JMIR Research Protocols最新文献

{"title":"A Complex Intervention to Strengthen Person-Centered Care and Leadership in Residential Care Facilities (the PERLE Study): Protocol for a Development and Implementation Study.","authors":"Anna-Karin Edberg, Annica Backman","doi":"10.2196/76185","DOIUrl":"https://doi.org/10.2196/76185","url":null,"abstract":"<p><strong>Background: </strong>Although the benefits of person-centered care (PCC) are widely recognized, there is a lack of empirical research on how PCC is best developed and implemented by the leaders responsible for driving such initiatives. To achieve meaningful change and ensure the sustainability of PCC practices, it is crucial to understand how leaders can foster care environments rooted in person-centered values while managing operational challenges. This knowledge gap highlights the need for an in-depth exploration of the conceptual foundations, experiences, mechanisms, strategies, and outcomes of person-centered leadership (PCL) to design an intervention for strengthening such leadership.</p><p><strong>Objective: </strong>The Person-Centered Care and Leadership in Residential Care Facilities (PERLE) study aims to (1) explore and develop tools to measure PCL; (2) develop, test, implement, and investigate the effects of an intervention to strengthen PCL in residential care facilities (RCFs) for older people; and (3) generate knowledge about the process of development and implementation of the intervention.</p><p><strong>Methods: </strong>The PERLE study builds on the Medical Research Council framework for the development of complex interventions. It includes several studies with exploratory, descriptive, correlational, and quasi-experimental designs and is based on the research group's previous research on PCL. The project is composed of 5 work packages (WPs). Each WP includes research questions with different samples; data collection; and methodological approaches, such as qualitative, mixed methods, and quantitative studies. As this project involves sensitive issues, a high level of ethical awareness was maintained throughout. The primary challenge is the possible interference with participants' work time, which could otherwise be devoted to supporting older people and staff. Nevertheless, the involvement of leaders and staff can lead to valuable knowledge that can improve the quality of PCC. Participants will be provided with both oral and written information about the study and assured of their right to withdraw at any time without providing a reason.</p><p><strong>Results: </strong>As of July 2025, 6 studies in WP I have been conducted, and one is in progress. The conducted studies address leaders' understanding of PCC, the meaning of PCL in RCFs from the perspective of leaders, the ethical challenges in providing PCC during the COVID-19 pandemic, and the cultural adaptation of the aged care clinical leadership qualities framework.</p><p><strong>Conclusions: </strong>This project aims to provide new insights into the support that first-line managers need to advance PCC in RCFs, highlight their specific challenges, and create tailored support measures for the implementation of PCL. The intervention could potentially reduce staff turnover and related costs while supporting leadership training and education to benefit future leaders i","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76185"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving the Predictive Accuracy of the National Early Warning Score 2: Protocol for Algorithm Refinement.","authors":"Chris Plummer, Cen Cong, Madison Milne-Ives, Lynsey Threlfall, Peta Le Roux, Edward Meinert","doi":"10.2196/70303","DOIUrl":"https://doi.org/10.2196/70303","url":null,"abstract":"<p><strong>Background: </strong>The National Early Warning Score 2 (NEWS2) has been widely adopted for predicting patient deterioration in health care settings using routinely collected physiological observations. The use of NEWS2 has been shown to reduce in-hospital mortality, but it has limited accuracy in the prediction of clinically important outcomes, especially over longer time periods.</p><p><strong>Objective: </strong>This project aims to improve the predictive accuracy of the NEWS2 scoring system, particularly its accuracy over more than 24 hours and its predictive value in older patients and children. It will investigate whether using the currently collected data differently and the inclusion of additional data would result in an improved algorithm.</p><p><strong>Methods: </strong>The study will use historical patient data from the Newcastle upon Tyne Hospitals NHS Foundation Trust, including observational data (eg, vital signs), BMI- related data, and other outcome-related variables (eg, mortality rates) to train and test an algorithm to predict the risk of key clinical outcomes, including mortality, intensive therapy unit admission, sepsis, and cardiac arrest, to demonstrate a proof of concept for a modified scoring system. The algorithm's performance will be assessed based on its accuracy, precision, F₁-score, area under the curve, and receiver operating characteristic curve.