{"title":"Effectiveness and Cost-Effectiveness of a Mobile Psychoeducation Program (OkeyMind) for Social Anxiety Symptoms Among Youths: Protocol for a Randomized Controlled Trial.","authors":"Yi-Zhou Wang, De-Hui Ruth Zhou, Siu-Man Ng, Bei-Bei Wang, Yu-Ya Feng, Xue Weng","doi":"10.2196/64518","DOIUrl":"https://doi.org/10.2196/64518","url":null,"abstract":"<p><strong>Background: </strong>Social anxiety is increasingly prevalent among youths, leading to social withdrawal, isolation, and heightened depression risk. Mobile health (mHealth) interventions offer anonymity, accessibility, and personalized support, but their effectiveness and cost-effectiveness for young individuals with social anxiety remain unclear.</p><p><strong>Objective: </strong>This randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a mobile-based psychoeducation program (OkeyMind) for mitigating social anxiety symptoms among youth.</p><p><strong>Methods: </strong>Participants aged 15 years through 24 years with mild or more severe social phobia (Social Phobia Inventory [SPIN] ≥25) and access to WeChat will be recruited and screened onsite and then randomly assigned to the intervention or waiting list control group. The study will recruit 180 participants, with 90 in each group. The intervention group will receive a 1-month mobile psychoeducation program (OkeyMind), which includes both psychoeducation and meditation components, with all content fully automated. The waiting list control group will receive the same intervention after 3 months. The primary outcome is social anxiety symptoms measured using SPIN. Secondary outcomes include depression (Patient Health Questionnaire-9) and health-related quality of life (EuroQol-5). Assessments will be conducted at baseline, postintervention, and a 3-month follow-up.</p><p><strong>Results: </strong>Recruitment began in September 2024. The study was funded in April 2024, and the first participant was enrolled in September 2024; as of the end of March 2025, 132 participants had been recruited. Recruitment is ongoing. Data collection will conclude in July 2025, after which data analysis will begin and be completed in August 2025, with primary findings targeted for publication in spring 2026.</p><p><strong>Conclusions: </strong>This research evaluates the effectiveness and cost-effectiveness of OkeyMind, a mobile-based psychoeducation program, for reducing social anxiety symptoms among youth. OkeyMind might be a promising strategy for combating social anxiety, especially in low- and middle-income countries with limited medical resources. If effective, this intervention could provide an accessible, cost-effective approach to managing social anxiety, particularly in resource-limited settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06490315; https://clinicaltrials.gov/study/NCT06490315.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/64518.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64518"},"PeriodicalIF":1.4,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637049","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}
Chloe Connan, Sébastien Fromentin, Mourad Benallaoua, Anne-Sophie Alvarez, Nicolas Pons, Benoît Quinquis, Christian Morabito, Julie-Anne Nazare, Elise Borezée-Durant, Florence Haimet, Stanislav Dusko Ehrlich, Karine Valeille, Alexandre Cavezza, Hervé Blottière, Patrick Veiga, Mathieu Almeida, Joël Doré, Robert Benamouzig
{"title":"Correction: Associations Among Diet, Health, Lifestyle, and Gut Microbiota Composition in the General French Population: Protocol for the Le French Gut - Le Microbiote Français Study.","authors":"Chloe Connan, Sébastien Fromentin, Mourad Benallaoua, Anne-Sophie Alvarez, Nicolas Pons, Benoît Quinquis, Christian Morabito, Julie-Anne Nazare, Elise Borezée-Durant, Florence Haimet, Stanislav Dusko Ehrlich, Karine Valeille, Alexandre Cavezza, Hervé Blottière, Patrick Veiga, Mathieu Almeida, Joël Doré, Robert Benamouzig","doi":"10.2196/80127","DOIUrl":"10.2196/80127","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2196/64894.].</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e80127"},"PeriodicalIF":1.4,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144626378","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}
Chi-Shan Tsai, Warren Szewczyk, Michelle Drerup, Jason Liao, Alexi Vasbinder, Heather Greenlee, Jaimee L Heffner, Rachel Yung, Kerryn W Reding
