Implementation burden and hidden labor in a multisite digital psychiatry trial

Implementation burden and hidden labor in a multisite digital psychiatry trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Perspective Implementation burden and hidden labor in a multisite digital psychiatry trial Linda Rubene-Kesele This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8678202/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Multisite digital psychiatry trials increasingly rely on complex onboarding and implementation processes at local research sites. While outcome-focused evaluations are common, less attention has been paid to the site-level labor required to operationalize such studies in real-world settings, particularly at smaller or resource-constrained sites. Methods: This paper adopts a reflexive, practice-based qualitative approach to examine onboarding and implementation processes at a single Latvian research site participating in a multisite digital psychiatry trial (ClinicalTrials.gov: NCT04953208). The analysis is based on systematic reflection informed by site-specific documentation, onboarding timelines, internal communications, and longitudinal involvement in site coordination and implementation activities. An inductive thematic approach was used to identify recurring challenges and contextual factors shaping implementation burden. Results: Five interrelated themes were identified: hidden labor and role overload; resource scarcity at small research sites; fragmented remote communication and technical coordination; multi-role professional contexts and competing demands; and the impact of external systemic disruptions. Findings illustrate how diverse administrative, technical, logistical, and coordination tasks were absorbed into individual roles, often exceeding initial role expectations. Despite limited resources, the site achieved high performance through intensified individual effort, masking the true implementation burden. Reliance on remote coordination redistributed labor onto site personnel, while external crises further amplified workload and uncertainty. Conclusions: This site-level reflexive account highlights the central role of hidden labor in sustaining implementation in multisite digital psychiatry trials. Recognizing and explicitly resourcing implementation work, particularly at small research sites, may improve feasibility, sustainability, and equity across study settings. Reflexive, practice-based approaches offer valuable insight into implementation processes that are often invisible in outcome-focused research. implementation burden digital psychiatry multisite studies hidden labor resource-constrained settings reflexive qualitative research site-level implementation Contributions to the literature Provides a site-level reflexive account of onboarding and implementation burden in a multisite digital psychiatry trial. Highlights hidden labor and role compression as central but underrecognized components of implementation work. Illustrates how resource scarcity at small research sites can coexist with high performance through intensified individual effort. Examines how remote, digitally mediated coordination redistributes implementation workload onto site personnel. Demonstrates the value of reflexive, practice-based approaches for understanding real-world implementation processes. Background This paper provides a site-level reflexive account of onboarding and implementation processes in a multisite digital psychiatry study, highlighting practical challenges and underrecognized sources of implementation burden. The paper focuses exclusively on experiences at the Latvian study site and does not draw on consortium-wide outcome data or comparative analyses across participating centers. The account is intentionally site-specific and reflexive, based on the author’s role in local onboarding and implementation processes. Identifiable individuals and institutions are not described, and all examples are presented in anonymized form. The aim is not to generalize findings to all sites within the study or to multisite digital psychiatry research broadly, but rather to offer a contextualized reflection on implementation burden as it was experienced within a specific healthcare and research setting, with the intention of contributing practice-informed insights to the implementation literature. Literature Review Multisite digital psychiatry and mental health intervention studies have expanded rapidly in recent years, driven by advances in digital technologies and the need to improve access to care across diverse settings ( 1 ). While outcome-focused evaluations of such interventions are common, a growing body of literature highlights that implementation processes, particularly at the site level, play a critical role in determining feasibility, sustainability, and real-world impact ( 2 , 3 ). However, these processes are often underreported, especially in publications centered on clinical efficacy ( 4 ). Implementation science literature has consistently identified structural and organizational barriers in complex clinical studies, including staffing limitations, time pressures, competing institutional priorities, and coordination challenges across sites( 1 , 3 , 4 ). Qualitative studies examining trial staff perspectives have shown that recruitment, onboarding, and intervention delivery frequently require substantial informal labor that extends beyond formally defined roles ( 2 , 5 ). These challenges are particularly pronounced in digital mental health research, where technical infrastructure, platform usability, and ongoing troubleshooting introduce additional layers of complexity( 1 , 2 ). Research on multisite and multinational clinical trials further emphasizes coordination burden as a recurring challenge( 2 , 4 – 6 ). Studies describing collaborative trials across institutions note that communication across geographic, institutional, and professional boundaries can be fragmented, leading to delays, misunderstandings, and increased reliance on site-level problem-solving( 2 , 4 – 6 ). Such coordination demands are often managed through ad hoc solutions and individual effort, rather than through standardized or well-resourced support structures. Despite their importance, these forms of labor are rarely foregrounded in final trial reports( 2 ). A related body of literature addresses resource constraints and inequities between research sites. Smaller or less-resourced sites may face persistent human resource limitations, lack of redundancy in key roles, and reduced access to technical or administrative support ( 1 , 3 , 4 ). Paradoxically, some studies suggest that these sites may demonstrate high levels of efficiency or rapid recruitment, achieved through intensified individual workload rather than structural advantage ( 2 , 4 ). This dynamic raises concerns about sustainability and staff well-being, particularly when implementation success depends on unacknowledged personal investment. Methodologically, reflexive and practice-based qualitative approaches have been increasingly recognized as valuable for examining implementation processes in healthcare and research settings ( 7 – 9 ). Such approaches foreground contextual knowledge, experiential insight, and positionality, offering perspectives that complement formal process evaluations and quantitative metrics ( 1 – 3 ). Reflexive accounts by clinicians, researchers, and coordinators provide important insight into the lived realities of implementing complex interventions, particularly in environments shaped by systemic constraints ( 2 ). Despite these contributions, there remains limited published work that explicitly examines onboarding and implementation burden from the perspective of individual research sites within digital psychiatry trials, especially in smaller healthcare systems( 1 – 3 ). The present paper addresses this gap by offering a site-level reflexive account of onboarding