Contemporary clinical trials最新文献

{"title":"A one-day acceptance and commitment therapy workshop for the prevention of chronic post-surgical pain and long-term opioid use following spine surgery: Protocol for a pilot feasibility randomized controlled trial","authors":"Jolin B. Yamin ,&nbsp;Bethany D. Pester ,&nbsp;Ramya Kommu ,&nbsp;Caroline Allen ,&nbsp;Diya Dharmendran ,&nbsp;Kylie Steinhilber ,&nbsp;Madelyn Crago ,&nbsp;Savannah Kazemipour ,&nbsp;Angelina Franqueiro ,&nbsp;Delia Fentazi ,&nbsp;Kristin L. Schreiber ,&nbsp;Robert R. Edwards ,&nbsp;Robert N. Jamison ,&nbsp;Samantha M. Meints","doi":"10.1016/j.cct.2024.107785","DOIUrl":"10.1016/j.cct.2024.107785","url":null,"abstract":"<div><h3>Background</h3><div>Back pain is increasingly common, leading to more spine surgeries. While most people experience pain relief and improved function after surgery, many continue to suffer from chronic post-surgical pain (CPSP) with limited functional improvement. CPSP is often treated with opioids, raising concerns about misuse, poor functional outcomes, and broader public health impacts. Therefore, perioperative interventions are needed to enhance outcomes and reduce the risk of opioid misuse after surgery.</div></div><div><h3>Objective</h3><div>This article outlines a study protocol evaluating the feasibility, acceptability, and preliminary efficacy of a brief, perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at improving pain and reducing opioid use after spine surgery.</div></div><div><h3>Design</h3><div>In this pilot randomized controlled trial, participants scheduled for spine surgery (<em>anticipated N</em> = 100) are assigned to the ACT intervention or a treatment-as-usual group.</div></div><div><h3>Intervention</h3><div>The ACT intervention is a 5-h, single-session, virtual workshop with a booster call two weeks post-workshop or post-surgery, whichever is later.</div></div><div><h3>Outcome measures</h3><div>The primary outcome is patient-reported treatment helpfulness immediately after the intervention. Secondary outcomes include patient-reported treatment credibility and expectancy post-intervention, treatment helpfulness at 1 month post-surgery, and pain interference, pain intensity and opioid use at 1, 3, and 6 months post-surgery.</div></div><div><h3>Conclusion</h3><div>This pilot trial examines a novel, brief ACT intervention aimed at preventing CPSP and reducing opioid dependence. If successful, feasibility and preliminary efficacy results will be utilized to inform a future, full-scale randomized trial of this intervention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107785"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The “Mammograms Available Due to Resources and Education” (MADRE) Study: Rationale and Design","authors":"Sean P. McClellan ,&nbsp;Elizabeth De La Paz ,&nbsp;Juanita Arroyo ,&nbsp;Silvia Montoya ,&nbsp;Jocelyn Perez ,&nbsp;Ezra Wright ,&nbsp;Emely Moreno ,&nbsp;Monica Padilla ,&nbsp;Candyce H. Kroenke ,&nbsp;Garth H. Rauscher ,&nbsp;Erin Neuschler ,&nbsp;Pamela Ganschow ,&nbsp;Nathan Stackhouse ,&nbsp;Marc Atkins ,&nbsp;John J. Dziak ,&nbsp;Jennifer Watling Neal ,&nbsp;Araceli Lucio ,&nbsp;Yamile Molina","doi":"10.1016/j.cct.2024.107786","DOIUrl":"10.1016/j.cct.2024.107786","url":null,"abstract":"<div><h3>Background</h3><div>Latinas suffer disproportionately from breast cancer, partially due to lower uptake of guideline-concordant breast cancer screening. We describe the design of a study to compare two approaches addressing this important public health problem.</div></div><div><h3>Design/methods</h3><div>We are conducting a 5-year randomized controlled trial. From a federally qualified health center network and through community outreach, we are recruiting 400 Latinas from Chicago who are non-adherent with United States Preventive Services Task Force breast cancer screening guidelines. Participants are randomized at a 1:1 ratio to receive one of two phone-based interventions (empowerment, education) administered across 3 weekly sessions. Both interventions provide information about breast cancer early detection. The empowerment intervention additionally teaches participants to share information about breast cancer screening with family and friends, while the education intervention educates patients about breast cancer prevention. Non-adherent Latina participants recruit family and friends eligible for breast cancer screening to take part in the study as network members. Network members do not participate in the intervention. Primary outcomes are initial (any mammogram post-enrollment) and repeat (measured at two-year intervals after enrollment) breast cancer screening among intervention participants and network members. Additionally, we will use multi-level structural equation models to assess potential mediators of the impact of the interventions.