</p><p><strong>Results: </strong>The study is expected to start in April 2025. The findings are expected to be produced by the end of 2026 and will be disseminated at symposia, conferences, and in journal publications.</p><p><strong>Conclusions: </strong>The refined NEWS2 algorithm will address limited accuracy in predicting clinical deterioration beyond 24 hours in the original system by incorporating additional variables. Improved accuracy in the early detection of deterioration can lead to timely interventions, potentially reducing mortality and adverse clinical events. The enhanced algorithm also has the potential to be integrated into existing clinical decision support systems to facilitate health care professionals' decision-making.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/70303.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70303"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Electroacupuncture Through Nerve Stimulation in Patients With Anxiety Disorders: Protocol for a Randomized, Assessor-Blind, Three-Arm, Parallel-Group Clinical Trial.","authors":"In Chul Jung, Dong-Hoon Kang, Sunyoung Choi, Yujin Choi, Ojin Kwon, Hye Jeong Kook, Daeun Lee, Yang-Chun Park, Jieun Kim","doi":"10.2196/68166","DOIUrl":"10.2196/68166","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Anxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Clinical Research Information Servic","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68166"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Repeated Pressure and Shear Stress at the Posterior Heel Following Localized Skin Cooling: Protocol for a Repeated Measures Cohort Study.","authors":"Ralph Gordon, Charlotte Stevens, Peter Worsley, Davide Filingeri","doi":"10.2196/73250","DOIUrl":"https://doi.org/10.2196/73250","url":null,"abstract":"<p><strong>Background: </strong>Pressure in combination with shear forces can deform soft tissues and lead to development of pressure ulcers. The prevalence rate of pressure ulcers in the United Kingdom remains unacceptably high and can occur across the human lifespan. The posterior heel represents a common anatomical site for pressure ulcers due to soft tissues lying adjacent to bony prominences and being exposed to pressure and shear during lying postures. Localized cooling and interface materials that reduce shear may offer potentially therapeutic benefits in the development of pressure ulcers. Yet the physiological mechanisms underpinning the potential benefits of localized cooling are not fully understood.</p><p><strong>Objective: </strong>This study protocol aims to investigate how localized cooling influences the skin's microvascular, inflammatory, structural, and perceptual tolerance to repeated shear loading at the heel.</p><p><strong>Methods: </strong>The protocol will be tested on individuals of different age, sex, skin tone, and comorbidities, using a repeated measures design. Three cohorts will be recruited: (1) young and healthy (n=35), (2) older and healthy (n=35), and (3) with spinal cord injury (n=35). Participants will complete 3 testing sessions using a custom-built shearing rig with integrated thermal plate, during which the posterior aspect of the heel will be exposed to a standardized mechanical stimulus to elicit repeated pressure and shear loading. The experimental condition of each session will be determined by the temperature of the thermal plate, which will be set to either 36 °C (no cooling), 24 °C (mild cooling), or 16 °C (strong cooling). Continuous measurements will include kinetic coefficient of friction (CoF) and skin blood flow (via laser Doppler flowmetry; 40 Hz). Pro- and anti-inflammatory biomarkers in skin sebum (via Sebutape), structural skin properties (via optical coherence tomography), skin conductance (in microsiemens) and ratings of thermal sensation, comfort, and acceptance (via Likert scales) will also be assessed before and after the shear stress protocol.</p><p><strong>Results: </strong>Recruitment began in January 2024. As of February 2025, 43 participants had been enrolled in the study. Data collection and analysis are ongoing, and published findings are expected to be available in early 2026.</p><p><strong>Conclusions: </strong>This analysis will help identify mechanisms of skin damage following repeated shear stress at the heel, furthering our understanding of superficial pressure ulcers. It will also establish physiological and perceptual thresholds for the protective effects of cooling from shearing-induced damage at the heel.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/73250.