Background:Black, Caribbean, and African immigrant communities in Canada face compounding systemic inequities that undermine mental well-being and limit access to culturally grounded mental health promotion (MHP) strategies. Despite growing national policy attention to these disparities, the landscape of MHP programs and initiatives developed for, with, or by Black, Caribbean, and African populations remains fragmented and poorly synthesized. Objective:This scoping review aims to (1) map existing MHP strategies, programs, and activities targeting Black, Caribbean, and African immigrant communities in Canada; (2) identify barriers and facilitators influencing their implementation and uptake; and (3) illuminate gaps in current research, policy, and practice. Methods:Guided by Arksey and O'Malley's scoping review framework and the Joanna Briggs Institute Manual for Evidence Synthesis, the review draws on 6 databases: MEDLINE (OVID), APA PsycINFO (OVID), Embase (OVID), PubMed, CINAHL Plus (EBSCOhost), and Google Scholar. Gray literature sources include community reports and government-funded initiatives such as those supported by the Public Health Agency of Canada's Promoting Health Equity: Mental Health of Black Canadians Fund. Eligibility criteria focus on English-language sources addressing MHP or mental illness prevention within the Canadian Black, Caribbean, and African immigrant context. Data will be charted independently in duplicate using Covidence and analyzed through descriptive methods, including tabular summaries and narrative synthesis. Results:Preliminary searches were conducted in June 2025. Formal database searches were completed in October 2025, yielding 2349 records across 6 databases. Following automated and manual deduplication (n=1048), 1301 records proceeded to title and abstract screening. Of these, 193 studies were sought for retrieval and full-text assessment. Data extraction is underway, with full results expected for publication in late 2026. Conclusions:This review will produce the first consolidated map of MHP strategies targeting Black, Caribbean, and African immigrant communities in Canada. Findings are expected to reveal heterogeneity in intervention design, with a concentration of reactive, treatment-adjacent programs and limited representation of upstream, community-led, and culturally rooted approaches. Results will inform equity-driven policy development, support culturally responsive service design, and provide a foundation for future participatory research that centers Black, Caribbean, and African communities as knowledge producers.
Background:Mental health problems frequently emerge during adolescence and young adulthood, yet many young people do not seek or receive timely support. Digital mental health interventions, including serious games and gamified tools, may improve accessibility and engagement, but evidence for their feasibility and preliminary efficacy across diverse European settings remains limited. Objective:This protocol describes the evaluation and trial component of the SMILE (Supporting Mental Health in Young People: Integrated Methodology for Clinical Decisions and Evidence-Based Interventions) project, which aims to evaluate the acceptability, feasibility, reach, and preliminary efficacy of a cognitive behavioral therapy (CBT)-informed gamified mobile intervention for adolescents and young adults, and to explore mechanisms of change and the impact of its implementation contexts. Methods:SMILE uses a cluster-randomized, multisite, multiarm adaptive proof-of-concept design across 7 European countries, complemented by semistructured stakeholder interviews. Adolescents and young adults aged 10-24 years are recruited mainly through schools, universities, and community channels; the target sample is 1438 participants. Clusters are assigned to 1 of 3 sequences comprising a neutral baseline period followed by 2, 4, or 5 game modules, and are randomized to a feedback or no-feedback version of the intervention. The intervention consists of the SMILE Game App (Nurogames and DigitalTwin Technology) and Companion App (RDIUP), which deliver CBT-based gamified content, self-monitoring, experience sampling, and, in one of the study conditions, automated personalized feedback. Primary outcomes are anxiety and depression. Secondary outcomes include well-being, resilience, emotion regulation, self-efficacy, and social anxiety. Feasibility, acceptability, engagement, app usage, in-game metrics, and diary-based digital markers are also assessed. Quantitative data will be analyzed using linear mixed-effects models with adaptive interim analyses. Qualitative stakeholder interviews with young people, their legal guardians, school professionals, and clinicians will be analyzed using inductive thematic analysis within a mixed-methods realist evaluation framework. Results:The proof-of-concept trial was prospectively registered on April 29, 2025 (ISRCTN32523126). Study rollout is taking place from September 2025 to June 2026. As of March 2026, recruitment is ongoing, 2 study sequences have been completed, and the third sequence began at the end of March 2026. Primary results are expected in September 2026. Conclusions:SMILE is designed to generate evidence on the feasibility, acceptability, and preliminary efficacy of a scalable gamified mental health intervention for young people across diverse European contexts. The findings will inform intervention refinement, evaluation of the added value of personalized feedback, and the design of a future definitive randomized controlled trial and broader implementation in educational and clinical settings.
