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Background: Aggression, substance use, and gambling behaviour often co-occur in a larger pattern of dysregulated behaviour. One of the factors that may underlie this phenomenon is impaired inhibitory control. Inhibitory Control Training (ICT) is an alternative intervention being tested for addressing addictive behaviours by targeting inhibitory control. Given the shared underlying mechanisms of these behaviours, applying ICT to aggression represents a possible extension of this intervention. This research will mark the first implementation of a cognitive bias modification approach to managing aggression among patients with co-occurring substance use disorder and gambling behaviour in the Indian context. A secondary aim of this study will be to assess whether changes in aggression and inhibitory control will be associated with reductions in substance use disorder and gambling behaviour.

Methods: A two-group, parallel randomized controlled trial will be carried out in 130 male in-patients at a tertiary care centre. Participants fulfilling the DSM-5 criteria for substance use disorders, and screening positive for problem (Score ≥ 1) or pathological (Score ≥ 5) gambling on the South Oaks Gambling Screen will be randomly allocated to either experimental (ICT) or control (Sham Training) group. The ICT consists of six 15-min sessions over three days, using a Go/No-Go paradigm with 100% contingency. ST is matched with the active training in terms of both stimulus exposure and response requirements, but reduces the contingency agreement to 50%, thereby preventing the formation of associations between aggressive stimuli and inhibitory responses. Primary and secondary outcome measures will be assessed at baseline, 1-day, 1-month, and 3-months post-intervention.

Discussion: As aggression is frequently observed in individuals with addictive behaviors and is closely linked to deficits in regulatory behaviour, the intervention, if proven efficacious, could offer a cost-effective and time-efficient alternative to traditional cognitive-behavioral and anger management interventions. Conversely, should the intervention prove ineffective, the findings would indicate that this may not be a potential area for further exploration in this population.

Trial registration: The study protocol was registered prospectively with the Clinical Trials Registry of India (CTRI) on August 07, 2024 (Registration Number: CTRI/2024/08/072033) (URL: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=113292&EncHid=61291.44954&modid=1&compid=19).

Background: Seated exercises may reduce the need for in-person support during home-based exercise programs in people with balance impairments. However, it is uncertain if these exercises can transfer to improved lower extremity function and mobility. Thus, the objective is to investigate the effects of a remotely delivered 10-week seated exercise intervention on functional mobility, compared with control, in individuals living with a chronic stroke who have balance impairments.

Methods: The study is a multi-site, assessor blinded, randomized controlled trial that will recruit across five provinces in Canada using the CanStroke Recovery Trials platform. A total of 100 adults living with a chronic stroke (≥ 6 months post-stroke) and mobility impairment (using a walking aid) will be recruited. Participants will be randomized (1:1) to the 10-week Virtual Physical Activity Seated Exercise (V-PASE) or control group. All exercise sessions will be delivered one-on-one through videoconferencing by a trained instructor. Sessions will be 60 min in duration and completed 3 times/week at a moderate intensity (40%-60% Heart Rate Reserve). The primary outcome measure is the 30s Sit-To-Stand score at the end of the 10-week intervention. Secondary outcome measures will be mobility, balance, quality of life, stroke-related quality of life, cognition, fatigue, anxiety, depression, and blood profiles (glucose and lipids).

Discussion: Exercises completed in a chair have the potential to transfer to improved functional mobility in people with balance impairments, such as individuals with stroke. The stability of the seated position may improve safety during home-based exercises and thus increase participation.

Trial registration: ClinicalTrials.gov NCT05724823. Registered on February 13th, 2023.