{"title":"A Personalized, Texting-Based Conversational Agent to Address Sleep Disturbance in Individuals Who Have Survived Breast Cancer: Protocol for a Pilot Waitlist Randomized Controlled Trial.","authors":"Chi-Shan Tsai, Warren Szewczyk, Michelle Drerup, Jason Liao, Alexi Vasbinder, Heather Greenlee, Jaimee L Heffner, Rachel Yung, Kerryn W Reding","doi":"10.2196/62712","DOIUrl":"https://doi.org/10.2196/62712","url":null,"abstract":"<p><strong>Background: </strong>Sleep disturbance is one of the most common health concerns reported by individuals who have survived breast cancer (BC) and is associated with poor quality of life (QoL) and greater mortality after treatment. Cognitive behavioral therapy for insomnia (CBTi) has shown efficacy for improving sleep and QoL for this population. Considered the gold standard for insomnia treatment, CBTi can be delivered remotely, including via digital intervention. Despite the potential for wider dissemination of CBTi via digital means, these modalities have unique challenges, including technology barriers and poor adherence. We developed a conversational agent (CA) to deliver CBTi via a SMS text messaging intervention, supported by mobile-ready web content. Named \"Cecebot,\" this CA delivers sleep education, implements sleep compression, provides just-in-time interventions for sleep-disrupting behaviors, and includes enhanced support for physical activity (PA) beyond what is typically included in CBTi. This represents a novel modality for a CBTi and PA intervention among individuals who have survived BC.</p><p><strong>Objective: </strong>We aim to examine the safety and acceptability of the Cecebot intervention, developed by an academic partnership between Dr Reding's research team and Moby Inc, for individuals who have survived BC and experience symptoms of insomnia, and to explore its efficacy.</p><p><strong>Methods: </strong>This trial will recruit 60 individuals who have survived BC and are experiencing moderate to severe sleep disturbance. Participants will be assigned to the Cecebot intervention or waitlist control group at a 1:1 ratio. The treatment group will receive the Cecebot intervention during weeks 1-6 of the study, while the waitlist control condition will receive the Cecebot intervention during weeks 6-12. The Cecebot intervention uses SMS text messaging technology paired with a Fitbit. Participants will be assessed at baseline, week 6, and week 12. Measurements will include feasibility and acceptability and will explore the effect of the Cecebot intervention. Feasibility will be assessed through recruitment, enrollment, and retention rates. Acceptability will be evaluated using a satisfaction survey and open-ended responses. Quantitative analysis, such as t test, Fisher exact tests, and generalized linear models, will be used to assess feasibility, baseline group differences, and the outcomes of the intervention.</p><p><strong>Results: </strong>Recruitment of participants began in Fall 2024. The completion of data collection is anticipated to be by Fall 2025.</p><p><strong>Conclusions: </strong>The study results will give insight into the potential for an SMS text messaging-based CA to improve sleep in individuals who have survived BC and experience sleep disturbances.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06392789; https://clinicaltrials.gov/study/NCT06392789.</p><p><strong>International regi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e62712"},"PeriodicalIF":1.4,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637048","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":"Integrating Lived Experience Into Medical Education Related to Children With Medical Complexity or Developmental Disabilities: Protocol for a Scoping Review.","authors":"Noah Pollard, Leslie Christensen, Heidi Kloster, Danielle Gerber, Gail Chödrön","doi":"10.2196/64911","DOIUrl":"https://doi.org/10.2196/64911","url":null,"abstract":"<p><strong>Background: </strong>Involving people with lived experience in medical education can benefit them, their caregivers, and medical students, and may particularly impact medical education about children requiring comprehensive, individualized, multidisciplinary care, including those with medical complexity or developmental disabilities. Yet, there is no summary of how children with medical complexity or developmental disabilities, or their families or caregivers have been included in medical education for medical students, residents, and fellows. To advance the effective inclusion of lived experience in medical education related to this patient population, a synthesis of existing literature is needed.</p><p><strong>Objective: </strong>This scoping review aims to identify and synthesize the literature on including the lived experiences of children with medical complexity or developmental disabilities and their caregivers in medical education, where in the curricular development process they are involved, and the level of engagement of people with lived experience in the process.