BACKGROUND:Primary care professionals (PCPs) are responsible for identifying eligibility and supporting patient decisions for a wide range of recommended screenings. However, the number of recommendations (42 for adults in France), complex eligibility criteria, limited consultation time, and competing priorities hinder their systematic delivery. Clinical decision support systems (CDSSs) with patient decision aids may help structure prevention-focused consultations and support shared decision-making, but their feasibility and acceptability in routine primary care remain uncertain. As part of the Aide aux Dépistages Recommandés (ADER) research program, we developed Lianeli, a CDSS designed to provide individualized, patient-centered support for all nationally recommended screenings. OBJECTIVE:ADER-Faisabilité (ADER-F) is a study with the primary objective of assessing the feasibility of implementing Lianeli in routine primary care by estimating the proportion of patients for whom the CDSS is used to completion. Secondary objectives are to (1) quantitatively and qualitatively describe implementation feasibility, (2) describe organizational adjustments and interprofessional work related to the intervention, (3) explore the association between interprofessional use of Lianeli, health literacy, social deprivation, and feasibility, and (4 and 5) estimate the proportion of eligible, overdue or never screened patients who engage in organized or opportunistic cancer screening, respectively. METHODS:ADER-F is a noncomparative, multicenter feasibility study with a mixed methods design conducted in primary care centers in the Auvergne-Rhône-Alpes region in France. We plan to recruit 210 adult patients from 21 general practitioners (GPs) across 17 sites. During routine consultations, eligible patients will be invited to complete a self-administered digital health questionnaire in Lianeli, which applies guideline-based algorithms to identify recommended screenings. Within 60 days, patients will attend a dedicated screening consultation during which the GP will validate the patient's responses, discuss benefits and harms of each screening using shared decision-making, and update the patient's screening pathway. Quantitative data will include Lianeli metadata, sociodemographic characteristics, health literacy, social deprivation, implementation feasibility measures (Guideline Implementation with Decision Support [GUIDES]-based questionnaires), and usability measures (French version of the System Usability Scale [F-SUS]). Semistructured interviews with patients and PCPs will be analyzed thematically and integrated with quantitative findings in a convergent metasynthesis. RESULTS:The ADER-F study was funded in 2023. Following ethics approval in October 2025 and French National Commission on Data Protection authorization in February 2026, recruitment started in March 2026, with a planned 2-month inclusion period and an overall study duration of 6 months. The results are expected to be published in 2027. CONCLUSIONS:ADER-F will provide evidence on the feasibility and acceptability of a patient-centered CDSS to support recommended screenings in French primary care. The findings will identify determinants of successful implementation, guide possible developments of the Lianeli software and care pathways, and determine whether a subsequent effectiveness study is justified. TRIAL REGISTRATION:ClinicalTrials.gov NCT07270926; https://clinicaltrials.gov/study/NCT07270926. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/89922.
Background:Aging in place is a priority for many older adults but often requires home adaptations when temporary or permanent physical disabilities arise. It reduces the risk of falls, improves health-related quality of life, and enhances social participation. Two new digital innovations aim to support home adaptation: Hygiene 2.0, which facilitates the adaptation of baths and showers, and MapIt, which provides 3D mapping of the environment. Objective:This action study aims to cocreate and evaluate the implementation of the Hygiene 2.0 and MapIt innovations and to measure their impact on supporting older adults who experience difficulties with personal hygiene or are in the process of adapting their homes. Methods:This study uses a multiple case study approach with a mixed convergent design, guided by the i-PARIHS (integrated-Promoting Action on Research Implementation in Health Services) framework. We will conduct semistructured interviews with 66 participants, including 8 older adults-informal caregiver dyads (or individual older adults when no informal caregiver is available) for MapIt only, 20 dyads for Hygiene 2.0 or the combined use of Hygiene 2.0 and MapIt, and 10 assistive technology advisors across all innovation scenarios. A cost analysis will be conducted from both the Quebec public system and patient perspectives. Qualitative data and mixed data integration will be analyzed using analytical questioning. Results:This study was conducted within the framework of, and with financial support from, the Bien vieillir chez soi au Bas-Saint-Laurent action research program. Recruitment began in May 2024. We completed data collection in February 2026 and began data cleaning and analysis in March 2026. As of September 2025, we enrolled 1 dyad of older adults and informal caregivers using MapIt, 5 dyads using Hygiene 2.0 or the combination of Hygiene 2.0 and MapIt, and 10 assistive technology advisors. The manuscript describing the results of the study is expected to be published at the beginning of 2027. May. Conclusions:This study will provide valuable insights into how innovative digital tools can facilitate home adaptations that promote aging in place. By assessing their implementation, usability, and cost-effectiveness, the findings are expected to inform best practices, guide decision-making for health and social care stakeholders, and ultimately contribute to improving the quality of life and autonomy of older adults.