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73250"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Falls Prevention Among Older Adults in Rural Communities: Protocol for a Scoping Review.","authors":"Megan Funk, Juanita-Dawne Bacsu, Melba Sheila D'Souza, Anila Virani, Zahra Rahemi, Matthew Lee Smith","doi":"10.2196/63716","DOIUrl":"10.2196/63716","url":null,"abstract":"<p><strong>Background: </strong>Falls are a critical source of injury and hospitalization and leave many older adults unable to return home, especially in rural communities with limited access to health care and support services. Studying falls prevention among rural older adults is essential because they may face an increased risk of falls due to unique environmental factors, geography, and outdoor activities. Moreover, rural older adults may have limited awareness regarding fall-related risks and preventive activities.</p><p><strong>Objective: </strong>The objective of this scoping review is to explore the literature about falls prevention from the perspectives of older adults living within a rural context. This review protocol aims to identify the search parameters and methodology that will be used in the scoping review.</p><p><strong>Methods: </strong>This scoping review will be guided by Arksey and O'Malley's 5-step methodological framework. We will search for relevant peer-reviewed English language literature from 5 databases: CINAHL, PubMed, Academic Search Complete, PsycINFO, and Scopus. The reference lists of relevant studies will be hand-searched to identify papers. Inclusion criteria (English language, peer-reviewed journal papers, original research, focusing on rural perspectives to support falls prevention, and published from January 2013 to December 31, 2023) will be used to determine the eligibility of the journal papers. The data from the included papers will be extracted using a standardized table and analyzed using thematic analysis.</p><p><strong>Results: </strong>This protocol was registered with the Open Science Framework on June 26, 2024. The scoping review's data collection and analysis were conducted from September to December 2024. Results from the review will be distributed through publication in a peer-reviewed journal paper, conference presentation, webinar, and a rural community workshop.</p><p><strong>Conclusions: </strong>Understanding rural older adults' perspectives of falls prevention is critical to supporting independence and healthy aging in rural communities. This review's findings about falls prevention may have important implications for rural community leaders, policy makers, and health practitioners working to support falls prevention in rural communities.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/63716.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63716"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anti-Inflammatory Versus Antifibrotic Therapies for the Management of Rheumatoid Arthritis-Associated Interstitial Lung Disease: Protocol for a Systematic Review and Meta-Analysis.","authors":"Sneh Sonaiya, Alexandra Jianu, Nicholas Jianu, Kavita Batra","doi":"10.2196/73219","DOIUrl":"10.2196/73219","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that affects approximately 0.5% to 1% of the population in the United States and Northern Europe. Interstitial lung disease (ILD) is the most common and severe pulmonary manifestation of RA, collectively referred to as RA-associated ILD (RA-ILD). RA-ILD contributes significantly to morbidity and mortality and often presents with a variable clinical course. Although corticosteroids and disease-modifying antirheumatic drugs (DMARDs) remain the cornerstone of RA management, their role in RA-ILD is less clearly defined. In contrast, antifibrotic therapies such as pirfenidone and nintedanib, initially developed for idiopathic pulmonary fibrosis, are now being explored for their potential in treating fibrosing variants of RA-ILD. Despite increasing clinical use, no systematic review has comprehensively compared the safety and efficacy of antifibrotic versus anti-inflammatory therapies in chronic RA-ILD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to compare the impact of antifibrotic and anti-inflammatory therapies on lung function, radiologic progression, clinical outcomes, and safety in patients with chronic RA-ILD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered with PROSPERO (CRD42024583847). A comprehensive search of PubMed, Embase, and the Cochrane Library will be conducted for studies published between January 1991 and August 2024. Eligible studies will include adult patients (aged ≥18 years) with a diagnosis of RA and confirmed ILD based on radiological or histopathological findings who have been treated with either antifibrotic or anti-inflammatory therapies. The PECOS (Population, Exposure, Comparator, Outcome, Study Design) framework will be used to define inclusion criteria. The primary outcomes assessed in this review will include the following pulmonary function parameters: forced vital capacity, forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide. Anti-inflammatory therapies will be