and implementation processes at a Latvian study site, contributing contextualized insights to the broader implementation literature. Study Context and Setting The present paper is situated within a multisite psychiatry study conducted under the DisCoVeR project. The trial investigated a combined digital intervention targeting cognitive and affective processes in individuals with major depressive disorder, incorporating computerized cognitive training and non-invasive brain stimulation and was implemented across multiple research sites. The full study protocol, including detailed methodological descriptions, has been published previously (DisCoVeR protocol; ClinicalTrials.gov registration NCT04953208 with a registration date of July 9, 2021) and is therefore not reproduced here ( 10 ). The Latvian site participated as one of the recruiting and implementing centers, with responsibilities defined in accordance with the published protocol. Recruitment and clinical monitoring of participants were conducted by site clinicians under the supervision of a local principal investigator. The reflections presented in this paper focus exclusively on the Latvian site and its onboarding and implementation processes. Preparatory activities at the Latvian site began in 2019, including ethics submissions, translation and adaptation of study materials, and coordination of documentation, in which the author was actively involved. The author formally assumed the role of site coordinator in March 2020 and remained in this role through March 2024, and continues to be involved in data analysis and manuscript preparation related to the study. Author Role and Site Responsibilities The author’s formal role at the Latvian site was that of site coordinator. In practice, this role encompassed a broad range of responsibilities related to local onboarding and implementation. These included organizing and maintaining site-specific documentation; supporting clinicians with study-related documentation; conducting participant onboarding sessions; providing technical support related to the digital intervention; and managing ongoing troubleshooting throughout the study. The role also involved coordinating communication between the Latvian site, other participating sites, and central study teams when clarification or problem-solving was required. In addition, the author was responsible for coordinating the physical components of the study at the Latvian site, including the receipt, storage, distribution, and maintenance of study devices, as well as the secure handling and transfer of biological samples for centralized analysis. The author was also involved in local data quality assurance processes, including monitoring data completeness and participating in data cleaning activities. Parallel to these responsibilities, the author contributed to data analysis and manuscript preparation as part of doctoral research associated with the project. Although the site coordination role was initially shared between two staff members, these responsibilities were assumed by the author alone during the later stages of the study. The Latvian site operated with a relatively small team but achieved rapid participant recruitment and data provision compared to other participating centers, some of which experienced recruitment delays. This combination of limited staffing, overlapping responsibilities, and accelerated implementation timelines constitutes an important contextual backdrop for the site-level reflections presented in this paper. Methods This paper adopts a reflexive, practice-based qualitative approach to examine onboarding and implementation processes at a single study site. Rather than generating new empirical data, the analysis is based on systematic reflection on the author’s direct involvement in site coordination and implementation activities throughout the study period. Reflections were informed by multiple sources, including onboarding timelines, site-specific documentation, internal communications with clinicians, central study teams, and external partners, as well as records related to troubleshooting, device management, and data quality assurance. These materials were reviewed iteratively to identify recurring challenges, patterns of workload distribution, and contextual factors influencing implementation. An inductive, thematic approach was used to organize reflections into core themes. Themes were refined through repeated comparison of experiences across different phases of the study, with attention to how structural conditions, resource availability, and communication processes shaped implementation burden. Reflexivity was integral to the analytic process, with the author explicitly acknowledging the influence of her dual role as clinician-researcher and site coordinator on the observations presented. This approach aligns with established reflexive methodologies in implementation science and health services research, where experiential and contextual knowledge is recognized as a valuable source of insight into real-world research processes. Results Hidden Labor and Role Overload A central theme emerging from the site-level reflection was the extent of hidden labor embedded in onboarding and implementation processes. While the formal role at the Latvian site was defined as site coordination, the practical demands of implementation extended far beyond this designation. Responsibilities accumulated across administrative, technical, logistical, and coordination domains, often without clear delineation or redistribution of tasks. Many of these activities such as repeated troubleshooting, informal problem-solving, and ad hoc coordination between stakeholders were essential for study continuity but remained largely invisible within formal project structures. This role expansion intensified over time, particularly during later stages of the study when staffing at the site was reduced. As responsibilities became increasingly concentrated, the distinction between defined roles and emergent needs blurred, resulting in sustained role overload. The reliance on individual flexibility and informal labor functioned as a key enabling factor for implementation but also represented a significant, underacknowledged burden. Resource Scarcity at Small Research Sites Implementation processes at the Latvian site were shaped by persistent resource constraints, particularly in terms of human resources. The site operated with a small core team, limiting opportunities for task sharing, redundancy, or coverage during periods of increased demand. In this context, even routine implementation tasks required careful prioritization and negotiation of limited capacity. Despite these constraints, the site achieved rapid participant recruitment and timely data provision compared to other participating centers. However, this performance was sustained through intensive individual effort rather than structural support. Resource scarcity thus did not manifest as inefficiency but rather as increased personal workload and reduced buffering against disruptions. This dynamic highlights how high-performing small sites may carry disproportionate implementation burden that remains obscured in aggregate project reporting. Fragmented Remote Communication and Technical Coordination Another prominent theme concerned the challenges of fragmented, predominantly remote communication across institutional and organizational boundaries. Coordination with external partners particularly device manufacturers relied on asynchronous communication, which complicated troubleshooting, device repair, and replacement processes. The absence of direct, in-person contact limited opportunities for rapid resolution and mutual understanding of technical issues. These communication barriers had downstream consequences for both participants and site staff. Participants were sometimes required to make repeated visits to the study site to address technical problems, disrupting