JMIR Publications

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  Systematic Review Protocols

  Jun 9, 2026

  Evolution of Chatbots as an Educational and Supportive Digital Intervention for Family Caregivers of People With Dementia: Protocol for a Systematic...

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  Authors List:

  • Sarath Rathnayake  
  • Ana Barbosa  
  • Jiada Tu  
  • Rebecca Randell  

  Abstract:

  Background: Most people with dementia reside in the community and are cared for by family members. Family caregivers play an essential role in supporting their loved ones with dementia and require adequate education and support to address their care needs. In recent years, there has been growing interest in the use of chatbot technologies in health care, particularly to provide education and support for caregivers. However, evidence on the development, use, and effectiveness of these technologies in dementia care remains limited. Objective: This systematic integrative review aims to synthesize evidence on chatbot applications as an educational and supportive tool for family caregivers of people with dementia. Methods: A systematic integrative literature review will be conducted following a validated framework. The findings will be reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The search strategy will be structured around 3 broad concepts: “dementia,” “caregiver,” and “chatbot applications.” Full-text articles based on empirical studies published in English from inception to 2026 that address the design, development, or evaluation of chatbot applications for family caregivers of people with dementia will be included. Editorials, study protocols, review articles, opinion and perspective papers, technical notes, and non-English publications will be excluded. Covidence software will be used to manage study screening. At least 2 independent reviewers will screen titles, abstracts, and full texts and extract data using a pretested data extraction form. Methodological quality will be assessed using Mixed Methods Appraisal Tool (version 2018), and data relevance will be evaluated using a 2-point scale (high or low). Results: The literature search will commence in May 2026, and the findings are expected to be published as a systematic integrative review, with submission planned for January 2027. Conclusions: This systematic integrative review aims to synthesize evidence from qualitative, quantitative, and mixed methods studies to provide a comprehensive understanding of how chatbot interventions are conceptualized, developed, and evaluated within dementia caregiving contexts. In addition, this review will identify key barriers and challenges as well as ethical and safety concerns associated with the design, development, and implementation of chatbot applications for family caregivers of people with dementia. Trial Registration: PROSPERO CRD420261288076; https://www.crd.york.ac.uk/PROSPERO/view/CRD420261288076

  • JMIR Res Protoc 2026;15(1):e91741

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  RCTs - Protocols/Proposals (non-eHealth)

  Jun 8, 2026

  Efficacy and Safety of Electroacupuncture for Postoperative Insomnia in Patients With Spinal Metastasis: Protocol of a Prospective, Multicenter, Randomized...

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  Authors List:

  • Cuifang Jiang  
  • Mengchen Yin  
  • Xia Peng  
  • Junqiao Zhao  
  • Fan Zhang  
  • Junming Ma  
  • Dong Wang  
  • Yan Cao  

  Abstract:

  Background: Postoperative insomnia is one of the common complaints caused by spinal metastatic cancer surgery. It affects patients’ functional recovery, greatly reduces their quality of life, and adversely impacts disease prognosis. Compared with traditional pharmacological treatments, acupuncture is an alternative therapy for postoperative insomnia. However, standardized, high-quality randomized controlled trials on electroacupuncture for postoperative insomnia in patients with spinal metastasis (SM) are scarce, and there is a lack of clear inclusion criteria for this specific population. Postoperative insomnia in patients with SM has distinct clinical characteristics compared with general cancer-related insomnia, necessitating targeted investigation. Objective: This study aims to evaluate the efficacy and safety of electroacupuncture in the treatment of postoperative insomnia in patients with SM, and to provide high-level clinical evidence for the inclusion of electroacupuncture in the clinical management plan of postoperative insomnia in patients with SM. Methods: This is a study protocol for a randomized controlled trial. We will randomly assign 196 patients with insomnia after spinal metastatic cancer surgery to the acupuncture group (n=98) or the control group (sham acupuncture group; n=98). All participants will be treated on the first day after surgery and receive 12 sessions in total (30 min per session, 3 sessions per wk for 4 weeks). The primary outcome is the change in Pittsburgh Sleep Quality Index score from baseline to post treatment (wk 4). The secondary outcomes include actigraphy records (sleep efficiency, number of sleep awakenings, total sleep time, sleep latency, and wake after sleep onset), Insomnia Severity Index, Spine Oncology Study Group Outcomes Questionnaire 2.0, and Patient Health Questionnaire-9. All results will adhere to the intention-to-treat principle and will be evaluated at baseline, posttreatment (wk 4), and follow-up (wk 12). Results: This study was funded in June 2023 (supported by the Project of Shanghai Municipal Health Commission, National Natural Science Foundation of China, etc). Recruitment will start in mid-2026 and end in December 2027. Data collection will be completed in October 2027, and data analysis is expected to be finished in December 2027. The results of this study are anticipated to be published in the first half of 2028. Conclusions: This study is designed to rigorously assess the therapeutic value of electroacupuncture for postoperative insomnia in patients with SM. If proven effective, electroacupuncture is expected to become a safe and feasible alternative or complementary therapy for this population, reducing reliance on hypnotic drugs and improving patients’ quality of life and prognosis. The results will fill the gap in current clinical evidence for electroacupuncture in the treatment of spinal metastatic postoperative insomnia and provide a basis for the optimization of clinical treatment strategies. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000930; https://itmctr.ccebtcm.org.cn/mgt/project/view/3490899198481888581 International Registered Report Identifier (IRRID): PRR1-10.2196/81489