Background:Wellness my Way is a chronic disease prevention model of care being piloted across South West Queensland, Australia, a region of high chronic disease burden. Wellness my Way is an initiative of the Queensland Government through Health and Wellbeing Queensland, delivered in partnership with Queensland Health's Health Contact Centre and South West Hospital and Health Service, supported by multisectoral collaborations. Objective:This protocol aims to describe the development of Wellness my Way and the protocol for evaluating the program's pilot implementation. Methods:The context for the Wellness my Way pilot and the multisectoral approach and co-design activities that informed program development and implementation are described. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework has guided the evaluation. The primary outcome is the uptake (reach) of Wellness my Way. Secondary outcomes include consumer satisfaction and stakeholder experiences. Data were derived from quantitative and qualitative measures collected from consumers and stakeholders. Results:Ethics approval has been granted. The Wellness my Way pilot program within South West Queensland, Australia, concluded in January 2026, with findings anticipated to be shared in late 2026. Conclusions:The findings will offer new insights on the impact of a collaboratively delivered program in a community with high unmet needs.
Background:Advances in the understanding of type 1 diabetes (T1D) natural history have enabled screening for islet autoantibodies and the detection of presymptomatic (early-stage) T1D prior to clinical presentation and the need for insulin replacement therapy. As screening programs expand, increasing numbers of children are being identified with early-stage T1D, creating a pressing need for relevant, accessible, evidence-based educational resources. Due to the rapidly changing paradigm of T1D care in such settings, many health care professionals currently lack awareness or guidance on which educational resources to recommend to families. To date, no review has systematically identified and evaluated educational resources for families navigating early-stage T1D or for health care professionals supporting them. Objective:This scoping review aims to (1) systematically identify and evaluate educational resources for early-stage T1D; (2) assess resource readability, understandability, quality, and credibility; (3) create an inventory of resources consistent with current care and health literacy guidelines; and (4) identify resource gaps and priorities for future development. Methods:A comprehensive search of peer-reviewed (MEDLINE, CINAHL, PsycInfo, and Scopus) and gray literature databases (Google advanced searches and targeted searches of professional organizations, advocacy groups, research consortiums, and screening programs) will be conducted to identify English-language resources (eg, fact sheets, websites, videos, and infographics). Resources must target, or be suitable for adaptation for, audiences including youth (aged <25 years), families, parents, carers, and/or health care professionals. Resources must provide information about early-stage T1D, monitoring of early-stage T1D, trajectories, psychosocial aspects, or care navigation. Eligible resources will undergo standardized assessment using validated tools for readability (Flesch-Kincaid Grade Level [FKGL] and Simple Measure of Gobbledygook [SMOG]), understandability (Patient Education Materials Assessment Tool [PEMAT]), information quality (Quality Evaluation Scoring Tool [QUEST]), and credibility (adherence to current early-stage T1D guidelines). Two reviewers will abstract data using a charting tool prepared for the study. Results:Resources will be grouped by type, audience, and origin. Readability, understandability, quality, and credibility assessments will be presented in tables. Resource gaps will be identified to make recommendations for future resource development. The review will begin in March 2026, and data extraction and analysis will be completed by August 2026, with manuscript submission by October 2026. Conclusions:This paper presents the protocol for the first scoping review to systematically compile and appraise educational resources for early-stage T1D. The findings will offer a clear overview of the current resource landscape, identify gaps, highlight resources that adhere to current early-stage T1D and health literacy guidelines, and provide a foundation for future development and co-design of fit-for-purpose materials.
Background:Periodontitis and low bone mineral density (BMD) are both highly prevalent among older women and share inflammatory and metabolic pathways, yet their co-occurrence and combined impact on tooth loss remain insufficiently characterized, particularly in Middle Eastern populations. Active matrix metalloproteinase-8 (aMMP-8), measured by point-of-care testing (PoCT) in oral rinse, is a candidate biomarker that may support periodontal screening in geriatric settings. Objective:The primary objective is to determine and compare the prevalence and severity of periodontitis, classified using the 2017 American Academy of Periodontology and European Federation of Periodontology (AAP and EFP) classification system, between older women with low BMD (osteopenia or osteoporosis) and age-matched women with normal BMD. Secondary objectives are to compare clinical periodontal parameters and tooth loss between groups; to evaluate the diagnostic performance of aMMP-8 PoCT against the clinical periodontal diagnosis; and to examine associations among BMD, periodontal status, aMMP-8, and risk factors. Methods:This single-center, cross-sectional study will recruit postmenopausal women aged 50 years or older who attend the geriatric clinics at Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar. Cases are women with a dual-energy X-ray absorptiometry (DXA) T-score of -1.0 or lower; controls are women with a T-score greater than -1.0. Each case will be individually matched to a control by age within 3 years. All participants will undergo a full-mouth periodontal examination by a single calibrated examiner, assessment of tooth loss, aMMP-8 oral rinse PoCT (20 ng/mL cutoff), and comprehensive geriatric assessment and complete a structured questionnaire, with DXA results obtained from records. The target sample is 400 participants (200 per group). The primary matched comparison of periodontitis prevalence between groups will use the McNemar tests and conditional logistic regression; secondary analyses will use chi-square, t, or Mann-Whitney U tests; correlation; and regression in SPSS (version 27; 2-sided α of .05). Results:This protocol describes a study in its data collection phase. The study received ethics approval on September 1, 2025 (MRC-01-25-782), and it is funded by the Hamad Medical Corporation Medical Research Center (funding awarded in January 2026). Screening of eligible participants who met the inclusion criteria started in June 2026. Recruitment is anticipated to commence in October 2026 and is expected to be completed by October 2027. The primary results are anticipated for publication in early 2028. No outcome data are available at the time of submission. Conclusions:The study will generate local evidence on the relationship between skeletal and oral health in older women and will evaluate whether aMMP-8 PoCT can serve as a practical, noninvasive screening adjunct in geriatric clinics. The findings are intended to inform integrated preventive and referral pathways in Qatar. Given the cross-sectional design, the study will characterize associations rather than establish causality.
