Contemporary clinical trials最新文献

{"title":"Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) — Study design and methods","authors":"Catherine P. Ward ,&nbsp;Dalia Perelman ,&nbsp;Lindsay R. Durand ,&nbsp;Jennifer L. Robinson ,&nbsp;Kristen M. Cunanan ,&nbsp;Sailendharan Sudakaran ,&nbsp;Roujheen Sabetan ,&nbsp;Maggie J. Madrigal-Moeller ,&nbsp;Christopher Dant ,&nbsp;Erica D. Sonnenburg ,&nbsp;Justin L. Sonnenburg ,&nbsp;Christopher D. Gardner","doi":"10.1016/j.cct.2025.107834","DOIUrl":"10.1016/j.cct.2025.107834","url":null,"abstract":"<div><h3>Background</h3><div>Recent research underscores the crucial role of the gut microbiota in human health, particularly during states of altered homeostasis, including pregnancy. Additionally, it is not well understood how dietary changes during pregnancy affect the development of microbiomes of both mother and child.</div></div><div><h3>Methods</h3><div>Here, we describe the study design and methods for our randomized controlled trial, the fermented and fiber-rich foods on maternal and offspring microbiome study (FeFiFo-MOMS). We enrolled 135 women during early pregnancy, randomizing them to one of four diet arms: increased fiber, increased fermented foods, increase in both, and no dietary intervention as a comparator arm. Samples were collected across pregnancy continuing to 18 months post-birth for clinical, microbiome, and immune marker analysis.</div></div><div><h3>Results</h3><div>Our trial design intended to investigate the effects of dietary interventions—specifically, increased intake of high-fiber and fermented foods—on maternal gut microbiota diversity and its subsequent transmission to infants.</div></div><div><h3>Conclusion</h3><div>The FeFiFo-MOMS trial was designed to provide valuable insights into the modifiable dietary factors that could influence maternal and infant health through microbiota-mediated mechanisms and examine the broader implications of diet on pregnant mothers' and infants' health and disease.</div><div><span><span><strong>Clinicaltrials.gov</strong></span><svg><path></path></svg></span> <strong>ID:</strong> <span><span>NCT05123612</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107834"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122268","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":"Improving weight loss and cardiometabolic risk in black patients with diabetes or pre-diabetes: Rationale and protocol for a digital medicine hybrid type 1 implementation trial","authors":"Peter T. Katzmarzyk ,&nbsp;Eboni G. Price-Haywood ,&nbsp;John W. Apolzan ,&nbsp;Kara D. Denstel ,&nbsp;Kimberly L. Drews ,&nbsp;Elise Farris ,&nbsp;Jewel Harden-Barrios ,&nbsp;Larry R. Hearld ,&nbsp;Emily F. Mire ,&nbsp;Corby K. Martin ,&nbsp;Robert L. Newton ,&nbsp;Maria Pisu","doi":"10.1016/j.cct.2024.107806","DOIUrl":"10.1016/j.cct.2024.107806","url":null,"abstract":"<div><h3>Background</h3><div>The goal of the PROPEL-IT study is to conduct an effectiveness-implementation (hybrid type 1) study to 1) test the effectiveness of a digital technology focused 24-month, patient-centered precision public health approach to weight-loss, facilitated by an electronic medical record (EMR) in Black patients with obesity and type 2 diabetes mellitus or prediabetes, and 2) better understand the external validity and context for implementation.</div></div><div><h3>Methods</h3><div>Patients in the Intensive Lifestyle Intervention (ILI) participate in a high-intensity behavioral intervention to facilitate weight loss through reducing dietary intake and increasing physical activity. The ILI is delivered by health coaches in the digital medicine program of a large health care organization facilitated by the patient portal of their EMR. Patients in the usual care (UC) group continue to receive routine medical care from their health care team. The primary outcome is percent weight change from baseline. Study implementation is guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) evaluative framework.</div></div><div><h3>Results</h3><div>Patient recruitment began on August 31, 2022 and was completed on January 22, 2024. During the ∼17-month recruitment period, 352 patients were recruited and randomized (176 to ILI; 176 to UC).</div></div><div><h3>Conclusion</h3><div>The results of this study will provide evidence on the effectiveness of a remotely delivered high-intensity weight loss program within a large health care organization, and provide important information regarding its implementation in a digital medicine setting.