  • JMIR Res Protoc 2026;15(1):e81489

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  NIH funded proposals with peer-review...

  Jun 8, 2026

  Cannabis Effects on Neurocognition and HIV-Related Outcomes: Protocol for a Longitudinal Observational Cohort Study

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  Authors List:

  • Isabella Matthews  
  • Allison Wilson  
  • Mainza Durrell  
  • Ella Remund Wiger  
  • Anna Hotton  
  • Joseph E Rower  
  • Ofir Livne  
  • Raul Gonzalez  
  • Dustin T Duncan  
  • Jennifer Manuzak  
  • Phil Schumm  
  • Adam Carrico  
  • Camille Demarco  
  • Ellen Almirol  
  • Leona Kondic  
  • Isaac Toscano  
  • Joseph DeBrosse  
  • Sarah Keedy  
  • John A Schneider  
  • Justin Knox  

  Abstract:

  Background: Heavy cannabis use may impact neurocognitive functions, particularly prefrontal and limbic systems responsible for risk/reward processing and executive function, which are essential for certain health behaviors, such as HIV prevention. Rigorous research into the effects of cannabis on neurocognitive functions remains limited, particularly among populations with a high burden of HIV. Objective: This study aims to (1) evaluate associations between cannabis use and neurocognition, (2) evaluate associations between cannabis use and engagement in HIV status–neutral care outcomes (eg, pre-exposure prophylaxis persistence, viral suppression), and (3) assess whether cannabis use motivations modify associations between cannabis use and engagement in HIV status–neutral care outcomes. Methods: This longitudinal cohort study is enrolling a community-based sample of individuals aged 16 to 29 years residing in Chicago using multiple recruitment strategies. Participants complete 3 in-person assessments annually over 2 years that include (1) computer-assisted questionnaires, (2) neurocognitive assessments (functional magnetic resonance imaging, executive function tasks), and (3) biospecimen collection. Triangulation approaches combine objective and self-reported measures. Results: The Frontal Lobe Outcomes and Well-Being (FLOW) Study was funded by the National Institutes of Health in April 2023, with data collection commencing in October 2023. As of April 2026, 148 participants have been enrolled and completed baseline assessments, with 63 participants completing their first follow-up appointment and 4 participants completing their second follow-up appointment. Following a temporary administrative pause from March to August 2025 and subsequent federal review confirming regulatory compliance, the study resumed operations in July 2025. Recruitment is currently ongoing, with data collection expected to continue through June 2027. Preliminary analyses are pending completion of longitudinal data collection. Conclusions: This study addresses critical knowledge gaps by examining potential associations between cannabis use, neurocognition, and HIV. While geographic specificity, structural barriers, measurement challenges, and sample size constraints present some limitations, our methodological approaches—including longitudinal design, triangulation of both objective and self-reported measures, and rigorous neurocognitive assessments—strengthen the investigation. Findings will advance understanding of how cannabis use impacts neurocognition and HIV-related health behaviors, potentially informing targeted interventions that address both substance use and HIV transmission.