Background:Obesity is a growing public health issue associated with comorbidities and substantial medical costs. Although bariatric and metabolic surgery (BMS) is often recommended for individuals with severe obesity, prehabilitation may optimize their physical and psychological status. However, face-to-face delivery can limit accessibility, and evidence on home-based approaches remains scarce. Objective:This study protocol aims to compare the effectiveness of a home-based prehabilitation program with a face-to-face prehabilitation program on physical and psychological variables in individuals with severe obesity awaiting BMS. Methods:This is a study protocol for a randomized, controlled, parallel-group trial. To ensure ecological validity, recruitment will be stratified to target 50% low-income and 20% rural participants. Participants with grade III obesity and an indication for BMS will be allocated via block randomization to 3 groups (1:1:1): a face-to-face group, a home-based group, and a control group. The intervention will last 7 weeks (1 week of familiarization plus 6 weeks of training) and will include 12 combined aerobic and resistance exercise sessions and 3 health education sessions. The primary outcome will be the total score of the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes include the HADS subscales (HADS-A and HADS-D), sleep quality, mood states, self-efficacy, quality of life, and functional performance (6-minute walk test, handgrip strength, and 5-repetition sit-to-stand test). Results:This study was funded in August 2025 by the Research Support Program of the Santa Catarina State University. Recruitment is scheduled to begin in April 2026. The intervention phase is expected to be completed in September 2026, followed by data analysis between October and November 2026. Results are expected to be published in mid-2027. Conclusions:This trial will provide evidence on the comparative effectiveness of home-based and face-to-face prehabilitation for individuals with severe obesity. The findings can be used to support the implementation of feasible, accessible, equitable, and cost-effective preoperative care models.
Background:Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality worldwide and continues to have poor survival outcomes, with most patients diagnosed at advanced stages of disease. In New Zealand, NSCLC contributes substantially to cancer inequities, with Māori communities experiencing disproportionately high incidence and mortality rates. Although low-dose computed tomography screening can improve early detection, major limitations remain, including false-positive findings, overdiagnosis, high infrastructure costs, and limited accessibility for rural and underserved populations. Liquid biopsy approaches using circulating tumor DNA (ctDNA), particularly DNA methylation profiling, have emerged as promising, minimally invasive strategies for improving cancer detection, treatment monitoring, and precision oncology. Objective:This study aims to establish integrated genomic and epigenomic predictive and prognostic biomarkers using ctDNA, tumor tissue, and transcriptomic profiling to improve early detection, risk stratification, treatment selection and response prediction, and longitudinal monitoring, with particular emphasis on identifying molecular mechanisms associated with treatment resistance and disease progression. Methods:This prospective observational translational biomarker study is being conducted through the University of Otago and associated respiratory and oncology services in New Zealand. The study will recruit participants with NSCLC (including squamous and nonsquamous subtypes), individuals referred to fast-track lung nodule assessment clinics, and nonmalignant respiratory controls. Serial peripheral blood sampling will be performed in selected participants at predefined clinical follow-up time points to evaluate treatment response and disease progression. The availability of formalin-fixed paraffin-embedded archival tissues will be recorded, but will not be mandatory for enrollment. Genome-scale DNA methylation profiling will be performed using cell-free reduced representation bisulfite sequencing (cfRRBS), while targeted genomic profiling and transcriptomic analyses will be conducted using targeted sequencing panels and RNA sequencing. Integrative bioinformatic analyses will be used to identify molecular biomarkers associated with early-stage disease, advanced disease, treatment response, and therapeutic resistance. Results:Ethics approval for the study has been obtained from the New Zealand Health and Disability Ethics Committee (2022 EXP 12566). This study commenced in 2022, and recruitment and biospecimen collection are ongoing. The study aims to recruit approximately 450 participants, including patients with NSCLC, individuals referred through respiratory diagnostic pathways, and nonmalignant controls. As of July 31, 2026, 205 participants have been recruited, with recruitment continuing until the target sample size is reached. Molecular and data analyses are ongoing, with additional publications expected as the cohort matures. Conclusions:This study will generate one of the first integrated genomic, epigenomic, and transcriptomic liquid biopsy datasets for NSCLC in New Zealand. The findings are expected to support the development of sensitive, accessible, and equitable blood-based biomarkers for NSCLC detection and treatment monitoring while also contributing to improved precision oncology approaches and reducing NSCLC inequities among Māori populations.
