Contemporary clinical trials最新文献

{"title":"Correlative complexity: Insights into correlative management at a large academic cancer center","authors":"Jamie Voyten ,&nbsp;Alexander Yant ,&nbsp;Julie Urban ,&nbsp;Mary Horak ,&nbsp;Theresa Cummings","doi":"10.1016/j.cct.2025.107917","DOIUrl":"10.1016/j.cct.2025.107917","url":null,"abstract":"<div><h3>Introduction</h3><div>Clinical trials are becoming increasingly complex to operate at an organizational level. Hidden complexities arise from industry's shift towards precision medicine and personalized therapies, which require a closer examination of organizational processes that no longer align with current demands. Maintaining a diverse clinical trial portfolio is crucial for providing patients with a range of treatment options.</div></div><div><h3>Materials and methods</h3><div>Rates of increasing trial complexity were tracked using a system to unify staff processes and streamline clinical trial correlative operations. Quarterly data were compiled from departmental inventory counts, organizational movement reports from Slope, and usage across disease centers and community sites. Data was aggregated and reviewed alongside standardized laboratory tracking to identify trends.</div></div><div><h3>Results</h3><div>Required trial correlative samples demand significant time from staff. Tasks often overlap and intersect within the lab, requiring detailed communication surrounding correlatives. Standardizing processes for trial notification, inventory correlative kits on site, and specimen tracking improves communication and optimizes staff time dedicated to trial correlatives.</div></div><div><h3>Conclusions</h3><div>Correlative kits are hidden variables that integrate trial experience and organizational financial costs. As clinical trial complexity increases, diverse tools that enable a more nimble approach to data capture are needed to maintain stability despite growing variables. By harmonizing organizational data, technology systems, and streamlined processes, decisions can be made that lead to optimized staff time, diverse solutions, improved process sharing across organizations, and ultimately enhance the overall patient trial experience.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107917"},"PeriodicalIF":2.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143860690","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 high-dose lisdexamfetamine and contingency management, alone or in combination, for the treatment of methamphetamine use disorder: The ASCME study","authors":"Paxton Bach ,&nbsp;Bernard Le Foll ,&nbsp;Sara Davidson ,&nbsp;Alexandra de Kiewit ,&nbsp;Hamzah Bakouni ,&nbsp;Ginette Poulin ,&nbsp;Monty Ghosh ,&nbsp;Didier Jutras-Aswad","doi":"10.1016/j.cct.2025.107916","DOIUrl":"10.1016/j.cct.2025.107916","url":null,"abstract":"<div><h3>Background</h3><div>The prevalence of methamphetamine use disorder is increasing in North America. Well-evidenced treatment options are currently limited to behavioural interventions, with contingency management (CM) regarded as the most effective approach. Psychostimulants have been identified as a potentially promising treatment for methamphetamine use disorder, particularly at higher doses. This study was designed to examine the effectiveness of a high-dose daily psychostimulant (lisdexamfetamine; LDX) and CM, both alone and in combination, in addition to treatment-as-usual (TAU) for the treatment of moderate-to-severe methamphetamine use disorder.</div></div><div><h3>Methods</h3><div>The ASCME study is a multicentre, four-arm, blinded, randomized, placebo-controlled clinical trial examining the effectiveness of adding LDX (250 mg) and CM, alone or in combination, to TAU in reducing days of methamphetamine use among adults with moderate-to-severe methamphetamine use disorder. A total of 440 participants will be randomized across 5 sites to 12 weeks of 1) LDX + TAU + CM; 2) LDX + TAU; 3) placebo + CM + TAU; and 4) placebo + TAU. The primary outcome is reduction in days of self-reported methamphetamine use, with secondary outcomes including treatment retention, sustained abstinence, safety, medication adherence, satisfaction, and quality of life.</div></div><div><h3>Conclusion</h3><div>This study will be the largest study to date examining the effectiveness of a prescribed psychostimulant in the treatment of methamphetamine use disorder, and the first of its kind to employ a four-arm approach to evaluate the added benefit of its combination with CM on psychostimulant treatment. The development of pharmacologic treatments for methamphetamine use disorder remains an urgent research goal.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107916"},"PeriodicalIF":2.0,"publicationDate":"2025-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143843628","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 the counterfactual framework to estimate non-intention-to-treat estimands in randomised controlled trials: A methodological scoping review","authors":"Ellie Medcalf ,&nbsp;Fiona Stanaway ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2025.107912","DOIUrl":"10.1016/j.cct.2025.107912","url":null,"abstract":"<div><h3>Background</h3><div>Randomised controlled trials (RCTs) commonly estimate intention-to-treat (ITT) estimands. However, when nonadherence to assigned treatment occurs, ITT estimands reflect the effect of being offered treatment, rather than adhering to it and thus are less useful for clinical decision-making.