  • JMIR Res Protoc 2026;15(1):e86814

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  RCTs - Protocols/Proposals (non-eHealth)

  Jun 8, 2026

  Lymphovenous Bypass as an Adjunct to Standard Care for Diabetic Peripheral Neuropathy: Protocol for a Randomized Assessor-Blinded Superiority Trial

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  Authors List:

  • Hsin-Ying Lee  
  • Chih-Yuan Wang  
  • Tien-Jyun Chang  
  • Chi-Chao Chao  
  • Sung-Tsang Hsieh  
  • Nai-Chen Cheng  
  • Sung-Chuan Chao  

  Abstract:

  Background: Diabetic peripheral neuropathy (DPN) is a length-dependent, symmetric sensorimotor polyneuropathy with a substantial global and regional burden. Current pharmacologic options are largely symptomatic and do not modify the disease. Lymphovenous bypass (LVB), a supermicrosurgical procedure established for lymphedema, may modulate lymphatic-immune-microvascular dysfunction relevant to DPN. Objective: The primary objective is to determine whether LVB combined with standard of care (SOC) improves small-fiber and autonomic function compared with SOC alone at 6 months. Secondary objectives are to evaluate the effects of LVB on large-fiber function, neuropathic pain, ulcer healing, quality of life, and relevant biomarkers, as well as to characterize the safety profile of LVB. Methods: This is a SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)–aligned, single-center, randomized, controlled, parallel-group superiority trial with a 2:1 allocation (LVB+SOC vs SOC alone). Randomization is stratified based on the presence or absence of active diabetic foot ulcers, as defined by the International Working Group on the Diabetic Foot and Infectious Diseases Society of America criteria. In total, 60 adults aged 20 to 80 years with confirmed DPN will be enrolled. LVB involves lymphatic-venous anastomosis to venules ≤0.8 mm. SOC consists of guideline-based glycemic and risk-factor management, pain control, and standardized wound care. Outcome assessors and statisticians are blinded. The primary outcomes are changes in clinical neuropathy burden and pain severity at 6 and 12 months. Secondary outcomes comprise objective measures of somatic and autonomic physiology, histopathological nerve fiber density, biological serum markers, and longitudinal ulcer epithelialization parameters. Data analysis will use mixed-effects models for repeated measures, with a sample size of 60 adults providing 80% power to detect a conservative between-group effect size of Cohen =0.70. Results: Recruitment commenced in February 2026 and is planned to continue through July 31, 2027, with follow-up through July 31, 2028. As of May 2026, we have enrolled 3 participants. The first participant has been treated, and a second participant is scheduled to undergo treatment. Data analysis and reporting are anticipated between late 2027 and early 2028. No outcome data are included. Conclusions: This trial tests a mechanism-based, nonpharmacologic adjunct targeting lymphatic-immune-microvascular dysfunction in DPN. If effective, LVB could inform phenotype-directed treatment algorithms and motivate multicenter evaluation and health economic analyses. Trial Registration: ClinicalTrials.gov NCT07126197; https://clinicaltrials.gov/study/NCT07126197 International Registered Report Identifier (IRRID): PRR1-10.2196/84826

  • JMIR Res Protoc 2026;15(1):e84826

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  NIH funded proposals with peer-review...

  Jun 8, 2026

  Using Collaborative Model Building to Better Understand the Mechanisms of Alcohol-Involved Sexual Violence on College Campuses: Post Hoc Protocol

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  Authors List:

  • Michelle Dougherty  
  • Jessica G Burke  
  • Joseph Alejandro  
  • Travis R Moore  
  • Robert W S Coulter  
  • Regina Futcher  
  • Elizabeth Miller  
  • Christina Mair  

  Abstract:

  Background: The Collaborative Model Building Project to Understand Sexual Violence (CAMPUS) study seeks to address alcohol-involved sexual violence (AISV) by collaboratively developing an agent-based model (ABM) that can support the decisions of college campuses seeking to address this issue among students. As a first step toward ABM development, we used collaborative model building (CMB), an adaptation of group model building, to co-develop a causal loop diagram (CLD) depicting key causes and effects of AISV and opportunities for intervention. Our goal of cocreating a CLD that can be translated into an ABM to support intervention decision-making differentiates our approach from other participatory systems science studies. Objective: This paper provides a detailed, transferable post hoc protocol for using CMB to cocreate a CLD of AISV on college campuses that can be translated into an ABM to support intervention decision-making. Methods: Our approach consisted of 4 iterative phases that involved ongoing weekly discussion by the project’s core modeling team (CMT), consisting of researchers with systems science and subject matter expertise. In the first phase, we conducted 4 CMB sessions with 3 groups of college campus collaborators to develop 1 preliminary CLD each. Second, our CMT reviewed each variable and causal connection across the CLDs in consultation with peer-reviewed literature to help ensure eventual ABM translation. Third, the CMT combined 3 CLDs into one, identifying specific loops for review by collaborators. Fourth, we conducted a feedback session with collaborators and created a finalized CLD linked with intervention opportunities. Results: Between January 2023 and March 2025, we engaged with 39 collaborators in Allegheny County, Pennsylvania, across three groups: (1) college campus practitioners (eg, student life staff; n=8), (2) undergraduate students (n=12), and (3) a mix of practitioners and students (n=19). The final output of our process was a complete CLD with 26 loops containing 28 variables showing key AISV mechanisms and intervention opportunities. Analysis of results from the CAMPUS study, funded from September 2022 to June 2027, is ongoing, and results from aim 1 of the study are expected to be published in late 2026. Conclusions: Given our goal of using the finalized CLD for ABM development, our approach emphasized the selection of potentially measurable and modifiable variables and causal connections. Compared with other participatory systems science approaches, our approach also emphasized intervention identification and prioritization. International Registered Report Identifier (IRRID): RR1-10.2196/92071

  • JMIR Res Protoc 2026;15(1):e92071

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  RCTs - Protocols/Proposals (eHealth)

  Jun 5, 2026

  Minimally Guided App-Based Intervention for Nontreatment-Seeking Psychologically Distressed Adults: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Paulomi Sudhir  
  • Abhishek Karishiddimath  
  • Pramita Sengupta  
  • Angelina Francis  
  • Sravya Buddhavarapu  
  • Jagadisha Thirthalli  
  • Srikanth TK  
  • Rajesh Sagar  
  • Seema Mehrotra  

  Abstract:

  Background: Mental health conditions impose a significant burden worldwide, often remaining untreated due to multiple demand- and supply-side barriers such as stigma, limited awareness, and poor access to services. Mobile-based interventions offer a scalable solution to address some of these barriers, including low rates of help-seeking. However, most evidence has emerged from high-income countries, with minimal research in the Indian setting, particularly among psychologically distressed individuals not currently seeking treatment. Objective: This study aims to evaluate the effectiveness of a minimally guided mobile app in promoting help-seeking behaviors among individuals experiencing self-reported common mental health concerns and significant psychological distress who are not currently engaged in formal treatment. Additionally, it will examine the utility of the intervention in reducing perceived barriers to seeking professional help for mental health, improving the inclination to seek help from mental health professionals, and alleviating psychological distress. Perceived benefits of using the app will also be documented. Methods: A parallel-arm randomized controlled trial will be used to evaluate the effectiveness of the minimally guided, indigenously developed mobile app in enhancing help-seeking behaviors among distressed, nontreatment-seeking adults. The intervention arm will receive a multimodule app while the active control will receive a mood-logging app. Assessments will occur at baseline, 5 weeks after the intervention, and at the 1-month follow-up using standardized self-report tools and additional items. The primary outcome will be actual help-seeking behavior in accessing mental health professionals, while secondary outcomes will include help-seeking inclination, perceived barriers, psychological distress, and perceived benefits. Results: The trial commenced in September 2025 and is currently in the recruitment and data collection phase. Participant enrollment is ongoing. Data collection is anticipated to be completed by July 2026, and findings from the study are expected to be disseminated through a peer-reviewed publication by December 2026. Conclusions: This study will provide contextually relevant insights into the utility of a minimally guided mobile app-based intervention in improving professional help-seeking among psychologically distressed, nontreatment-seeking individuals in India. Findings may inform the design and scaling of accessible digital interventions to bridge the mental health treatment gap in low-resource settings. Clinical Trial: Clinical Trial Registry of India CTRI/2024/11/077461; https://tinyurl.com/2edf5a32

  • JMIR Res Protoc 2026;15(1):e85267

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  Non-Randomized Studies (funded,...