intervention continuity and increasing participant burden. At the same time, site coordinators assumed intermediary roles, translating technical information between parties and managing delays. This added layer of coordination further contributed to implementation workload and reinforced the centrality of informal labor in sustaining the study. Multi-Role Professional Contexts and Competing Demands Implementation at the Latvian site took place within a broader professional context characterized by multi-role employment and competing institutional demands. None of the personnel involved in the study worked exclusively on the project. Clinicians and research staff simultaneously balanced clinical duties, teaching responsibilities, research activities, and work across public and private healthcare settings. This pattern reflects common structural features of the Latvian medical system, where role multiplicity is normative rather than exceptional. As a result, study-related tasks were frequently embedded within already full schedules, limiting the availability of protected time for onboarding and implementation activities. Implementation work therefore competed with other professional obligations, increasing cognitive and logistical load. This context amplified the impact of unforeseen challenges and reduced flexibility in responding to implementation disruptions. External Crises During Implementation Finally, implementation unfolded against a backdrop of broader external crises that introduced additional strain and uncertainty. The COVID-19 pandemic emerged during active recruitment and onboarding phases, necessitating rapid adaptations to workflows, safety procedures, and participant interactions. These changes increased complexity and unpredictability in implementation processes. In addition, geopolitical instability affecting another study site during the recruitment phase had indirect effects on the wider project team. Although the Latvian site was not directly exposed to these events, awareness of colleagues operating under conditions of war contributed to emotional and organizational strain within the consortium. These experiences underscore how multisite studies remain vulnerable to global disruptions that extend beyond local contexts and can influence implementation dynamics even at geographically distant sites. Discussion Rather than mapping findings onto a predefined implementation framework, this analysis adopts an interpretive approach to examine how implementation burden is produced and managed within a specific organizational context. The following discussion situates these findings in relation to existing implementation literature. Key Contribution and Relation to Existing Literature The most salient implementation challenge observed at the Latvian site was the extent of multitasking and the breadth of skills required to sustain onboarding and implementation, which substantially exceeded initial role expectations. Consistent with prior literature, this study confirms that digital and multisite trials impose significant operational and coordination burdens on site staff, including time pressure, role strain, and reliance on informal problem-solving. However, the present reflexive account adds nuance by illustrating how these burdens accumulate within single individuals when staffing is limited, leading to pronounced role compression across administrative, technical, clinical, logistical, and analytical domains. While previous studies acknowledge implementation burden in general terms, the concentration of heterogeneous responsibilities within one or two individuals and its implications for sustainability and well-being remains underemphasized. This site-level perspective highlights that successful implementation may depend less on formal role design than on unanticipated skill acquisition and continuous multitasking by individual actors. Hidden Labor and Role Compression in Digital Psychiatry Trials Hidden labor appears particularly salient in digital psychiatry trials due to the hybrid nature of the work involved. Such studies require not only clinical and research competencies but also technical literacy, coordination with external technology partners, and real-time troubleshooting within participant-facing contexts. The findings suggest that role compression where multiple specialized tasks are absorbed into a single role can distort assumptions about feasibility and cost by masking the true human resources required for implementation. While project timelines and budgets may appear adequate on paper, they often fail to account for the informal labor needed to bridge gaps between protocol design and real-world execution. This observation extends existing implementation literature by demonstrating how digital complexity amplifies reliance on individual adaptability rather than institutional support, thereby shifting risk and workload onto site personnel. Resource Scarcity and the High-Performance Paradox at Small Sites The experience of the Latvian site underscores a paradox frequently overlooked in multisite research: small or resource-constrained sites may demonstrate high performance such as rapid recruitment and timely data delivery precisely because of intensified individual effort rather than structural advantage. While prior literature acknowledges disparities in resources across sites, this account highlights how apparent efficiency can conceal significant personal workload and reduced resilience to disruption. In such contexts, high performance is maintained through sustained overextension rather than scalable processes, raising concerns about long-term feasibility and equity between sites. Communication Technologies and the Human Interface The reliance on remote and asynchronous communication across sites and external partners emerged as a critical factor shaping implementation burden. Although digital trials presume technological efficiency, this study illustrates how communication breakdowns particularly with device manufacturers or technical support teams can propagate delays, increase participant burden, and require substantial intermediary work by coordinators. These findings align with existing concerns about coordination complexity in multisite trials but add specificity regarding the human labor required to translate between technical, clinical, and organizational domains. The results suggest that digital infrastructure does not eliminate coordination work but redistributes it, often invisibly. Systemic Context, External Shocks, and Implementation Fragility Implementation processes were further shaped by broader systemic and geopolitical disruptions, including the COVID-19 pandemic and conflict affecting other study sites. While the impact of such events on research productivity has been widely acknowledged, this account highlights how external shocks compound existing implementation burden by increasing uncertainty, emotional load, and coordination demands. Even when not directly experienced at a given site, awareness of crises elsewhere in a multisite consortium can influence morale, communication, and workflow, underscoring the interconnected vulnerability of large collaborative studies. Strengths, Limitations, and Implications for Future Research and Practice A key strength of this study lies in its reflexive, site-level perspective, which provides detailed insight into implementation processes that are rarely captured in outcome-focused publications. By foregrounding experiential and contextual knowledge, the paper complements existing implementation research and highlights areas requiring greater structural attention. Limitations include its focus on a single site and reliance on reflective analysis rather than formal qualitative interviews, which constrains generalizability. Nonetheless, the findings suggest important implications for future digital psychiatry research, including the need for more explicit resourcing