https://www.researchprotocols.org/issue/feedJMIR Research Protocols2023-01-05T08:30:04-05:00JMIR Publicationseditor@jmir.orgOpen Journal Systems Unless stated otherwise, all articles are open-access distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work ("first published in JMIR Research Protocols...") is properly cited with original URL and bibliographic citation information. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org/, as well as this copyright and license information must be included. JMIR Res Protoc publishes research protocols, current and ongoing trials, and grant proposals in all areas of medicine (with an initial focus on ehealth/mhealth). Publish your work in this journal to let others know what you are working on, to facilitate collaboration and/or recruitment, to avoid duplication of efforts, to create a citable record of a research design idea, and to aid systematic reviewers in compiling evidence. Research protocols or grant proposals that are funded and have undergone peer-review will receive an expedited review if you upload peer-review reports as supplementary files. https://www.researchprotocols.org/2024/1/e56242/ Homestay Hosting Dynamics and Refugee Well-Being: Protocol for a Scoping Review2024-03-19T08:45:22-04:00Areej Al-HamadYasin M YasinKateryna MeterskySepali GurugeKhadija Mahsud<strong>Background:</strong> The process of refugee resettlement and integration into new communities is a complex and multifaceted challenge, not only for the refugees themselves but also for the host families involved in homestay housing arrangements. While these homestay arrangements are designed to facilitate smoother transitions and enhance the well-being of refugees, the nuanced dynamics of these interactions and their overall impact on both refugees and their host families remain underexplored. Understanding the experiences of refugees and their host families is vital for effective refugee settlement, integration, and well-being. However, the intricacies of homestay refugee hosting, their interactions with host families, and the impact on their well-being are still unclear and ambiguous. <strong>Objective:</strong> The aim of this scoping review is to examine the breadth of literature on the experiences of refugees living in homestay arrangements with their host families. This review seeks to understand how these dynamics influence refugee well-being, including their integration, social connections, and mental health. Additionally, this scoping review aims to synthesize existing literature on homestay hosting dynamics, focusing on the experiences of refugees and their host families, to identify gaps in knowledge and suggest areas for future research. <strong>Methods:</strong> This scoping review follows Joanna Briggs Institute methodology and will search databases such as CINAHL, SOCIndex, MEDLINE through EBSCO; APA PsycInfo, Scopus through OVID; and Web of Science Core Collection, ProQuest Dissertations, and Theses, and SciELO Citation Index, focusing on literature from 2011 onward, in English, in relation to refugee groups in different host countries, including all types of literature. Literature will be screened by 2 independent reviewers, with disagreements resolved by consensus or a third reviewer. A custom data extraction tool will be created by the research team. <strong>Results:</strong> The results will be organized in tables or diagrams, accompanied by a narrative overview, emphasizing the main synthesized findings related to the dynamics of homestay hosting with host families and refugee well-being. No critical appraisal will be conducted. This scoping review is expected to identify research gaps that will inform the development of homestay refugee hosting models, policies, and practices. It will also offer insights into best practices and policy recommendations to improve homestay hosting programs, ultimately contributing to more effective refugee settlement and integration strategies. <strong>Conclusions:</strong> Understanding the intricate dynamics of homestay hosting arrangements is crucial for developing policies and programs that support the well-being of refugees and the families that host them. This scoping review will shed light on the current knowledge landscape, identify research gaps, and suggest ways to enhance the homestay hosting experience for all parties involved. Through this work, we aim to contribute to the development of more inclusive, supportive, and effective approaches to refugee hosting, resettlement, and integration. <strong>Trial Registration:</strong> 2024-03-19T08:45:22-04:00 https://www.researchprotocols.org/2024/1/e55210/ Providing Lesbian, Gay, Bisexual, Transgender, Nonbinary, and Queer Adolescents With Nurturance, Trustworthiness, and Safety: Protocol for Pilot Cluster Randomized Controlled Trial