Contemporary Clinical Trials Communications最新文献

{"title":"Effectiveness of hippotherapy on balance performance, neurophysiological parameters and clinical symptoms of multiple sclerosis: Study protocol of a randomized controlled multicenter study (MS-HIPPO II - Movement in Balance)","authors":"Isabel Stolz ,&nbsp;Leonard Braunsmann ,&nbsp;Franca Rosiny ,&nbsp;Dieter Poehlau ,&nbsp;Thomas Abel ,&nbsp;Volker Anneken ,&nbsp;Marion Drache ,&nbsp;Kristel Knaepen","doi":"10.1016/j.conctc.2025.101583","DOIUrl":"10.1016/j.conctc.2025.101583","url":null,"abstract":"<div><h3>Background</h3><div>Exercise and physical therapy have been shown to be effective in the non-pharmacological symptomatic treatment of multiple sclerosis (MS). Hippotherapy as an additive physical therapy intervention is applied in this study to promote balance and postural control, since the number of sufficiently high-quality randomized controlled trials indicating its effectiveness is limited.</div></div><div><h3>Objective</h3><div>This study aims to provide more in-depth insights into the effectiveness of hippotherapy in MS in terms of balance and other patient-relevant outcomes, building on the results of a preliminary study (MS-HIPPO II, evidence level 1b).</div></div><div><h3>Methods</h3><div>Based on a prospective, randomized, investigator-blinded, controlled multicenter study design, the primary endpoint of differences in balance will be investigated. Patients will be randomized to an intervention group (12 weeks of hippotherapy) or a control group (12 weeks of treatment as usual). Balance will be measured using the Berg Balance Scale (BBS) plus a standardized balance task on a force plate (AccuGait-Optimized, Advanced Mechanical Technology, Inc., Massachusetts, US) and a balance perturbation task on an oscillating sensorimotor therapy device (Bioswing Posturomed®, Haider, Pullenreuth, Germany). During balance tasks, electrocortical activity will be investigated using electroencephalography (EEG) (LiveAmp 32, Brain Products GmbH, Gilching, Germany). Secondary endpoints include fatigue (FSS), quality of life (MSQoL-54), pain (VAS), spasticity (NRS) and participation (WHODAS 2.0). Therapy progress will be documented via an ICF-based hippotherapy assessment-tool (EQUITEDO®, Frechen, Germany).</div></div><div><h3>Results and conclusions</h3><div>The results should contribute to improve the understanding of non-pharmaceutical treatment options in the field of exercise and movement therapy in MS.</div></div><div><h3>Trial registration</h3><div>The trial was registered at March 05, 2024 in the German Clinical Trial Register under DRKS00033449.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101583"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for neuro-oncology anywhere 242: Pilot study evaluating telehealth and in-person assessments in patients with glioma receiving oral chemotherapy","authors":"Ugur Sener ,&nbsp;Taylor Galloway ,&nbsp;Bryan Neth ,&nbsp;Joon Uhm ,&nbsp;Sani H. Kizilbash ,&nbsp;Jian L. Campian ,&nbsp;Samantha Caron ,&nbsp;William G. Breen ,&nbsp;Eric Lehrer ,&nbsp;Elizabeth Golembiewski ,&nbsp;Sydney Schultz ,&nbsp;Heather Hughes ,&nbsp;Sue Steinmetz ,&nbsp;Susan Geyer ,&nbsp;Carolyn Mead-Harvey ,&nbsp;Carey Huebert ,&nbsp;William Tauer ,&nbsp;Charles Mason ,&nbsp;Terry C. Burns ,&nbsp;Joshua Pritchett ,&nbsp;Tufia Haddad","doi":"10.1016/j.conctc.2025.101593","DOIUrl":"10.1016/j.conctc.2025.101593","url":null,"abstract":"<div><div>Care at high volume centers is associated with an overall survival benefit for patients with glioma. However, access to these centers is challenging for patients who experience neurologic deficits, leading to loss of independence and rendering travel difficult. Patients with low socio-economic status (SES) often lack logistical resources for travel, leading to poorer outcomes. There is a critical need for scalable telehealth solutions to increase access to specialized care. The Neuro-Oncology Anywhere 242 study systematically compares telehealth and in-person neuro-oncology assessments, as decentralization of care delivery may enable glioma patients with neurologic deficits and low SES to access specialized care and experience improved health outcomes. The primary objective of this study is to assess patient satisfaction with care delivered as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments. A key secondary objective is to assess the completion rate of planned oral chemotherapy among patients with glioma within 28 days of telehealth visits compared to in-person visits. Chemotherapy adherence is evaluated using a novel digital pill diary that has been developed for this study. Other secondary objectives include preference for telehealth versus in-person evaluations as well as acute care utilization, neurologic impairment, and quality of life among participants after telehealth versus in-person visits. Successful demonstration of this will offer a strong scientific rationale to incorporate telehealth into interventional clinical trials to accelerate development of novel therapeutics unconstrained by geographic location, disability, or SES.