</p><p><strong>Methods: </strong>To complete the scoping review, MEDLINE, Scopus, PsycINFO, ERIC, Academic Search Premier, and Google Scholar were searched for studies investigating patient and caregiver involvement in medical education related to children with medical complexity or developmental disabilities. Studies involving continuing professional development or patients who are not children with medical complexity or developmental disabilities were excluded. Data will be extracted to identify the stage of curriculum development in which lived experience is included based on Kern's 6-step approach, and to examine the level of engagement in medical education of children with medical complexity or developmental disabilities, their families, or their caregivers. Data from the scoping review will be presented in tables, diagrams, or matrices to demonstrate how lived experience caring for children with medical complexity or children with developmental disabilities has been included in the 6 steps of curriculum development and to characterize the level of engagement of people with lived experience in this process. Descriptive analysis will be performed to identify the findings from the included sources pertaining to the research objective.</p><p><strong>Results: </strong>Database searches were completed on April 19, 2024. In total, 4382 unique articles were identified and screened against the eligibility criteria in July 2024, resulting in 30 articles being included in the scoping review. Data extraction began in July 2024.</p><p><strong>Conclusions: </strong>Our results will identify areas of improvement for medical education pertaining to the care of children with medical complexity or developmental disabilities. The findings will support and contribute to the development of medical school curricula surrounding care for children with medical complexity and children ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64911"},"PeriodicalIF":1.4,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612156","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}
Hagen Kerndl, Thomas Peter Millian, Karlheinz Gürtler, Alexander Hyhlik-Duerr
{"title":"Measuring Stress Reduction in Patients Receiving Multimedia Entertainment During Vascular Surgery Under Regional Anesthesia: Protocol for a Randomized Controlled Study.","authors":"Hagen Kerndl, Thomas Peter Millian, Karlheinz Gürtler, Alexander Hyhlik-Duerr","doi":"10.2196/70597","DOIUrl":"https://doi.org/10.2196/70597","url":null,"abstract":"<p><strong>Background: </strong>This study explores the treatment of internal carotid artery stenosis in patients with a high risk for cardiovascular events. The use of regional anesthesia permits ongoing neurological monitoring and enhances patient safety during the procedure. However, the operation can be stressful and lengthy, highlighting the need for strategies to alleviate patient discomfort. This study evaluates audiovisual distractions such as video goggles to potentially improve patient experiences during carotid surgeries, a topic that has not yet been comprehensively researched.</p><p><strong>Objective: </strong>We aimed to (1) determine whether there is a benefit for patients regarding stress reduction when using video goggles during vascular surgery of the carotid artery and (2) determine whether any parameters can effectively measure such a potential benefit.</p><p><strong>Methods: </strong>This prospective, randomized study at the University Hospital Augsburg is evaluating the use of HappyMed video goggles by patients undergoing carotid endarterectomy under regional anesthesia. Participants are randomized into either the intervention group, which receives the video goggles, or the control group, which does not. The surgical and anesthetic procedures remain consistent across both groups. Patients are eligible if they meet the surgical criteria, are able to lie supine, and are cooperative. Patients are excluded if they are receiving corticosteroids, have dementia, or have a language barrier. The study uses questionnaires and vital/laboratory parameters, including cortisol levels and heart rate, to assess stress and anxiety. To monitor potential motion sickness, the occurrence of nausea or vomiting is documented. Both patients and surgical staff will evaluate the experience postoperatively to determine the goggles' impact on patient experience and stress management during surgery.</p><p><strong>Results: </strong>The study has been approved by the local ethics committee and is registered at ClinicalTrials.gov. Patient inclusion started in September 2022 and should be completed within 3 to 4 years. This paper presents a study protocol that was finalized and approved by the local ethics committee in September 2022. At the time of this protocol's final submission for publication, approximately 90% of the recruitment had been completed. Following completion of recruitment and data acquisition, the results are intended to be published within one year.