JMIR Research Protocols最新文献

{"title":"Virtual Reality-Based Social Musical Exergame Guided by Self-Determination Theory for Young Adults With Depression and Anxiety: Protocol for a Randomized Controlled Trial.","authors":"GuangZheng Wan, Yu Zhang, MengQi Li","doi":"10.2196/83737","DOIUrl":"https://doi.org/10.2196/83737","url":null,"abstract":"<p><strong>Background: </strong>Depression and anxiety frequently emerge during late adolescence and young adulthood; however, many conventional and app-based interventions struggle to sustain engagement. Virtual reality (VR) exergaming, music-based activities, and social interaction each show promise for supporting young people's mental health, but their combined therapeutic value remains insufficiently tested.</p><p><strong>Objective: </strong>This study aims to evaluate the effectiveness of a 6-week VR-based social musical exergame for reducing depressive and anxiety symptoms in young adults. The secondary objectives are to explore whether changes in basic psychological need satisfaction are associated with symptom change and to assess the effects on loneliness, presence, cardiorespiratory fitness, and in-game music-movement synchronization.</p><p><strong>Methods: </strong>This study is a 3-arm, parallel-group randomized controlled trial. A total of 110 participants aged 18 to 25 years with mild to moderate depression or anxiety will be recruited and randomized in a 1:1:1 ratio to (1) a VR social musical exergame, (2) a matched VR solo musical exergame active control, or (3) a waitlist control receiving standardized mental health guidance. Assessments will be completed at baseline, at the postintervention assessment (week 6), and at the 1-month follow-up assessment (week 10). The primary planned comparison is the experimental group vs the active control group.</p><p><strong>Results: </strong>This study was approved by the ethics committee of Hunan Traditional Chinese Medical College on September 8, 2025 (YXLL202509006) and prospectively registered at ClinicalTrials.gov on March 15, 2026 (NCT07482852). Internal institutional funding had been secured. As of April 2026, the trial status was \"not yet recruiting;\" no participants had been enrolled, and no data analysis had been conducted. Recruitment is anticipated to begin in May 2026, with primary completion on March 1, 2028, study completion on May 1, 2028, and publication of the primary findings expected in late 2028.</p><p><strong>Conclusions: </strong>This protocol describes a self-determination theory-informed, multicomponent VR intervention designed to evaluate whether adding a bundled social layer to a matched solo exergame improves short-term mental health outcomes. The trial is expected to provide initial evidence on efficacy, safety, and potential mechanisms while generating hypotheses for future dismantling and longer-term trials.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT07482852; https://clinicaltrials.gov/ct2/show/NCT07482852.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/83737.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e83737"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815306","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":"Telehealth-Delivered Mindfulness-Based Intervention: Protocol for a Randomized Clinical Trial for Individuals With Alcohol Use Disorder.","authors":"Megan Kirouac, Daniel S Otero, David I K Moniz-Lewis, Sarah Bowen, Corey R Roos, Christine Vinci, Angel R Vasquez, Matison McCool, Frank J Schwebel, Roberta Chavez, Amber Martinez, Rena Quintana, Rachel Olson, Katie Witkiewitz","doi":"10.2196/92198","DOIUrl":"https://doi.org/10.2196/92198","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Globally, approximately 8.6% of people will meet criteria for alcohol use disorder (AUD) in their lifetimes, with 2.2% meeting criteria for AUD in the past 12 months. In the United States, AUD prevalence is even greater, with 13.9% meeting criteria in the past 12 months. Effective treatments for AUD exist, although most people receive help through mutual support groups (ie, Alcoholics Anonymous [AA]). However, AA and other mutual support programs may not be desirable for all individuals, particularly those who do not seek abstinence-based approaches. Treatments that support reductions in drinking have been shown to be as effective as abstinence-based treatments in reducing alcohol-related harms, and may be more appealing to a broader range of people. Mindfulness-based interventions may be particularly effective in supporting long-term recovery, whole-person health, and functioning for those with abstinent and nonabstinent recovery goals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study is designed to test a novel rolling group-based mindfulness-based relapse prevention (MBRP) delivered via videoconferencing, focused on drinking reduction goals and whole-person functioning.