</div></div><div><h3>Trial registration id</h3><div><span><span>NCT06625047</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101593"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promoting the recruitment of historically underrepresented children and families in clinical trials: Perspectives of pediatric clinic staff","authors":"Janvi D. Nanavati ,&nbsp;Daniel Mendoza Martinez ,&nbsp;Grace W. Ryan ,&nbsp;Melissa Goulding ,&nbsp;Sonia Radu ,&nbsp;Michelle Spano ,&nbsp;Ted Kremer ,&nbsp;Kali Pereira ,&nbsp;John Almeida ,&nbsp;Christine Frisard ,&nbsp;Sybil Crawford ,&nbsp;Milagros C. Rosal ,&nbsp;Nancy Byatt ,&nbsp;Stephenie C. Lemon ,&nbsp;Lori Pbert ,&nbsp;Michelle Trivedi","doi":"10.1016/j.conctc.2026.101607","DOIUrl":"10.1016/j.conctc.2026.101607","url":null,"abstract":"<div><h3>Introduction</h3><div>Children and families from historically marginalized ethnic/racial backgrounds have low participation in clinical trials and pediatric practice staff perspectives on this topic are underexplored.</div></div><div><h3>Methods</h3><div>We conducted interviews (n = 20) with pediatric practice staff and used rapid template analysis to identify themes and sub-themes.</div></div><div><h3>Results</h3><div>We identified several primary themes related to strategies that both research staff and pediatric practice staff can use in order to support the recruitment of historically marginalized populations into research. For example, researchers can facilitate running reports within practices to identify potential trial participants with limited access to care and pediatric providers can offer research opportunities at well visits noting potential benefits of research and directly discuss mistrust in research.</div></div><div><h3>Discussion</h3><div>While the dynamics involved in the recruitment of historically marginalized children and families into trials are inherently complex, we identified several concrete strategies to support this work and increase diversity in pediatric clinical trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101607"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cognitive behavioral therapy for insomnia for individuals with multiple sclerosis (CALM): A randomized control trial protocol","authors":"Catherine F. Siengsukon ,&nbsp;Jade Robichaud ,&nbsp;Eryen Nelson ,&nbsp;Allison Glaser ,&nbsp;Garrett R. Baber ,&nbsp;Matthew K.P. Gratton ,&nbsp;Anna Zanotto ,&nbsp;Milind A. Phadnis ,&nbsp;Sharon Lynch","doi":"10.1016/j.conctc.2026.101595","DOIUrl":"10.1016/j.conctc.2026.101595","url":null,"abstract":"<div><div>Insomnia is a common problem for individuals with multiple sclerosis (MS) occurring in at least 40 % of individuals with MS. Sleep disturbances in people with MS have been associated with a reduction in cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. Cognitive behavioral therapy for insomnia (CBT-I), a multicomponent treatment strategy, addresses thoughts and behaviors that can negatively impact sleep and is the recommended treatment for chronic insomnia. CBT-I is shown to be more effective than pharmacological interventions long-term for treating insomnia with improvements remaining up to 10 years following CBT-I. However, there are limited studies that have examined the effect of CBT-I on sleep outcomes and comorbid symptoms in people with MS. The objective of the proposed study is to determine the efficacy of CBT-I delivered via telehealth to improve insomnia symptoms, fatigue, and health-related quality of life in people with MS. CBT-I offers a low-risk, cost-effective, non-pharmacological approach to improving sleep quality, fatigue, and daily functioning in individuals with MS. Targeting insomnia in MS may also reduce disability, enhance quality of life, increase employment rates, and lower healthcare and support costs. Furthermore, understanding factors that impact improvement in outcomes will allow more accurate individualization of insomnia treatment for people with MS.</div></div><div><h3>Trial registration</h3><div>The CALM study is registered at: <span><span>https://clinicaltrials.gov</span><svg><path></path></svg></span> (NCT06428006).