Background: Post-traumatic stress disorder (PTSD) can have detrimental effects for those afflicted and is associated with increased health care utilization and substantial societal costs. Thus, there is a need for accessible, effective, and cost-efficient preventive interventions for post-traumatic psychological sequelae. Research indicates that trauma-focused cognitive-behavioral therapy (CBT-T) could effectively prevent PTSD when applied as an indicated secondary prevention. CIPE is a scalable, low-threshold, therapist-assisted digital CBT-T, which could be readily implemented in services delivering psychosocial support after traumatic incidents if proven effective and cost-effective. The Early Support after Exposure to Trauma (EASE) study evaluates the effectiveness, cost-effectiveness, and implementation of Condensed Internet-delivered Prolonged Exposure (CIPE), applied as an indicated secondary prevention in the context of Norwegian municipal crisis teams.

Methods/design: The EASE study is a hybrid Type 1 effectiveness and implementation trial. The effectiveness trial is a parallel two-armed multicenter randomized controlled add-on superiority trial, enrolling individuals who receive support from psychosocial crisis teams within 7 weeks after trauma. Participants are randomized to CIPE + treatment as usual (TAU) or TAU only. The primary outcome is the level of PTSD symptoms 6 weeks after randomization (10-13 weeks post trauma). Secondary outcomes include symptoms of depression and insomnia, quality of life, and CIPE cost-effectiveness. The implementation trial examines policy-level factors influencing CIPE implementation, using the Exploration, Preparation, Implementation, Sustainment framework.

Discussion: This study will guide further research, policy shaping, and clinical initiatives for implementing preventive interventions aimed at reducing post-traumatic psychological sequelae by integrating evidence-based interventions into routine psychosocial services.

Trial registration: ClinicalTrials.gov NCT06592677. Registered on 10.09.2024.

Background: The Daqing Diabetes Prevention Study II (Daqing DPS-II) builds on the landmark study Daqing Diabetes Prevention Study to develop real-world implementation strategies for preventing type 2 diabetes (T2DM). This study aims to evaluate the effectiveness of digital and complex lifestyle intervention in reducing the incidence of T2DM among adults with increased risk of T2DM, compared to usual care over a 36-month period.

Methods: A three-arm, stratified, cluster-randomized controlled trial will be conducted in eight factories in Daqing, with clusters as the unit of randomization and individual participants as the unit of analysis. Fifty-seven clusters will be randomly allocated (1:1:1) to one of three groups: (1) Digital-based lifestyle intervention, (2) complex lifestyle intervention, or (3) usual care. Eligible participants will be adults aged 25-55 with increased risk of T2DM, defined by IFG, IGT, HbA1c 5.7-6.4%, and/or 1-h PG above 8.6 mmol/L, while not meeting the criteria for diabetes. Exclusion criteria include significant cardiovascular disease (CVD) within 6 months, impaired liver function, renal dysfunction, other significant medical or psychological conditions, or participation in similar studies. The interventions will run for 3 years. The primary outcomes are the 3-year cumulative incidence of T2DM. The study will utilize the RE-AIM framework and Implementation Outcome Framework (IOF) to assess Reach, Adoption, Implementation, Maintenance, Feasibility, Acceptability, and Appropriateness through process measures. Data collection will include plasma glucose (0, 1, and 2 h) and insulin levels (0, 1, and 2 h) based on the oral glucose tolerance test, laboratory tests, blood pressure, body mass index, waist circumference, and dietary and physical activity behaviors, diabetes knowledge, and quality of life. These measures will be assessed by trained doctors or nurses at baseline and at 6-,12-, 24-, and 36-month follow-ups.

Discussion: The study will provide evidence on how population-level strategies of digital and complex lifestyle intervention can be implemented in real-world settings to prevent diabetes. If proven effective, these strategies could be integrated into Workplace Wellness Program in China and other countries to prevent diabetes and other noncommunicable diseases.

Trial registration: Chinese Clinical Trial Registry ChiCTR2400080790. Registered on 7th February 2024 TRIAL ACRONYM: Daqing DPS-II: Daqing Diabetes Prevention Study II.