</div><div><strong>Clinical Trials Registration Number:</strong> <span><span>NCT05523375</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107806"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930550","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 Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease","authors":"Jesse C. Christensen ,&nbsp;Shuchi Anand ,&nbsp;Glenn M. Chertow ,&nbsp;Kate Lyden ,&nbsp;Amara Sarwal ,&nbsp;Terrence Bjordahl ,&nbsp;Robert Boucher ,&nbsp;Azeem Mohammed ,&nbsp;Evan G. Oro ,&nbsp;Farahnaz Akramimoghaddam ,&nbsp;Niharika Katkam ,&nbsp;Augustine Takyi ,&nbsp;George Bissada ,&nbsp;Akhil Ramanujam Chakravartula ,&nbsp;Edison Lee ,&nbsp;Ann Zheng ,&nbsp;Guo Wei ,&nbsp;Tom Greene ,&nbsp;Srinivasan Beddhu","doi":"10.1016/j.cct.2024.107766","DOIUrl":"10.1016/j.cct.2024.107766","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.</div></div><div><h3>Method/design</h3><div>The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m²). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.</div></div><div><h3>Results</h3><div>Enrollment, interventions, and follow-up are ongoing.</div></div><div><h3>Conclusions</h3><div>Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107766"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750281","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":"Improving colonoscopy quality in the national VA healthcare system","authors":"Andrew J. Gawron ,&nbsp;Travis Bailey ,&nbsp;Rachel Codden ,&nbsp;Jason Dominitz ,&nbsp;Samir Gupta ,&nbsp;Christian Helfrich ,&nbsp;Charles Kahi ,&nbsp;Lila Krop ,&nbsp;Carmel Malvar ,&nbsp;Grace McKee ,&nbsp;Morgan Millar ,&nbsp;Ashley Mog ,&nbsp;Tiffany Nguyen-Vu ,&nbsp;Olga Patterson ,&nbsp;Angela P. Presson ,&nbsp;Sameer Saini ,&nbsp;Mary Whooley ,&nbsp;Yiwen Yao ,&nbsp;Susan Zickmund ,&nbsp;Tonya Kaltenbach","doi":"10.1016/j.cct.2024.107784","DOIUrl":"10.1016/j.cct.2024.107784","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) prevention is a Veterans Affairs (VA) priority. Colonoscopy quality, especially adenoma detection rate (ADR), is critical for effective screening. Our research indicates considerable variation in ADR among VA providers. Even a slight increase in ADR can reduce fatal CRC rates, and audit and feedback strategies have improved ADR in other settings. A recent report identified deficiencies in VA colonoscopy quality, highlighting the need for standardized documentation and reporting. To address this, we developed the VA Endoscopy Quality Improvement Program (VA-EQuIP), which aims to improve colonoscopy quality through benchmarking and collaborative learning, aligning with VA's modernization priorities and HSR&amp;D and QUERI goals of accelerating evidence-based implementation.</div></div><div><h3>Methods</h3><div>We will conduct a stepped wedge cluster randomized trial to evaluate whether VA-EQuIP improves provider ADR compared to usual care, the implementation of VA-EQuIP, site-level factors associated with colonoscopy quality improvement, and components of provider behavior change. Using mixed methods our study will measure outcomes like reach, implementation, adoption, maintenance of VA-EQuIP, and provider behavior change. The analysis will include primary and secondary outcomes, such as overall and screening ADR, cecal intubation rate, and bowel preparation quality, using mixed effects generalized linear models and interrupted time-series analyses. Adoption and implementation will be evaluated through usage statistics, surveys, and qualitative interviews to identify factors influencing success.</div></div><div><h3>Discussion</h3><div>This study will assess the impact of VA-EQuIP on colonoscopy quality metrics and factors associated with effective implementation. VA-EQuIP infrastructure allows for national-scale implementation and evaluation of quality reporting with minimal manual labor, guiding future quality improvement efforts to ensure optimal patient care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107784"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892487","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":"Development of the Positive Outcomes through Supported Transition (POST) opioid preventive intervention for youth in the legal system: Study protocol for a sequential multiple assignment randomized trial","authors":"Ahnalee M. Brincks ,&nbsp;Kevin P. Haggerty ,&nbsp;Alexandria Kolberg ,&nbsp;Katie M. Albertson ,&nbsp;Carolyn A. McCarty ,&nbsp;Margaret R. Kuklinski ,&nbsp;Ted Ryle ,&nbsp;Kym R. Ahrens","doi":"10.1016/j.cct.2024.107782","DOIUrl":"10.1016/j.cct.2024.107782","url":null,"abstract":"<div><div>Adolescents and young adults in the legal system (AYALS) are at high risk for opioid use disorder (OUD). Effective, efficient interventions to prevent OUD that support youth as they transition to the community are needed. The Positive Outcomes through Supported Transition intervention trial is designed to identify the optimal intensity and sequence of behavioral skills and case management components for OUD prevention.