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a hybrid type 1 effectiveness-implementation design to prospectively test the effectiveness of MBRP and to identify barriers and facilitators of group participation to inform future implementation of MBRP as continuing care. Individuals with AUD (n=470) interested in stopping or reducing their drinking, meet criteria for AUD based on a symptom checklist, report heavy drinking at least once in the past 6 months, consent and understand study procedures in English, and provide a valid US mailing address are recruited nationwide via online sources in the United States. Participants are randomized to either MBRP groups via Zoom (Zoom Video Communications, Inc) or referral to online mutual support (eg, AA). All participants receive an individual orientation session delivered via Zoom that includes brief motivational interviewing and an overview of their assigned condition and next steps (MBRP condition: overview of the MBRP groups and instructions on participating in MBRP via Zoom; referral condition: referral to online mutual support groups). Participants provide blood samples for phosphatidylethanol testing at baseline and 3-year follow-up and complete self-report measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment began on September 13, 2023, and the last recruited participant was randomized on March 20, 2025. Follow-up data collection is ongoing with all 6-month follow-ups completed (86% retention).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study evaluates the effectiveness and mechanisms of MBRP delivered via videoconferencing, compared with referra","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e92198"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13134644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815303","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":"The Effects of Body-Oriented Interventions on Cancer-Related Symptoms of Women Who Survived Breast Cancer: Protocol for a Systematic Review.","authors":"Daniela Guerreiro, Ana Cruz-Ferreira, Graça Duarte Santos, Brenda M S da Silva, José Marmeleira, Guida Veiga","doi":"10.2196/76858","DOIUrl":"https://doi.org/10.2196/76858","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Breast cancer is one of the most prevalent cancers worldwide, with a 5-year survival rate exceeding 90%. Despite advances in treatment, survivors frequently experience persistent cancer- and treatment-related symptoms that negatively impact their quality of life. Body-oriented interventions (BOIs) have demonstrated effectiveness in symptom management; however, systematic reviews focused exclusively on BOIs for women who survived breast cancer (WSBC) remain limited. This systematic review protocol outlines the methodology for evaluating the scientific evidence on the effects of BOIs on cancer- and treatment-related symptoms in WSBC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to examine the scientific evidence on the effects of BOIs on cancer- and treatment-related symptoms, well-being, and quality of life in WSBC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This protocol follows PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. We will conduct searches in 6 electronic databases: PubMed, Cochrane, Web of Science, Scopus, APA PsycNet, and Portal Regional da BVS. Studies will be considered for inclusion if they are written in English, French, Portuguese, or Spanish, with no restrictions on publication date; they consist of WSBC (aged 18 to 64 years); they are randomized controlled trials, quasi-randomized controlled trials, and pilot studies focusing on BOIs; they include a control group receiving no intervention, standard care, or a non-BOI; and the primary outcomes of interest include preintervention and postintervention measures of cancer- and treatment-related symptoms, well-being, and quality of life. The methodological quality of the studies and the risk of bias will be assessed using the PEDro scale and version 2 of the Cochrane risk-of-bias tool, respectively. The synthesis of results will be measured through the Best Evidence Synthesis. Two experienced independent reviewers will conduct study selection, data extraction, methodological quality assessment, and scientific evidence assessment. Disagreements will be resolved by a third reviewer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This protocol describes the prespecified methodology for the systematic review. At the time of publication of this protocol, the corresponding full systematic review manuscript was under peer review. The outcomes will synthesize the scientific evidence on the effects of BOIs on cancer- and treatment-related symptoms in WSBC. It is anticipated that this systematic review will identify benefits and directions for future research to support the integration of BOIs tailored to this population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Considering that previous systematic reviews focused on the effects of BOIs in survivors of all cancer types, challenges related to study risk of bias such as heterogeneity in intervention types, study designs, and outcome measures are anticipated, potentially leading ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e76858"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815289","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":"Status of Evidence on the Efficacy and Safety of Indian Traditional Medicine for Prediabetes and Type 2 Diabetes Mellitus: Protocol for a Systematic Review and Evidence Map Synthesis.","authors":"Galib Ruknuddin, Azeem Ahmad, Manohar S Gundeti, Meena R, Eugene Wilson, Malik Itrat, Ghazala Javed, Mohd Aleemuddin Quamri, Deepti Singh Chalia, Pooja Yadav, Athul T P, Karthik K P, Anjana C S, Mythri H S, Aparna Dileep, Shifa Shetty P","doi":"10.2196/70617","DOIUrl":"https://doi.org/10.2196/70617","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Noncommunicable diseases, particularly diabetes, pose a growing global burden, with India disproportionately affected. India also has a rich repository of traditional medical systems-Ayurveda, yoga and naturopathy, Unani, Siddha, Sowa Rigpa, and homeopathy (AYUSH)-collectively governed under the Ministry of Ayush. These systems adopt a personalized and integrative approach to diabetes management, addressing glycemic control alongside metabolic and lifestyle factors. Despite growing use and evidence for AYUSH interventions, standardized evaluation methods remain limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to quantitatively evaluate the evidence status for AYUSH interventions for the management of prediabetes and type 2 diabetes mellitus and establish a road map of evidence through research for better outcomes in the future.