</p><p><strong>Conclusions: </strong>This study aims to improve patient comfort and perioperative care during vascular surgery. Therefore, our study aims to investigate if the use of video goggles during surgery is feasible and if there are parameters that indicate a benefit for patients. This study is being conducted as a pilot trial to provide a foundation for future research aimed at improving patient comfort during carotid artery surgery under local anesthesia.</p><p><strong>Trial registrat","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70597"},"PeriodicalIF":1.4,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612157","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}
Ana Carolina Aparecida Marcondes-Scalli, Patricia Rehder-Santos, Étore De Favari Signini, Alex Castro, Carla Dato, Leonardo Furlan, Richard Eloin Liebano, Aparecida Maria Catai
{"title":"Effects of Therapeutic Ultrasound and Aussie Current With High-Intensity Interval Training on Abdominal Adiposity in Young Adults With Overweight and Obesity: Protocol for a Randomized Controlled Trial.","authors":"Ana Carolina Aparecida Marcondes-Scalli, Patricia Rehder-Santos, Étore De Favari Signini, Alex Castro, Carla Dato, Leonardo Furlan, Richard Eloin Liebano, Aparecida Maria Catai","doi":"10.2196/71829","DOIUrl":"https://doi.org/10.2196/71829","url":null,"abstract":"<p><strong>Background: </strong>More than half of the world's population will be overweight or obese by 2035, and it is known that physical exercise, such as high-intensity interval training (HIIT), is a tool for controlling obesity by improving body composition and the metabolic profile. Noninvasive techniques such as therapeutic ultrasound (TUS) and the Aussie current have shown potential in controlling adipose tissue, but their effects combined with HIIT remain unknown. TUS may be combined with the Aussie current to potentiate the specific effects of each intervention, such as lipolysis induced by TUS and lymphatic activation promoted by the Aussie current. The integration of HIIT into this protocol is justified by its ability to stimulate β-oxidation and facilitate the metabolic use of fatty acids mobilized by the electrophysical resources. Furthermore, the use of HIIT as opposed to moderate-intensity continuous training contributes to reducing the total duration of the intervention.</p><p><strong>Objective: </strong>This study aims to evaluate the effects of TUS+Aussie current combined with HIIT on body composition, serum metabolic profile, and cardiovascular autonomic modulation (CAM) in individuals with overweight and obesity.</p><p><strong>Methods: </strong>This is a randomized, double-blind (researcher and outcome assessor) clinical study. The participants will be randomized into 3 groups: active TUS+Aussie current with HIIT group, placebo for TUS+Aussie current with HIIT group, and TUS+Aussie current-only group. All participants will undergo nutritional monitoring 30 days before the proposed interventions to adjust macronutrients, optimize energy intake, and improve diet quality. Primary outcomes include changes in subcutaneous adipose tissue thickness, body composition, and serum metabolic profile. Secondary outcomes assess perceived stress, body image, blood biochemistry, sleep quality, and CAM. Data analysis involves linear mixed models estimated using the maximum likelihood method with an appropriate covariance matrix structure.</p><p><strong>Results: </strong>A total of 60 participants will be recruited and randomized between February 2024 and June 2025. The baseline assessments and intervention are scheduled to be completed in August 2025, and data collection will be completed by the end of September 2025. Data acquisition is still ongoing; therefore, data analysis has not yet been carried out.</p><p><strong>Conclusions: </strong>This is the first study to combine TUS+Aussie current with HIIT, potentially integrating the effects of lipolysis and fat oxidation and possible changes in the serum metabolic profile and CAM. The results could optimize treatment duration, promote changes in lipid profile, and maintain cardiovascular health in people with overweight and obesity.</p><p><strong>Trial registration: </strong>Brazilian Registry of Clinical Trials RBR-4xh6232, Universal Trial Number: U1111-1287-2345; https://ensaiosclinicos.gov","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71829"},"PeriodicalIF":1.4,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612155","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}