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101595"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Behavioral health technician delivered written exposure therapy for posttraumatic stress disorder in the military: Design of a hybrid implementation effectiveness trial","authors":"Carmen P. McLean ,&nbsp;Meghan M. Bell ,&nbsp;Christopher K. Haddock ,&nbsp;Stefanie T. LoSavio ,&nbsp;Jeffrey Mann ,&nbsp;Shannon McCaslin ,&nbsp;Nazia Rahman ,&nbsp;Lauren Rodden ,&nbsp;Timothy Rogers ,&nbsp;Craig S. Rosen ,&nbsp;Craig Woodworth ,&nbsp;Jeffrey Cook","doi":"10.1016/j.conctc.2026.101598","DOIUrl":"10.1016/j.conctc.2026.101598","url":null,"abstract":"<div><div>Posttraumatic stress disorder (PTSD) affects up to 13–17 % of active duty military personnel who deployed after 9/11 and significantly impacts military readiness. However, behavioral health providers in the Military Health System (MHS) face significant challenges in implementing evidence-based psychotherapies (EBPs) such as Written Exposure Therapy (WET). One of the main obstacles is the limited capacity to schedule and conduct weekly therapy sessions due to large patient panels and heavy workloads. This study uses a Hybrid Type 1 implementation-effectiveness design to increase access to WET by task sharing delivery with behavioral health technicians (BHTs). We will compare BHT-delivered WET plus treatment as usual (TAU) to TAU alone in a Phase II randomized clinical trial with 150 active-duty participants. The primary aims are to evaluate the clinical effectiveness of BHT-delivered WET, patient acceptability, and BHT treatment fidelity. Secondary aims include identifying barriers and facilitators to WET implementation. Participants will be randomly assigned to BHT-delivered WET or TAU alone, with WET delivered weekly over five sessions either in-person or via telehealth. Quality control will be maintained through rigorous BHT training, supervision, and fidelity assessments. Community-Based Participatory Research methods will ensure stakeholder engagement and feedback throughout the study. Data analysis involves linear mixed-effects models and rapid qualitative analysis to assess outcomes. The results will demonstrate the effectiveness of WET in routine care settings and the feasibility of BHT-delivered WET as an implementation strategy. The findings have the potential to enhance PTSD treatment accessibility and inform best practices within the MHS and similar settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101598"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An updated review of the SMA clinical trial landscape in the United States: Findings from analysis of recruitment targets on ClinicalTrials.gov and a survey of SMA clinical trial sites on factors affecting site capacity and readiness","authors":"Fatou Sarr ,&nbsp;Ilse Peterson ,&nbsp;Jacqueline Glascock ,&nbsp;Mary Curry","doi":"10.1016/j.conctc.2026.101601","DOIUrl":"10.1016/j.conctc.2026.101601","url":null,"abstract":"<div><div>The approval of new disease-modifying treatments, diagnostic tools, and expansion of the drug pipeline has evolved the clinical trial landscape for spinal muscular atrophy (SMA) – a rare neuromuscular disease. Nonetheless, significant unmet needs for the SMA population remain and require continued evolution of the SMA clinical trial landscape. In 2023, Cure SMA developed a series of activities to assess the current SMA clinical trial landscape including the Cure SMA Capacity and Recruitment Survey. The purpose of the survey was to understand site capacity for SMA clinical trials in the US, identify factors that may limit site trial capacity and/or readiness, and identify opportunities to increase site capacity. Twenty-four (24) sites across the US with experience in conducting SMA clinical trials are represented in the results. Although existing clinical trial sites may have the capacity to take on additional SMA trials, many factors are inhibiting efficient trial management and study start-up. As recruitment needs for SMA clinical trials continue to evolve, action is needed to address the site needs – such as increased clinical staff support and bandwidth, streamlining training, and adequate funding to conduct trials – to further optimize trial site readiness and capacity. SMA clinical trial sites, sponsors, and contract research organizations will need to work together to optimize trial site readiness address challenges to capacity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101601"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mechanistic trial of the neurobiology of extinction learning and intraparietal sulcus stimulation: Protocol","authors":"Sonalee A. Joshi,&nbsp;Tao Lin,&nbsp;Nicholas L. Balderston,&nbsp;Kevin G. Lynch,&nbsp;Mingcong Tang,&nbsp;Milan Patel,&nbsp;Ivy Sun,&nbsp;Barbara Fureman,&nbsp;Desmond J. Oathes,&nbsp;David F. Gregory,&nbsp;Yvette I. Sheline,&nbsp;Lily A. Brown","doi":"10.1016/j.conctc.2025.101591","DOIUrl":"10.1016/j.conctc.2025.101591","url":null,"abstract":"<div><div>Post-traumatic