JMIR Research Protocols最新文献

{"title":"Outcome Evaluation of a Multimodal Suicide Prevention Program Designed Through International Collaboration: Protocol for a Controlled Interrupted Time Series Study.","authors":"Jean-Daniel Carrier, Marie-Claude Geoffroy, Michel Walter, Katia Dumont, Massimiliano Orri, Sofian Berrouiguet, Christophe Lemey, Monique Séguin","doi":"10.2196/66976","DOIUrl":"10.2196/66976","url":null,"abstract":"<p><strong>Background: </strong>The Coopération Québec-France contre la Dépression et l'Isolement (CQFD-I) initiative represents a collaborative effort between Outaouais, a region in Quebec, and Brest, a metropolitan area in France, to reduce suicide through a multimodal approach. CQFD-I integrates 5 key strategies: a web portal on depression, education of primary care physicians on depression, training for mental health professionals in suicide risk assessment and management, and standardized postcrisis outreach and outpatient monitoring protocols.</p><p><strong>Objective: </strong>This paper aims to evaluate the effectiveness of CQFD-I in reducing outcomes related to suicidal behavior, namely suicide mortality, hospitalizations due to suicide attempts, and emergency room visits for suicide attempts, across the implementation sites compared to control areas.</p><p><strong>Methods: </strong>The evaluation will use a controlled, segmented interrupted time series design, spanning 3 distinct phases: preimplementation (2015 to 2020), implementation (2020 to 2022), and postimplementation (2022 to 2024) phases. The outcomes will be (1) suicide mortality, (2) hospitalizations for suicide attempts, and (3) emergency room visits for suicide attempts. Datasets covering September 2015 to August 2024 will be provided by public health organizations in both jurisdictions, that is, the Institut national de la santé publique du Québec and Santé publique France. In Quebec, control sites will consist of the 14 other health regions with a population of at least 50,000, while in France, control sites will include the 18 metropolitan areas with a status comparable to that of Brest Métropole. The analysis will focus on age- and sex-adjusted monthly rates of the specified outcomes, with an emphasis on changes across the study phases to assess the putative effectiveness of the CQFD-I intervention. We hypothesize that each study outcome will decrease by 20% at implementation sites compared to control sites between the preimplementation and postimplementation phases.</p><p><strong>Results: </strong>This project is funded by the Ministère de la Santé et des Services Sociaux du Québec, with access to data and expertise representing in-kind contributions from Santé publique France and Institut national de la santé publique du Québec. Data collection, led by the first author, will take place in September 2027 to allow for the delay required to confirm suicide deaths in official registers, with analysis planned between 2027 and 2028.</p><p><strong>Conclusions: </strong>To our knowledge, this study will be the first to document the outcomes of a multimodal suicide prevention program targeting geographically defined areas within 2 countries, not limited to the European Union.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/66976.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66976"},"PeriodicalIF":1.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086140","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":"AI-Based Algorithm to Detect Heart and Lung Disease From Acute Chest Computed Tomography Scans: Protocol for an Algorithm Development and Validation Study.","authors":"Anne Sophie Overgaard Olesen, Kristina Miger, Silas Nyboe Ørting, Jens Petersen, Marleen de Bruijne, Mikael Ploug Boesen, Michael Brun Andersen, Johannes Grand, Jens Jakob Thune, Olav Wendelboe Nielsen","doi":"10.2196/77030","DOIUrl":"10.2196/77030","url":null,"abstract":"<p><strong>Background: </strong>Dyspnea is a common cause of hospitalization, posing diagnostic challenges among older adult patients with multimorbid conditions. Chest computed tomography (CT) scans are increasingly used in patients with dyspnea and offer superior diagnostic accuracy over chest radiographs but face limited use due to a shortage of radiologists.</p><p><strong>Objective: </strong>This study aims to develop and validate artificial intelligence (AI) algorithms to enable automatic analysis of acute CT scans and provide immediate feedback on the likelihood of pneumonia, pulmonary embolism, and cardiac decompensation. This protocol will focus on cardiac decompensation.</p><p><strong>Methods: </strong>We designed a retrospective method development and validation study. This study has been approved by the Danish National Committee on Health Research Ethics (1575037). We extracted 4672 acute chest CT scans with corresponding radiological reports from the Copenhagen University Hospital-Bispebjerg and Frederiksberg, Denmark, from 2016 to 2021. The scans will be randomly split into training (2/3) and internal validation (1/3) sets. Development of the AI algorithm involves parameter tuning and feature selection using cross validation. Internal validation uses radiological reports as the ground truth, with algorithm-specific thresholds based on true positive and negative rates of 90% or greater for heart and lung diseases. The AI models will be validated in low-dose chest CT scans from consecutive patients admitted with acute dyspnea and in coronary CT angiography scans from patients with acute coronary syndrome.</p><p><strong>Results: </strong>As of August 2025, CT data extraction has been completed. Algorithm development, including image segmentation and natural language processing, is ongoing. However, for pulmonary congestion, the algorithm development has been completed. Internal and external validation are planned, with overall validation expected to conclude in 2025 and the final results to be available in 2026.