Background:Dog bites represent a significant global public health concern, particularly among children and adolescents. Approximately 330,000 emergency department visits occur annually in the United States alone due to dog-bite injuries, with pediatric populations bearing a disproportionate burden. Despite this, existing systematic reviews remain fragmented, focusing on isolated aspects such as breed-specific risk, educational interventions, or legislative measures, without comprehensively addressing the global incidence, prevalence, and multifactorial risk profile in pediatric cohorts. Objective:This protocol describes a planned systematic review aimed at synthesizing international evidence on the incidence and prevalence of dog bites in pediatric populations (aged ≤18 y), with concurrent analysis of demographic, behavioral, and environmental risk and protective factors. Secondary objectives are to characterize the clinical severity, psychological sequelae, and health economic consequences of pediatric dog-bite injury as reported in the eligible literature. Methods:This protocol is reported in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 statement. A comprehensive search of PubMed, Embase, Web of Science, Scopus, CINAHL, and the World Health Organization Global Index Medicus, supplemented by forward and backward citation tracking and gray literature sources, will be conducted with no date restrictions and limited to English-language observational studies (cross-sectional, case-control, and cohort) and population-based surveys. The PECOS (population, exposure, comparator, outcome, and study design) framework will guide inclusion and exclusion criteria. Two independent reviewers will screen records and extract data using a standardized codebook, with discrepancies resolved by consensus or by a third reviewer. Study quality will be assessed using validated tools appropriate for each study design. Findings will be synthesized narratively with descriptive statistics. When studies are sufficiently homogeneous, prevalence and incidence will be pooled using random-effects meta-analysis of Freeman-Tukey double arcsine-transformed proportions, with prediction intervals reported alongside pooled estimates. The certainty of evidence for each outcome will be rated using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Results:The systematic database search across PubMed, Embase, and Web of Science was conducted on August 1, 2025. At the time of manuscript submission, study screening and data extraction are ongoing. The anticipated completion of data extraction and evidence synthesis is in December 2026, with submission of the completed systematic review for publication expected thereafter. As this manuscript describes the review protocol, no study findings are available at this time. Conclusions:By aggregating data across diverse populations and settings, this systematic review will deliver the most comprehensive global assessment of pediatric dog-bite epidemiology to date, stratified by age group, geographic region, sex, and socioeconomic context, with direct implications for reducing the burden of these preventable injuries worldwide.
BACKGROUND:An estimated 17 million children have severe acute malnutrition (SAM) worldwide, with the majority residing in South Asia. Routine empirical antibiotics are prescribed for Community-based Management of Severe Acute Malnutrition (CSAM) to address presumed clinical/subclinical infections and improve nutritional recovery for children with uncomplicated SAM, but low prevalence of infection has been reported. Thus, targeted antibiotics (eg, single-dose azithromycin or 7-day amoxicillin) are recommended over empirical antibiotics to limit emerging antimicrobial resistance (AMR), but there is limited literature on the relevance. OBJECTIVE:This study aims to (1) estimate the prevalence of clinical/subclinical infections and describe AMR patterns among children aged 6-59 months with uncomplicated SAM and assess associations with sociodemographic, clinical, and nutritional factors; (2) explore health-seeking behavior, antibiotic use, and care preferences among caregivers and health care providers; and (3) evaluate the efficacy of 7-day amoxicillin versus single-dose azithromycin versus no antibiotics in weight gain and nutritional recovery among children with SAM. METHODS:This mixed methods study will be part of the ongoing CSAM program implemented in selected districts of Telangana, India. Phase 1 will be a cross-sectional analytical study with a laboratory component to estimate the prevalence of clinical/subclinical infections and AMR among 606 children. Phase 2 will use a qualitative design (focus group discussions with caregivers and in-depth interviews with health care providers) to explore perceptions and practices related to management and antibiotic use among the children. Phase 3 will be an open-label, parallel-group randomized controlled trial (RCT) with three groups of ~250 children each to compare nutritional recovery: 7 days of amoxicillin + standard nutritional care, single-dose azithromycin + standard nutritional care, and no antibiotics + standard nutritional care (control). Children will be followed for up to 6 months, with periodic anthropometric, clinical, and laboratory assessments. RESULTS:Participant recruitment began in June 2026. Baseline assessments, interventions, and final evaluations are anticipated to be completed over a 24-month period (ie, by May 2028). Funding was received in August 2025; ethical approval was obtained on February 17, 2025; Clinical Trial Registry - India approval was obtained on March 18, 2025; and administrative approvals from the state government are in process. Preparatory phase activities (ie, obtaining ethical approval, Standard Operating Procedure development, project team recruitment, field site identification, and meeting with district stakeholders and the state government) were completed by March 2026. As there was a delay in initiation of the RCT component of the study, phases 1 and 2 have been initiated after obtaining required approvals at this time. CONCLUSIONS:This study will provide critical evidence on the burden of clinical/subclinical infections and AMR among children aged 6-59 months with uncomplicated SAM and inform the rational use of empirical antibiotics for CSAM amid growing AMR concerns. TRIAL REGISTRATION:Clinical Trials Registry India CTRI/2025/03/082358; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyMDI2&Enc=&userName=.