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The systematic review will be conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered in PROSPERO. All primary study designs, including randomized controlled trials, nonrandomized controlled trials, parallel-arm intervention trials, pretest-posttest trials, observational studies (including cross-sectional, case-control, and cohort studies), and case series and case reports will be assessed. Systematic reviews and meta-analyses will be screened for background information and identification of relevant primary studies but will not be included in the evidence synthesis. Studies involving AYUSH interventions either as stand-alone therapies or as an add-on to standard care will be reviewed. Electronic databases along with AYUSH-specific sources, including PubMed, CENTRAL, clinical trial registries, AYUSH Research Portal, MEDLINE, Scopus, Web of Science, Embase, Digital Helpline for Ayurveda Research Articles, and IndMED, will be searched using database-specific search strategies combining AYUSH-related and diabetes-specific keywords with Boolean operators. Outcome measures will include clinical recovery, biochemical parameters, quality of life, and adverse events. Data will be synthesized systematically and represented through an evidence map.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Database searches and pilot-testing of strategies are planned to commence in September 2025. Screening of eligible studies, data extraction, and quality assessment are planned for December 2025; data compilation and manuscript preparation will be conducted from July 2026 to October 2026; and the final systematic review and evidence map are anticipated by December 2026. Publication of the results is expected in early 2027. Anticipated findings will include a systematic integration of data relevant to the efficacy and safety profiles of AYUSH interventions for prediabetes and type 2 diabetes accompanied by an evidence map showcasing the allocation and reliability of the current evidence base on different A","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e70617"},"PeriodicalIF":1.5,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13131314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815305","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":"Demographic Profiles and Methodologies Used in the Generation and Validation of Resting Metabolic Rate Prediction Equations: Protocol for a Systematic Review.","authors":"James W Navalta, Jafrā D Thomas, Whitley J Stone","doi":"10.2196/82482","DOIUrl":"https://doi.org/10.2196/82482","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Resting metabolic rate (RMR) prediction equations used today often rely on the consideration of binary sex. Significant intrasex variability and a lack of data on diverse populations raise concerns about these equations' validity and generalizability. Existing systematic reviews have focused on specific populations like individuals with obesity or athletes, but none have systematically examined the demographic characteristics of participants used to derive these equations. Our central hypothesis is that the accuracy of RMR prediction is influenced by the demographic alignment between the equation's derivation population and the individual. We present a systematic review protocol to critically evaluate the literature and participant demographic profiles that underpin current RMR prediction equations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;Our objectives are to (1) determine the characteristics of participant populations, including reporting on gender and sex diversity, used in RMR equation research; (2) critically appraise the methodologies, findings, and reporting practices of studies that developed RMR equations for binary populations; and (3) use the Sex and Gender Equity in Research guidelines to assess sex and gender terminology and variable inclusion in the generative RMR prediction literature.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Following a PROSPERO-registered protocol (CRD420251084400), we will conduct a comprehensive search across multiple databases, including Academic Search Premier, PubMed, and Web of Science. The final search string will be: ((resting metab* rate) OR (RMR) OR (basal metab* rate) OR (BMR) OR (metabol*) OR (resting energy expenditure) OR (metab* rate)) AND ((predict* equation) OR (predict* model) OR (predict* algorithm) OR (formula) OR (estimation equation)) AND ((demograph*) OR (characterist*) OR (age) OR (race) OR (ethnicity) OR (sex) OR (gender)). We will include peer-reviewed, English-language articles reporting studies that generated RMR prediction equations and reported human participant demographic characteristics. Exclusion criteria include studies not generating prediction equations, without demographic data, or involving animals. Data extraction will include reported participant demographics (eg, sex, gender, race or ethnicity, age, and body composition), RMR test protocols, and reported reliability or validity metrics. Risk of bias will be assessed using PROBAST (Prediction Model Risk of Bias Assessment Tool).