Background: The use of high-flow oxygen therapy (HFOT) compared with standard low-flow oxygen therapy (LFOT) may improve outcomes in people with oxygen-dependent chronic respiratory failure (CRF). The primary aim of this multicentre trial was to evaluate HFOT in addition to LFOT, compared with regular LFOT in people with CRF due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

Methods: Registry-based randomised controlled trial (R-RCT) of people on LFOT for CRF due to COPD (n = 270) and ILD (n = 40), at ten Swedish secondary care centres within the Swedish Register for Respiratory Failure (Swedevox). People with ongoing LFOT are randomised in a 1:1 ratio to standard treatment with LFOT (control) or LFOT with added HFOT during nighttime and at the patient's discretion daytime (intervention). HFOT is provided using the ResMed Lumis HFT system and the AcuCare HFNC Cannula. Primary outcome is time to first hospitalisation or death up to 1 year in people with COPD. Secondary outcomes include symptoms, health-related outcomes (HRQL), health-economics, adverse events, and to explore the effects of HFOT in people with CRF due to ILD. Outcome data will be obtained from national registries and from patient questionnaires at 3 and 12 months.

Discussion: This R-RCT will combine the advantages of a prospective randomised trial and large clinical national registries to improve the evidence-based use of long-term oxygen therapy. Recruitment started in June 2024 and is ongoing.

Trial registration: ClinicalTrials.gov, ID: NCT06247397. Registered 2024-02-07.

Background: Clinical trial funders aim for trials conducted with high quality, within the planned time and budget. The majority of non-commercial investigator-initiated clinical trials do not complete participant recruitment in time or are discontinued early. In addition, the implementation of the results may be challenging. We aim to list the good practices available for public funders of clinical trials in Europe. Our focus is on practice-oriented trials exploring research questions not studied by industry.

Methods: We list the funding practices at the public trial funder KCE Trials in Belgium, together with good practices identified at the National Institute of Health and Care Research (NIHR) in England and ZonMw in The Netherlands. The literature on practices of public trial funders was searched.

Results: Assessment of the effectiveness of individual clinical trial funding practices is an under-studied area of research. Many funding practices have been integrated for decades in the NIHR HTA program, resulting in trials with significant health impact. Some practices of the commercial sector are now also used by public trial funders, such as on-site feasibility checks for recruitment capacity and paying sites based on participant recruitment and retention. The array of public funder practices with the collective aim to reduce risk and enhance impact can be grouped into ten categories: integration of the funder in the research user landscape; the funder's team and transparency in the use of public money; support for the sponsor's team; the terms and conditions of the funding, access rights and data sharing; an efficient and pragmatic trial design; trial selection and improvement; budget and payments, the importance of feasibility checks and site payments; recruitment and retention; dissemination and implementation of results; collaboration between funders and multi-national clinical trials in the EU.

Conclusions: Public funders of practice-oriented clinical trials have tools available to improve the health impact of the trials they fund. The relative contribution of each practice in a funding program in relation to its cost remains to be studied. Challenges remain for recruitment in non-commercial trials and efficient funding and management of multi-national non-commercial trials.

Background: Progress towards elimination and eventual eradication of malaria is threatened by challenges such as the rise in insecticide resistance and low coverage of existing vector control tools. Spatial repellents offer personal and household protection against biting mosquitoes by disseminating repellents into a given area. The trial described here aims to evaluate the efficacy of an active transfluthrin-based spatial repellent device (Mossie-GO™) against malaria in Uganda, using a placebo-controlled, double-blinded cluster randomised control trial. The study's primary objective is to demonstrate and quantify the protective efficacy of Mossie-GO™ in reducing the prevalence of malaria infection in children ≤ 5 years of age. The study's secondary objectives are to measure the impact of the intervention on entomological correlates of transmission, to determine user acceptance of the device and to quantify transfluthrin concentration in the air.

Methods: The trial has fifty-six clusters randomly assigned in a 1:1 ratio to either the intervention or placebo-control arm. One hundred children at baseline and sixty children ≤ 5 years of age will be sampled in each cluster at 6 and 12 months to measure the primary endpoint. Each child will be sampled from a different household to avoid within-house replication. A subset of households from each cluster will be selected for secondary endpoint sampling. All households enrolled into the study will be encouraged to continue use of other malaria control tools.

