, and to generate data to inform future large-scale trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention period and a 4-week follow-up. Enrolled patients will be randomly assigned to either the Tai Chi group (30 patients) or the health education group (30 patients). The Tai Chi group will receive the 24-style simplified Tai Chi intervention, while the control group will receive a health education intervention. Following the 12-week intervention, a 4-week follow-up will be conducted. The Tai Chi group will train 3 times per week, consisting of 2 in-person sessions at the Physical Education Center of Shanghai University of Traditional Chinese Medicine and 1 self-directed session guided online by an instructor. The primary outcome measure is the 20-item Multi-Dimensional Fatigue Inventory (MFI-20). The secondary outcome measures include the Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), Attention Network Test (ANT), working memory performance (N-Back task), and magnetic resonance imaging.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The research protocol and informed consent form were approved by the Shanghai Clinical Research Ethics Committee on March 18, 2024 (approval number SECCR2024-22-01). Participant recruitment began in April 2024. All interventions and concurrent data collection will be completed by October 2025, and the 4-week postintervention follow-up assessments will be finalized by the end of October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;As a pilot trial, the findings of this study will provide preliminary clinical evidenc","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65958"},"PeriodicalIF":1.4,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12064975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Rent Subsidy and Identity Capital Intervention for Youth Exiting Homelessness: Protocol for the Transitioning Youth Out of Homelessness 2.0 Pilot Randomized Controlled Trial.","authors":"Naomi S Thulien, Rowen K Stark, Alexandra Amiri, Alex Abramovich, Alex Akdikmen, Alexandra Carasco, Mardi Daley, Bernice Downey, Oluwapelumi Pukky Fambegbe, Tyler Frederick, Stephen W Hwang, Nicole Kozloff, Amanda Noble, Cheryl Pedersen, Marsha Rampersaud, Ruth Rodney, Tadios Tibebu, Rosane Nisenbaum","doi":"10.2196/66210","DOIUrl":"10.2196/66210","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;For young people who have experienced homelessness, relative housing stability alone is insufficient to achieve socioeconomic inclusion. There is little peer-reviewed research investigating interventions targeting socioeconomic inclusion outcomes for youth who have experienced homelessness. Our previous community-engaged work signaled that identity capital (purpose, control, self-efficacy, and self-esteem) may mediate socioeconomic inclusion outcomes for youth exiting homelessness. This 12-month pilot randomized controlled trial (RCT) explores whether portable rent subsidies and an intervention targeting identity capital hold promise as a way to facilitate socioeconomic inclusion for youth exiting homelessness and living in market rent housing in Ontario, Canada.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objectives of this study were (1) to examine the feasibility and acceptability of an RCT of targeted economic and identity-based supports to foster socioeconomic inclusion (primary objective), (2) to estimate the effect of adding identity-based supports to economic supports (intervention group) compared with economic supports alone (control group) at the 12-month end point with respect to self-reported proxy indicators of socioeconomic inclusion (secondary objective), and (3) to explore, among the intervention group, whether the estimated effect of the intervention differs by baseline variables or level of engagement with the intervention (exploratory objective).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a convergent mixed methods, 2-arm parallel RCT, open-label design with 1:1 allocation. All youth participants (n=40) received rent subsidies; half were randomly assigned an identity capital intervention (co-designed leadership guide+coach). The overall study was guided by community-based participatory action research axiology. The qualitative component used a qualitative descriptive design underpinned by critical social theory. The measures used were (1) recruitment, enrolment, and dropout metrics; self-report composite checklists regarding intervention engagement; coaching session attendance; and qualitative focus groups (primary measures); (2) education, employment, and training; housing security; and identity capital (secondary measures); and (3) impact of baseline variables (eg, participant demographics such as gender or mental health symptoms as measured by the Global Appraisal of Individual Needs-Short Screener) or level of engagement with intervention (coaching session attendance) on secondary measures (exploratory measures).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment and enrolment began March 1, 2023, and ended June 19, 2023. Data collection began March 7, 2023, and ended June 17, 2024. Qualitative and quantitative data analyses concluded on August 20, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Findings from this RCT will help inform the way we conceptualize the types of supports that are necessary to susta","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66210"},"PeriodicalIF":1.4,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12064965/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mapping the Evidence on Compassion Skills in Applied Behavior Analysis: Protocol for Scoping Review.","authors":"Daniele Nunes Longhi Aleixo, Daiton Junior Martins de Souza, Stela Regina Pedroso Vilela Torres de Carvalho, Marcia Regina Furlani, Cíntia Canato Martins, Emerson Roberto Dos Santos, João Daniel de Souza Menezes, Matheus Querino da Silva, Sônia Maria Maciel Lopes, Marcos Sanches Rodrigues, Natalia Almeida de Arnaldo Silva Rodriguez Castro, Helena Landim Gonçalves Cristóvão, Josimerci Ittavo Lamana Faria, Vânia Maria Sabadoto Brienze, Alba Regina de Abreu Lima, Patrícia da Silva Fucuta, Denise Cristina Móz Vaz Oliani, Neide Aparecida Micelli Domingos, Maria Cristina Oliveira Santos Miyazaki, Gerardo Maria de Araújo Filho, Júlio César André","doi":"10.2196/66399","DOIUrl":"https://doi.org/10.2196/66399","url":null,"abstract":"<p><strong>Background: </strong>Applied behavior analysis (ABA) is a scientific approach that applies principles of learning and motivation to assess, design, implement, and evaluate social and environmental modifications to produce meaningful changes in human behavior. It has been widely used in various settings, particularly in the treatment of individuals with autism spectrum disorders and other developmental disabilities. Recently, compassion has emerged as a topic of growing scientific interest within ABA. To improve socially relevant behaviors, it is essential to explore how behavior analysts can provide maximum support to clients and promote significant changes through compassionate care. Although compassion skills have been studied by ABA researchers, the literature still presents gaps in understanding how these skills can be effectively integrated into ABA practice.</p><p><strong>Objective: </strong>This study aimed to map, identify, and provide data available in the existing literature on compassion skills and applied behavior analysis.</p><p><strong>Methods: </strong>This scoping review will follow the methodological framework of Arksey and O'Malley with previously proposed refinements. The search strategy will use combinations of descriptors and their synonyms according to the Health Sciences Descriptors and MeSH (Medical Subject Headings) terms, using the PCC (population, concept, and context) mnemonic, combined with the Boolean operators AND Mesh OR. The electronic databases to be searched include Embase, Index Psicologia, Lilacs, PubMed, Scopus, and Web of Science. Studies published between 2020 and 2024 in English, Portuguese, and Spanish will be included. Two independent reviewers will screen titles, abstracts, and full texts, with a third reviewer resolving any disagreements.</p><p><strong>Results: </strong>As this is a protocol, results are pending. The review will synthesize definitions of compassion in ABA, map compassionate skills, analyze existing interventions, and identify outcomes associated with compassionate ABA practice.</p><p><strong>Conclusions: </strong>This scoping review is expected to contribute to the evolution of ABA toward a more compassionate and holistic approach, potentially leading to improved outcomes for clients and practitioners. The findings may inform the development of compassion training programs and influence care policies in ABA.</p><p><strong>Trial registration: </strong>OSF Registries 10.17605/OSF.IO/F3A6H; https://osf.io/f3a6h.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/66399.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66399"},"PeriodicalIF":1.4,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12062760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}