of implementation roles, recognition of hidden labor, clearer delineation of responsibilities, and contingency planning for systemic disruptions. Addressing these factors may improve sustainability, equity, and transparency in multisite digital mental health trials. Conclusion This site-level reflexive account highlights how onboarding and implementation in multisite digital psychiatry trials depend on substantial, often unrecognized labor at the local level. The findings illustrate that implementation burden is not solely a function of protocol complexity or technological demands but is shaped by role compression, resource scarcity, and the accumulation of diverse responsibilities within individual actors. While such labor can enable high performance and timely delivery, it frequently remains invisible within formal project structures, distorting assumptions about feasibility, cost, and sustainability. By foregrounding the lived realities of implementation at a small research site, this paper contributes contextualized insight to the digital mental health and implementation science literature. Recognizing and explicitly resourcing the human work required to bridge protocol design and real-world execution may improve equity between sites, protect staff well-being, and enhance the long-term viability of complex digital interventions. Greater attention to site-level experiences, including vulnerability to external disruptions, is essential for advancing digital psychiatry research that is both effective and sustainable. Declarations Competing interests The author declares no competing interests. Funding The underlying DisCoVeR study was funded by ERA-NET NEURON. National funding agencies included the Federal Ministry of Education and Research (BMBF, Germany), the Ministry of Health (Israel), the Swiss National Science Foundation (SNSF), and the State Education Development Agency (VIAA) of Latvia. This reflexive analysis did not receive additional dedicated funding. Ethics approval and consent to participate Ethical approval for the DisCoVeR trial was obtained from the relevant institutional ethics committees at all participating sites, including the Ethics Committee of the Medical Faculty of Ludwig-Maximilians-Universität München (Ethikkommission bei der Ludwig-Maximilians-Universität München; project number 20-503), including all protocol amendments; the Research Ethics Committee of Rīga Stradiņš University (Rīgas Stradiņa universitātes Pētījumu ētikas komiteja; decision No. 6-1/06/13); and the Institutional Review Board of Hadassah Medical Center, Jerusalem, Israel. All procedures involving human participants in the DisCoVeR trial were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to participation in the trial. The present manuscript does not report new empirical data and did not involve additional participant recruitment or data collection. No additional ethics approval or informed consent was required for this reflexive analysis. Consent for publication Not applicable. Availability of data and materials No new datasets were generated or analysed for this study. Use of artificial intelligence Artificial intelligence tools were used to assist with language editing and improving the clarity of the manuscript. The author reviewed and edited all content and takes full responsibility for the accuracy, integrity, and originality of the work. Authors’ contributions LRK conceived the study, conducted the reflexive analysis, and drafted the manuscript. LRK reviewed and approved the final version of the manuscript. Acknowledgements The author acknowledges the clinicians, research staff, and participants involved in the DisCoVeR project at the Latvian site, as well as collaborators across the wider study consortium, whose work made this research possible. 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Sappor EE, Chakraborty R. Exploring Staff Perceptions of the Management of Clinical Trials and Its Impact on Enhancing Health Service Delivery. Hospitals. 2025 Mar;2(1):1. Peralta G, Sánchez-Santiago B. Navigating the challenges of clinical trial professionals in the healthcare sector. Front Med [Internet]. 2024 June 3 [cited 2026 Jan 9];11. Available from: https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1400585/full Rana K, Poudel P, Chimoriya R. Qualitative Methodology in Translational Health Research: Current Practices and Future Directions. Healthcare. 2023 Jan;11(19):2665. Renjith V, Yesodharan R, Noronha JA, Ladd E, George A. Qualitative Methods in Health Care Research. Int J Prev Med. 2021 Feb 24;12:20. Hamilton AB, Finley EP. Qualitative Methods in Implementation Research: An Introduction. Psychiatry Res. 2019 Oct;280:112516. Dechantsreiter E, Padberg F, Morash A, Kumpf U, Nguyen A, Menestrina Z, et al. Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol. Eur Arch Psychiatry Clin Neurosci. 2023;273(1):85–98. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8678202","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Perspective","associatedPublications":[],"authors":[{"id":585389803,"identity":"862b3982-1e3d-4f07-8c73-39f4c4f37c8e","order_by":0,"name":"Linda Rubene-Kesele","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAElEQVRIiWNgGAWjYDCCAwyMBxIYmEFMNhAhBxZ8gF8LA4oWY7BgAiEtDEhaEhtAJD4tfLcPMBx4uMNankH6jNmDjzts0ueHHX4ItMVOTrcBuxbJcwkMBxLPpBs28OWYG848k5a78XaaAVBLsrHZAexaDM4AHZbYdpixgYfHTJq37XDuxtkJIC0HErcR0GIP1vK37X+64ez0D0RpSQRrYWw7kCAvnYPfFskzjA1ALenJbTxs5Ya9bcmGG6RzCg4kGOD2C98Z5oMPf7ZZ2/bzMG978LPNTl5+dvrmDx8q7ORwaWFgYGwAU2xwp4JVGuBSjg3IN5CiehSMglEwCkYCAABu7mKwarg4gQAAAABJRU5ErkJggg==","orcid":"","institution":"Riga Stradiņš University","correspondingAuthor":true,"prefix":"","firstName":"Linda","middleName":"","lastName":"Rubene-Kesele","suffix":""}],"badges":[],"createdAt":"2026-01-23 10:38:26","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8678202/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8678202/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":103049463,"identity":"73a555d4-002c-4c43-b42a-b21633e7b319","added_by":"auto","created_at":"2026-02-20 07:41:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":734048,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8678202/v1/e5d72215-f37b-4d15-a0c2-06282c6e8351.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Implementation burden and hidden labor in a multisite digital psychiatry trial","fulltext":[{"header":"Contributions to the literature","content":"\u003cul\u003e\n \u003cli\u003eProvides a site-level reflexive account of onboarding and implementation burden in a multisite digital psychiatry trial.\u003c/li\u003e\n \u003cli\u003eHighlights hidden labor and role compression as central but underrecognized components of implementation work.\u003c/li\u003e\n \u003cli\u003eIllustrates how resource scarcity at small research sites can coexist with high performance through intensified individual effort.\u003c/li\u003e\n \u003cli\u003eExamines how remote, digitally mediated coordination redistributes implementation workload onto site personnel.\u003c/li\u003e\n \u003cli\u003eDemonstrates the value of reflexive, practice-based approaches for understanding real-world implementation processes.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eThis paper provides a site-level reflexive account of onboarding and implementation processes in a multisite digital psychiatry study, highlighting practical challenges and underrecognized sources of implementation burden.\u003c/p\u003e \u003cp\u003eThe paper focuses exclusively on experiences at the Latvian study site and does not draw on consortium-wide outcome data or comparative analyses across participating centers. The account is intentionally site-specific and reflexive, based on the author\u0026rsquo;s role in local onboarding and implementation processes. Identifiable individuals and institutions are not described, and all examples are presented in anonymized form. The aim is not to generalize findings to all sites within the study or to multisite digital psychiatry research broadly, but rather to offer a contextualized reflection on implementation burden as it was experienced within a specific healthcare and research setting, with the intention of contributing practice-informed insights to the implementation literature.