Background:Military sexual trauma (MST) among veteran men is common, underreported, and associated with substantial psychological morbidity. Despite evidence that gender-related distress and shame pertaining to masculinity contribute to treatment avoidance and dropout, MST interventions within the US Department of Veterans Affairs have not been developed specifically for men. Objective:The objective of this study is to develop a gender-tailored group psychotherapy for veteran men with histories of MST. Guided by implementation science frameworks, the mixed methods study described in this paper proposes to iteratively refine the previously implemented Men's MST Group (MMG), a 12-session, gender-tailored, trauma-focused group intervention that integrates dynamic group processes, mindfulness-informed distress tolerance, and psychoeducation. Methods:We draw on a synthesis of the intervention mapping framework and the access reconceptualization model to identify patient and system characteristics that contribute to treatment access and engagement. For aim 1, we will refine MMG through focus groups, qualitative interviews, and expert consultation. For aim 2, we will pilot-test MMG in a randomized controlled trial (n=32) comparing MMG to present-centered group therapy. For aim 3, we will evaluate implementation barriers and facilitators and iteratively refine the intervention through posttreatment qualitative interviews and expert panel review. Results:This study was funded with a start date of January 2025 and is anticipated to end in December 2029. As of July 2026, we have completed data collection for aim 1 and are currently analyzing data from 31 semistructured interviews. As of July 2026, we are also refining the MMG treatment protocol, which we plan to implement in a pilot randomized controlled trial in January 2027. Results of aim 1 are anticipated to be published in 2027. Participant recruitment for the aim 2 pilot trials has not begun. Conclusions:The goal of the current project is to refine and pilot-test a gender-tailored group psychotherapy for veteran men with histories of MST. We anticipate that the intervention will demonstrate feasibility, acceptability, and implementation potential because it was developed through an iterative process incorporating feedback from veterans, clinicians, and subject matter experts. Should study objectives be met, the next step will be to conduct a fully powered randomized controlled multisite trial. We additionally plan to disseminate findings regarding treatment needs, preferences, and barriers to care among men with histories of MST, which may inform future treatment development and implementation efforts beyond the current project.
Background:Indigenous communities continue to experience significant mental and physical health disparities associated with historical trauma, structural inequities, and disruptions to cultural continuity. Indigenous older adults residing in long-term care settings may be particularly vulnerable to social isolation, psychological distress, chronic pain, and reduced opportunities for cultural engagement. Music-based interventions (MBIs) have demonstrated potential for improving psychosocial and physical health outcomes; however, few MBIs have been culturally grounded in Indigenous worldviews or codeveloped with Indigenous communities. Objective:This manuscript reports the protocol for an ongoing pilot feasibility study evaluating a culturally grounded MBI for Indigenous older adults residing in long-term care settings in northern Arizona. The primary objectives are to assess the feasibility, acceptability, and implementation of the intervention, and to generate preliminary data regarding changes in mental health, pain, coping, and cultural connectedness. Methods:The study uses a quasi-experimental convergent parallel mixed methods design informed by the Indigenist Stress-Coping Model. The intervention was codeveloped through collaboration with a Community Advisory Board consisting of Indigenous elders, clinicians, researchers, and Indigenous musical consultants. The 6-session curriculum incorporates active music participation, including drumming, singing, storytelling, rhythmic engagement, and guided reflection. Participants are recruited from 2 residential long-term care facilities. Quantitative measures are collected before and after intervention participation and include assessments of depression, anxiety, perceived stress, pain, coping, and cultural connectedness. Qualitative interviews, observational field notes, and implementation data are collected concurrently to assess participant experiences, cultural relevance, intervention fidelity, and contextual factors influencing implementation. Results:This study was first funded in February 2024 by The NARBHA Institute and the James Wurgler, MD Endowed Chair. Continued funding was secured in September 2025 through the National Institute on Minority Health and Health Disparities through the Southwest Health Equity Research Collaborative Pilot Project Program (grant U54MD012388). Recruitment and intervention implementation began in March 2024 and are expected to conclude in May 2027. As of June 2026, 39 participants have been enrolled across 2 residential long-term care facilities. Quantitative and qualitative analyses are expected to begin in summer 2026. Findings will be disseminated through community stakeholder meetings, conference presentations, and peer-reviewed publications, with initial results anticipated in summer 2027. Conclusions:This protocol describes the development and evaluation of a culturally grounded MBI designed to support mental, physical, and cultural well-being among Indigenous older adults. Findings will inform intervention refinement, feasibility assessment, and future large-scale studies evaluating culturally responsive behavioral health interventions for Indigenous communities.