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in June 2025 by the University of Nevada, Las Vegas Sports Innovation Initiative Catalyst Grant Funding Program and in July 2025 by the National Association for Kinesiology in Higher Education Hellison Interdisciplinary Research Grant. The databases were searched using the final search string between August 1, 2025, and August 8, 2025. Training of team members began on September 3, 2025, and concluded on October 20, 2025.&lt;/p&gt;&lt;p&gt;","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82482"},"PeriodicalIF":1.5,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147814977","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":"Use of Shared Decision-Making in Non-Muscle-Invasive Bladder Cancer: Protocol for a Scoping Review.","authors":"Tullika Garg, Tierney Lyons, Kirstin Rabinowitz, Jazmine Gabriel","doi":"10.2196/90101","DOIUrl":"https://doi.org/10.2196/90101","url":null,"abstract":"<p><strong>Background: </strong>With a growing range of treatment options for non-muscle-invasive bladder cancer (NMIBC), the emergence of longitudinal patient-reported quality-of-life data, and an aging population managing the treatment burden of coexisting conditions, there is an increasing need for shared decision-making processes and tools to support urologists and patients in navigating complex treatment decisions. What remains unknown is how shared decision-making is currently incorporated into NMIBC treatment decisions and which factors inform key decisions in NMIBC.</p><p><strong>Objective: </strong>The objective of this scoping review is to map and characterize the existing literature on shared decision-making in NMIBC, with a focus on decision-making tools, decision points in the NMIBC cancer journey, and factors influencing patient and clinician decision-making.</p><p><strong>Methods: </strong>This scoping review protocol was designed in accordance with the Joanna Briggs Institute scoping review methodology. The final results will be reported in a subsequent publication in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) 2018 guidelines. A comprehensive search strategy will identify published, unpublished, and gray literature from databases (PubMed, Embase, CINAHL, PsycInfo, and Web of Science), professional society websites, and foundation websites. Eligibility criteria were determined based on the population, concept, and context framework. The population will include adults aged ≥18 years at the time of NMIBC diagnosis, with urothelial histology. The concept focuses on existing shared decision-making tools and patient- and urologist-level factors contributing to decisions. The context includes urology clinics in academic and community settings.</p><p><strong>Results: </strong>The literature search was conducted in September 2025. Title and abstract screening, full-text review, qualitative data coding, and quantitative data analysis are anticipated to be completed by October 2026.</p><p><strong>Conclusions: </strong>The treatment landscape for NMIBC is rapidly evolving, with a growing range of options, each with its own risks and benefits. This scoping review will help elucidate how shared decision-making is currently used in NMIBC treatment decisions and identify the key factors that are important to both urologists and patients. These data will guide future intervention development and research to enhance the quality of shared decision-making in NMIBC.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e90101"},"PeriodicalIF":1.5,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13131830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815270","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":"Vitamin C Supplementation in Hospitalized Patients With Community-Acquired Pneumonia: Protocol for a Randomized Controlled Trial.","authors":"Yogesh Sharma, Arduino A Mangoni, Richard Woodman, Huah Shin Ng, Manisha Arthur, Subodha Sumanadasa, Shailesh Bihari, Campbell Thompson","doi":"10.2196/91037","DOIUrl":"https://doi.org/10.2196/91037","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Community-acquired pneumonia (CAP) remains a leading cause of hospitalization, morbidity, and mortality worldwide, particularly among older adults with multimorbidity and frailty. Despite advances in antimicrobial therapy, clinical outcomes have improved little, highlighting the need for safe, inexpensive adjunctive treatments. Vitamin C plays a critical role in immune function, redox homeostasis, and endothelial integrity, all disrupted during acute infection. Hypovitaminosis C is common in hospitalized patients with CAP and has been associated with increased disease severity, longer length of stay (LOS), and worse outcomes. However, prior randomized trials of vitamin C have produced inconsistent results, often focusing on critically ill patients with sepsis, using short treatment durations, and discontinuing therapy abruptly.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The Vitamin C in Community-Acquired Pneumonia (VitCAP) trial aims to evaluate whether high-dose oral vitamin C administered over an extended period improves clinical recovery and patient-centered outcomes in adults hospitalized with CAP.