</p><p><strong>Conclusions: </strong>The results are expected to enhance clinical decision-making by providing immediate, AI-driven insights from CT scans, which will be beneficial for both clinicians and patients.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/77030.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77030"},"PeriodicalIF":1.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091770","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":"Evaluation of the Implementation of an Outreach Clinic for Opioid Use Disorder: Protocol for a Participatory Cocreation and Implementation Study.","authors":"Andrée-Anne Paré-Plante, Laurence Fortin, David-Martin Milot, Catherine Langlois, Charlotte Payette-Toupin, Bao Duyen Angéline Nguyen, Sophie Poulin, Karine Bertrand, Caroline Leblanc, Lara Maillet, François Racine-Hemmings, Isabelle Wilson, Christine Loignon","doi":"10.2196/72457","DOIUrl":"10.2196/72457","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The opioid overdose crisis currently affecting Canada has resulted in thousands of deaths, and the COVID-19 pandemic has exacerbated the consequences of this crisis, particularly through the instability of the unregulated drug market. The province of Quebec is observing a similar pattern: the opioids consumed are more dangerous, and the number of overdoses is rising. Opioid use disorder (OUD) therefore represents a major public health issue. Offering appropriate interventions, such as opioid agonist therapy integrated into primary care, is one strategy to reduce the risk of death from overdose.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this research is to evaluate the implementation of an outreach clinic offering a low-threshold treatment program for OUD in Quebec. The secondary objective is to identify the factors that foster the participation in primary care research of people who are socially excluded and have current or past lived experience of OUD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is being conducted in the Montérégie region of Quebec and comprises 3 phases: exploratory, photovoice, and participatory evaluation. The qualitative research adopts a participatory approach by involving people who are socially excluded and targeted by the outreach clinic's services (eg, people experiencing homelessness and living with OUD). A committee of peer researchers, made up of experts with current or past lived experience of OUD, will be set up and will hold 10 meetings at various stages of the research. Two participant profiles will be involved: (1) health care professionals and community workers, who will take part in semistructured interviews; and (2) people with current or past lived experience of OUD, who will take part in the photovoice sessions or peer researcher committee meetings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The peer researcher committee was formed in winter 2024, and 10 meetings had been held as of June 2025. As of August 2025, 4 photovoice sessions had been conducted, and 14 health care professionals and community workers had participated in the semistructured interviews. This study was funded in September 2022, with funding available through March 2025. Data were collected from September 2022 through June 2025. The analysis was finished in spring 2025. Results of the study are expected to be published in winter 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The anticipated outcome is the establishment of an outreach clinic for OUD outside a major urban center, with a range of services tailored to the needs of people who are socially excluded and living with OUD. The coconstruction of this clinic in collaboration with people with current or past lived experience of OUD will enable an adequate response to the targeted population's overall health needs and help reduce the barriers to access that they may face in conventional care structures.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irrid):","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72457"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080564","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":"Application of the ADAPT-ITT Model to Develop Trauma-Focused Cognitive Behavioral Therapy for Interpersonal and Racial Trauma and Racial Socialization: Protocol for a Mixed Methods Study.","authors":"Isha W Metzger, Sawyer Adams, Karissa Smith, Ashanti Brown, Deron Morrison, Chinelo Aghaji, Liana Giglio, Ashley Ford, Caleb Brown","doi":"10.2196/77762","DOIUrl":"10.2196/77762","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Black youth experience higher rates of interpersonal and racial trauma than other youth, yet they are less likely to use and benefit from evidence-based mental health services. These disparities highlight the need for culturally responsive adaptations of existing interventions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study integrated racial socialization (RS)-a protective process for Black youth-into trauma-focused cognitive behavioral therapy (TF-CBT) using the ADAPT-ITT framework (assessment, decision, adaptation, production, topical experts-integration, training, and testing) to improve treatment engagement, acceptability, and outcomes for Black youth and their families.