</div></div><div><h3>Discussion</h3><div>This study will inform the development of empowerment approaches to increase participation in breast cancers screening among Latinas and reduce health disparities. <span><span>NCT05841355</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107786"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The sleep for health study: A randomized clinical trial of the impact of insomnia treatment on glycemia in people with prediabetes","authors":"Erin S. LeBlanc ,&nbsp;Ning Smith ,&nbsp;Dennis Hwang ,&nbsp;Deborah R. Young ,&nbsp;Caryn Oshiro ,&nbsp;Meghan Mayhew ,&nbsp;Stefan Massimino ,&nbsp;Chris Catlin ,&nbsp;Gregory Clarke","doi":"10.1016/j.cct.2024.107796","DOIUrl":"10.1016/j.cct.2024.107796","url":null,"abstract":"<div><h3>Background</h3><div>Insomnia is a modifiable risk factor for type 2 diabetes.</div></div><div><h3>Objective</h3><div>Describe the methodology for the Sleep for Health study, a randomized clinical trial examining the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) in reducing hyperglycemia in 300 people with both insomnia and prediabetes.</div></div><div><h3>Outcomes</h3><div>Primary outcome is glucose level 2 h after a 75-g glucose load. Secondary outcomes include fasting glucose, hemoglobin A1c, insulin resistance score, mean glucose from continuous glucose monitoring (CGM), standard deviation of CGM values, and number of CGM values &gt;140 mg/d.</div></div><div><h3>Methods</h3><div>Participants with a hemoglobin A1c in the prediabetes range (5.7 % to 6.4 %) and clinically significant insomnia are randomized to a dCBT-I program or patient education control program. dCBT-I includes six sessions that focus on changing sleep habits and scheduling factors that affect sleep and addresses misconceptions about sleep and insomnia, utilizing interactive components and goal-setting. Those in the control arm receive access to a sleep-education website, which presents informational content in a simple, static form, without interactive components or active skills training, and all content is provided at once, rather than in modules that unlock over time.</div><div>At baseline, 11 weeks and 33 weeks after randomization, participants undergo laboratory testing with a 2-h oral glucose tolerance test, hemoglobin A1c, and insulin resistance score. They also undertake 10 days of CGM and actigraphy wear and complete two dietary recalls.</div></div><div><h3>Summary</h3><div>This trial is testing whether a program to improve sleep will positively impact glycemia among those with prediabetes.</div><div>Registration with <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> on October 3, 2023: <span><span>NCT06067139</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107796"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing representation of special populations: An approach to the inclusion of women veterans in VA clinical trials","authors":"Karen M. Goldstein ,&nbsp;Elizabeth M. Yano ,&nbsp;Paula P. Schnurr ,&nbsp;Lori A. Bastian ,&nbsp;Susan Alton Dailey ,&nbsp;Alyssa Pomernacki ,&nbsp;Diane Carney ,&nbsp;Jennifer M. Gierisch ,&nbsp;Alison B. Hamilton ,&nbsp;Andrea Nevedal ,&nbsp;Dawne Vogt ,&nbsp;Susan M. Frayne","doi":"10.1016/j.cct.2025.107812","DOIUrl":"10.1016/j.cct.2025.107812","url":null,"abstract":"<div><div>The under-recruitment of historically marginalized populations into clinical trials thwarts equitable inclusion of individuals who could benefit from healthcare innovations and limits the generalizability of results. For decades, the Veterans Health Administration (VA) has conducted large clinical trials that impact clinical guidelines for veterans and civilians alike. Within the VA, women are a numeric minority, and recruitment of this population into trials is challenged by gender-specific care structures, distinct demographic characteristics, and mistreatment such as higher rates of military sexual trauma and harassment on VA grounds. We describe our approach to enhancing the inclusion of women veterans in clinical trials through the VA Women's Enhanced Recruitment Program (WERP) as developed for the VA Cooperative Studies Program. This information is relevant to clinical trial teams seeking to include women veterans in their trials. Our findings also have implications for other researchers seeking equitably increase participation of marginalized populations so that findings are generalizable to broader populations.