  Jun 5, 2026

  Evaluating the Effectiveness of the School-Based Sustainable Innovation for Children Transporting Actively Intervention: Protocol for an Age-Cohort Study

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  Authors List:

  • Hanna Forsberg  
  • Anna-Karin Lindqvist  
  • Stina Rutberg  
  • Palma Chillón  
  • Veronica Sjöberg  
  • Annie Palstam  

  Abstract:

  Background: Few children achieve the recommended daily levels of physical activity. Active school transportation (AST) offers a valuable opportunity to increase children’s physical activity. Initiatives promoting AST in early childhood are important and have the potential to reverse the decline in physical activity. Objective: This study protocol outlines an age-cohort design to evaluate the effectiveness of the Sustainable Innovation for Children Transporting Actively (SICTA) intervention on children’s AST. Methods: SICTA is a 4-week school-based intervention that incorporates gamification elements to enhance motivation and aims to increase AST in children. The intervention involves children and their parents as gatekeepers, as well as teachers delivering the intervention. All children, parents, and teachers in all schools, from grades 4 to 6 in one municipality in the southern part of Sweden, will be invited to participate in the evaluation. Following the age-cohort design, students at baseline (late fall 2024) will be compared with students of the same age from the same schools 1 year later at follow-up (late fall 2025) after receiving the intervention (implemented in late fall 2025). Using questionnaires at baseline and follow-up, this study will examine the effects of the intervention on children’s levels of AST. Children’s independent mobility and several mediators related to AST in both children and parents, based on the theory of planned behavior, the transtheoretical model of change, and self-determination theory, will also be examined. The intervention will also be evaluated from a sustainable perspective using the sustainable value equation. At follow-up, data collection will include a questionnaire for teachers assessing the feasibility of the intervention. Results: The project is funded for the period 2024-2026, and follow-up data collection is ongoing following completion of the intervention in late fall 2025. Results will be reported according to the predefined outcomes, including changes in AST, children’s independent mobility, psychosocial determinants among children and parents, and sustainability outcomes, as well as feasibility. Conclusions: The findings are expected to provide valuable insights into the effectiveness of the SICTA intervention, facilitating knowledge dissemination among end users and policymakers. Trial Registration: Swedish National Research Database Researchweb.org 283668; https://tinyurl.com/496rc6r4

  • JMIR Res Protoc 2026;15(1):e92946

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  RCTs - Protocols/Proposals (non-eHealth)

  Jun 5, 2026

  Screen-Free Time With Friends to Promote Face-to-Face Peer Interaction and Reduce Recreational Screen Use Among Children Aged 9-11 Years: Protocol for a...

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  Authors List:

  • Sara Kruse Lange  
  • Sarah Overgaard Sørensen  
  • Teresa Victoria Høy  
  • Kristian Traberg Larsen  
  • Anders Blædel Gottlieb Hansen  
  • Russell Jago  
  • Peter Lund Kristensen  
  • Anders Grøntved  
  • Mette Toftager  
  • Anne Kær Gejl  

  Abstract:

  Background: Children’s leisure time has changed in recent decades—with more time spent on screen media and less time face-to-face with peers—potentially affecting their physical and mental well-being. Objective: This protocol outlines a cluster randomized controlled trial evaluating the Screen-Free Time With Friends intervention, which aims to promote face-to-face peer interaction and reduce recreational screen media use among children aged 9‐11 years. Methods: The study is conducted as a cluster randomized controlled trial involving 9-11-year-old children and their parents from 18 schools in Denmark. Schools are randomized (1:1) to either a control or an intervention group. The intervention includes five core components: (1) curricular activities, (2) two family meetings, (3) a brief parent exercise, (4) a development program for after-school clubs, and (5) two community workshops. It is designed to allow local adaptation while maintaining fidelity to the core components. Primary and key secondary outcomes, including face-to-face peer interaction across leisure domains and solitary screen time, are assessed at baseline, 6‐10 months, and 13‐15 months follow-up. Additional exploratory outcomes (e.g., leisure activities, social relations, and well-being) are measured at baseline and follow-up. Time spent in face-to-face interactions with peers was assessed using a short SMS-based questionnaire sent to registered parents. The instrument has not been formally validated but was tested in a feasibility study. A comprehensive process evaluation explores implementation, context, and mechanisms of change. Results: The project was funded in July 2020. Schools were recruited from July 2023 to January 2024, while children and parents were recruited from November 2023 to April 2024. At baseline, 685 children were enrolled at the participating schools, with 343 (50%) having at least one parent enrolled in the questionnaire. The primary outcome is therefore assessed among a subset of participants, which may affect the effective sample size. Baseline data were collected from December 2023 to June 2024, and follow-up data from March to August 2025. As of March 2026, data analysis has not yet commenced, and no study results are currently available. Findings are expected to be published by the end of 2026. Conclusions: Regardless of the findings, this study will generate important knowledge about the intervention’s potential effectiveness, complemented by insights into its implementation, context, and mechanisms of change. These insights can assist municipalities, schools, after-school clubs, community stakeholders, and parents in shaping everyday environments that foster children’s face-to-face interaction and encourage balanced screen use. The findings may inform policy decisions, guide the development of new national and local initiatives, and inspire future research into feasible, real-world interventions that support meaningful and enriching leisure experiences for children. Trial Registration: ClinicalTrials.gov NCT06163495; https://clinicaltrials.gov/study/NCT06163495 International Registered Report Identifier (IRRID): DERR1-10.2196/84831