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Adaptation followed the 8 phases of the ADAPT-ITT model. During assessment, a literature review and previous studies identified racial discrimination and socialization as salient risk and protective factors for Black youth, underscoring the need for culturally responsive interventions. In the decision phase, TF-CBT was chosen given its evidence base and gaps in addressing racial trauma. The administration phase embedded RS messages such as racial pride, barriers, spirituality, and extended family involvement into TF-CBT's components (psychoeducation, relaxation, affect modulation, cognitive coping, trauma narrative and processing, in vivo mastery, conjoint sessions, and enhancing safety) to enhance psychoeducation, coping, trauma processing, conjoint sessions, and safety planning. In the production phase, manuals and fidelity checklists were drafted to preserve TF-CBT's core elements while embedding RS content. To ensure clinical and cultural relevance, the topical experts phase included interviews with 10 Black caregivers and 12 Black youths (aged 12-18 years) who had completed TF-CBT, as well as focus groups with 15 clinicians. Thematic analysis identified adaptations to increase feasibility and acceptability. During integration, a racial trauma task force of faculty, graduate, and undergraduate researchers refined the model and produced The C.A.R.E. Package for Racial Healing, a culturally informed workbook. In the training phase, 28 clinicians from 13 community organizations participated in a Substance Abuse and Mental Health Services Administration-funded learning community, receiving 2 days of training and 12 months of consultation on delivering TF-CBT that integrates RS (TF-CBT-RS). Role-plays, demonstrations, and case discussions supported fidelity and cultural responsiveness. Finally, during testing, surveys and feedback indicated that TF-CBT-RS was feasible, acceptable, and associated with improved clinician efficacy, greater treatment engagement, and positive client perceptions of support. Preliminary outcomes suggested reductions in trauma symptoms and improved coping, supporting the need for larger randomized trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Integrating RS into TF-CBT enhanced cultural relevance","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77762"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086068","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 Health Sector Response to Gender-Based Violence and Sexual Reproductive Health Programs in the Commonwealth and Selected African Countries: Protocol for a Mixed Methods Systematic Review and Meta-Analysis.","authors":"Refilwe Nancy Phaswana-Mafuya, Edith Phalane, Nompumelelo Zungu, Alfred Musekiwa, Lebogang Ramalepe, Kayla Bagg, Peter Nyasulu, Olive Shisana","doi":"10.2196/67571","DOIUrl":"10.2196/67571","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The intertwining nature of gender-based violence (GBV) and violence perpetrated against women and girls (VAWG), as well as sexual and reproductive health rights (SRHR), underlines the urgent need for the health sector to enhance the coordination of services to improve health outcomes. Importantly, GBV and VAWG are intricately linked to a spectrum of SRHR challenges, ranging from unintended pregnancies to severe maternal, gynecological, and mental health outcomes. Cumulative GBV had a more significant effect on abortion risk than associated variables. Recognizing the interplay between GBV, VAWG, and SRHR highlights the necessity for a comprehensive health sector response. A systematic review of the health sector response to GBV, VAWG, and SRHR will be conducted to understand the extent and array of health facility-based coordinated responses to GBV, VAWG, and SRHR; lessons learned; and successes and challenges in the Commonwealth and selected African countries.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aim to understand the context of GBV, VAWG, and SRHR by conducting a comprehensive review of health sector responses in different national, cultural, and socioeconomic contexts, and we aim to share best practices, experiences, and lessons learned.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A mixed methods systematic review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. The population, intervention, comparison, and outcome framework will be applied to screen and select relevant sources guided by the inclusion and exclusion criteria. The review will include relevant research papers published in the last 15 years and conducted in the 24 Commonwealth and 7 selected African countries. Electronic databases to be searched will include PubMed, Google Scholar, Science Direct, EBSCOhost, Web of Science, Embase, PsycINFO, Cochrane, CINAHL, Index Medicus for the Eastern Mediterranean Region, and POPline.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ethics approval will be waived as the study will use data in the public domain. The project has been commissioned by the Commonwealth Secretariat (2022-2025). The database search, data screening, and data extraction process for the review will be completed by September 2025. A manuscript will be submitted to a peer-reviewed international journal by November 2025. The initial online database searches, citations of eligible studies, and Microsoft Copilot identified 38,200 studies focusing on GBV, VAWG, and SRHR interventions. To date, 60 studies have been found eligible for inclusion in the review. The majority of these studies were conducted in eastern Africa (n=34), South Africa (n=14), and Asia (n=13). Evidence generated from this review will be made available through journal publications, seminars and workshops with key stakeholders, ministries of health, and local and international conferences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/stron","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67571"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086106","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":"Co-Designing Technology to Reduce Health Disparities and Address New Norms Post-COVID-19: Proposal for a Mixed Methods Community-Based Participatory Research Approach.","authors":"Christina K Holub, Konane Martinez, Noe C Crespo, Diane Hoang, Michael Markidis, Tana Lepule","doi":"10.2196/73927","DOIUrl":"10.2196/73927","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Everyday life has changed since the COVID-19 pandemic. Existing health disparities among underserved communities have been exacerbated. Latino and Native Hawaiian and Pacific Islander (NHPI) populations disproportionately experience health disparities, even when compared to other minority populations. Both populations have heart disease, cancer, and diabetes as the leading causes of death, and both have high rates of obesity. As we recover from the pandemic, we must consider the intersection of continued health disparities, new social norms and attitudes, and new patterns of health behavior.