stress disorder (PTSD) links to impaired extinction learning post-trauma. While treatments like prolonged exposure therapy improve this learning, they benefit only 40–60 % of patients. Optimal arousal supports extinction learning, but excessive arousal can hinder it. The intraparietal sulcus (IPS) is involved in arousal regulation but has not yet been targeted using continuous theta burst stimulation (cTBS) in PTSD. This study is the first to explore the effect of IPS cTBS on extinction learning in PTSD. This study aims to 1) evaluate the impact of IPS cTBS on anxiety potentiated startle (APS) among patients with PTSD compared to sham IPS cTBS, 2) examine whether IPS cTBS improves extinction learning relative to neutral learning, and 3) identify the ideal dose of cTBS. Adults with PTSD will participate in six visits, involving clinical assessments, functional MRI (fMRI), and IPS cTBS. Participants will undergo diagnostic interviews, generate trauma and neutral scripts, and complete script-driven imagery tasks. They will receive active or sham cTBS (counterbalanced) paired with trauma or neutral scripts during separate visits. Follow-up assessments occur at 24 h and 30 days post-intervention. IRB approval and preliminary preparations began in January 2024. Recruitment started in April 2024 and is projected to conclude by April 2028. Ethical procedures are approved by the University of Pennsylvania IRB (Protocol Number: 849571). This will be the first study to evaluate the synergistic effects of extinction training with IPS cTBS in individuals with PTSD. Our findings will strengthen the neurobiological basis of augmenting extinction training with IPS cTBS.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101591"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of patient and site engagement in the SYNCHRONIZE™ phase 3 clinical trial program for survodutide in obesity through clinical trial simulation","authors":"Domenica M. Rubino ,&nbsp;Vicki Mooney ,&nbsp;Viviënne van de Walle ,&nbsp;David Baanstra ,&nbsp;Wouter Daniëls ,&nbsp;Christopher Recaldin ,&nbsp;Joe Nadglowski","doi":"10.1016/j.conctc.2026.101611","DOIUrl":"10.1016/j.conctc.2026.101611","url":null,"abstract":"<div><h3>Introduction</h3><div>Clinical trial simulations (CTSs) are an increasingly common way to incorporate site staff and participant feedback into clinical trial design. CTSs can help overcome the unique challenges presented in obesity trials. Here, a CTS was conducted for three trials from the SYNCHRONIZE™ phase 3 program of survodutide in obesity.</div></div><div><h3>Methods</h3><div>Individuals meeting the inclusion criteria of the SYNCHRONIZE trials (referred to as “participants”), and clinical trial professionals with experience in conducting obesity trials (“site staff”), were recruited. Trial designs were reviewed by participants and site staff, and participant-facing materials by participants. Both groups were interviewed about these aspects of the trials.</div></div><div><h3>Results</h3><div>Overall responses to the clinical trial designs were positive. Site staff were comfortable with the inclusion/exclusion criteria and thought recruitment would not be difficult. However, they indicated that pre-screening could help ensure participants' appropriateness for the trial. Additionally, they felt steps should be taken to encourage participant engagement throughout the trial. Participants’ concerns focused on optimizing training and educational materials, time commitments for the trial, and burden of data collection. Recommendations from the CTS led to changes in visit interval, increased virtual visit options, and changes in participant materials. <em>Psychological support</em> was identified as potentially helpful by both site staff and participants. However, understanding how to implement this in clinical trials remains to be elucidated.</div></div><div><h3>Conclusions</h3><div>These results suggest participant and site staff input from a CTS could help improve obesity clinical trial design, which may ultimately lead to more robust data and reliable clinical findings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101611"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146214354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital health physical activity coaching for older family caregivers of persons with heart failure – TPA4You: Protocol for a pilot randomized controlled trial","authors":"Dawon Baik ,&nbsp;Heather Coats ,&nbsp;Blaine Reeder ,&nbsp;Larry A. Allen ,&nbsp;Catherine Jankowski","doi":"10.1016/j.conctc.2026.101604","DOIUrl":"10.1016/j.conctc.2026.101604","url":null,"abstract":"<div><h3>Background</h3><div>Older adult family caregivers of persons with heart failure experience substantial burden due to the complex care needs of their care recipients. Targeted interventions for this population remain limited. To address this gap, we developed a digital health physical activity coaching intervention specifically designed for older family caregivers of persons with heart failure. In this paper, we describe the protocol for a pilot randomized controlled trial evaluating the preliminary feasibility and effects of the intervention in improving physical and mental health as well as caregiving self-efficacy and quality of life.