Pub Date : 2026-02-01Epub Date: 2025-12-23DOI: 10.1016/j.conctc.2025.101591
Sonalee A. Joshi, Tao Lin, Nicholas L. Balderston, Kevin G. Lynch, Mingcong Tang, Milan Patel, Ivy Sun, Barbara Fureman, Desmond J. Oathes, David F. Gregory, Yvette I. Sheline, Lily A. Brown
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.
{"title":"A mechanistic trial of the neurobiology of extinction learning and intraparietal sulcus stimulation: Protocol","authors":"Sonalee A. Joshi, Tao Lin, Nicholas L. Balderston, Kevin G. Lynch, Mingcong Tang, Milan Patel, Ivy Sun, Barbara Fureman, Desmond J. Oathes, David F. Gregory, Yvette I. Sheline, 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}
Pub Date : 2026-02-01Epub Date: 2026-02-04DOI: 10.1016/j.conctc.2026.101611
Domenica M. Rubino , Vicki Mooney , Viviënne van de Walle , David Baanstra , Wouter Daniëls , Christopher Recaldin , Joe Nadglowski
Introduction
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.
Methods
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.
Results
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. Psychological support was identified as potentially helpful by both site staff and participants. However, understanding how to implement this in clinical trials remains to be elucidated.
Conclusions
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.
{"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 , Vicki Mooney , Viviënne van de Walle , David Baanstra , Wouter Daniëls , Christopher Recaldin , 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}
Pub Date : 2026-02-01Epub Date: 2026-01-20DOI: 10.1016/j.conctc.2026.101604
Dawon Baik , Heather Coats , Blaine Reeder , Larry A. Allen , Catherine Jankowski
Background
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.
Methods
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.
Conclusion
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.
{"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 , Heather Coats , Blaine Reeder , Larry A. Allen , 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}
Pub Date : 2026-02-01Epub Date: 2026-01-22DOI: 10.1016/j.conctc.2026.101606
Thomas Gärtner , Fabian Stolp , Bert Arnrich , Stefan Konigorski
Background:
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.
Methods:
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.
Discussion:
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.
{"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 , Fabian Stolp , Bert Arnrich , 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}
Pub Date : 2026-02-01Epub Date: 2026-01-12DOI: 10.1016/j.conctc.2026.101596
Charlie Olvera , Vanessa Ramirez-Zohfeld , Alaine Murawski , Angela Fidler Pfammatter , Lee A. Lindquist
Traditional clinical trial designs such as the isolated two-arm randomized controlled trial (RCT) do not offer robust solutions for evaluating and optimizing delivery of complex, multi-component behavioral interventions. A recent alternative design, the Multiphase Optimization Strategy (MOST), addresses many shortcomings of the isolated two-arm RCT. The MOST framework for trial design provides researchers opportunities to perform independent evaluations of intervention content, dosage levels, delivery formats, and potential intra-intervention interactions. Results from factorial trials which implement MOST frameworks are used to optimize ongoing interventions.
Herein, we describe the protocol for a MOST RCT which evaluates NegotiAge, an artificial intelligence-based negotiation and dispute resolution training program for family caregivers of older adults. Many family caregivers experience conflicts as they support older adult care recipients. Teaching negotiation skills to family caregivers has potential to improve communication and resolve conflicts more efficiently. The trial evaluation of NegotiAge eschews traditional two-arm RCT design and instead employs the MOST framework. Our MOST trial tests eight treatment combination packages against one another and evaluates associations between specific treatment combinations and user-centered outcomes.
This research is the first to apply the MOST framework in geriatrics and family caregiving. Our use of the MOST framework to evaluate and optimize NegotiAge enables us to identify which components are most effective for family caregivers and isolate the interactional effects of each component. The protocol and eventual results of our MOST trial will demonstrate how to optimize an intervention to be efficient and potent for busy family caregivers of older adults.