  • JMIR Res Protoc 2026;15(1):e84831

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  RCTs - Protocols/Proposals (non-eHealth)

  Jun 5, 2026

  A Novel Therapy With a One-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB‑YOUTH...

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  Authors List:

  • Yixuan Yang  
  • Feiran Zhou  
  • Yanfei Ren  
  • Fudong Li  
  • Qingluan Yang  
  • Yuying He  
  • Xiaoling Wei  
  • Xing Wang  
  • Jianfeng Luo  
  • Feng Sun  
  • Lingyun Shao  
  • Jinlan Li  
  • Qiaoling Ruan  
  • Wenhong Zhang  

  Abstract:

  Background: Close contacts of individuals with active pulmonary tuberculosis (TB) face an elevated risk of TB acquisition, necessitating systematic screening for latent TB infection and subsequent TB preventive treatment (TPT). Major TPT regimens require ≥3 months of drug exposure and demonstrate suboptimal safety profiles, significantly compromising treatment completion rates. Therefore, the development of shorter, safer chemoprophylaxis strategies represents a critical need in global TB control. Among close contacts, school-aged children and adolescents constitute the most vulnerable demographic subgroup, warranting prioritized intervention efforts. Objective: The primary objective of this study is to demonstrate noninferiority of an ultrashort, 1-month TPT regimen of isoniazid plus rifapentine, administered 3 times a week (1HP) compared with the standard 3-month daily isoniazid plus rifampicin (3HR) regimen in preventing active TB, as measured by the 24-month cumulative incidence of active TB following randomization. Methods: An investigator-initiated, prospective, multicenter, open-label, noninferiority, cluster-randomized controlled clinical trial is being implemented under the auspices of the national TB control program in China. Close contacts of school pulmonary TB index cases, regardless of diagnostic type, are actively screened for symptoms using interferon-gamma release assays, chest imaging, and sputum molecular diagnostic testing to detect TB infection and exclude active TB. Eligible latent TB infection cases will be randomized in a 1:1 cluster ratio to receive either the standard 3HR regimen or the novel ultrashort 1HP regimen for TPT, with subsequent follow-up for up to 2 years to assess disease progression. The primary composite end point includes microbiologically confirmed TB (sputum culture or molecular diagnostic testing) or clinically diagnosed TB. With 80% power to detect noninferiority (20% margin), the study requires 1760 participants per arm, accounting for cluster design effects. Results: Recruitment started in September 2023. By the end of December 2025, a total of 2478 participants, comprising 627 index cases, had been enrolled, and recruitment is estimated to continue until September 2026. Data analysis will commence after the 2-year follow-up period, and the results are expected to be published by March 2029. Conclusions: This cluster randomized controlled trial aims to establish the noninferiority of a novel, ultrashort 1HP regimen compared to the standard 3-month 3HR regimen for preventing active TB in infected school contacts. If successful, this well-tolerated 1-month regimen could significantly improve treatment completion and optimize preventive therapy delivery in high-transmission congregate settings, thereby contributing substantively to global TB control efforts. Trial Registration: ClinicalTrials.gov NCT06022146; https://clinicaltrials.gov/study/NCT06022146 International Registered Report Identifier (IRRID): PRR1-10.2196/89584

  • JMIR Res Protoc 2026;15(1):e89584

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  NIH funded proposals with peer-review...