Design2024-03-19T08:45:03-04:00Robert WS CoulterIsabella Kaur MahalClarisse A LinShari Kessel SchneiderAaryn S MathiasKaruna BaralElizabeth MillerKaleab Z Abebe<strong>Background:</strong> Sexual and gender minority youths (lesbian, gay, bisexual, transgender, nonbinary, and queer individuals) face elevated risks of substance use (eg, alcohol and tobacco) and mental health issues (eg, depressive symptoms and suicidality) compared to their cisgender heterosexual peers. These inequities are hypothesized to be reduced by building supportive high school environments via the training of school staff. An intervention that trains school staff to better understand and support sexual and gender minority youths and engage in positive bystander behaviors that protect them from bullying exposure may reduce disparities in drug and alcohol use among them. Experts, school staff, and sexual and gender minority youths developed Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety (PLANTS), a web-based intervention to train school staff on how to support, affirm, and protect sexual and gender minority youths. <strong>Objective:</strong> This paper describes the design of the PLANTS pilot trial primarily aimed at assessing its acceptability, usability, appropriateness, and feasibility. We hypothesize PLANTS will have high acceptability, usability, appropriateness, and feasibility as rated by the school staff. Secondary objectives focus on implementation, safety, and pre-post changes in high school staff outcomes, including self-efficacy and skills (eg, active-empathic listening and bullying intervention). Exploratory objectives focus on the impact of PLANTS on student health outcomes. <strong>Methods:</strong> In a 2-arm cluster randomized controlled trial, high schools in Massachusetts are allocated to PLANTS or an active comparator group (publicly available sexual and gender minority youths resources or training). High school staff complete pretest and posttest surveys containing validated scales. Primary outcomes are validated measures of acceptability, usability, appropriateness, and feasibility of the intervention completed by staff during posttest surveys. To test our primary hypotheses for each outcome, we will calculate means and 95% CIs and <i>P</i> values using 1-sample 2-sided <i>t</i> tests against a priori thresholds or benchmarks of success. Secondary outcomes include staff’s active-empathetic listening skills, self-efficacy for working with sexual and gender minority youths, bystander intervention behaviors for bullying and cyberbullying, and self-efficacy for PLANTS’ change objectives completed during pretest and posttest staff surveys. Staff can also complete a posttest interview guided by the Information-Motivation-Behavior model and Consolidated Framework for Implementation Research. Exploratory outcomes include student-level data collected via the 2021 and 2023 MetroWest Adolescent Health Surveys, a health behavior surveillance system in 30 Massachusetts schools. <strong>Results:</strong> School enrollment began in May 2023 and participant enrollment began in June 2023. Data collection is expected to be completed by February 2024. <strong>Conclusions:</strong> This pilot trial will yield important information about the PLANTS intervention and provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the deleterious health inequities experienced by sexual and gender minority youths. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05897827; https://clinicaltrials.gov/study/NCT05897827 2024-03-19T08:45:03-04:00 https://www.researchprotocols.org/2024/1/e55193/ Examining Parent Mood, Feeding Context, and Feeding Goals as Predictors of Feeding Practices Used by Parents of Preschool Children With Avid Eating Behavior: Protocol for an Ecological Momentary Assessment Study2024-03-19T08:30:23-04:00Katie EdwardsHelen CrokerClaire FarrowEmma HaycraftMoritz HerleClare LlewellynAbigail PickardJacqueline Blissett<strong>Background:</strong> An avid eating behavior profile is characterized by a greater interest in food and a tendency to overeat in response to negative emotions. Parents use specific strategies to manage feeding interactions with children with avid eating behavior. While momentary and contextual factors, such as parental mood, have been found to influence parental feeding practices, there is a lack of research examining parents’ daily experiences of feeding children with avid eating behavior. Examining this is important because parental feeding practices are key levers in tailored interventions to support children’s healthy eating behavior. <strong>Objective:</strong> We aim to describe the ecological momentary assessment methods and procedures used in the APPETItE (Appetite in Preschoolers: Producing Evidence for Tailoring Interventions Effectively) project, which