</div><div>This sequential, multiple assignment randomized trial addresses three research questions: 1.whether to begin with a high-intensity, broad-scope intervention (Enhanced Adolescent Community Reinforcement Approach; <em>E</em>-ACRA) or a lower intensity intervention (Assertive Community Support; ACS), 2. whether to continue with <em>E</em>-ACRA or step-down to ACS after release, and 3. whether to step-up to E-ACRA or continue ACS for youth reporting problematic substance use after release.</div><div>Youth committed to state custody will be recruited prior to their release and randomized to <em>E</em>-ACRA or ACS. At five weeks post-release, E-ACRA participants will be re-randomized to <em>E</em>-ACRA or ACS. ACS participants reporting problematic substance use at five weeks will be re-randomized to <em>E</em>-ACRA or ACS. Primary analyses will test the effects of initial intervention (E-ACRA vs. ACS); secondary analyses will test the effects of second-stage interventions. Cost-effectiveness analysis will determine whether the additional resources deployed to <em>E</em>-ACRA are justified economically by the outcomes achieved.</div><div>Prevention is critical for this population. High-intensity interventions can be burdensome for participants (and agencies) and costly to deliver. This study examines how best to sequence high and low intensity interventions to maximize beneficial outcomes for the most youth.</div><div>This study's design was pre-registered with <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT04901312</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107782"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871570","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":"Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial","authors":"Sneha B. Sridhar ,&nbsp;Assiamira Ferrara ,&nbsp;Susan D. Brown ,&nbsp;Charles P. Quesenberry ,&nbsp;Fei Xu ,&nbsp;Emily Liu ,&nbsp;Tali Sedgwick ,&nbsp;Page Kissel ,&nbsp;Hillary D. Serrato Bandera ,&nbsp;Cheryl Albright ,&nbsp;Monique M. Hedderson","doi":"10.1016/j.cct.2024.107781","DOIUrl":"10.1016/j.cct.2024.107781","url":null,"abstract":"<div><h3>Background</h3><div>More than half of pregnant patients with overweight or obesity exceed national gestational weight gain (GWG) guidelines, increasing their risk of adverse outcomes. There is an urgent need to develop effective and scalable interventions to improve GWG.</div></div><div><h3>Objective</h3><div>To describe the protocol of <u><strong>L</strong></u>ifestyle, <u><strong>E</strong></u>ating, and <u><strong>A</strong></u>ctivity in <u><strong>P</strong></u>regnancy (LEAP), a cluster randomized controlled trial evaluating a mobile health (mHealth) intervention promoting appropriate GWG in an integrated healthcare system.</div></div><div><h3>Methods</h3><div>LEAP is a cluster randomized trial with randomization at the clinician level. Patient eligibility includes a pre-pregnancy BMI of 25.0–40.0 kg/m² and singleton pregnancy. Consented patients receive standard care or standard care plus mHealth intervention per their clinician's randomization. The patient adaptive intervention provides personalized, automated feedback on GWG and physical activity using 1) a smartphone application, 2) a Wi-Fi scale and activity tracker; 3) weekly educational topics; and 4) step-wise support (added when GWG is &gt;75th percentile of the GWG guidelines). Intervention clinicians receive newsletters with motivational interviewing tips to facilitate discussing GWG. Primary outcomes are total GWG (last measured weight – pre-pregnancy weight) and weekly rate of GWG (total GWG/gestational weeks at delivery) as continuous variables and categorized per the IOM GWG guidelines. Secondary outcomes include trimester-specific rate of GWG, GWG trajectory, diet and physical activity, postpartum weight retention, birthweight, infant size for gestational age, and infant growth to 12 months.