{"title":"Evaluating a negotiation training program for family caregivers of older people using a Multiphase Optimization Strategy (MOST) design and protocol","authors":"Charlie Olvera , Vanessa Ramirez-Zohfeld , Alaine Murawski , Angela Fidler Pfammatter , Lee A. Lindquist","doi":"10.1016/j.conctc.2026.101596","DOIUrl":"10.1016/j.conctc.2026.101596","url":null,"abstract":"<div><div>Traditional clinical trial designs such as the isolated two-arm randomized controlled trial (RCT) do not offer robust solutions for evaluating and optimizing delivery of complex, multi-component behavioral interventions. A recent alternative design, the Multiphase Optimization Strategy (MOST), addresses many shortcomings of the isolated two-arm RCT. The MOST framework for trial design provides researchers opportunities to perform independent evaluations of intervention content, dosage levels, delivery formats, and potential intra-intervention interactions. Results from factorial trials which implement MOST frameworks are used to optimize ongoing interventions.</div><div>Herein, we describe the protocol for a MOST RCT which evaluates NegotiAge, an artificial intelligence-based negotiation and dispute resolution training program for family caregivers of older adults. Many family caregivers experience conflicts as they support older adult care recipients. Teaching negotiation skills to family caregivers has potential to improve communication and resolve conflicts more efficiently. The trial evaluation of NegotiAge eschews traditional two-arm RCT design and instead employs the MOST framework. Our MOST trial tests eight treatment combination packages against one another and evaluates associations between specific treatment combinations and user-centered outcomes.</div><div>This research is the first to apply the MOST framework in geriatrics and family caregiving. Our use of the MOST framework to evaluate and optimize NegotiAge enables us to identify which components are most effective for family caregivers and isolate the interactional effects of each component. The protocol and eventual results of our MOST trial will demonstrate how to optimize an intervention to be efficient and potent for busy family caregivers of older adults.</div></div><div><h3>Trial registration ID</h3><div>NCT04837937.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101596"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977559","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}
Pub Date : 2026-02-01Epub Date: 2026-01-13DOI: 10.1016/j.conctc.2026.101597
Alexandria M. Boykins , Asos Mahmood , Mona N. Wicks , Satya Surbhi , Santos A. Martinez , Frankie B. Stentz , James E. Bailey
Background
Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.
Objective
To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.
Study design
The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023–August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (<6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.
Conclusions
This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.
{"title":"Healthy eating and active living to reverse diabetes (HEAL Diabetes-USA): a randomized controlled pilot study protocol to assess the feasibility of a weight loss intervention for diabetes remission","authors":"Alexandria M. Boykins , Asos Mahmood , Mona N. Wicks , Satya Surbhi , Santos A. Martinez , Frankie B. Stentz , James E. Bailey","doi":"10.1016/j.conctc.2026.101597","DOIUrl":"10.1016/j.conctc.2026.101597","url":null,"abstract":"<div><h3>Background</h3><div>Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.</div></div><div><h3>Objective</h3><div>To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.</div></div><div><h3>Study design</h3><div>The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023–August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (<6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.</div></div><div><h3>Conclusions</h3><div>This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101597"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977558","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}
Pub Date : 2026-02-01Epub Date: 2026-01-14DOI: 10.1016/j.conctc.2026.101600
Ting Lu , Zhixuan Shi , Shuna Huang , Lan Lv , Xinyuan Chen , Ke Ma , Xu Li , Fancai Lai , Jun Ni
<div><h3>Aims</h3><div>Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ("the programme") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care.</div></div><div><h3>Methods</h3><div>This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P < 0.05, the difference was considered statistically significant.</div></div><div><h3>Results</h3><div>In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29–12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found.</div></div><div><h3>Conclusion</h3><div>Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of p
{"title":"Effect of preoperative inspiratory muscle training combined with education course on postoperative pulmonary complications in high-risk patients with lung cancer after video-assisted thoracoscopic surgery: a randomized controlled trial","authors":"Ting Lu , Zhixuan Shi , Shuna Huang , Lan Lv , Xinyuan Chen , Ke Ma , Xu Li , Fancai Lai , Jun Ni","doi":"10.1016/j.conctc.2026.101600","DOIUrl":"10.1016/j.conctc.2026.101600","url":null,"abstract":"<div><h3>Aims</h3><div>Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education (\"the programme\") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care.</div></div><div><h3>Methods</h3><div>This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P < 0.05, the difference was considered statistically significant.</div></div><div><h3>Results</h3><div>In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29–12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found.</div></div><div><h3>Conclusion</h3><div>Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of p","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101600"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977690","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}