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107812"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142977926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of a digital health intervention to enhance well-being among adolescent and young adult cancer survivors: Design and methods of the EMPOWER full factorial trial","authors":"John M. Salsman ,&nbsp;Karly M. Murphy ,&nbsp;Elizabeth L. Addington ,&nbsp;Janet A. Tooze ,&nbsp;Laurie E. McLouth ,&nbsp;Dershung Yang ,&nbsp;Stacy Sanford ,&nbsp;Lynne Wagner ,&nbsp;Stephanie C. Bunch ,&nbsp;Abby R. Rosenberg ,&nbsp;Carmina G. Valle ,&nbsp;Brad Zebrack ,&nbsp;Dianna Howard ,&nbsp;Michael Roth ,&nbsp;Judith T. Moskowitz","doi":"10.1016/j.cct.2024.107783","DOIUrl":"10.1016/j.cct.2024.107783","url":null,"abstract":"<div><div>Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations and have not been routinely tested in AYA survivors. We are optimizing a web-based positive skills intervention for AYA cancer survivors called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) by: (1) determining which intervention components have the strongest effects on well-being and (2) identifying demographic and individual difference variables that mediate and moderate EMPOWER's efficacy. EMPOWER is a five-session online intervention that teaches behavioral and cognitive skills for increasing psychological well-being. Guided by the Multiphase Optimization Strategy (MOST), we assign two levels (yes, no) to each of five intervention components (positive events, capitalizing, &amp; gratitude; mindfulness; positive reappraisal; personal strengths &amp; goal-setting; acts of kindness), allowing us to evaluate the effects of individual and combined intervention components on positive affect in a full factorial design. Post-treatment AYA cancer survivors (<em>N</em> = 352) are recruited from participating NCI-designated comprehensive cancer centers and randomized to one of 32 experimental conditions. Our primary outcome is positive affect; potential mediating and moderating variables include coping self-efficacy and emotional support, respectively. Upon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will be scalable and primed for a large, multi-site trial among AYAs who would otherwise not have access to supportive care interventions to manage distress and enhance well-being.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107783"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RETRAGAM: Resistance training based on gamification during physical education. Rationale and study protocol","authors":"Pepe Vanaclocha-Amat ,&nbsp;Avery Faigenbaum ,&nbsp;Javier Molina-García ,&nbsp;Emilio Villa-González","doi":"10.1016/j.cct.2024.107805","DOIUrl":"10.1016/j.cct.2024.107805","url":null,"abstract":"<div><div>Children's physical inactivity and increasing sedentary behaviour have become major public health concerns, with a concurrent decline in muscular fitness (MF) contributing to poor physical outcomes during childhood and adolescence, highlighting the importance of developing resistance training (RT) programs. Furthermore, several educational strategies such as <em>gamification</em> seem to increase students' motivation which can produce an increase in performance outcomes. This study describes the rationale and protocol of a school-based randomized controlled trial called “RETRAGAM” (REsistance TRAining based on GAMification). For this investigation, a total of ≃180 children (grades 5 and 6; 10–12 years of age) from 6 randomly selected schools in Valencia (Spain) will be enrolled for 8 weeks in one of the experimental groups: EG (15 min of RT Functional HIIT circuit program), EG + G (the same EG program but with a gamification approach) or CG (Control Group). Outcomes will include physical activity profile, MF, anthropometry and body composition, as well as the enjoyment and motivation during Physical Education (PE). An interactive app for digital devices will be used for gamified storytelling, earning points for personalized children's avatars, and implementing a flipped classroom learning model. We conclude that the RETRAGAM will provide information about the effectiveness and implementation of a school-based RT intervention during PE with and without gamification in students' MF, body composition, motivation and enjoyment.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107805"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cancer clinical trial participation in socioeconomically vulnerable patients; A risk model to aid in targeted interventions","authors":"Joseph M. Unger ,&nbsp;Katherine Szarama","doi":"10.1016/j.cct.2024.107803","DOIUrl":"10.1016/j.cct.2024.107803","url":null,"abstract":"<div><h3>Background</h3><div>In patients with cancer, those with lower incomes are less likely to participate in clinical trials. A broad-based evaluation of variables that could contribute to this disparity has not been conducted.