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;VitCAP is a single-center, double-blind, placebo-controlled, parallel-group randomized clinical trial conducted at a tertiary hospital in Australia. Adults aged 18 years and older hospitalized with CAP will be randomized within 48 hours of admission in a 1:1 ratio to receive either oral sodium ascorbate (1 g 3 times daily for 7 days, followed by 500 mg twice daily for 30 days) or a matching placebo in addition to standard care. Randomization will be computer generated with allocation concealment via a centralized pharmacy service, and all participants, clinicians, investigators, and outcome assessors will remain blinded. The primary outcome is time to clinical stabilization, defined using standard physiological criteria. Secondary outcomes include early clinical response, symptom burden at 30 days, intensive care unit admission, need for ventilatory or vasopressor support, LOS, all-cause mortality at 30 days and 6 months, hospital readmission, health-related quality of life, and changes in inflammatory biomarkers (C-reactive protein and procalcitonin). Analyses will follow the intention-to-treat principle. The primary outcome will be analyzed using Cox proportional hazard regression adjusted for prespecified covariates, with sensitivity analyses including restricted mean survival time.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The VitCAP trial received ethics approval from the Southern Adelaide Local Health Network Human Research Ethics Committee in 2025 and funding in September 2025. Recruitment is expected to commence in 2026 and continue for 18 to 24 months. A total of 124 participants will be enrolled to provide 80% power to detect a clinically meaningful difference in time to clinical stabilization while allowing for attrition. Data analysis will follow completion of follow-up, with primary results","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91037"},"PeriodicalIF":1.5,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771825","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":"Portrayals of Mental Health in Video Games: Protocol for a Scoping Review.","authors":"Helga Dis Isfold Sigurdardottir, Víctor Manuel Perez-Colado, Cathrine Fredriksen Moe, Terje Geir Solvoll, Stefan Rennick-Egglestone","doi":"10.2196/78379","DOIUrl":"10.2196/78379","url":null,"abstract":"<p><strong>Background: </strong>Digital games are increasingly influential in shaping public perceptions of mental health due to their interactive and narrative nature. While serious games designed for therapeutic use have been studied, less is known about how mental health challenges are portrayed in mainstream video games for leisure and the impact of these portrayals on players.</p><p><strong>Objective: </strong>This scoping review aims to explore how academic studies address the representation of mental health challenges in contemporary video games for leisure, with particular attention to game design features, depictions of coping or living with a mental health condition, recovery, and intervention.</p><p><strong>Methods: </strong>The review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) methodology and applies the population, concept, and context framework. A comprehensive literature search was conducted across 6 databases (PubMed, Scopus, ProQuest, ERIC, IEEE Xplore, and Web of Science) in July 2024 and will be updated to include studies published until November 2025. Eligible studies include peer-reviewed original research on the portrayal of mental health in mainstream digital games. Screening and data extraction were conducted independently by 2 reviewers using Rayyan and NVivo software. Data synthesis will be narrative, focusing on themes of representation, game mechanics, recovery, and audience impact.</p><p><strong>Results: </strong>As this is a protocol, no empirical results are available. The completed review will map how scholarly studies conceptualize and analyze portrayals of mental health in video games, identify recurring thematic and design patterns, and synthesize trends in how researchers frame the relationship between gameplay and mental health representation.</p><p><strong>Conclusions: </strong>By systematically mapping the current literature, this review will contribute to a deeper understanding of how mental health is depicted in mainstream games and will highlight areas for future research, including ethical considerations and opportunities for more informed, empathetic, and responsible game design.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e78379"},"PeriodicalIF":1.5,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771755","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":"Effect of Acupuncture for Chronic Nonspecific Low Back Pain: Study Protocol for a Randomized Double-Blind, Placebo-Controlled Trial.","authors":"Hiroyoshi Yajima, Miho Takayama, Tomoaki Takanashi, Tomohiro Tanaka, Morihiro Nasu, Takahiro Yamada, You Hiramatsu, Ted Kaptchuk, Judith Schlaeger, Jian Kong, Shigeki Tanaka, Nobuari Takakura","doi":"10.2196/78713","DOIUrl":"10.2196/78713","url":null,"abstract":"<p><strong>Background: </strong>Chronic nonspecific low back pain (CNSLBP) is the most common chronic condition worldwide. Although recommended in several clinical guidelines, high-quality double-blind studies supporting the evidence for acupuncture remain limited.