\u003c/p\u003e"},{"header":"Literature Review","content":"\u003cp\u003eMultisite digital psychiatry and mental health intervention studies have expanded rapidly in recent years, driven by advances in digital technologies and the need to improve access to care across diverse settings (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). While outcome-focused evaluations of such interventions are common, a growing body of literature highlights that implementation processes, particularly at the site level, play a critical role in determining feasibility, sustainability, and real-world impact (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). However, these processes are often underreported, especially in publications centered on clinical efficacy (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eImplementation science literature has consistently identified structural and organizational barriers in complex clinical studies, including staffing limitations, time pressures, competing institutional priorities, and coordination challenges across sites(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Qualitative studies examining trial staff perspectives have shown that recruitment, onboarding, and intervention delivery frequently require substantial informal labor that extends beyond formally defined roles (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). These challenges are particularly pronounced in digital mental health research, where technical infrastructure, platform usability, and ongoing troubleshooting introduce additional layers of complexity(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eResearch on multisite and multinational clinical trials further emphasizes coordination burden as a recurring challenge(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e–\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Studies describing collaborative trials across institutions note that communication across geographic, institutional, and professional boundaries can be fragmented, leading to delays, misunderstandings, and increased reliance on site-level problem-solving(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e–\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Such coordination demands are often managed through ad hoc solutions and individual effort, rather than through standardized or well-resourced support structures. Despite their importance, these forms of labor are rarely foregrounded in final trial reports(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA related body of literature addresses resource constraints and inequities between research sites. Smaller or less-resourced sites may face persistent human resource limitations, lack of redundancy in key roles, and reduced access to technical or administrative support (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Paradoxically, some studies suggest that these sites may demonstrate high levels of efficiency or rapid recruitment, achieved through intensified individual workload rather than structural advantage (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). This dynamic raises concerns about sustainability and staff well-being, particularly when implementation success depends on unacknowledged personal investment.\u003c/p\u003e \u003cp\u003eMethodologically, reflexive and practice-based qualitative approaches have been increasingly recognized as valuable for examining implementation processes in healthcare and research settings (\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e–\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Such approaches foreground contextual knowledge, experiential insight, and positionality, offering perspectives that complement formal process evaluations and quantitative metrics (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e–\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Reflexive accounts by clinicians, researchers, and coordinators provide important insight into the lived realities of implementing complex interventions, particularly in environments shaped by systemic constraints (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDespite these contributions, there remains limited published work that explicitly examines onboarding and implementation burden from the perspective of individual research sites within digital psychiatry trials, especially in smaller healthcare systems(\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e–\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The present paper addresses this gap by offering a site-level reflexive account of onboarding and implementation processes at a Latvian study site, contributing contextualized insights to the broader implementation literature.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Context and Setting\u003c/h2\u003e \u003cp\u003eThe present paper is situated within a multisite psychiatry study conducted under the DisCoVeR project. The trial investigated a combined digital intervention targeting cognitive and affective processes in individuals with major depressive disorder, incorporating computerized cognitive training and non-invasive brain stimulation and was implemented across multiple research sites. The full study protocol, including detailed methodological descriptions, has been published previously (DisCoVeR protocol; ClinicalTrials.gov registration NCT04953208 with a registration date of July 9, 2021) and is therefore not reproduced here (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe Latvian site participated as one of the recruiting and implementing centers, with responsibilities defined in accordance with the published protocol. Recruitment and clinical monitoring of participants were conducted by site clinicians under the supervision of a local principal investigator. The reflections presented in this paper focus exclusively on the Latvian site and its onboarding and implementation processes.\u003c/p\u003e \u003cp\u003ePreparatory activities at the Latvian site began in 2019, including ethics submissions, translation and adaptation of study materials, and coordination of documentation, in which the author was actively involved. The author formally assumed the role of site coordinator in March 2020 and remained in this role through March 2024, and continues to be involved in data analysis and manuscript preparation related to the study.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eAuthor Role and Site Responsibilities\u003c/h3\u003e\n\u003cp\u003eThe author’s formal role at the Latvian site was that of site coordinator. In practice, this role encompassed a broad range of responsibilities related to local onboarding and implementation. These included organizing and maintaining site-specific documentation; supporting clinicians with study-related documentation; conducting participant onboarding sessions; providing technical support related to the digital intervention; and managing ongoing troubleshooting throughout the study. The role also involved coordinating communication between the Latvian site, other participating sites, and central study teams when clarification or problem-solving was required.\u003c/p\u003e \u003cp\u003eIn addition, the author was responsible for coordinating the physical components of the study at the Latvian site, including the receipt, storage, distribution, and maintenance of study devices, as well as the secure handling and transfer of biological samples for centralized analysis. The author was also involved in local data quality assurance processes, including monitoring data completeness and participating in data cleaning activities. Parallel to these responsibilities, the author contributed to data analysis and manuscript preparation as part of doctoral research associated with the project.