stratified into corticosteroids, conventional synthetic DMARDs, and biologic DMARDs to account for heterogeneity. The Cochrane Risk of Bias 2 (RoB 2) and Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tools will be used for quality assessment, and GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology will be used to evaluate the certainty of evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The literature search and screening commenced in August 2024, and data extraction is underway. The final results are expected by December 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This systematic review and meta-analysis will provide a comprehensive comparison of antifibrotic and anti-inflammatory therapies in the treatment of chronic RA-ILD. The findings will help inf","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73219"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reduction of Salt and Sugar Contents in Canteen Foods and Intakes By Students and Staff at a Malaysian Higher Education Institution: Protocol for a Mixed Methods Study.","authors":"Yook Chin Chia, Yee-How Say, Maong Hui Cheng, Felicia Fei Lei Chung, Tze Pheng Lau, Pei Boon Ooi","doi":"10.2196/69610","DOIUrl":"10.2196/69610","url":null,"abstract":"<p><strong>Background: </strong>University students and staff members, especially those who frequently eat out and spend considerable time on campus, form a crucial demographic facing challenges related to high salt and sugar intake in out-of-home food. Recognizing the high prevalence of eating out among these populations, it is imperative to understand the salt and sugar consumption levels of campus communities.</p><p><strong>Objective: </strong>This protocol describes the rationale and design of a 3-part cross-sectional and longitudinal interventional study to reduce salt and sugar contents in canteen foods and intakes among students and staff at Sunway University and Sunway College in Malaysia.</p><p><strong>Methods: </strong>First, the knowledge, attitudes, and practices (KAPs) and perception, barriers, and enablers (PBEs) of salt and sugar intake and reduction were assessed among students and staff (part 1 of the study). Second, the KAPs and PBEs of salt, oil, and sugar reduction were assessed among canteen staff (part 2 of the study). Third, a longitudinal interventional study was conducted by implementing a campus-wide executive order to reduce salt and sugar in all foods sold on campus (part 3 of the study). The salt and sugar contents of selected foods were measured at baseline and at 3 months and 6 months postreduction. Participants who eat frequently on campus were selected as the intervention group, while those who do not comprised the control group. All participants had their urine electrolytes and body compositions measured and recorded 24-hour dietary intakes for 2 weekdays and 1 weekend at baseline, 3 months, and 6 months after salt and sugar reduction.</p><p><strong>Results: </strong>The study protocols were approved by the institutional review board of Sunway University (SUREC 2024/029 and SUREC 2024/040). Recruitment for the cross-sectional studies began in May 2024, while that for the longitudinal intervention study began in June 2024. The 6-month intervention began in September 2024 immediately after the official launch of the campus-wide executive order to reduce salt and sugar. We targeted recruitment of 1000, 50, and 300 participants for parts 1, 2, and 3, respectively. We anticipate reduced dietary salt and sugar intakes by 30% and 50%, respectively (World Health Organization targets), and beneficial health effects on the participants.</p><p><strong>Conclusions: </strong>The insights gained from this study will help to create a healthier food environment, benefitting individuals who regularly eat out, especially at the workplace.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06473038; https://clinicaltrials.gov/study/NCT06473038.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/69610.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69610"},"PeriodicalIF":1.4,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Human-Centered Approach for a Student Mental Health and Well-Being Mobile App: Protocol for Development, Implementation, and Evaluation.","authors":"Maryam Gholami, David Wing, Manas Satish Bedmutha, Job Godino, Anahi Ibarra, Byron Fergerson, Nicole May, Christopher A Longhurst, Nadir Weibel, Anne Duffy, Heidi Rataj, Karandeep Singh, Kevin Patrick","doi":"10.2196/68368","DOIUrl":"https://doi.org/10.2196/68368","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The rising prevalence of mental health concerns among students is prompting universities to explore innovative solutions to support student well-being. This paper describes the protocol for the development, implementation, and evaluation of a mobile app designed to address the mental health and wellness needs of students. This project employs a student-centered approach, partnering with students from the initial needs analysis through to the final design and implementation stages.