</p><p><strong>Objective: </strong>This study aims to test the efficacy of penetrating acupuncture for CNSLBP using double-blind needles that blind both the acupuncturist and the participant, which provides the most rigorous methodology for acupuncture trials to date.</p><p><strong>Methods: </strong>This study was a randomized double-blind (acupuncturist-patient) placebo-controlled trial conducted at the Tokyo Ariake University of Medical and Health Sciences Acupuncture Clinic. Seventy-five adult participants with CNSLBP were randomized to genuine penetrating, skin-touch placebo, and no-touch placebo needles that do not touch the skin. Consistent with prior studies and clinical practice, acupoints on the bladder meridian were mainly used. The study has 2 primary outcomes: an objective outcome and a subjective outcome. The primary objective outcome is the flexion-relaxation phenomenon, an index associated with low back pain, assessed using surface electromyography (sEMG) recordings of the bilateral lumbar erector spinae muscles and hamstrings. The primary subjective outcome is pain intensity measured using a visual analog scale (VAS) before and after the intervention.</p><p><strong>Results: </strong>The Ethics Committee approved the study protocol of Tokyo Ariake University of Medical and Health Sciences in April 2018 (approval number: 0246). This study started in July 2018 and was completed in March 2025.</p><p><strong>Conclusions: </strong>This trial used a double-blind design and objective outcome measures to rigorously evaluate the efficacy of acupuncture for CNSLBP.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e78713"},"PeriodicalIF":1.5,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13128048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771734","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":"Liquid Biopsy Biomarkers in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Prostate-Specific Membrane Antigen Radioligand Therapy: Protocol for a Prospective, Longitudinal Multicenter Observational Study.","authors":"Kerstin Michalski, Theo Lorenzini, Tim Jedamzik, Marieke Heinrich, Aleksander Kosmala, Isabel Rauscher, Mika Bauch, Lena Reichl, Luisa Amann, Simon Liebl, Andreas Buck, Matthias Eiber, Constantin Lapa, Rainer Claus","doi":"10.2196/86737","DOIUrl":"10.2196/86737","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Prostate cancer is the second leading cause of cancer-related mortality in men worldwide. Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) has emerged as a theranostic strategy for metastatic castration-resistant prostate cancer (mCRPC), with [177Lu]Lu-PSMA-617 demonstrating survival benefits in the VISION trial. However, clinical responses are heterogeneous, and resistance mechanisms remain poorly understood. Liquid biopsy (LBx), particularly circulating tumor DNA (ctDNA), may provide a minimally invasive approach to assess tumor heterogeneity, monitor response, and detect emerging resistance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The LOOPS (Liquid Biopsy as a Biomarker in Patients Treated with PSMA Radioligand Therapy) study aims to prospectively investigate the prognostic and predictive value of ctDNA in patients undergoing PSMA RLT.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;LOOPS is a prospective, multicenter observational biomarker trial recruiting 100 patients with mCRPC eligible for PSMA RLT across 3 Bavarian cancer research centers in Germany. Patients will undergo up to 6 cycles of [177Lu]Lu-PSMA-617. Blood samples for ctDNA analysis will be collected longitudinally (at baseline and after cycles 1, 2, 4, and 6) and processed according to standardized protocols. Imaging with PSMA positron emission tomography-computed tomography and clinical and biochemical data will be systematically collected. The primary end points are the prognostic and predictive value of baseline ctDNA for treatment response, defined by imaging- and prostate-specific antigen (PSA)-based response criteria after 2 cycles of PSMA RLT. Predictive performance will be evaluated using receiver operating characteristic analyses, including the determination of optimal ctDNA cutoffs, sensitivity, specificity, positive and negative predictive values, and multivariable logistic regression models adjusting for relevant clinical confounders. Secondary end points assess the concordance and correlation between ctDNA dynamics, systematically assessed PSMA positron emission tomography-computed tomography response, and PSA changes, as well as associations between ctDNA and clinical or laboratory (eg, age, Gleason score, and other) characteristics at baseline and during follow-up. Exploratory analyses will investigate early molecular response patterns based on short-term ctDNA changes and will characterize clonal dynamics and potential resistance mechanisms under therapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study has been funded by the German Research Foundation (Deutsche Forschungsgemeinschaft) since July 2025. Patient recruitment has already commenced, and in January 2026, a total of 63 patients have been enrolled. Analysis of LBx samples was initiated in January 2026, while recruitment and data collection are ongoing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The LOOPS study will provide the first prospective, systematic evaluation of ctDNA as ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e86737"},"PeriodicalIF":1.5,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13128046/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771808","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}