JMIR Research Protocols

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

2026-06-05T17:00:03-04:00

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

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

2026-06-05T16:30:55-04:00

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

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 Cluster Randomized Controlled Trial

2026-06-05T16:00:07-04:00

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

A Novel Therapy With a One-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB‑YOUTH Study): Protocol for a Cluster Randomized Controlled Trial

2026-06-05T15:15:11-04:00

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

Evaluating an Abbreviated Version of Mindfulness-Based Cognitive Therapy Delivered via Telephone or Videoconferencing Compared to Enhanced Usual Care—Treatment for Migraine and Mood (TEAM-M) Study: Protocol for a Three-Arm Multisite Randomized Controlled Feasibility Trial

2026-06-05T15:15:11-04:00

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

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

2026-06-05T14:15:04-04:00

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

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

2026-06-04T17:00:23-04:00

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:

Bowel Stimulation Before Loop Ileostomy Closure Using Probiotics: Study Protocol for a Randomized Controlled Trial at a Single Center

2026-06-04T16:45:19-04:00

Background: Low anterior resection syndrome (LARS) is a common functional problem after sphincter-preserving rectal cancer surgery and includes urgency, frequent bowel movements, clustering, and fecal incontinence. Diverting ileostomy may further disrupt the intestinal environment and alter the gut microbiota, potentially worsening bowel dysfunction after ileostomy closure. However, evidence remains limited on whether bowel stimulation with probiotics before ileostomy closure can improve postoperative bowel function and reduce LARS severity. Objective: This study aims to evaluate the safety, feasibility, and efficacy of probiotic bowel stimulation through the distal limb of a diverting ileostomy before ileostomy closure in patients with rectal cancer. Methods: This single-center randomized controlled trial will be conducted at Keimyung University Dongsan Medical Center, Republic of Korea. Eligible participants are adults aged 18‐80 years with clinical stage II or III rectal adenocarcinoma who completed neoadjuvant chemoradiotherapy and underwent laparoscopic or robotic low anterior resection with total mesorectal excision and diverting ileostomy, and who are scheduled for elective ileostomy closure. Participants will be randomly assigned in a 1:1 ratio to receive either 250 mL of normal saline with 4 g of Lacidofil or 250 mL of normal saline alone via the distal limb of the ileostomy once daily for 2 weeks before closure. The primary outcome is the LARS score 3 months after ileostomy closure. Secondary outcomes include postoperative complications, bowel recovery, stool habits, laboratory findings, and length of hospital stay. Analyses will primarily follow the intention-to-treat principle. Results: The study was approved by the Institutional Review Board of Keimyung University Dongsan Medical Center (DSMC-2024-03-016) and registered with the Clinical Research Information Service (KCT0011052). Recruitment is planned to begin in March 2026 and is expected to continue through March 2029. At the time of manuscript submission, the study is in the pre-enrollment stage, with no participants recruited and no data analysis performed. Results are expected to be published in 2029. Conclusions: This trial will provide prospective evidence on whether probiotic bowel stimulation before ileostomy closure is a safe and effective strategy for improving postoperative bowel function and alleviating LARS in patients undergoing rectal cancer surgery with diverting ileostomy. Trial Registration: Clinical Research Information Service KCT0011052; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=27021 International Registered Report Identifier (IRRID): PRR1-10.2196/87422

Rehabilitation Involving Tailored Subsymptomatic Aerobic Exercise in Adult Patients With Persistent Postconcussion Symptoms (REPCon Project): Protocol for an Assessor-Blinded, Parallel-Group, Randomized Controlled Trial