</div></div><div><h3>Methods</h3><div>We used data from Health Information National Trends Survey (HINTS) databases for survey years 2014, 2017, and 2020, the survey years that included questions about whether patients with cancer participated in a clinical trial. We examined 21 demographic, socioeconomic, behavioral, geographic, and health information questions. We derived a risk model to predict clinical trial participation using a training/validation approach with best subset selection and k-fold cross-validation. Logistic regression was used.</div></div><div><h3>Results</h3><div>We examined <em>N</em> = 1023 participants with household income &lt;$75,000 (the U.S. median). In the training dataset (<em>n</em> = 614), a 5-variable model was identified including race/ethnicity, education, trust, anxiety/depression, and geographic locale. A quartile-level risk score was constructed based on the sum of adverse risk factors. In the validation cohort (<em>n</em> = 409), each increase in quartile level was associated with a 73 % increase in the odds of trial nonparticipation (OR = 1.73, 95 %-CI, 1.19–2.53, <em>p</em> = 0.004), indicating successful model validation. Among all individuals, trial participation rates decreased from 18.6 % to 7.5 % to 4.6 % to 2.8 %, respectively, as the number of adverse risk factors increased from 0 to 1 to 2 to 3 to 4–5.</div></div><div><h3>Conclusions</h3><div>We developed and validated a 5-variable risk model that identified a large set of lower-income individuals at lower risk of trial participation. These findings could aid in identification of patients who may benefit from additional support to navigate the treatment trial decision-making process.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107803"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Everyday Function Intervention Trial (EFIT) protocol: A randomized clinical trial","authors":"Lesley A. Ross ,&nbsp;Courtney Fine ,&nbsp;Abigail T. Stephan ,&nbsp;Hye Won Chai ,&nbsp;Ava McVey ,&nbsp;Christine B. Phillips ,&nbsp;Alyssa Gamaldo ,&nbsp;Jacqueline Mogle ,&nbsp;Nancy Dennis ,&nbsp;Martin Sliwinski ,&nbsp;Kristina Visscher","doi":"10.1016/j.cct.2025.107829","DOIUrl":"10.1016/j.cct.2025.107829","url":null,"abstract":"<div><h3>Background</h3><div>Preserving cognition and everyday function is essential for maintaining independence and reducing risk of Alzheimer's disease and related dementias (ADRD). Useful Field of View training (UFOV<em>t</em>) is a computerized cognitive training program that achieves these goals; however, the mechanisms underlying UFOV<em>t</em> are unclear. The Everyday Function Intervention Trial (EFIT) is a double-blind randomized clinical controlled trial designed to assess potential cognitive, psychosocial, biological, and lifestyle mechanisms underlying UFOV<em>t</em>. In the current paper, we outline the protocol employed in EFIT.</div></div><div><h3>Methods</h3><div>Community-dwelling older adults (<em>N</em> = 96) completed cognitive, psychosocial, health, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up, along with additional daily cognitive, psychosocial, health, and lifestyle assessments on a study-provided smartphone throughout the study period. Following baseline, participants were randomized into the cognitive training or active control group completing twenty hours of brain games across ten weeks. A subsample (<em>n</em> = 38) completed additional activities: wearing a FitBit, undergoing MRI scans, and using at-home sleep monitors across two nights at baseline and post-test. Aside from MRI sessions, participants completed study activities remotely.</div></div><div><h3>Discussion</h3><div>EFIT's design included several novel features: ecological momentary assessment; remote data collection; evaluation of mediators before, during, and after training; training tasks targeting one cognitive domain at a time; performance-based <em>and</em> self-reported everyday function and instrumental activities of daily living measures; use of an active control group; and an exploratory multilevel modeling analytic approach. These features will provide an in-depth understanding of intervention transfer effects and guide the design of future cognitive interventions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107829"},"PeriodicalIF":2.