</div></div><div><h3>Conclusions</h3><div>LEAP addresses gaps in the implementation of GWG interventions in healthcare settings. The adaptive and mHealth nature of the intervention may enhance scalability.</div><div>Trial Registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT03880461</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107781"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876438","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":"Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial","authors":"Olayinka O. Shiyanbola ,&nbsp;Martha A. Maurer ,&nbsp;Megan E. Piper ,&nbsp;Daniel Bolt ,&nbsp;Lisa K. Sharp ,&nbsp;Mariétou H. Ouayogodé ,&nbsp;Edwin Fisher","doi":"10.1016/j.cct.2024.107804","DOIUrl":"10.1016/j.cct.2024.107804","url":null,"abstract":"<div><h3>Background</h3><div>Black and Hispanic adults with diabetes are more likely to experience diabetes complications and die from diabetes compared to non-Hispanic whites. This disparity may be due to medication adherence being negatively affected by social determinants of health (SDOH) and negative beliefs about diabetes and diabetes medicines. Pharmacist delivered medication therapy management (MTM) improves clinical outcomes. However, pharmacists have limited capacity and expertise to address SDOH barriers and health misperceptions. Supplementing MTM with Community Health Workers (CHWs) to address these factors may be more effective with potential for implementation.</div></div><div><h3>Aim</h3><div>To investigate what combination of two possible components, pharmacist delivered MTM and CHWs addressing SDOH barriers and health misperceptions, represents the optimized intervention for Black and Hispanic adults with uncontrolled diabetes.</div></div><div><h3>Methods/design</h3><div>We will use a 2 × 2 factorial design (MTM, CHW: ON vs. OFF) where participants will be randomized to one of four treatment conditions in a 6-month intervention delivered mostly by phone. We will recruit 376 Black or Hispanic adults with type 2 diabetes and hemoglobin A1C of ≥8 %, a clinical indicator of uncontrolled type 2 diabetes. The primary outcome is A1C measured at 6 months, and at 12 months for sustained change. The secondary outcome is medication adherence. Several psychosocial factors will be examined as potential mediators. An embedded experimental mixed methods approach will be used to obtain participant perspectives through qualitative interviews and integrated to assess intervention acceptability.</div></div><div><h3>Discussion</h3><div>Our findings will identify the optimized intervention, e.g., comprising MTM or CHW or both intervention components, that effectively and efficiently improves diabetes outcomes among Black and Hispanic adults with uncontrolled diabetes, informing dissemination.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107804"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945908","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 LvL UP trial: Protocol for a sequential, multiple assignment, randomised controlled trial to assess the effectiveness of a blended mobile lifestyle intervention","authors":"Oscar Castro ,&nbsp;Jacqueline Louise Mair ,&nbsp;Shenglin Zheng ,&nbsp;Sarah Yi Xuan Tan ,&nbsp;Ahmad Ishqi Jabir ,&nbsp;Xiaoxi Yan ,&nbsp;Bibhas Chakraborty ,&nbsp;E Shyong Tai ,&nbsp;Rob M. van Dam ,&nbsp;Florian von Wangenheim ,&nbsp;Elgar Fleisch ,&nbsp;Konstadina Griva ,&nbsp;Tobias Kowatsch ,&nbsp;Falk Müller-Riemenschneider","doi":"10.1016/j.cct.2025.107833","DOIUrl":"10.1016/j.cct.2025.107833","url":null,"abstract":"<div><h3>Background</h3><div>Blended mobile health (mHealth) interventions – combining self-guided and human support components – could play a major role in preventing non-communicable diseases (NCDs) and common mental disorders (CMDs). This protocol describes a sequential, multiple assignment, randomised trial aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalised lifestyle support with scalability.