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The overarching goal of this project is to reduce health disparities among Latino and NHPI populations, considering new health behavior patterns, social norms, and increased technology use. The research project-specific aims are to (1) conduct key informant interviews and focus groups among Latino and NHPI populations; (2) develop and implement a community health and health behavior survey; and (3) co-design, develop, and test new technology that is meaningful and responsive to community needs and preferences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using community-based participatory research (CBPR) and mixed methods approaches, the interdisciplinary research team will develop new technology based on community insights (key informant interviews, focus groups, and a community health survey). With our community liaisons, we will recruit adult (18+ years old) Latino and NHPI community members from the northern region in San Diego County (ie, Oceanside, San Marcos, and Escondido), largely from culturally related groups and organizations, such as dance schools (hālaus) and churches. Qualitative data will be analyzed using directed content analysis, and quantitative data will be analyzed using descriptive and multivariate statistics. The main outcomes include the identification of community health needs, culturally appropriate interventions, desired modality of intervention strategies, and acceptability of the technology. We expect the new technology to be focused on mobile health (mHealth) smartphone apps. Components will likely include strategies to improve obesity-related health behaviors and mental health.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study received funding from the National Institute of General Medical Sciences in April 2022 as part of the Support for Research Excellence (SuRE) Program (R16). Key informant interviews and focus groups were completed in July 2023. Community health surveys were completed in August 2024. The development of the beta mHealth app began in September 2024 in partnership with California State University San Marcos (CSUSM) computer science students. Beta testing and evaluation will be completed by December 2025. The qualitative findings, identifying themes for a new mHealth app, were published in June 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A major strength of this stud","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73927"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491890/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080524","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":"Neural Activity Disparities in Deficiency and Excess Patterns of Depression: Protocol for a Systematic Review and Meta-Analysis.","authors":"Liling Chen, Xinyu Jia, Jianjun Wang, Liling Li, Jianxiang Chen, Songjun Lin, Haotao Zheng, Xinbei Li, Xiude Qin, Lanying Liu, Hanqing Lyu","doi":"10.2196/68996","DOIUrl":"10.2196/68996","url":null,"abstract":"<p><strong>Background: </strong>Major depressive disorder (MDD) is a complex and heterogeneous condition. Current diagnosis relies on symptom-based assessments, leading to varied treatment responses. Data-driven approaches have attempted to identify MDD subtypes, but their clinical applicability remains limited. Traditional Chinese Medicine (TCM) provides a theory-driven classification system that categorizes MDD into syndrome subtypes of deficiency pattern and excess pattern, offering insights into the biological mechanisms and personalized treatment strategies.</p><p><strong>Objective: </strong>This systematic review and meta-analysis aims to identify potential neurobiological distinctions of TCM-based deficiency and excess patterns in MDD by examining differences in the brain activity by using various functional magnetic resonance imaging (fMRI) modalities, including resting-state and task-based fMRI, diffusion tensor imaging, and magnetic resonance spectroscopy.</p><p><strong>Methods: </strong>In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P), we will conduct a comprehensive search of 7 electronic databases (PubMed, Embase, Web of Science, Chinese Biological Medical Literature database, China National Knowledge Infrastructure, Chinese Wanfang database, and Chongqing VIP database) for studies published up to December 2024. Eligible studies will be screened by 2 independent reviewers based on predefined inclusion criteria, followed by data extraction and quality assessment. For the meta-analysis, resting-state fMRI studies will be analyzed in Montreal Neurological Institute space using Seed-based d Mapping-Permutation of Subject Images software (version 6.21), enabling a focused evaluation of brain activity differences in deficiency and excess MDD patterns.