\u003c/p\u003e \u003cp\u003eAlthough the site coordination role was initially shared between two staff members, these responsibilities were assumed by the author alone during the later stages of the study. The Latvian site operated with a relatively small team but achieved rapid participant recruitment and data provision compared to other participating centers, some of which experienced recruitment delays. This combination of limited staffing, overlapping responsibilities, and accelerated implementation timelines constitutes an important contextual backdrop for the site-level reflections presented in this paper.\u003c/p\u003e "},{"header":"Methods","content":"\u003cp\u003eThis paper adopts a reflexive, practice-based qualitative approach to examine onboarding and implementation processes at a single study site. Rather than generating new empirical data, the analysis is based on systematic reflection on the author’s direct involvement in site coordination and implementation activities throughout the study period.\u003c/p\u003e\u003cp\u003eReflections were informed by multiple sources, including onboarding timelines, site-specific documentation, internal communications with clinicians, central study teams, and external partners, as well as records related to troubleshooting, device management, and data quality assurance. These materials were reviewed iteratively to identify recurring challenges, patterns of workload distribution, and contextual factors influencing implementation.\u003c/p\u003e\u003cp\u003eAn inductive, thematic approach was used to organize reflections into core themes. Themes were refined through repeated comparison of experiences across different phases of the study, with attention to how structural conditions, resource availability, and communication processes shaped implementation burden. Reflexivity was integral to the analytic process, with the author explicitly acknowledging the influence of her dual role as clinician-researcher and site coordinator on the observations presented.\u003c/p\u003e\u003cp\u003eThis approach aligns with established reflexive methodologies in implementation science and health services research, where experiential and contextual knowledge is recognized as a valuable source of insight into real-world research processes.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eHidden Labor and Role Overload\u003c/h2\u003e \u003cp\u003eA central theme emerging from the site-level reflection was the extent of hidden labor embedded in onboarding and implementation processes. While the formal role at the Latvian site was defined as site coordination, the practical demands of implementation extended far beyond this designation. Responsibilities accumulated across administrative, technical, logistical, and coordination domains, often without clear delineation or redistribution of tasks. Many of these activities such as repeated troubleshooting, informal problem-solving, and ad hoc coordination between stakeholders were essential for study continuity but remained largely invisible within formal project structures.\u003c/p\u003e \u003cp\u003eThis role expansion intensified over time, particularly during later stages of the study when staffing at the site was reduced. As responsibilities became increasingly concentrated, the distinction between defined roles and emergent needs blurred, resulting in sustained role overload. The reliance on individual flexibility and informal labor functioned as a key enabling factor for implementation but also represented a significant, underacknowledged burden.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eResource Scarcity at Small Research Sites\u003c/h3\u003e\n\u003cp\u003eImplementation processes at the Latvian site were shaped by persistent resource constraints, particularly in terms of human resources. The site operated with a small core team, limiting opportunities for task sharing, redundancy, or coverage during periods of increased demand. In this context, even routine implementation tasks required careful prioritization and negotiation of limited capacity.\u003c/p\u003e \u003cp\u003eDespite these constraints, the site achieved rapid participant recruitment and timely data provision compared to other participating centers. However, this performance was sustained through intensive individual effort rather than structural support. Resource scarcity thus did not manifest as inefficiency but rather as increased personal workload and reduced buffering against disruptions. This dynamic highlights how high-performing small sites may carry disproportionate implementation burden that remains obscured in aggregate project reporting.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eFragmented Remote Communication and Technical Coordination\u003c/h2\u003e \u003cp\u003eAnother prominent theme concerned the challenges of fragmented, predominantly remote communication across institutional and organizational boundaries. Coordination with external partners particularly device manufacturers relied on asynchronous communication, which complicated troubleshooting, device repair, and replacement processes. The absence of direct, in-person contact limited opportunities for rapid resolution and mutual understanding of technical issues.\u003c/p\u003e \u003cp\u003eThese communication barriers had downstream consequences for both participants and site staff. Participants were sometimes required to make repeated visits to the study site to address technical problems, disrupting intervention continuity and increasing participant burden. At the same time, site coordinators assumed intermediary roles, translating technical information between parties and managing delays. This added layer of coordination further contributed to implementation workload and reinforced the centrality of informal labor in sustaining the study.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eMulti-Role Professional Contexts and Competing Demands\u003c/h3\u003e\n\u003cp\u003eImplementation at the Latvian site took place within a broader professional context characterized by multi-role employment and competing institutional demands. None of the personnel involved in the study worked exclusively on the project. Clinicians and research staff simultaneously balanced clinical duties, teaching responsibilities, research activities, and work across public and private healthcare settings. This pattern reflects common structural features of the Latvian medical system, where role multiplicity is normative rather than exceptional.\u003c/p\u003e \u003cp\u003eAs a result, study-related tasks were frequently embedded within already full schedules, limiting the availability of protected time for onboarding and implementation activities. Implementation work therefore competed with other professional obligations, increasing cognitive and logistical load. This context amplified the impact of unforeseen challenges and reduced flexibility in responding to implementation disruptions.\u003c/p\u003e\n\u003ch3\u003eExternal Crises During Implementation\u003c/h3\u003e\n\u003cp\u003eFinally, implementation unfolded against a backdrop of broader external crises that introduced additional strain and uncertainty. The COVID-19 pandemic emerged during active recruitment and onboarding phases, necessitating rapid adaptations to workflows, safety procedures, and participant interactions. These changes increased complexity and unpredictability in implementation processes.\u003c/p\u003e \u003cp\u003eIn addition, geopolitical instability affecting another study site during the recruitment phase had indirect effects on the wider project team. Although the Latvian site was not directly exposed to these events, awareness of colleagues operating under conditions of war contributed to emotional and organizational strain within the consortium. These experiences underscore how multisite studies remain vulnerable to global disruptions that extend beyond local contexts and can influence implementation dynamics even at geographically distant sites.