</div></div><div><h3>Methods</h3><div>The study aims to test a 12-week, two-arm pilot randomized controlled trial of older caregivers of persons with heart failure. Study enrollment began in June 2024. Participants are enrolled from inpatient units and outpatient clinics at a large medical center in the U.S. and randomized to the intervention or control arm. Participants in the intervention arm receive 24 exercise coaching sessions and motivational text messages over 12 weeks. Both groups are provided with Fitbit devices to monitor physical activity. Data are collected at baseline, during the intervention (1 and 2 months), on exit, and post-intervention (1 and 3 months following completion). Participants in the control arm receive a 1-page handout with general information on caregiver self-care. The primary outcome is daily step counts as measured by the Fitbit device.</div></div><div><h3>Conclusion</h3><div>Findings from this pilot trial will inform a subsequent efficacy study of the digital health physical activity coaching intervention in a larger, more diverse population of older family caregivers of adults with heart failure.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov <span><span>NCT05852509</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101604"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for PIANo-1: Personalized Investigation of music’s effect on Attention in a series of N-of-1 trials","authors":"Thomas Gärtner ,&nbsp;Fabian Stolp ,&nbsp;Bert Arnrich ,&nbsp;Stefan Konigorski","doi":"10.1016/j.conctc.2026.101606","DOIUrl":"10.1016/j.conctc.2026.101606","url":null,"abstract":"<div><h3>Background:</h3><div>Focus and concentration are influenced by various environmental factors, such as listening to music. Recent research highlights the individualized nature of music’s effects on concentration, as responses vary significantly between individuals based on music genres and personal preference. Traditional population-based studies often obscure these between-person differences, while N-of-1 trials, which are individual crossover trials, can provide a personalized approach by allowing each participant to serve as their own control. This study design is particularly suited for examining how self-selected music genres might enhance or alter concentration in each individual. By leveraging an N-of-1 trial design, this study aims to contribute to the growing body of research investigating personalized cognitive interventions, providing insights into individual effects and variations in response to music.</div></div><div><h3>Methods:</h3><div>The study will include approximately 23 participants, who will be allocated to a block-randomized sequence with two cycles, each consisting of 3-min periods of listening to music (intervention, A) and 3 min of no music (control, B) in random order. Study participants will select one of fourteen predefined music genres, with or without lyrics, as their intervention. A playlist with preselected songs from this genre will be played and compared to not listening to music. To minimize the effects of carryover and concentration loss during the study, a 1-min break is planned between each period, resulting in a total duration of around 15 min. Concentration will be assessed by the number of correct classifications of a digital version of the Stroop test within each period. After each period, a short questionnaire will be administered to collect self-assessed concentration and stress scores. Additionally, physiological biomarkers will be assessed using wearables such as Electroencephalography, Heart Rate Variability, Electrodermal Activity, and eye- and pupil-movement data. In the statistical analysis, Bayesian generalized linear mixed models will be used to estimate the intervention effects of music on correct answers of the Stroop task on the individual level and population level.</div></div><div><h3>Discussion:</h3><div>This study will provide insights into the personalized effects of music on concentration, providing a blueprint for individuals on how they may test and improve their concentration.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101606"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}