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older women living with disabilities","authors":"Janiece L. Taylor ,&nbsp;Catherine A. Clair ,&nbsp;Shelbie Atkins ,&nbsp;Claire Wang ,&nbsp;Ashley Booth ,&nbsp;M. Carrington Reid ,&nbsp;Elaine Wethington ,&nbsp;Natalie G. Regier","doi":"10.1016/j.cct.2025.107826","DOIUrl":"10.1016/j.cct.2025.107826","url":null,"abstract":"<div><h3>Background</h3><div>Women aging with disabilities experience higher rates of chronic pain and co-occurring depressive symptoms than women without disabilities and men with and without disabilities. Pain and depression can exacerbate the inability to fulfill social roles and complete activities of daily living among women with disabilities. Although there are existing interventions for both pain and depressive symptoms, few interventions have been developed with women aging with disabilities that address both chronic pain and depressive symptoms.</div></div><div><h3>Purpose</h3><div>The aim of this study is to ascertain the acceptability and feasibility of the Women in Pain Reduction &amp; Improved Mood through Empowerment (PRIME) intervention in a sample of middle-aged and older women living with pain, depressive symptoms, and physical disabilities (i.e., mobility disability).</div></div><div><h3>Methods</h3><div>In this wait-list, randomized controlled trial we will assess the intervention's 1) feasibility by determining recruitment and retention rates; 2) acceptability through qualitative interviews with all enrolled participants; and 3) preliminary efficacy by determining changes in pain and depressive symptoms between immediate intervention and waitlist control participants to estimate effect sizes to inform future research.</div></div><div><h3>Conclusion</h3><div>This intervention has two main components, which have the potential to decrease pain and depressive symptoms and lead to increased quality of life. It is imperative that clinical trials are designed and structured with the partnership and needs of women with disabilities at the center.</div><div>This trial is registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span>, <span><span>NCT05619510</span><svg><path></path></svg></span>, 11/09/2022.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107826"},"PeriodicalIF":2.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using augmented reality to deliver cue exposure treatment for smoking cessation: App usability findings and protocol for a randomized controlled trial","authors":"Ranjita Poudel ,&nbsp;Skye O. Dougan ,&nbsp;Helen Yates ,&nbsp;Leslie Sawyer ,&nbsp;Ursula Martinez ,&nbsp;Karen O. Brandon ,&nbsp;Steven K. Sutton ,&nbsp;Damon J. Vidrine ,&nbsp;Lee M. Ritterband ,&nbsp;Kara P. Wiseman ,&nbsp;Katrina A. Vickerman ,&nbsp;Kea Turner ,&nbsp;Margaret M. Byrne ,&nbsp;Min-Jeong Yang ,&nbsp;Marilyn Horta ,&nbsp;Thomas H. Brandon ,&nbsp;Christine Vinci","doi":"10.1016/j.cct.2025.107827","DOIUrl":"10.1016/j.cct.2025.107827","url":null,"abstract":"<div><h3>Background</h3><div>Augmented Reality (AR) is a rapidly developing technology with potential utility for treating addictive behaviors, including tobacco smoking. AR inserts digital images into a natural real-time scene as viewed on a smartphone or other video devices. With respect to smoking cessation, AR can place virtual smoking cues (i.e., smoking “triggers”) within an individual's natural smoking environment. Repeated exposure to these cues could enhance smoking cessation through Pavlovian extinction processes.</div></div><div><h3>Method</h3><div>In a usability study (<em>N</em> = 10), we evaluated the acceptability of a smoking cessation AR app to inform modifications to the app prior to an upcoming randomized controlled trial (RCT). For the subsequent RCT, individuals who enroll in a state tobacco quitline will be referred to the study and, if eligible and consented, randomized to use the app with AR features or without AR features (control) for 5 weeks. The efficacy of the AR features to enhance smoking cessation in the context of concurrent quitline treatment will be evaluated with the primary outcome of self-reported 7-day point-prevalence cigarette abstinence at 6 months post-enrollment. Implementation will be evaluated via incremental cost-effectiveness analyses and interviews with participants, quitline staff, and app coaches.</div></div><div><h3>Conclusions</h3><div>Interventions utilizing emerging mobile technologies such as AR have the potential, compared to traditional therapies, to improve both reach and efficacy by administering therapeutic elements in users' natural environments. Our AR app will target tobacco smoking, but the approach could be used to deliver exposure therapies for other addictive behaviors, as well as anxiety disorders.</div><div><strong><em>Clinical Trial Registration</em>:</strong> <span><span>NCT06088498</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107827"},"PeriodicalIF":2.0,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}