Pub Date : 2026-02-01Epub Date: 2026-01-31DOI: 10.1016/j.conctc.2026.101599
Yanbiao Zhong , Meng Ren , Wenjing Wang , Juanlian He , Yonghui Zhong , Jingjing Xu , YuanLi Li , Sicong Zhang , Chunlei Shan
Introduction
Intermittent theta-burst stimulation (iTBS) is a specific type of repetitive transcranial magnetic stimulation (rTMS) paradigm with long-lasting effects and a short session duration. Although randomized controlled trials have suggested that iTBS is effective for treating depression, few studies have investigated the effects of iTBS in treating post-stroke depression (PSD). The purpose of the present study is to investigate whether iTBS can be used to treat PSD. We will also investigate the corresponding mechanisms of iTBS via functional magnetic resonance imaging (fMRI).
Methods and analysis
We will recruit 36 PSD patients for this single-center, randomized, sham-controlled trial. Subjects will be randomly divided into the following two groups according to a 1:1 ratio: the active iTBS group and the sham iTBS group. The data will be collected at 0 and 10 d after the commencement of treatment. The primary outcome will be comprised of scores on the 17-item Hamilton Depression Rating Scale. The secondary outcomes will consist of MRI results and the results of neuropsychological tests, including the Brief 16-item Quick Inventory of Depressive Symptomatology Self-Report, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale for clinician administration, and Young Mania Rating Scale.
Ethics and dissemination
Ethics approval has been granted by the Ethics Committee of Yueyang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine (Shanghai, China; Grant No. 2019-108). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.
{"title":"Effects of intermittent theta-burst stimulation (iTBS) on post-stroke depression (PSD): A study protocol for a single-center randomized controlled trial","authors":"Yanbiao Zhong , Meng Ren , Wenjing Wang , Juanlian He , Yonghui Zhong , Jingjing Xu , YuanLi Li , Sicong Zhang , Chunlei Shan","doi":"10.1016/j.conctc.2026.101599","DOIUrl":"10.1016/j.conctc.2026.101599","url":null,"abstract":"<div><h3>Introduction</h3><div>Intermittent theta-burst stimulation (iTBS) is a specific type of repetitive transcranial magnetic stimulation (rTMS) paradigm with long-lasting effects and a short session duration. Although randomized controlled trials have suggested that iTBS is effective for treating depression, few studies have investigated the effects of iTBS in treating post-stroke depression (PSD). The purpose of the present study is to investigate whether iTBS can be used to treat PSD. We will also investigate the corresponding mechanisms of iTBS via functional magnetic resonance imaging (fMRI).</div></div><div><h3>Methods and analysis</h3><div>We will recruit 36 PSD patients for this single-center, randomized, sham-controlled trial. Subjects will be randomly divided into the following two groups according to a 1:1 ratio: the active iTBS group and the sham iTBS group. The data will be collected at 0 and 10 d after the commencement of treatment. The primary outcome will be comprised of scores on the 17-item Hamilton Depression Rating Scale. The secondary outcomes will consist of MRI results and the results of neuropsychological tests, including the Brief 16-item Quick Inventory of Depressive Symptomatology Self-Report, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale for clinician administration, and Young Mania Rating Scale.</div></div><div><h3>Ethics and dissemination</h3><div>Ethics approval has been granted by the Ethics Committee of Yueyang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine (Shanghai, China; Grant No. 2019-108). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.</div></div><div><h3>Trial registration number</h3><div>ChiCRT1900027686.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101599"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167124","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}
Pub Date : 2025-12-01Epub Date: 2025-11-24DOI: 10.1016/j.conctc.2025.101577
Samantha E. Daruwala , Kayley Stratton , Grace Y. Cho , Michael D. Anestis , Craig J. Bryan , Nicholas P. Allan
Background
In the United States (US), the proportion of firearm suicide deaths are higher among military personnel compared to the general population. Secure firearm storage practices (e.g., gun safe, unloaded) can reduce the risk of firearm suicide. A randomized controlled trial, called Project Safe Guard (PSG) found that providing lethal means counseling (LMC) to firearm-owning service members increased secure firearm storage practices; however, some still stored at least one firearm unsecurely. Intolerance of uncertainty (IU) may be a barrier to secure firearm storage that decreases the effectiveness of LMC. This study will examine the impact of a brief intervention that targets IU (i.e., Cognitive behavioral therapy for Uncertainty Enhanced; CUE) on improving the effectiveness of PSG-LMC on secure firearm storage practices among firearm-owning service members. In this protocol paper, we describe the rationale and methodology for this study.