  Jun 5, 2026

  Evaluating an Abbreviated Version of Mindfulness-Based Cognitive Therapy Delivered via Telephone or Videoconferencing Compared to Enhanced Usual...

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  Authors List:

  • Chelsea J Siwik  
  • Hallie Tankha  
  • Jacob D Hill  
  • Pallavi Visvanathan  
  • Devyn Gaskins  
  • Marisa DeSciscio  
  • Narissa McCarty  
  • Hannah O’Brien  
  • Marissa Salvaterra  
  • Cuiling Wang  
  • Richard Lipton  
  • Rebecca E Wells  
  • Elizabeth Seng  
  • Amanda J Shallcross  

  Abstract:

  Background: Migraine ranks among the leading causes of disability worldwide. Comorbid depressive symptoms are highly prevalent in patients with migraine and are associated with worsened pain severity, greater migraine-related disability, and poorer migraine prognosis. Despite this burdensome comorbidity, the treatment of these co-occurring disorders has rarely been studied. While mindfulness-based cognitive therapy (MBCT) shows promise for addressing both migraine-related disability and depressive symptoms, its traditional format—8 weekly 2-hour sessions in person—creates substantial access barriers, particularly for patients who experience frequent debilitating migraine and mood symptoms. Objective: The objective of the Treatment for Migraine and Mood (TEAM-M) trial is to evaluate the feasibility of an abbreviated MBCT intervention (MBCT-Brief) delivered via telephone or videoconferencing in adults with migraine and elevated depressive symptoms. Methods: TEAM-M is a 3-site trial with a goal sample size of 145 adults with episodic migraine and elevated depressive symptoms randomized to MBCT-Brief telephone, MBCT-Brief videoconferencing, or enhanced usual care (EUC). To be eligible, participants must meet the criteria for migraine as defined by the International Classification of Headache Disorders 3rd edition, have ≥1 year of migraine history, and have mild to moderate depressive symptoms (scores 5‐19 on the Patient Health Questionnaire-9). Results: Our primary outcomes include treatment feasibility, acceptability, and fidelity. Our secondary outcomes include headache disability, migraine-specific quality of life, and depressive symptoms. This trial was funded in May 2021. We began recruitment in November 2023 and completed enrollment in January 2026. As of May 2026, we have randomized 145 participants, of which 104 have completed the intervention and provided data for our primary outcomes. Data analysis is currently in progress, and primary outcome results are expected to be submitted for publication in spring 2027. Conclusions: The TEAM-M trial addresses a gap in clinical care by evaluating an abbreviated version of MBCT that has scalability and accessibility advantages over full-length MBCT and the potential to address both migraine and depressive symptoms. By reducing the time commitment while maintaining the core MBCT components, MBCT-Brief can potentially address significant access barriers that often prevent patients from receiving evidence-based health care for comorbid physical and mental health symptoms. The remote delivery model offers enhanced scalability. This trial will also yield information about potential differences in telephone versus videoconferencing delivery, which will inform optimal integration into existing primary care and mental health clinic workflows, allowing for improved access to specialized care for mental health and migraine across diverse health care settings. Trial Registration: ClinicalTrials.gov NCT05576467; https://clinicaltrials.gov/study/NCT05576467 International Registered Report Identifier (IRRID): DERR1-10.2196/93627

  • JMIR Res Protoc 2026;15(1):e93627

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  Non-Randomized Study Protocols and...

  Jun 5, 2026

  Integrated Depression Care and Livelihood Interventions for Low-Income Women in Vietnam: Protocol for a Cluster Nonrandomized Controlled Trial (LIFE-DM)

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  Authors List:

  • Victoria Khanh Ngo  
  • Thinh Toan Vu  
  • Kunmi Sobowale  
  • Trung Tu Lam  
  • Tam Nguyen  
  • Sebastian Linnemayr  
  • Wenjing Huang  

  Abstract:

  Background: In Vietnam, economically disadvantaged women face compounded risks due to gender inequality, financial instability, and limited access to mental health care. Community health stations (CHSs), the frontline entry point into the health system and the most accessible primary care facilities, typically lack trained mental health providers, further exacerbating an already existing treatment gap. While evidence-based treatments for depression exist, most interventions address either mental health or economic hardship separately, limiting their effectiveness in resource-constrained settings. Objective: This study aims to evaluate the effectiveness of Livelihood Integration for Effective Depression Management (LIFE-DM), an integrated intervention combining group-based psychotherapy with microfinance and livelihood support, compared with enhanced treatment as usual (E-TAU), among low-income women. We hypothesize that LIFE-DM participants will show greater program participation and improvements in mental health, psychosocial, and economic outcomes relative to E-TAU. Methods: A matched-pair cluster nonrandomized controlled trial was conducted at 4 CHSs in Da Nang, Vietnam, with 2 sites allocated to LIFE-DM and 2 to E-TAU. A total of 166 low-income women aged 18 to 55 years who screened positive for depression (9-item Patient Health Questionnaire score ≥10) were enrolled. LIFE-DM participants received group behavioral activation treatment and were offered microfinance loans, vocational training, and personal finance support. E-TAU participants were offered free antidepressant treatment and referral as usual to the Women’s Union for livelihood support. Primary outcomes are severity of depression symptoms and remission rates at 6- and 12-month follow-up. Secondary outcomes include economic variables such as income and employment status, as well as functioning, quality of life, self-efficacy, behavior activation, and program participation. The data were collected using in-person surveys, clinic logs, and program records. Analyses will follow an intention-to-treat approach using longitudinal regression models with propensity score weighting and adjustment for clustering. Results: This study was funded prior to implementation, and the data were collected from February 2014 to September 2015. Participant recruitment has been completed, with 166 women enrolled across 4 CHSs. Data analysis is in progress, and the findings are expected to be disseminated in 2027. Conclusions: This study is among the first to rigorously evaluate an integrated mental health and livelihood intervention targeting both depression and poverty among economically disadvantaged women. If effective, LIFE-DM may offer a scalable, community-based model for improving mental health and economic well-being among vulnerable women in low-resource settings. Trial Registration: ClinicalTrials.gov NCT02069301; https://clinicaltrials.gov/study/NCT02069301 International Registered Report Identifier (IRRID): DERR1-10.2196/80546

  • JMIR Res Protoc 2026;15(1):e80546

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  Scoping Review Protocols

  Jun 4, 2026

  Quality Improvement Competencies for Health Care Quality Professionals: Protocol for a Scoping Review

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  Authors List:

  • Nurhayati Shaharuddin  
  • Khalidah Maruan  
  • Divya Nair Narayanan  
  • Normaizira Hamidi  
  • Nurul Izzaty Bahar  
  • Roslina Supadi  
  • Mariyah Mohamad  
  • Samsiah Awang  

  Abstract:

  Background: Health care professionals play a crucial role in executing, supporting, and assessing quality improvement programs. Clearly defined competencies in health care quality are essential for optimal performance and serve as the foundation for both quality practice and the design of a capacity development program. Objective: This study aims to identify and explore the requisite health care quality professional competencies in implementing quality improvement initiatives. Methods: The study will apply a validated scoping review methodology and the JBI recommendations. An extensive search of the PubMed, Scopus, and Embase databases will be conducted. Gray literature documents will be identified by searching selected Ministry of Health websites in Organization for Economic Co-operation and Development countries and World Health Organization regions with National Quality Policy and Strategy, as well as the Google search engine, using keywords related to quality improvement competencies. The study approach will be reported using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Data will be systematically extracted into a matrix using predefined inclusion and exclusion criteria. Analysis will subsequently be conducted using inductive thematic analysis and narrative synthesis. Results: This scoping review has commenced, and the search strategy has been developed. Preliminary searches conducted in November 2025 through selected electronic databases and gray literature identified 5339 records. Study selection, data extraction, and inductive thematic analysis are scheduled in July 2026 to November 2026. The final findings of this scoping reviews are anticipated to be ready for publication by December 2026. The findings of this study will inform future, larger-scale studies aimed at developing a competency framework for quality improvement among health care quality professionals. Conclusions: Conducting this scoping review will provide relevant evidence regarding the quality improvement competencies required for health care quality professionals. The results will provide valuable insights to stakeholders in identifying and prioritizing the competencies necessary to enhance the quality improvement skills of health care quality professionals in Malaysia. Trial Registration:

  • JMIR Res Protoc 2026;15(1):e88787

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