Discussion: Trial results will contribute to the growing research on spatial repellent efficacy in sub-Saharan Africa and will inform recommendations for the use of spatial repellents in malaria control, specific to rural and peri-urban contexts in Uganda. Information on household characteristics, behaviour related to malaria exposure and user acceptability of the intervention will also be collected to improve understanding of the intervention usage and impact. Following the trial, results will be publicly disseminated.

Trial registration: The trial is registered with ClinicalTrials.gov 01/04/2024 unique identification (ID): NCT06232954.

Background: Knee osteoarthritis (OA) is the most common chronic arthritis and is a leading cause of pain and disability. Chronic care model (CCM) has been proved successful in Hong Kong primary care setting. This study aims to assess the clinical effectiveness of a CCM, named Assessment and Management Program on Knee Osteoarthritis (RAMP-Knee OA), compared to usual care in adults with knee OA.

Methods: The study is a 52-week, two-arm, parallel, open-label randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N = 114) versus usual care (N = 114) on self-reported knee pain and other secondary outcomes. Measurement instruments will be tested at baseline, 16, 32, and 52 weeks. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; 5-point Likert) pain at 52 weeks. Secondary outcomes include a set of biopsychosocial parameters: Physical function will be measured subjectively by WOMAC function subscale and objectively by the 30-second chair and stand performance test. Lower limb muscle mass will be measured by bioimpedance analysis. Physical activity level will be measured by the Chinese International Physical Activity Questionnaire (Short form). Self-management efficacy will be measured by Pain-Self Efficacy questionnaire. Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) will be used to measure anxiety and depression, respectively. Insomnia will be measured by the 7-item Insomnia Severity Index (ISI), and loneliness will be measured by the 6-item De Jong Gierveld Loneliness Scale. EuroQuol-5D questionnaire will be used to measure health-related quality of life. Both primary and secondary outcomes at different points will be conducted using analysis of covariance, adjusting for baseline values. Secondary analyses include adjustments for potential confounders and exploration of interaction effects of treatment and the potential moderators.

Discussion: The findings will address the evidence-to-practice gap for the implementation of a CCM that incorporates a comprehensive risk assessment, care protocol, self-management support, and scheduled health assessments in Hong Kong.

Trial registration: ClinicalTrials.gov, 1 NCT06283147. Registered on 22 February 2024.

Background: Advanced Trauma Life Support® (ATLS®) is the most widely adopted form of trauma life support training worldwide, but there is no high-quality evidence that it can improve patient outcomes. The aim of this trial is to compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.

Methods: ADVANCE TRAUMA is a batched stepped-wedge cluster randomised controlled trial in India, where ATLS® is not routinely implemented. The trial will be conducted in 30 clusters (hospitals), organised into six batches of five clusters each. All clusters transition through three phases: first, a standard care phase; second, a 1-month transition phase, during which the training is delivered; and finally, an intervention phase, for a total of 13 months. Each cluster is randomised to an implementation sequence that defines the duration of the standard care and intervention phases. The trial will include at least 4320 adult trauma patients (≥ 15 years) who present to emergency departments and are subsequently admitted or transferred for admission. The primary outcome is in-hospital mortality within 30 days of arrival at the emergency department.

Discussion: This will be the first large-scale trial to provide robust evidence of the effectiveness of ATLS® since the programme was initiated in 1978. Regardless of the findings, this study will have important implications for trauma life support training globally. If ATLS® training improves patient outcomes, ways to promote its use and optimise its implementation, especially in low- and middle-income countries such as India, should be explored. If patient outcomes do not improve, trauma life support training must change.

Trial registration: Clinical Trials Registry-India (CTRI/2024/07/071336), ClinicalTrials.gov (NCT06321419, first registered 2024-03-20).