Methods
This study uses a counterbalanced design with two conditions to test the acceptability, feasibility, and potential efficacy of both interventions with 100 current or recently discharged service members who report elevated IU and storing at least one firearm unsecurely. Participants are randomized to either receive CUE or PSG-LMC first, and then receive the second intervention approximately two weeks later. Participants will complete a baseline assessment, ecological momentary assessment (EMA) via their mobile devices, and follow-ups at 1-, 3-, 6-, 9-, and 12-months post-baseline. All interventions will be delivered remotely.
Conclusions
This study aims to inform how to improve firearm safety in military personnel with elevated IU.
{"title":"Study design and protocol for a randomized clinical trial investigating a brief fear of uncertainty-focused intervention as an adjunct to project safe guard for military personnel","authors":"Samantha E. Daruwala , Kayley Stratton , Grace Y. Cho , Michael D. Anestis , Craig J. Bryan , Nicholas P. Allan","doi":"10.1016/j.conctc.2025.101577","DOIUrl":"10.1016/j.conctc.2025.101577","url":null,"abstract":"<div><h3>Background</h3><div>In the United States (US), the proportion of firearm suicide deaths are higher among military personnel compared to the general population. Secure firearm storage practices (e.g., gun safe, unloaded) can reduce the risk of firearm suicide. A randomized controlled trial, called Project Safe Guard (PSG) found that providing lethal means counseling (LMC) to firearm-owning service members increased secure firearm storage practices; however, some still stored at least one firearm unsecurely. Intolerance of uncertainty (IU) may be a barrier to secure firearm storage that decreases the effectiveness of LMC. This study will examine the impact of a brief intervention that targets IU (i.e., Cognitive behavioral therapy for Uncertainty Enhanced; CUE) on improving the effectiveness of PSG-LMC on secure firearm storage practices among firearm-owning service members. In this protocol paper, we describe the rationale and methodology for this study.</div></div><div><h3>Methods</h3><div>This study uses a counterbalanced design with two conditions to test the acceptability, feasibility, and potential efficacy of both interventions with 100 current or recently discharged service members who report elevated IU and storing at least one firearm unsecurely. Participants are randomized to either receive CUE or PSG-LMC first, and then receive the second intervention approximately two weeks later. Participants will complete a baseline assessment, ecological momentary assessment (EMA) via their mobile devices, and follow-ups at 1-, 3-, 6-, 9-, and 12-months post-baseline. All interventions will be delivered remotely.</div></div><div><h3>Conclusions</h3><div>This study aims to inform how to improve firearm safety in military personnel with elevated IU.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101577"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623719","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}
Pub Date : 2025-12-01Epub Date: 2025-11-24DOI: 10.1016/j.conctc.2025.101579
Junhong Su , Bettina E. Hansen , Zifang Wang , Abylaikhan Sharmenov , Xueshan Xia , Michelle Broekhuizen , Zhongren Ma , Maikel P. Peppelenbosch
Background
Although the gut microbiome plays a crucial role for maintaining overall host homeostasis and metabolism, it is significantly influenced by dietary changes, leading to substantial temporal variations in microbial composition within and between individuals. Despite this, incidental fecal sampling remains the standard method for microbiome assessment. Recently, the blood microbiome, defined by microbial DNA (cmDNA) circulating in the bloodstream, has emerged as a potentially more stable and integrated alternative. Preliminary data suggest that blood microbiome analysis may offer more consistent insights than fecal-based approaches, although the methodological validity of the approach has been questioned.