Sophie A Roth, Angie E Lam, Barbara J Strupp, Richard L Canfield, Elisabeth Anne Larson
{"title":"The Effect of Maternal Choline Intake on Offspring Cognition in Adolescence: Protocol for a 14-year Follow-Up of a Randomized Controlled Feeding Trial.","authors":"Sophie A Roth, Angie E Lam, Barbara J Strupp, Richard L Canfield, Elisabeth Anne Larson","doi":"10.2196/73508","DOIUrl":"10.2196/73508","url":null,"abstract":"<p><strong>Background: </strong>Choline is an essential micronutrient crucial for fetal neurodevelopment. Numerous rodent studies reveal that compared to maternal consumption of standard chow, maternal prenatal choline deficiency produces lifelong offspring cognitive deficits, and maternal choline supplementation produces lifelong improvements in offspring cognition. Few studies have evaluated this question in humans, with mixed results. Nonetheless, the available data raise concerns about the low choline intakes of pregnant women and highlight the need for knowledge of the functional consequences of various choline intakes during pregnancy.</p><p><strong>Objective: </strong>This study will evaluate the cognitive and affective functioning of adolescents born to women who participated in a randomized controlled trial (RCT) of 2 levels of choline intake during pregnancy, with the primary aim of assessing offspring attention and spatial memory.</p><p><strong>Methods: </strong>In a double-blind, randomized controlled choline feeding trial 26 women beginning their third trimester of pregnancy were randomly assigned to 2 groups: daily choline consumption at 480 or 930 mg/day. In this 14-year follow-up, the offspring (n=21) of these women will complete cognitive tests proctored over videoconferencing software. Cognitive function domains will be assessed using web-based software from the Cambridge Neuropsychological Test Automated Battery (CANTAB Connect). We will also assess facets of mental health using the Achenbach System of Empirically Based Assessment (ASEBA). These assessments will test the hypothesis that third-trimester maternal choline intake exerts lasting effects on offspring attention, memory, executive function, and mental health.</p><p><strong>Results: </strong>Between January 2009 and October 2010, 26 women beginning their third trimester of pregnancy from the Ithaca area were enrolled in the original controlled feeding study. We successfully re-recruited 21 (80%) of the original 26 offspring to this 14-year remote follow-up study. Recruitment started in August 2023 and was concluded in October 2023. Analysis is ongoing, and the first results are expected to be submitted for publication in the fall of 2025. We hypothesize that adolescent offspring born to women in the 930 mg/day group will perform better in domains of attention, memory, executive function, and mental health than offspring of women in the 480 mg/day group. This study is unique because the total maternal choline intake is precisely known, and the offspring are followed into adolescence, a time when group differences are indicative of lifelong effects of prenatal intervention.</p><p><strong>Conclusions: </strong>The findings will provide important new information concerning the lasting functional consequences of maternal choline intake during pregnancy for offspring neurobehavioral health, thereby informing dietary recommendations and supplementation policies for pregnant wo","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73508"},"PeriodicalIF":1.4,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612158","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":"Interventions to Counter Health Misinformation Among Older People: Protocol for a Scoping Review.","authors":"Maryline Vivion, Valérie Reid, Valérie Trottier, Frédéric Bergeron, Isabelle Savard, Emilie Dionne, André Tourigny","doi":"10.2196/74138","DOIUrl":"10.2196/74138","url":null,"abstract":"<p><strong>Background: </strong>In contemporary society, misinformation and disinformation have emerged as significant challenges, impacting various aspects of public health and societal cohesion. Some authors argue that older adults are particularly vulnerable to the effects of misinformation due to potential digital health literacy challenges. A previous review identified pedagogical approaches most commonly adopted in interventions aiming to improve the digital literacy of older adults but did not specifically address digital health literacy.</p><p><strong>Objective: </strong>This scoping review protocol aims to explore digital health literacy interventions targeting health misinformation and designed specifically for older adults.