aims to examine how variation in parental mood, feeding goals, and the context of eating occasions affect the parental feeding practices used to manage feeding interactions with children with an avid eating behavior profile. <strong>Methods:</strong> Participants are primary caregivers from the APPETItE cohort who have a preschool-age child (aged 3-5 years) with an avid eating behavior profile. Caregivers complete a 10-day ecological momentary assessment period using signal- and event-contingent surveys to examine (1) mood and stress, (2) parental feeding goals, and (3) contextual factors as predictors of parental feeding practices. <strong>Results:</strong> Recruitment and data collection began in October 2023 and is expected to be completed by spring 2024. The data have a 3-level structure: repeated measurements (level 1) nested within days (level 2) nested within an individual (level 3). Thus, lag-dependent models will be conducted to test the main hypotheses. <strong>Conclusions:</strong> The findings from this study will provide an understanding of caregivers’ daily experiences of feeding preschool children with avid eating behavior, who are at greater risk for the development of obesity. Understanding the predictors of feeding practices at the moment they occur, and across various contexts, will inform the development of tailored resources to support caregivers in managing children’s avid eating behavior. 2024-03-19T08:30:23-04:00 https://www.researchprotocols.org/2024/1/e50177/ Implementing and Evaluating a National Integrated Digital Registry and Clinical Decision Support System in Early Intervention in Psychosis Services (Early Psychosis Informatics Into Care): Co-Designed Protocol2024-03-19T08:30:03-04:00Siân Lowri GriffithsGraham K MurrayYanakan LogeswaranJohn AinsworthSophie M AllanNiyah CampbellRichard J DrakeMohammad Zia Ul Haq KatshuMatthew MachinMegan A PopeSarah A SullivanJustin WaringTumelo BogatsuJulie KaneTyler WeetmanSonia JohnsonJames B KirkbrideRachel Upthegrove<strong>Background:</strong> Early intervention in psychosis (EIP) services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems (CDSSs) have revolutionized the delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. <strong>Objective:</strong> This paper reports the protocol for the program development phase of this study, in which we aimed to co-design and produce an evidence-based, stakeholder-informed framework for the building, implementation, piloting, and evaluation of a national integrated digital registry and CDSS for psychosis, known as EPICare (Early Psychosis Informatics into Care). <strong>Methods:</strong> We conducted 3 concurrent work packages, with reciprocal knowledge exchange between each. In work package 1, using a participatory co-design framework, key stakeholders (clinicians, academics, policy makers, and patient and public contributors) engaged in 4 workshops to review, refine, and identify a core set of essential and desirable measures and features of the EPICare registry and CDSS. Using a modified Delphi approach, we then developed a consensus of data priorities. In work package 2, we collaborated with National Health Service (NHS) informatics teams to identify relevant data currently captured in electronic health records, understand data retrieval methods, and design the software architecture and data model to inform future implementation. In work package 3, observations of stakeholder workshops and individual interviews with representative stakeholders (n=10) were subject to interpretative qualitative analysis, guided by normalization process theory, to identify factors likely to influence the adoption and implementation of EPICare into routine practice. <strong>Results:</strong> Stage 1 of the EPICare study took place between December 2021 and September 2022. The next steps include stage 2 building, piloting, implementation, and evaluation of EPICare in 5 demonstrator NHS Trusts serving underserved and diverse populations with substantial need for EIP care in England. If successful, this will be followed by stage 3, in which we will seek NHS adoption of EPICare for rollout to all EIP services in England. <strong>Conclusions:</strong> By establishing a multistakeholder network and engaging them in an iterative co-design process, we have identified essential and desirable elements of the EPICare registry and CDSS; proactively identified and minimized potential challenges and barriers to uptake and implementation; and addressed key questions related to informatics architecture, infrastructure, governance, and integration in diverse NHS Trusts, enabling us to proceed with the building, piloting, implementation, and evaluation of EPICare. 