Background:Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a debilitating condition characterized by persistent fatigue and a range of complex accompanying symptoms. While curative treatments remain limited, Tuina (a traditional manual therapy in Chinese medicine) has shown potential in alleviating fatigue in pilot studies. However, high-quality evidence from large-scale, multicenter trials regarding its efficacy and long-term sustainability is lacking. Objective:This trial aims to evaluate the efficacy and safety of Tuina combined with usual care (UC) for CFS compared with UC alone. Methods:This prospective, multicenter, randomized, open-label, assessor-blinded, parallel-group clinical trial will be conducted at 6 hospitals in China. The study consists of 3 phases: a 1-week run-in period, an 8-week treatment period, and a 24-week follow-up period. A total of 230 eligible participants diagnosed with CFS (Centers for Disease Control and Prevention 1994 criteria) will be recruited and randomly allocated (1:1) to receive either Tuina therapy plus UC (intervention group) or UC alone (control group). The intervention group will undergo 24 sessions of a standardized Tuina protocol over 8 weeks (3 sessions/week). Follow-up assessments will be conducted at weeks 4, 8, 20, and 32. The primary outcome is the change in fatigue severity measured by the 11-item Chalder Fatigue Questionnaire from baseline to week 8. Secondary outcomes include clinical response rate, sleep quality, anxiety, depression, quality of life, adverse events, and clinical global impression. Efficacy analysis will be performed using a mixed-effects model for repeated measures in the modified intention-to-treat population. Secondary outcomes will be analyzed as exploratory supportive end points using appropriate parametric or nonparametric tests based on data distribution, with week 8 defined as the main secondary time point and later follow-up visits interpreted as durability contrasts. Missing outcome data will be handled primarily through likelihood-based mixed-model estimation under a missing-at-random assumption, with multiple imputation and per-protocol analyses used as sensitivity analyses. Results:Recruitment for this trial will start in March 2026 and is expected to be completed by March 2027. The results of this study are expected to provide reliable evidence regarding the role of Tuina in the management of CFS. Conclusions:This multicenter randomized controlled trial will evaluate the effectiveness, long-term sustainability, and safety of Tuina therapy plus UC for improving fatigue, sleep, mood, and quality of life in CFS or ME. If proven beneficial, Tuina may serve as a scalable nonpharmacological option to support clinical decision-making and standardized implementation.
BACKGROUND:Adults with autism spectrum disorder (ASD) are at increased risk for chronic health conditions and reduced quality of life (QoL), often linked to lower physical activity (PA), motor impairments, and barriers to health care access. Although communication and social differences in ASD are well documented, motor impairments such as deficits in coordination, balance, and gait remain understudied in adulthood despite their relevance to fall risk and PA participation. Telehealth and wearable technologies may improve access to physical therapy assessment and remote monitoring of physical function in this underserved population. OBJECTIVE:This pilot study aims to evaluate the feasibility, construct validity, and rating reliability of remotely administered physical function and balance assessments in adults with ASD and to examine racial and ethnic disparities and associations among physical function, PA, fall risk, and QoL. METHODS:This pilot study uses a 2-phase, cross-sectional, noninterventional design with remote data collection in legally independent adults aged 18-59 years with ASD who were recruited through the Simons Powering Autism Research and Knowledge (SPARK) registry. Participants complete self-report questionnaires; 2 weeks of wearable step monitoring using a Fitbit Inspire 3 (Google LLC) device; and, for a randomized subset of 25 participants, 1 remote, telehealth-based physical function assessment session. Remote performance-based measures include the Five Times Sit-to-Stand, 30-second Sit-to-Stand, standing balance under eyes open and eyes closed conditions, and single-leg stance under eyes open and eyes closed conditions. Construct validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures will be examined using hypothesis testing with related indicators of health and functioning, including steps per day, lower-extremity functional outcome surveys, fall risk screening surveys, and comorbidity burden. Interrater and intrarater reliability of remote performance scoring will be evaluated from video-recorded sessions scored by 6 raters using intraclass correlation coefficients. Secondary analyses will examine racial and ethnic disparities in physical function, PA, and QoL, as well as associations among these variables and moderation by race and ethnicity. RESULTS:Study funding was available from August 2024 to May 2025. Recruitment occurred from December 2024 to March 2025, and final data collection was completed in May 2025. By May 2025, 155 adults with ASD had been recruited, of whom 65.2% were female and 77% identified as Black or Hispanic. Data analysis is projected to be completed in July 2026, and submission of the primary results manuscript is anticipated in August 2026. CONCLUSIONS:This protocol describes a pilot study designed to evaluate the feasibility, construct validity, and equity relevance of remotely administered physical function assessments in adults with ASD. If supported, the findings may provide preliminary evidence for more accessible telehealth-based assessment approaches and inform larger studies on physical functioning, PA, and QoL in this population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/86020.