</div></div><div><h3>Methods</h3><div>LvL UP is a 6-month mHealth holistic intervention targeting physical activity, diet, and emotional regulation. In this trial, young and middle-aged Singaporean adults at risk of developing NCDs or CMDs will be randomly allocated to one of two initial conditions (‘LvL UP’ or ‘comparison’). After 4 weeks, participants categorised as non-responders from the LvL UP group will be re-randomised into second-stage conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional motivational interviewing (MI) support sessions by trained health coaches (LvL UP + adaptive MI). The primary outcome is mental well-being. Secondary outcomes include anthropometric measurements, resting blood pressure, blood metabolic profile, health status, and health behaviours (physical activity, diet). Outcomes will be measured at baseline, 6 months (post-intervention), and 12 months (follow-up).</div></div><div><h3>Discussion</h3><div>In addition to evaluating the effectiveness of LvL UP, the proposed study design will contribute to increasing evidence on how to introduce human support in mHealth interventions to maximise their effectiveness while remaining scalable.</div></div><div><h3>Trial registration</h3><div>The LvL UP Pilot trial was prospectively registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06360029</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107833"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122269","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":"Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol","authors":"Zahra Hosseinian ,&nbsp;Ashley Lehan ,&nbsp;Jessica M. Powers ,&nbsp;Adrian Melendez ,&nbsp;Hannah M. Fisher ,&nbsp;Rebecca Shelby ,&nbsp;Tamara Somers ,&nbsp;Francis Keefe ,&nbsp;Judith Paice ,&nbsp;Gretchen Kimmick ,&nbsp;James Burns ,&nbsp;Ann Marie Flores ,&nbsp;Rina S. Fox ,&nbsp;Karen Kaiser ,&nbsp;David Farrell ,&nbsp;Kelly Westbrook ,&nbsp;Christine Rini","doi":"10.1016/j.cct.2024.107780","DOIUrl":"10.1016/j.cct.2024.107780","url":null,"abstract":"<div><h3>Background</h3><div>Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients.</div></div><div><h3>Objective</h3><div>The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia.</div></div><div><h3>Methods</h3><div>452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life.</div></div><div><h3>Discussion</h3><div>This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107780"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871571","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":"Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial","authors":"Beatrice Fadrigon ,&nbsp;Ariel Tseng ,&nbsp;Rachel L. Weisenburger ,&nbsp;Andrew Levihn-Coon ,&nbsp;Mary E. McNamara ,&nbsp;Jason Shumake ,&nbsp;Jasper A.J. Smits ,&nbsp;Tracy A. Dennis-Tiwary ,&nbsp;Christopher G. Beevers","doi":"10.1016/j.cct.2024.107797","DOIUrl":"10.1016/j.cct.2024.107797","url":null,"abstract":"<div><div>Cognitive models posit that negatively biased attention toward dysphoric information has a causal role in the maintenance of depression-related psychopathology. Attention bias modification (ABM) tests this idea by altering an attentional bias and examining subsequent effects on depression. Prior work finds that ABM alters negatively biased attention for dysphoric information and reduces depression; however, a number of studies have failed to show these effects. Other research suggests that adding game-like elements (i.e.game play, achievements, levels, challenges, and points) to cognitive training can enhance participant engagement. No prior work has examined the efficacy of gamified ABM for depression. The goal of this study is to conduct a large (<em>N</em> = 600) efficacy trial comparing gamified, mobile ABM and traditional, web-based ABM to traditional, web-based sham ABM among adults with elevated symptoms of depression. Participants in all conditions are asked to complete 16 ABM sessions across a four week period (i.e., 4 training sessions per week). We hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than traditional sham ABM. We further hypothesize that gamified ABM will be non-inferior to traditional ABM. Our third hypothesis is that people with a strong attentional bias will experience greater reductions in depression in response to either gamified or traditional ABM compared to sham ABM. Secondary analyses will examine putative mediators of ABM. Finally, we will estimate the durability of ABM by collecting post-treatment symptom data 2-, 3-, and 6-months after the acute ABM period.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID: <span><span>NCT06361095</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107797"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892469","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}