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The app aims to increase the use of campus resources that address student mental health and wellness by improving the awareness of these resources through user-designated preferences that are established on the initial use of the app and then iteratively refined as it is used. The app is linked to the campus student's electronic health record so that health and wellness services can be coordinated and enhanced and the student journey to and through care become more seamless. The long-term objective is to leverage data from both the app and electronic health record to improve individual and population health for the entire campus.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;At the beginning of the project, a comprehensive logic model was created to outline the core inputs, activities, outputs, outcomes, and long-term impacts that were desired for the app. The model emphasized the integration of the app within existing campus mental health and wellness services and its potential to foster a culture of well-being across the university community. An evaluation plan was developed that incorporates both quantitative and qualitative methods through biannual assessments to track trends and app impact across campus in addition to feasibility, acceptability, and usability as well as its reach, effectiveness, and sustainability. Validated measures such as the Patient Health Questionnaire and Generalized Anxiety Disorder scale were selected to track changes in mental health and wellness, while custom surveys and analytics will gauge user engagement and satisfaction. New students, including freshmen, transfers, and first-year medical students, are invited to participate after giving informed consent. They receive compensation for their involvement in both quantitative and qualitative assessments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of March 2025, we have collected over 600 survey responses from freshmen, transfer, and medical students. A second survey round and additional focus groups are planned for April to May 2025. No analyses have been conducted yet. The findings from this project have the potential to inform similar efforts at other institutions and contribute to the broader field of digital mental health innovation and the development of well-being interventions tailored for young people.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;By leveraging digital technology and actively engaging students in supporting their well-being, this ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68368"},"PeriodicalIF":1.4,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maintaining Resilience and Well-Being in the Era of Climate Change: Protocol of an Acceptability and Feasibility Pilot of the Bee Well Program for Treating Eco-Anxiety in Rural Children Exposed to Natural Hazards.","authors":"Suzanne M Cosh, Warren Bartik, Rosie Ryan, Amanda Jefferys, Kaii Fallander, Phillip J Tully, Amy D Lykins","doi":"10.2196/69005","DOIUrl":"https://doi.org/10.2196/69005","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The effects of climate change on mental health are becoming widely recognized. Mental health can be impacted through direct and indirect exposure to natural hazards, as well as through the overarching awareness of climate change and the resultant environmental decline-the latter is termed eco-anxiety. Exposure to natural hazards also increases eco-anxiety, further compounding mental health impacts. Young people are especially vulnerable to the mental health impacts of climate change and have higher rates of eco-anxiety than other age groups. Those in rural areas are also more likely to be impacted by natural hazards, further underscoring the need to support this population. To date, there remains scant evidence regarding how to support young people with eco-anxiety, and few interventions, especially for children, have been evaluated. There is a need for further research to inform treatment for young people for climate change-related distress.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study pilots a novel group-based mental health and resilience intervention in relation to eco-anxiety. Specifically, this project aims to explore the acceptability, feasibility, and clinical utility of a group-based eco-anxiety intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The project is an exploratory pilot assessing the acceptability, feasibility, and clinical utility of a group-based intervention using a pre-post design with a single group. A minimum sample of 12 children aged 10-14 years located in a rural area and with exposure to at least one natural hazard will be enrolled in this study. In order to assess clinical utility, changes from preintervention to postintervention in distress, resilience, and climate emotions will be assessed. To do so, children will complete measures of psychological distress (subjective units of distress, Depression Anxiety Stress Scale-21-youth version), climate emotions, and resilience (Resilience Scale for Children-10) before and after the intervention. Acceptability will be assessed post intervention through a series of Likert scale and open-ended questions. Feasibility will be assessed through enrollment and the proportion of participants completing the full intervention. Eligible children will take part in a novel 5-module group-based intervention designed to build resilience, promote nature connectedness, build social support, and foster meaning-focused coping.