BackgroundMental health disorders (MHDs) represent a growing global challenge and pose a significant risk to public health. Alongside developments in the field of large language models (LLMs), conversational mental health chatbots (CMHBs) have emerged and are increasingly being used by individuals in self-directed and independent ways for mental health support. Although users’ perspectives on CMHBs have been extensively examined and systematically synthesized, relatively little research has focused on how health care professionals (HCPs) perceive these tools. To develop a more comprehensive understanding of the implications of using CMHBs, the perspectives of HCPs should also be considered. As HCPs’ views are informed by their clinical expertise and professional responsibility, they may point to underexplored implications related to the safety, ethical use, and implementation of these tools. ObjectiveThis paper presents the protocol for a systematic review that aims to identify, synthesize, and critically appraise the available evidence on HCPs’ perspectives regarding the use of CMHBs for mental health support, including perceptions of their therapeutic role, trustworthiness, safety, risks and benefits, ethical concerns, and implementation barriers and facilitators. Where relevant, the completed review will discuss its findings in relation to the existing literature on user perspectives to contextualize possible areas of convergence and divergence. MethodsA systematic review of the literature will be conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Peer-reviewed qualitative, quantitative, and mixed methods studies will be identified through searches of PubMed (MEDLINE), PsycInfo, Embase, CINAHL, Web of Science, and Scopus, with no restrictions on publication date. Study screening will be supported by AI-assisted active learning using ASReview, following the SAFE stopping procedure, with independent quality-assurance (QA) screening by a second reviewer. Data will be synthesized using a convergent integrated mixed methods approach, and the findings will be reported narratively. Methodological quality will be appraised using the Mixed Methods Appraisal Tool (MMAT; version 2018). ResultsThe search for this review was conducted and completed in late November 2025 and identified 24,905 records before deduplication and 18,535 records after deduplication. The initial title and abstract screening began in January 2026 and is ongoing. Data extraction is expected to be completed by August 2026. ConclusionsThis protocol outlines a systematic review that will synthesize the available empirical evidence on HCPs’ perspectives on the use of CMHBs for mental health support. The completed review aims to identify aspects such as perceived benefits, barriers and facilitators, and ethical concerns. By integrating qualitative, quantitative, and mixed methods evidence, the review will contribute to a more comprehensive understanding of the implementation and broader implications of CMHBs in mental health care. Trial RegistrationPROSPERO CRD420251180957; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251180957 International Registered Report Identifier (IRRID)PRR1-10.2196/92780
Background:More than 5 million young adults in the United States meet criteria for cannabis use disorder (CUD), placing them at risk for adverse physical, psychiatric, and social outcomes. Most individuals with CUD do not receive treatment due to numerous barriers, including motivation, stigma, limited availability and accessibility of developmentally appropriate services, and competing demands for time and finances. A novel digital health intervention, Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy-Virtual (MOMENT-V), was developed and combines telehealth motivational enhancement therapy with mobile health ecological momentary intervention (EMI) to provide a fully remote brief intervention for CUD among young adults. Objective:We describe the protocol for a parallel, 2-arm, pilot randomized controlled trial of MOMENT-V vs enhanced usual care (EUC) to evaluate intervention and trial feasibility in young adults with CUD recruited from primary care clinics. Methods:We are inviting primary care patients, aged 18 to 26 years, to self-screen through clinic posters with QR codes, invitations from clinicians, and patient portal messages. Eligible patients (eg, Cannabis Use Disorder Identification Test-Revised score ≥12, cannabis use ≥3 days/week, and smartphone ownership; N=60) will be randomly assigned 1:1 to receive MOMENT-V or EUC. MOMENT-V will include 2 weekly sessions of motivational enhancement therapy via telehealth, then 2 weeks of mobile health EMI-mobile self-monitoring with messages following reports of personal triggers for use. EUC will include a brief meeting with a counselor to review cannabis use problems and provide substance use and mental health resources. Participants will be assessed via surveys and a timeline followback calendar interview at baseline, 3 weeks, 3 months, and 6 months, and by an interview at 6 months. Primary outcomes will include completion, EMI engagement, and acceptability as measures of intervention feasibility, and screening, eligibility, enrollment, and retention rates as measures of trial feasibility. Primary outcomes will be evaluated against a priori benchmarks. Secondary outcomes will include counselor adherence to motivational interviewing principles, therapeutic alliance, duration of study activities, barriers, facilitators, CUD symptoms, and amount of delta-9-tetrahydrocannabinol used in standard units for motivation to change cannabis use, psychological distress, cognitive function, and quality of life. We will also examine cannabis use frequency and problems resulting from cannabis use. For the quantitative analyses, we will use descriptive statistics, logistic regression, and generalized linear mixed effects modeling. For the qualitative analyses, we will use immersion/crystallization, template organizing style, and thematic analysis. Results:Recruitment began in August 2025 and is anticipated to end in January 2027. Data collection is projected to be completed in July 2027. We plan to submit a manuscript describing the main outcomes in early 2028. Conclusions:This study will provide data regarding the MOMENT-V digital health intervention and trial feasibility in anticipation of a fully powered efficacy trial in young adults with CUD who are being seen in primary care.