</p><p><strong>Methods: </strong>Following the methodology outlined by Arksey and O'Malley and the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist, this protocol delineates a systematic approach encompassing 5 stages: identification of research questions, identification of relevant studies, selection of studies, data charting, and collation of findings. Our scoping review will include peer-reviewed literature on interventions targeting misinformation for older adults. Research will be conducted on the MEDLINE (Ovid), Embase (Elsevier), PsycINFO (Ovid), CINAHL, and Web of Science databases. Gray literature will also be surveyed by performing a Google search to identify interventions and tools employed by public or private organizations, institutes, groups, or agencies. The databases and gray literature will be searched to identify relevant publications. Two members of our team will independently select publications to include in the review by using the Covidence review software (Veritas Health Innovation). The publications included will specifically address our research questions, be peer-reviewed, evidence-based, and published from January 1, 2005, in full-text English or French version. Data will be extracted from the included publications to mainly chart the intervention's objectives, types, target age groups, effectiveness, and risks reported. A thematic analysis will be conducted to categorize the study findings.</p><p><strong>Results: </strong>The funding for this project was provided in March 2024. The research questions were identified in January 2024. The databases and gray literature search strategies were developed in February 2024. The final selection of the publications; the charting, collating, and summarizing of data; along with the reporting of findings are planned for August to September 2025. The findings of this scoping review will be shared through publication in an open access journal and presentations scheduled between September and December 2025.</p><p><strong>Conclusions: </strong>This protocol will enable us to contribute to the advancement of knowledge in combating health misinformation among older adults. The results wil","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74138"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608391","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}
Rosiered Brownson-Smith, Ananya Ananthakrishnan, Oksana Hagen, Cen Cong, Amir Aly, Ray B Jones, Edward Meinert
{"title":"Conversational Systems for Social Care in Older Adults: Protocol for a Scoping Review.","authors":"Rosiered Brownson-Smith, Ananya Ananthakrishnan, Oksana Hagen, Cen Cong, Amir Aly, Ray B Jones, Edward Meinert","doi":"10.2196/72310","DOIUrl":"10.2196/72310","url":null,"abstract":"<p><strong>Background: </strong>Social care systems worldwide face increasing demographic and financial pressures. This necessitates exploring innovative technological solutions to enhance service delivery without substantially increasing costs. Conversational interfaces, including interactive voice response, chatbots, and voice assistants, have gained traction as a means to improve accessibility and efficiency in social care. The rapid development of large language models such as ChatGPT has further accelerated interest in conversational artificial intelligence (AI). These technologies can offer intuitive interactions, particularly for individuals with limited digital literacy. However, their real-world impact, usability, and ethical considerations in social care remain underexplored.</p><p><strong>Objective: </strong>This scoping review aims to synthesize existing literature on the implementation, evaluation, and impact of conversational AI systems within social care settings for older adults. The review will identify best practices, current gaps, and future directions for research and implementation. Key research questions include the following: how are conversational systems implemented on a technical level, and how do older adults and their support systems use them in a social care context? What methods are used to evaluate acceptability, usability, and the impact of broad well-being in the context of older adults' social care? and What are conversational technologies' acceptability, usability, and well-being impact in the context of older adults' social care?</p><p><strong>Methods: </strong>The review will follow the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) and Population, Concept, and Context (PCC) frameworks. A systematic search will be conducted across five databases (IEEE, Web of Science, PubMed, ACM, and Scopus) for English-language articles published from 2019 onward. Studies will be included if they empirically examine conversational systems' implementation, evaluation, or impact for older adults (aged ≥55 years) within a social care context. Two independent reviewers will screen articles and extract data. A descriptive analysis will then categorize findings across key domains such as accessibility, usability, ethical considerations, and well-being outcomes.