</p><p><strong>Results: </strong>The search and screening for the systematic literature review were completed in December 2024. This study relies on published, publicly accessible data. We found approximately 30 eligible studies in our preliminary search, suggesting that a quantitative meta-analysis is feasible. Data extraction, quality appraisal, and subsequent data synthesis will begin in September 2025. The review should be completed by December 2025, and the study results will be published in 2026.</p><p><strong>Conclusions: </strong>The results of this study may help to explain the neural mechanisms of depression's neurobiological subtypes from the perspective of TCM.</p><p><strong>Trial registration: </strong>PROSPERO CRD42023475178; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023475178.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/68996.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68996"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085998","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":"An mHealth App-Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, Black, Sexual Minority Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial.","authors":"Maira Sohail, Sophia A Hussen, Sarah Dougherty Sheff, Michael Mugavero, John Schneider, Lisa Hightow-Weidman, Janet M Turan, Madeline Lynam, Latesha Elopre","doi":"10.2196/66326","DOIUrl":"10.2196/66326","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Black Americans are disproportionately impacted by HIV. This disparity is more profound in the Southern United States, with the highest rates being among young, Black, sexual minority men, who are also less likely to receive state-of-the-art interventions such as pre-exposure prophylaxis (PrEP). Individual-level interventions to increase PrEP uptake do not often capitalize on the opportunity to leverage the significant effects of this group's social networks, including Black women, on attitudes, beliefs, and behaviors around HIV prevention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To increase PrEP use, an intervention, PrEP US NoW, was designed to engage young, Black, sexual minority men's social networks in discussions with supportive Black female facilitators and ultimately enhance their social capital.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;First, qualitative information on core health-promoting elements of social capital bonds was captured among young, Black, sexual minority men and Black women in extant social support networks. This information was then applied to adapt an existing, evidence-based mobile health app to create the PrEP US NoW pilot through an unblinded randomized controlled trial. Six social network groups (5 young, Black, sexual minority men + 1 Black woman) will participate in the intervention arm. These will be recruited through a network-based approach and will undergo tailored training (mobile-based and face-to-face) for app usage. At baseline, men will undergo HIV testing and both men and women will complete a sociodemographic survey. The groups in the intervention arm will engage in four 60-minute discussions led by Black women through the modified mobile health app. After the intervention, young, Black, sexual minority men will complete surveys electronically at 1 and 3 months (accompanied by HIV testing) on additional factors such as experiences of discrimination and PrEP stigma. The Black women will complete an electronic survey at 1 month, measuring feasibility and acceptability, and will participate in web-based qualitative interviews at 3 months to gain more knowledge on the PrEP US NoW facilitation process. Participants in the control arm will not engage in Black women-facilitated group discussions and will use a control version of the app. The baseline and follow-up surveys and HIV testing will be documented similarly to the intervention arm.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Phase 1 (development) of PrEP US NoW research activities lasted from November 2019 to June 2024. Data collection for the phase 2 randomized controlled trial began in August 2024 and is expected to be completed in December 2025. The findings will capture the intervention's feasibility and acceptability and changes in PrEP uptake among young, Black, sexual minority men.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The development and pilot implementation trial of the PrEP US NoW intervention is thought to leverage essential social capi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66326"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086047","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":"Behavioral Nudges to Enhance Fidelity in Telehealth Sessions (BENEFITS): Protocol for Developing and Pilot Testing a Telehealth Tool to Improve Cognitive Behavioral Therapy Implementation.","authors":"Emily M Becker-Haimes, David S Mandell, Patty B Kuo, Kevin G Lynch, Megan Brady, Sophia Young, Torrey A Creed","doi":"10.2196/76035","DOIUrl":"10.2196/76035","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The rapid expansion of telehealth provides a unique opportunity to integrate behavioral economics (BE) strategies into telehealth platforms to improve clinician fidelity to cognitive behavioral therapy (CBT)-either by enhancing clinicians' motivation to use CBT or by helping clinicians who are already motivated to act consistently on their intentions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We will develop and evaluate \"Tele-BE,\" a novel telehealth platform designed to nudge and incentivize clinicians to use core structural components of CBT. We focus on these structural components because they align with practices most likely to benefit from BE strategies, are delivered across diagnoses, and represent CBT competencies independently linked to improved patient outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will refine the Tele-BE prototype in collaboration with