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study has received ethics board approval by the University of New England's Human Research Ethics Committee (HE23-080). This study will be conducted from late 2024 to 2025. As of March 2025, 28 children have been enrolled in the study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Rural children and young people are an especially vulnerable population for the mental health impacts of climate change. To date, the evidence base for interventions for treating eco-anxiety remains sparse, especially for young people and","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69005"},"PeriodicalIF":1.4,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intervention for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders: Protocol for a Randomized Controlled Hybrid Effectiveness-Implementation Trial.","authors":"Kathryn Bruzios, Paige M Shaffer, Daniel M Blonigen, Michael A Cucciare, Michael Andre, Thomas Byrne, Jennifer Smith, David Smelson","doi":"10.2196/70750","DOIUrl":"10.2196/70750","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The US Veterans Affairs mental health residential rehabilitation treatment programs (MH RRTPs) provide residential care for veterans experiencing homelessness. However, those with co-occurring mental health and substance use disorders and criminal legal involvement require additional interventions to address risk factors for recidivism.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aimed to (1.1) evaluate whether the Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking Criminal Justice version (MISSION-CJ) intervention lowers criminal recidivism and improves health-related outcomes; (1.2) examine the mechanisms that impact outcomes; and (2) qualitatively assess the implementation of MISSION-CJ.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Veterans participating in an MH RRTP (N=226) will be randomized to the enhanced usual care (EUC) or MISSION-CJ conditions in a hybrid type 1 randomized controlled trial to test the effectiveness and implementation of MISSION-CJ, a multicomponent intervention for co-occurring disorder. Both conditions will receive 6 months of services beginning within a week of MH RRTP enrollment (duration of stay: 3 months) and continue for 3 months after the MH RRTP in the community. The veterans in the EUC group (113/226, 50%) will receive a peer support curriculum and community outreach and linkage delivered by a peer support specialist. The veterans in the MISSION-CJ group (113/226, 50%) will receive team-based (case manager and peer support specialist) care, including treatment planning, case management using a critical time intervention model to promote referrals and linkages, enhanced dual recovery therapy sessions, and peer support sessions. Assessments, including questions regarding substance use and mental health history, criminal history and recidivism risk, housing, employment, medication adherence, mutual-help group attendance, antisocial attitudes, affiliations with peers, community involvement, and treatment services received, will be conducted at baseline and 6 months and 15 months after baseline. We will use generalized linear mixed effects regression models to evaluate MISSION-CJ based on outcomes (objective 1.1). We will conduct mediation analysis to examine mechanisms of action (objective 1.2). For the qualitative evaluation (objective 2), we will use thematic analysis to identify themes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of March 2025, 118 veterans (site 1: n=52, 44.1% and site 2: n=66, 55.9%) have been enrolled. Overall, 58 veterans (site 1: n=27, 47% and site 2: n=31, 53%) have been randomized to the MISSION-CJ group, and 60 veterans (site 1: n=25, 42% and site 2: n=35, 58%) have been randomized to the EUC group. Overall, 23 interviews for the qualitative evaluation have been completed with veterans. Veterans are continuing to receive treatment and completing follow-up assessments. The findings from this trial and qualitative evaluation will be available by","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70750"},"PeriodicalIF":1.4,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144663830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}