</p><p><strong>Results: </strong>The results will be included in the scoping review, which began in March 2025. The analysis is underway and is expected to be completed and submitted for publication by September 2025.</p><p><strong>Conclusions: </strong>This scoping review will provide an overview of the role of conversational AI in social care, highlighting both opportunities and challenges in implementation. By synthesizing existing research, the review will inform future developments in the use of conversational agents to improve social inclusion, engagement, and well-being among older adults.</p><p><strong>In","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72310"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608389","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}
Annika Schmitz, Lucas Kueppers, Jacob Klein, Silke Frey, Arian Karimzadeh, Ana Luísa Neves, Birgitta Weltermann
{"title":"Digital Health Applications (DiGA) for Treating Depression and Generalized Anxiety Disorder: Protocol for a Systematic Health App Review and Systematic Review of Published Evidence.","authors":"Annika Schmitz, Lucas Kueppers, Jacob Klein, Silke Frey, Arian Karimzadeh, Ana Luísa Neves, Birgitta Weltermann","doi":"10.2196/63380","DOIUrl":"10.2196/63380","url":null,"abstract":"<p><strong>Background: </strong>Depression and generalized anxiety disorder (GAD) are widespread mental health diseases with significant individual and societal consequences. Psychotherapy, particularly cognitive behavioral therapy (CBT), is a common treatment approach, but its application is limited due to costs and staff shortages. Germany has been the first country to integrate and reimburse digital health applications (DiGAs) as an easily accessible treatment option since 2020. Despite regulatory processes, skepticism among physicians regarding clinical relevance and evidence persists.</p><p><strong>Objective: </strong>This protocol aims to describe the methodology of the planned systematic review. Using expert ratings, the app review will assess the guideline conformity, functions, and usability of German DiGAs for depression and GAD listed at the Federal Institute for Drugs and Medical Devices (BfArM). The additional systematic review will synthesize the effectiveness and quality of these DiGAs based on randomized controlled trials.</p><p><strong>Methods: </strong>The study protocol follows the 2015 PRISMA (Preferred Reporting Items for Systematic Reviews) guideline and was registered in the international Prospective Register of Systematic Reviews (PROSPERO). The review consists of 2 parts: (1) a systematic health app review of DiGAs addressing depression or GAD and (2) a systematic review of published evidence on these DiGAs. The systematic health app review comprises a summary of the DiGA features including the Institute for Healthcare Informatics (IMS) App Functionality Scoring System, a guideline conformity check, and the Mobile Application Rating Scale (MARS) assessment. The systematic review of published evidence is based on a systematic literature search in electronic databases (MEDLINE via PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], Web of Science), as well as relevant websites. The approach includes an effectiveness evaluation, a risk of bias assessment using the Cochrane tool, Risk of Bias 2 (RoB2), and an overall quality evaluation using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method.</p><p><strong>Results: </strong>The systematic literature search was conducted in July 2024 and August 2024, and an updated search is planned for November 2025. Data extraction, narrative synthesis, and evaluation of DiGA and corresponding studies are expected to be completed in spring 2026. The results will be presented using a PRISMA flow diagram and tables to display general information, risk of bias, and overall quality.</p><p><strong>Conclusions: </strong>The review will influence both the actual use and future developments of DiGAs. Good quality characteristics will enhance transparency and trust among physicians, while quality deficits provide options for improvement by manufacturers and governing institutions. Consequently, patients' care with DiGAs may improve.</p><p><strong>Trial","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63380"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608390","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}