clinicians and supervisors, who are the target end users (aim 1). Working closely with our web development team, we will field test and iteratively refine Tele-BE using rapid-cycle prototyping to optimize user experience and fine-tune the BE strategies (aim 2). The revised platform will then be evaluated in a 12-week open trial involving 30 community mental health clinicians, who will be randomized to either Tele-BE or telehealth as usual. Each clinician will deliver treatment to 2 patients, resulting in a total of 60 patient participants. All sessions will be recorded and coded to assess CBT fidelity. Clinicians and patients will complete questionnaires at weeks 1, 5, 9, and 12, with qualitative interviews conducted at the end of the trial. Primary outcomes will focus on fidelity to CBT structural components, measured via coding of recorded sessions. Secondary outcomes will include target implementation mechanisms-intentions and their determinants (attitudes, norms, and self-efficacy)-assessed using mixed methods, as well as overall CBT fidelity (aim 3). Additionally, trial data will be used to evaluate the acceptability and feasibility of Tele-BE from both patient and clinician perspectives, along with any potential ethical concerns associated with its use (aim 4).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study received National Institute of Mental Health funding in June 2024. Recruitment for aim 1 began in October 2024. As of March 2025, 6 participants had been enrolled in the initial development stage. Recruitment is ongoing, and we anticipate completing aim 1 by May 2025, after which we will prepare for aim 2 activities. We aim to complete all study data collection by the end of 2026. In accordance with our grant award, deidentified data from aims 3 and 4 will be submitted to the National Institute of Mental Health Data Archive for participants who consent to data sharing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Findings will provide insight into the utility of a BE-informed telehealth platform for increasing clinicians' use of core structural CBT components, thereby imp","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76035"},"PeriodicalIF":1.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086066","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":"Acute Next-Day Effects of Alcohol Use on Daily Cognitive Functioning Among Young Adults: Protocol for a 21-Day Diary Study.","authors":"Ashley N Linden-Carmichael, Jacqueline Mogle, Sara E Miller, Jennifer L Shipley, Stephen J Wilson","doi":"10.2196/77584","DOIUrl":"10.2196/77584","url":null,"abstract":"<p><strong>Background: </strong>Young adults exhibit the highest rates of binge drinking and heavy alcohol use of any age group. Blackout drinking, or alcohol-induced memory loss, is a negative consequence of heavy drinking and is common among young adults. Alcohol use has been found to affect postintoxication cognitive functioning, especially among those who have experienced blackout drinking. However, there have been a limited number of studies that have assessed alcohol use and cognitive functioning via ecological momentary assessment (EMA). This methodology allows researchers to have a better understanding of the association between alcohol use and next-day cognition as well as blackout drinking and potential moderators between these associations.</p><p><strong>Objective: </strong>The primary objective of the current study is to examine the association between alcohol use and next-day cognitive functioning among young adults. Multiple indices of alcohol use including blackout drinking and cognitive functioning will be examined. Additionally, moderators of these associations (at the day- and person-levels) will be examined. Potential moderators include other substance use, sleep, mood, hangover symptoms, and participant characteristics (eg, baseline alcohol use severity).</p><p><strong>Methods: </strong>Eligible participants had to be aged between 18-25 years, a current university or college student, residing in the Eastern time zone, endorsing heavy episodic drinking at least 2 times in a typical month, and reporting a blackout drinking episode at least once in the previous year. After completing a web-based screening survey, eligible participants were directed to a web-based baseline survey that asked about alcohol use, self-reported cognitive functioning, objective cognitive assessments, and demographic information. Participants were then sent 5 surveys a day for 21 consecutive days, which asked about substance use, sleep, mood, and self-reported and objective cognitive functioning. Multilevel models will be used to examine day-level associations between alcohol use and cognitive functioning.</p><p><strong>Results: </strong>A total of 304 participants were eligible, with 297 participants completing at least 1 EMA survey and cognitive assessment during the 21-day period. Data were collected between November 2023 and May 2024.</p><p><strong>Conclusions: </strong>The primary aim of this study is to examine the association between alcohol use (including blackout drinking) and next-day cognitive functioning, with a secondary objective of identifying potential day- and person-level moderators of these associations. Findings from the study may help inform momentary interventions and identify characteristics of young adults that may put them at higher risk for experiencing negative consequences.</p><p><strong>International registered report identifier (irrid): </strong>RR1-10.2196/77584.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77584"},"PeriodicalIF":1.5,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12489418/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080269","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}