2024-03-19T08:30:03-04:00 https://www.researchprotocols.org/2024/1/e49849/ Group Acceptance and Commitment Therapy for Recovery From Psychosis: Protocol for a Single-Group Waitlist Trial2024-03-18T09:45:03-04:00Marilyn L CugnettoEric M J MorrisSiobain F BonfieldJesse GatesIlona MorrisonEllie R NewmanJulia D NichollsLisa M SoaresMegan T AntonucciJacinta R ClementeClaire L M GarrattEliot GoldstoneDavid A PavoneJohn Farhall<strong>Background:</strong> Psychological interventions, along with antipsychotic medications, are recommended for adults diagnosed with a psychotic disorder. While initially designed to mitigate positive symptoms, psychological interventions targeting personal recovery were developed and aligned with the recovery framework that many mental health services have adopted. Acceptance and Commitment Therapy (ACT) for psychosis is one such intervention that shows promise when delivered in an individual format. There is preliminary evidence that ACT for psychosis in a group format improves recovery. <strong>Objective:</strong> This trial aims to evaluate the effectiveness of the “Recovery ACT” group program on personal recovery among adults living with a psychotic disorder. <strong>Methods:</strong> Our unfunded study is a multiagency, prospective, nonrandomized, waitlist control, single-group trial of the Recovery ACT group program. The program involves 7 weekly group sessions of 90 minutes duration and a 90-minute booster session held 1 month later. We intend to recruit 160 adults living with a psychotic disorder who enroll in a group that is offered as a routine clinical service at participating public mental health services in Melbourne, Victoria, Australia. The 4 assessment time points are 4-6 weeks before the start of the group program, at the start of the group program, at the end of the group program, and at the booster session. There is an optional midgroup assessment and follow-up study. The primary outcome is personal recovery. Secondary outcomes include participants’ well-being and psychological flexibility processes. Qualitative data are also collected from participants and facilitators. <strong>Results:</strong> Recruitment began in September 2019 and is ongoing until 2024, subsequent to a 24-month disruption due to the COVID-19 pandemic. As of the submission of this paper, 93 participants consented to the evaluation, 65 completed T1 measures, and 40 had a complete data set for the proposed analyses. <strong>Conclusions:</strong> This is the first trial evaluating the effectiveness of the Recovery ACT group program on personal recovery for adults living with a psychotic disorder. Findings will contribute to knowledge about psychosocial interventions for adults living with psychosis. This trial may also serve as an example of a partnership between clinicians and academics that can facilitate the translation of research into practice. <strong>Trial Registration:</strong> Australian New Zealand Clinical Trials Registry ACTRN12620000223932; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000223932 2024-03-18T09:45:03-04:00 https://www.researchprotocols.org/2024/1/e55198/ Characteristics of Occupational Therapy Interventions to Promote Healthy Aging: Protocol for a Scoping Review2024-03-18T08:30:28-04:00Katrina BanniganNicole Jade LarkanEmmanuelle Renee Rogelia MeurgueJason Chun Hin Sze<strong>Background:</strong> Healthy aging is a pressing public health priority. Focusing on what people do every day may be a meaningful approach to lifestyle change, suggesting a need for occupation therapy interventions to promote healthy aging. A preliminary database search was conducted, and no current or underway systematic or scoping reviews on the topic were identified. Developing an overview of studies of occupational therapy interventions to promote healthy aging is a necessary first step to understanding the existing knowledge and increasing the impact of future interventions. This scoping review will build on previously conducted reviews. <strong>Objective:</strong> This scoping review will identify the following: (1) what occupational therapy interventions exist for promoting healthy aging in community-dwelling adults? and (2) what are the intervention characteristics, their evaluated outcome, and the impact observed? <strong>Methods:</strong> This protocol was reviewed by 2 occupational therapists as part of a patient and public involvement consultation. The review will consider all studies and publications of occupational therapy focused on promoting healthy aging in community-dwelling adults who are aged 18 years and older. Databases to be searched are AMED, CINAHL, Cochrane Library, Embase, JBI EBP database, MEDLINE, OAlster, PsycINFO, PsycArticles, ProQuest Dissertations & Theses, ProQuest nursing and allied health source, PubMed, and Science Direct. Studies published in any language will be included. Titles and abstracts will be screened against the inclusion