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eRather than mapping findings onto a predefined implementation framework, this analysis adopts an interpretive approach to examine how implementation burden is produced and managed within a specific organizational context. The following discussion situates these findings in relation to existing implementation literature.\u003c/p\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eKey Contribution and Relation to Existing Literature\u003c/h2\u003e \u003cp\u003eThe most salient implementation challenge observed at the Latvian site was the extent of multitasking and the breadth of skills required to sustain onboarding and implementation, which substantially exceeded initial role expectations. Consistent with prior literature, this study confirms that digital and multisite trials impose significant operational and coordination burdens on site staff, including time pressure, role strain, and reliance on informal problem-solving. However, the present reflexive account adds nuance by illustrating how these burdens accumulate within single individuals when staffing is limited, leading to pronounced role compression across administrative, technical, clinical, logistical, and analytical domains. While previous studies acknowledge implementation burden in general terms, the concentration of heterogeneous responsibilities within one or two individuals and its implications for sustainability and well-being remains underemphasized. This site-level perspective highlights that successful implementation may depend less on formal role design than on unanticipated skill acquisition and continuous multitasking by individual actors.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eHidden Labor and Role Compression in Digital Psychiatry Trials\u003c/h2\u003e \u003cp\u003eHidden labor appears particularly salient in digital psychiatry trials due to the hybrid nature of the work involved. Such studies require not only clinical and research competencies but also technical literacy, coordination with external technology partners, and real-time troubleshooting within participant-facing contexts. The findings suggest that role compression where multiple specialized tasks are absorbed into a single role can distort assumptions about feasibility and cost by masking the true human resources required for implementation. While project timelines and budgets may appear adequate on paper, they often fail to account for the informal labor needed to bridge gaps between protocol design and real-world execution. This observation extends existing implementation literature by demonstrating how digital complexity amplifies reliance on individual adaptability rather than institutional support, thereby shifting risk and workload onto site personnel.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eResource Scarcity and the High-Performance Paradox at Small Sites\u003c/h2\u003e \u003cp\u003eThe experience of the Latvian site underscores a paradox frequently overlooked in multisite research: small or resource-constrained sites may demonstrate high performance such as rapid recruitment and timely data delivery precisely because of intensified individual effort rather than structural advantage. While prior literature acknowledges disparities in resources across sites, this account highlights how apparent efficiency can conceal significant personal workload and reduced resilience to disruption. In such contexts, high performance is maintained through sustained overextension rather than scalable processes, raising concerns about long-term feasibility and equity between sites.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCommunication Technologies and the Human Interface\u003c/h2\u003e \u003cp\u003eThe reliance on remote and asynchronous communication across sites and external partners emerged as a critical factor shaping implementation burden. Although digital trials presume technological efficiency, this study illustrates how communication breakdowns particularly with device manufacturers or technical support teams can propagate delays, increase participant burden, and require substantial intermediary work by coordinators. These findings align with existing concerns about coordination complexity in multisite trials but add specificity regarding the human labor required to translate between technical, clinical, and organizational domains. The results suggest that digital infrastructure does not eliminate coordination work but redistributes it, often invisibly.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eSystemic Context, External Shocks, and Implementation Fragility\u003c/h2\u003e \u003cp\u003eImplementation processes were further shaped by broader systemic and geopolitical disruptions, including the COVID-19 pandemic and conflict affecting other study sites. While the impact of such events on research productivity has been widely acknowledged, this account highlights how external shocks compound existing implementation burden by increasing uncertainty, emotional load, and coordination demands. Even when not directly experienced at a given site, awareness of crises elsewhere in a multisite consortium can influence morale, communication, and workflow, underscoring the interconnected vulnerability of large collaborative studies.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eStrengths, Limitations, and Implications for Future Research and Practice\u003c/h2\u003e \u003cp\u003eA key strength of this study lies in its reflexive, site-level perspective, which provides detailed insight into implementation processes that are rarely captured in outcome-focused publications. By foregrounding experiential and contextual knowledge, the paper complements existing implementation research and highlights areas requiring greater structural attention. Limitations include its focus on a single site and reliance on reflective analysis rather than formal qualitative interviews, which constrains generalizability. Nonetheless, the findings suggest important implications for future digital psychiatry research, including the need for more explicit resourcing of implementation roles, recognition of hidden labor, clearer delineation of responsibilities, and contingency planning for systemic disruptions. Addressing these factors may improve sustainability, equity, and transparency in multisite digital mental health trials.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis site-level reflexive account highlights how onboarding and implementation in multisite digital psychiatry trials depend on substantial, often unrecognized labor at the local level. The findings illustrate that implementation burden is not solely a function of protocol complexity or technological demands but is shaped by role compression, resource scarcity, and the accumulation of diverse responsibilities within individual actors. While such labor can enable high performance and timely delivery, it frequently remains invisible within formal project structures, distorting assumptions about feasibility, cost, and sustainability.\u003c/p\u003e \u003cp\u003eBy foregrounding the lived realities of implementation at a small research site, this paper contributes contextualized insight to the digital mental health and implementation science literature. Recognizing and explicitly resourcing the human work required to bridge protocol design and real-world execution may improve equity between sites, protect staff well-being, and enhance the long-term viability of complex digital interventions. Greater attention to site-level experiences, including vulnerability to external disruptions, is essential for advancing digital psychiatry research that is both effective and sustainable.