Method/design
This study aims to establish or rule-out cmDNA as a representative of the gut microbiome. In a prospective, single-arm crossover trial, effects of dairy product withdrawal and reintroduction of a yoghurt with a known consortium of bacteria will be assessed in healthy volunteers aged 18–65. Participants will first abstain from all dairy products, a phase expected to reduce yogurt-associated cmDNA in the bloodstream. Yogurt will then be reintroduced, during which reappearance of cmDNA of specific bacteria (especially LGG, LA-5 and BB-12) is anticipated. Shotgun metagenomic sequencing will be used to track cmDNA dynamics over time. This longitudinal sampling approach will provide experimental evidence supporting the existence and responsiveness of the circulating microbiome, while also revalidating the bioinformatic pipeline used for its analysis.
Conclusion
This pilot study will test whether blood-derived microbial DNA can serve as a valid surrogate for gut microbiome composition. If successful, this approach may provide a more stable and integrative alternative to fecal sampling and support future biomarker development and mechanistic research.
{"title":"Yogurt reintroduction and the circulating microbiome in healthy volunteers: protocol for a prospective, longitudinal, species-controlled crossover clinical trial (MAMI)","authors":"Junhong Su , Bettina E. Hansen , Zifang Wang , Abylaikhan Sharmenov , Xueshan Xia , Michelle Broekhuizen , Zhongren Ma , Maikel P. Peppelenbosch","doi":"10.1016/j.conctc.2025.101579","DOIUrl":"10.1016/j.conctc.2025.101579","url":null,"abstract":"<div><h3>Background</h3><div>Although the gut microbiome plays a crucial role for maintaining overall host homeostasis and metabolism, it is significantly influenced by dietary changes, leading to substantial temporal variations in microbial composition within and between individuals. Despite this, incidental fecal sampling remains the standard method for microbiome assessment. Recently, the blood microbiome, defined by microbial DNA (cmDNA) circulating in the bloodstream, has emerged as a potentially more stable and integrated alternative. Preliminary data suggest that blood microbiome analysis may offer more consistent insights than fecal-based approaches, although the methodological validity of the approach has been questioned.</div></div><div><h3>Method/design</h3><div>This study aims to establish or rule-out cmDNA as a representative of the gut microbiome. In a prospective, single-arm crossover trial, effects of dairy product withdrawal and reintroduction of a yoghurt with a known consortium of bacteria will be assessed in healthy volunteers aged 18–65. Participants will first abstain from all dairy products, a phase expected to reduce yogurt-associated cmDNA in the bloodstream. Yogurt will then be reintroduced, during which reappearance of cmDNA of specific bacteria (especially LGG, LA-5 and BB-12) is anticipated. Shotgun metagenomic sequencing will be used to track cmDNA dynamics over time. This longitudinal sampling approach will provide experimental evidence supporting the existence and responsiveness of the circulating microbiome, while also revalidating the bioinformatic pipeline used for its analysis.</div></div><div><h3>Conclusion</h3><div>This pilot study will test whether blood-derived microbial DNA can serve as a valid surrogate for gut microbiome composition. If successful, this approach may provide a more stable and integrative alternative to fecal sampling and support future biomarker development and mechanistic research.</div></div><div><h3>Clinical trial registration</h3><div>NCT06944002.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101579"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623835","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}
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