criteria using Covidence (Veritas Health Innovation). Potentially relevant studies will be retrieved in full and assessed against the inclusion criteria. No date limiters will be used. Study selection will be completed by 2 independent reviewers. Data will be extracted using a data extraction tool, including descriptive characteristics of the participants including age, sex, and socioeconomic status. Data will be charted using the TIDieR (Template for Intervention Description and Replication) checklist in alignment with the review objectives. The scoping review will be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) statement. <strong>Results:</strong> The research began in October 2023, and the results are expected to be published in 2024. <strong>Conclusions:</strong> This scoping review will produce valuable information about occupation-based interventions to promote healthy aging to support the development of an occupational therapy intervention. <strong>Trial Registration:</strong> Open Science Framework 5k36d; https://osf.io/5k36d/ 2024-03-18T08:30:28-04:00 https://www.researchprotocols.org/2024/1/e50200/ Promoting Return to Work After Vocational Rehabilitation Using a Work-Related Fitness App: Protocol for a Cluster-Randomized Controlled Trial2024-03-18T08:30:05-04:00David BühneJan Mathis EllingChristian HetzelTorsten Alles<strong>Background:</strong> Retraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the “WORKout-app” which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity. <strong>Objective:</strong> The aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes). <strong>Methods:</strong> We conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes. <strong>Results:</strong> This study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022). <strong>Conclusions:</strong> The findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation. 2024-03-18T08:30:05-04:00 https://www.researchprotocols.org/2024/1/e56683/ Integration of an Electronic Screening, Brief Intervention, and Referral to Treatment Program Into an HIV Testing Program to Reduce Substance Use and HIV Risk Behavior Among Men Who Have Sex With Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial2024-03-14T08:45:39-04:00Iván C BalánRuben O MaroneVictoria BarredaSylvie NaarYuxia Wang<strong>Background:</strong> Men who have sex with men (MSM) are disproportionally affected by HIV and drug and alcohol use; however, few effective HIV prevention interventions for MSM who use substances exist. Screening, Brief Intervention, and Referral to Treatment is an early intervention for non–treatment-seeking individuals with problematic substance use and for timely referral to treatment for those with substance use disorders. Electronic screening and brief interventions (e-SBIs) reduce implementation challenges. An e-SBI tailored for MSM at the time of HIV testing might be particularly opportune to strengthen their motivation to reduce substance use and HIV risk behavior. <strong>Objective:</strong> This study aims to develop a tailored e-SBI program to reduce substance use and HIV risk behavior among MSM seeking HIV testing at Nexo Asociación Civil, our community partners in Argentina (primary); assess the feasibility and acceptability of integrating the e-SBI into the Nexo HIV testing program (primary); assess the feasibility and acceptability of implementing an adapted Men’s Health Project (MHP) at Nexo (secondary); and finally, explore preliminary findings on substance use and sexual risk reduction outcomes (exploratory). <strong>Methods:</strong> This mixed methods study has 2 stages. During stage 1 (development), we will use the User Centered Rapid App Design process consisting of focus groups (n=16), individual interviews (n=24), and a pilot deployment of the e-SBI (n=50) to iteratively develop the e-SBI. Quantitative and qualitative assessments at each step will inform the revision of the e-SBI. Furthermore, we will use the assessment, decision, administration, production, topic experts, integration, training, testing framework to adapt MHP. During stage 2 (pilot randomized controlled trial [RCT]), we will randomize 200 MSM coming to Nexo for HIV testing. They will complete a baseline assessment and then their assigned intervention (e-SBI vs screening only) and will be followed-up for 6 months. We will also conduct in-depth interviews with up to 45 participants: 15 participants from either study condition who entered or completed MHP or other substance abuse treatment and 15 from each arm who met the criteria for MHP but did not request it. <strong>Results:</strong> The study began recruitment in October 2022, and the stage-1 pilot study is near completion. Preliminary findings from stage 1 show high e-SBI acceptability. Data analysis of the stage-1 pilot is now beginning. The stage-2 pilot RCT will be launched in March 2024, with all data collection completed by May 2025. <strong>Conclusions:</strong> This study will allow us to assess the acceptability and feasibility of e-SBI implementation during HIV testing encounters. We will also build the necessary research infrastructure for a subsequent RCT to assess the efficacy of e-SBIs in reducing substance use and HIV sexual risk behavior among MSM in this setting. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05542914; https://tinyurl.com/yyjj64dm. 2024-03-14T08:45:39-04:00 https://www.researchprotocols.org/2024/1/e56016/ Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial2024-03-14T08:45:21-04:00Angela R StarkweatherWanli XuKatherine E GnallMariel EmrichCamille L GarnseyZachary E MaginWeizi WuJoseph FettaErik J GroesslCrystal Park<strong>Background:</strong> Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. <strong>Objective:</strong> This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga’s effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. <strong>Methods:</strong> For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. <strong>Results:</strong> The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. <strong>Conclusions:</strong> The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297 2024-03-14T08:45:21-04:00 https://www.researchprotocols.org/2024/1/e55332/ Nonspecific Effects of the Bacillus Calmette-Guérin Vaccine in Portuguese Children Under 5 Years of Age: Protocol for a Population-Based Historical Birth Cohort Study2024-03-14T08:45:03-04:00Ines FronteiraMatilde PachecoFrederik Schaltz-BuchholzerPaulo Ferrinho<strong>Background:</strong> The Bacillus Calmette-Guérin vaccine (BCG) against tuberculosis (TB) shows beneficial nonspecific effects, which are likely related to innate immune training. Until 2016, a single BCG dose was administered to all newborns in Portugal. In July 2016, a clinical guideline established that only children under 6 years belonging to high-risk groups should receive BCG. This might have prevented nonvaccinated children from developing trained immunological responses as effectively as BCG-vaccinated children. <strong>Objective:</strong> This study aims to investigate if there is variation in TB-related and all-cause mortality, and severe, moderate, or mild morbidity in children under 5 years of age, and whether such variation might be explained by the BCG vaccination policy change in 2016. <strong>Methods:</strong> This population-based historical birth cohort study includes children under 5 years of age born in Portugal between July 1, 2010, and June 30, 2021. Newborns with low birth weight, premature status, or known or suspected HIV infection are excluded. The follow-up period is until the completion of 5 years of age or the end of follow-up (June 30, 2021). The study will use secondary data from the National Health Service user registry, death certificate database, vaccination registry, communicable diseases surveillance system, TB surveillance system, diagnosis-related group information system for hospital admissions and emergency department visits, and primary health care information system. The data will be linked. Primary outcomes include person-time incidence rates of death (all causes and TB), TB diagnosis, and all causes and some specific causes of severe, moderate, or mild morbidity, and the incidence rate ratio of nonvaccinated to BCG-vaccinated children. We will compare the probability of surviving the first and fifth years of life or of not having severe, moderate, or mild morbidity during the follow-up period according to exposure (BCG vaccinated or nonvaccinated, number of doses, and time from birth until the first dose), using the log-rank test for assessing differences in survival rates between exposed and nonexposed children and hazard ratios for quantifying the differences. Moreover, we will perform a proportional hazards regression analysis. <strong>Results:</strong> Ethics approval has been obtained. In March 2022, database owners were contacted to present the project and discuss the request for data. A unique identifier will be used. In July 2023, a process of redefinition of the variables per database was initiated. Data were received in October and November 2023. In November 2023, further work was conducted. By April 2024, we expect to start analyzing the full data set. <strong>Conclusions:</strong> The results will contribute to the accumulating body of knowledge and might have relevance to guide global BCG vaccination policy. Data linkage can contribute to a swifter mechanism to use available health data to conduct population-based studies and inform policy decision-making. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05471167; https://clinicaltrials.gov/study/NCT05471167 2024-03-14T08:45:03-04:00