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author declares no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe underlying DisCoVeR study was funded by ERA-NET NEURON. National funding agencies included the Federal Ministry of Education and Research (BMBF, Germany), the Ministry of Health (Israel), the Swiss National Science Foundation (SNSF), and the State Education Development Agency (VIAA) of Latvia. This reflexive analysis did not receive additional dedicated funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for the DisCoVeR trial was obtained from the relevant institutional ethics committees at all participating sites, including the Ethics Committee of the Medical Faculty of Ludwig-Maximilians-Universit\u0026auml;t M\u0026uuml;nchen (Ethikkommission bei der Ludwig-Maximilians-Universit\u0026auml;t M\u0026uuml;nchen; project number 20-503), including all protocol amendments; the Research Ethics Committee of Rīga Stradiņ\u0026scaron; University (Rīgas Stradiņa universitātes Pētījumu ētikas komiteja; decision No. 6-1/06/13); and the Institutional Review Board of Hadassah Medical Center, Jerusalem, Israel. All procedures involving human participants in the DisCoVeR trial were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to participation in the trial. The present manuscript does not report new empirical data and did not involve additional participant recruitment or data collection. No additional ethics approval or informed consent was required for this reflexive analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo new datasets were generated or analysed for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eUse of artificial intelligence\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eArtificial intelligence tools were used to assist with language editing and improving the clarity of the manuscript. The author reviewed and edited all content and takes full responsibility for the accuracy, integrity, and originality of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLRK conceived the study, conducted the reflexive analysis, and drafted the manuscript. LRK reviewed and approved the final version of the manuscript.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author acknowledges the clinicians, research staff, and participants involved in the DisCoVeR project at the Latvian site, as well as collaborators across the wider study consortium, whose work made this research possible.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBerardi C, Antonini M, Jordan Z, Wechtler H, Paolucci F, Hinwood M. Barriers and facilitators to the implementation of digital technologies in mental health systems: a qualitative systematic review to inform a policy framework. BMC Health Serv Res. 2024 Feb 26;24(1):243. \u003c/li\u003e\n\u003cli\u003eAllan S, Mcleod H, Bradstreet S, Bell I, Whitehill H, Wilson-Kay A, et al. Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial. JMIR Hum Factors. 2021 Mar 5;8(1):e24055. \u003c/li\u003e\n\u003cli\u003eHafner J, Tokg\u0026ouml;z P, Dockweiler C. Implementation Factors of Digital Health Interventions in Depression Care\u0026mdash;The Perspective of Health Professionals. Healthcare. 2025 Jan;13(21):2717. \u003c/li\u003e\n\u003cli\u003eForjuoh SN, Helduser JW, Bolin JN, Ory MG. Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care. Journal of Clinical Trials. 5(3):1\u0026ndash;6. \u003c/li\u003e\n\u003cli\u003eSappor EE, Chakraborty R. Exploring Staff Perceptions of the Management of Clinical Trials and Its Impact on Enhancing Health Service Delivery. Hospitals. 2025 Mar;2(1):1. \u003c/li\u003e\n\u003cli\u003ePeralta G, S\u0026aacute;nchez-Santiago B. Navigating the challenges of clinical trial professionals in the healthcare sector. Front Med [Internet]. 2024 June 3 [cited 2026 Jan 9];11. Available from: https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1400585/full\u003c/li\u003e\n\u003cli\u003eRana K, Poudel P, Chimoriya R. Qualitative Methodology in Translational Health Research: Current Practices and Future Directions. Healthcare. 2023 Jan;11(19):2665. \u003c/li\u003e\n\u003cli\u003eRenjith V, Yesodharan R, Noronha JA, Ladd E, George A. Qualitative Methods in Health Care Research. Int J Prev Med. 2021 Feb 24;12:20. \u003c/li\u003e\n\u003cli\u003eHamilton AB, Finley EP. Qualitative Methods in Implementation Research: An Introduction. Psychiatry Res. 2019 Oct;280:112516. \u003c/li\u003e\n\u003cli\u003eDechantsreiter E, Padberg F, Morash A, Kumpf U, Nguyen A, Menestrina Z, et al. Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol. Eur Arch Psychiatry Clin Neurosci. 2023;273(1):85\u0026ndash;98. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"implementation burden, digital psychiatry, multisite studies, hidden labor, resource-constrained settings, reflexive qualitative research, site-level implementation","lastPublishedDoi":"10.21203/rs.3.rs-8678202/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8678202/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eMultisite digital psychiatry trials increasingly rely on complex onboarding and implementation processes at local research sites. While outcome-focused evaluations are common, less attention has been paid to the site-level labor required to operationalize such studies in real-world settings, particularly at smaller or resource-constrained sites.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis paper adopts a reflexive, practice-based qualitative approach to examine onboarding and implementation processes at a single Latvian research site participating in a multisite digital psychiatry trial (ClinicalTrials.gov: NCT04953208). The analysis is based on systematic reflection informed by site-specific documentation, onboarding timelines, internal communications, and longitudinal involvement in site coordination and implementation activities. An inductive thematic approach was used to identify recurring challenges and contextual factors shaping implementation burden.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eFive interrelated themes were identified: hidden labor and role overload; resource scarcity at small research sites; fragmented remote communication and technical coordination; multi-role professional contexts and competing demands; and the impact of external systemic disruptions. Findings illustrate how diverse administrative, technical, logistical, and coordination tasks were absorbed into individual roles, often exceeding initial role expectations. Despite limited resources, the site achieved high performance through intensified individual effort, masking the true implementation burden. Reliance on remote coordination redistributed labor onto site personnel, while external crises further amplified workload and uncertainty.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis site-level reflexive account highlights the central role of hidden labor in sustaining implementation in multisite digital psychiatry trials. Recognizing and explicitly resourcing implementation work, particularly at small research sites, may improve feasibility, sustainability, and equity across study settings. Reflexive, practice-based approaches offer valuable insight into implementation processes that are often invisible in outcome-focused research.\u003c/p\u003e","manuscriptTitle":"Implementation burden and hidden labor in a multisite digital psychiatry trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-06 18:40:46","doi":"10.21203/rs.3.rs-8678202/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"96fcede4-cdb2-422e-9a31-027e6a62f2a7","owner":[],"postedDate":"February 6th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-02-18T09:27:14+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-06 18:40:46","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8678202","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8678202","identity":"rs-8678202","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}