2026-06-04T15:00:28-04:00

Background: Persistent postconcussion symptoms (PPCSs) represent a complex phenomenon following mild traumatic brain injury (mTBI), and this phenomenon is characterized by a diverse range of symptoms that greatly impact daily functioning, including the ability to engage in physical, cognitive, and social activities. Effective rehabilitation strategies and a nuanced understanding of brain function and patient perception remain insufficiently explored in adults with PPCSs. Objective: This study aims to assess the physiological and neurofunctional effects of targeted physical exercise carried out as a graded subsymptomatic aerobic exercise program. Furthermore, the project seeks to alleviate the complex symptomatology and perception of PPCSs through the planned intervention. In addition, the study aims to obtain feedback from patients and researchers involved in this interprofessional project and to conduct a comprehensive 360-degree evaluation combining subjective and objective data in order to obtain novel insights into the symptom complexity of PPCSs, ultimately paving the way for future strategic initiatives in mTBI treatment. Methods: This randomized controlled trial enrolled 70 patients with PPCSs. The patients were randomized in a 1:1 ratio to either a control group or a training group. Patients in the control group maintained their usual activities and care. Patients in the training group underwent a 12-week tailored aerobic exercise program designed to stay below symptom-provocation thresholds, using the Buffalo Concussion Bike Test (BCBT) as the assessment instrument. The study consisted of qualitative patient interviews, physical tests, exercise evaluations, neurofunctional and structural magnetic resonance imaging (MRI) scans, and process evaluations. MRI assessed neurophysiological changes, including blood-brain barrier integrity and cerebral metabolism. The primary outcome is improvement in physical performance on the BCBT. The secondary outcomes are symptom severity, neurophysiological function, and quality of life. The study will incorporate a multimodal approach, combining subjective patient reports with objective clinical and neuroimaging data, enabling the interdisciplinary research group to perform comprehensive evaluations of the complexity of PPCSs. Results: Study funding was awarded in December 2022. Enrollment and randomization of 70 patients were completed in March 2025. The 12-week postintervention assessments concluded in August 2025. Data analysis is ongoing and expected to conclude in 2026. The results will be published in separate manuscripts in 2027. Conclusions: This study is innovative in its approach to patients with PPCSs, focusing on the effect of an individualized exercise regimen and exploring the neurofunctional underpinnings of symptom improvements as well as the patient perceptions of dealing with PPCSs. The findings are anticipated to contribute greatly to the field of PPCS management, potentially transforming current rehabilitation practices. Trial Registration: ClinicalTrials.gov NCT05785000; https://clinicaltrials.gov/study/NCT05785000 International Registered Report Identifier (IRRID): DERR1-10.2196/93795

The Motor Neuron Disease Register for England, Wales, and Northern Ireland: Protocol for a Population Register

2026-06-03T18:00:24-04:00

Background: Despite the existence of several regional registries in the United Kingdom, gaps in geographic coverage have limited the ability to produce accurate national estimates of incidence, prevalence, and regional variation for motor neuron disease (MND). To address these challenges, a comprehensive national register encompassing England, Wales, and Northern Ireland was established to support epidemiological studies, health care planning, and clinical research. Objective: The primary objective of the MND Register is to provide a centralized research database aggregating clinical and demographic data to facilitate high-quality research. Secondary objectives include estimating disease incidence and prevalence, identifying regional differences in care and survival, evaluating potential disease clustering, and supporting data linkage and clinical trial recruitment. Methods: Eligible patients are those aged 16 years or older with a confirmed MND diagnosis made by a consultant neurologist. Data are collected prospectively and retrospectively through standardized templates, available via Microsoft Access, Microsoft Excel, or the REDCap (Research Electronic Data Capture; Vanderbilt University) web platform, and include up to 34 demographic and clinical variables. Additional self-reported data can be contributed through the Telehealth in MND–Research platform. All data are securely stored in the King’s College London Trusted Research Environment, undergo standardized preprocessing, and may be linked to National Health Service and national datasets for epidemiological analyses. Results: The register includes data on over 11,000 individuals with MND, of whom nearly 7000 are currently alive. Postcode data are available for more than 4300 patients, enabling future geospatial analyses. By October 2025, 60 clinical sites were participating in the register, with around 50 actively submitting data. Conclusions: The MND Register represents one of the largest national registries for MND worldwide, providing a robust foundation for epidemiological modeling, clinical research, and health care planning. Ongoing efforts to expand prospective data collection, improve completeness, and integrate digital tools will further enhance its impact and support national and international MND research collaborations. International Registered Report Identifier (IRRID): DERR1-10.2196/86458