</div></div><div><h3>Objective</h3><div>Summarise current literature on non-ITT estimands used in RCTs to estimate the effect of adhering to treatment and counterfactual framework estimators that are employed to obtain these non-ITT estimands.</div></div><div><h3>Study design and setting</h3><div>We conducted a methodological scoping review and searched MEDLINE and EMBASE from inception to March 2024, with forward and backward citation searching. Eligible records discussed counterfactual framework estimators to obtain non-ITT estimands in RCTs or simulation studies based on empirical RCTs.</div></div><div><h3>Results</h3><div>From 746 records screened, our search identified 56 eligible records. 47 (84 %) described specific estimators for addressing nonadherence and 9 (16 %) described frameworks for overall methodological approach. In the 47 estimator records, 51 non-ITT estimands were reported, including poorly defined estimands (<em>n</em> = 21, 41 %), complier average causal effects (<em>n</em> = 17, 33 %), switching-adjusted estimands (<em>n</em> = 7, 14 %), and per-protocol estimands (<em>n</em> = 6, 12 %). There were 83 estimator applications, including inverse probability weighting (<em>n</em> = 22, 27 %), instrumental variables (IVs) for time-varying treatments (<em>n</em> = 15, 18 %), and standard IVs (<em>n</em> = 14, 17 %). Other estimators included doubly-robust estimators using machine learning.</div></div><div><h3>Conclusion</h3><div>Non-ITT estimands in RCTs tended to be poorly defined and lacked relevance for clinical decision-making. Further research on using estimators from the counterfactual framework to estimate well-defined estimands, particularly per-protocol estimands, is needed to support greater uptake in practice and policy decision making.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107912"},"PeriodicalIF":2.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143835044","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":"Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for your diabetes care randomized trial","authors":"Alexandra K. Lee ,&nbsp;Jose J. Mejia ,&nbsp;Clarissa Ferguson ,&nbsp;Brookelle H. Li ,&nbsp;Richard W. Grant ,&nbsp;Rebecca L. Sudore","doi":"10.1016/j.cct.2025.107913","DOIUrl":"10.1016/j.cct.2025.107913","url":null,"abstract":"<div><h3>Background</h3><div>As adults with type 2 diabetes (T2D) age, they are increasingly vulnerable to treatment-related hypoglycemia and subsequent complications including falls and hospitalizations. Care planning helps patients communicate what is most important for their medical care with their family, friends, and clinicians and could help reduce treatment-related complications of T2D in older adults.</div></div><div><h3>Methods</h3><div>We applied an expanded care planning paradigm to the specific clinical problem of type 2 diabetes management in older patients. Applying user-centered design methods, we developed an educational, web-based program called “PREPARE for Your Diabetes Care,” incorporating input and feedback from patient and provider key informants. A randomized controlled trial (RCT) of this program vs. usual care is being conducted among Kaiser Permanente Northern California members ≥75 years of age, prescribed insulin or sulfonylureas, and at high risk for hypoglycemia. The primary outcome of the RCT is clinically significant hypoglycemia episodes (self-reported 3+ symptomatic episodes of hypoglycemia, self-reported severe hypoglycemia, and/or ED or hospitalization for hypoglycemia). Secondary outcomes will include medication de-intensification, 5-item RAND Patient Satisfaction, and 5-item Perceived Efficacy in Patient - Physician Interactions.</div></div><div><h3>Results</h3><div>This study has completed enrollment and randomized 673 participants; trial completion is expected in late 2025.</div></div><div><h3>Conclusions</h3><div>This research will evaluate an expanded care planning intervention to reduce treatment-related hypoglycemia in older adults with T2D. If successful, this web-based expanded care planning strategy could be applied to a wide variety of geriatric conditions requiring individualization of treatment based on patients' preferences.</div><div><strong>Trial registration numbers:</strong> <span><span>NCT05263310</span><svg><path></path></svg></span>; Pre-results.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107913"},"PeriodicalIF":2.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143834344","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":"Design and baseline characteristics of an implementation study to increase activity with social incentives: The STEP together trial","authors":"Krista Scheffey ,&nbsp;Joshua Aronson ,&nbsp;Yolande Goncalves ,&nbsp;S. Ryan Greysen ,&nbsp;Ashley Iwu ,&nbsp;Pui L. Kwong ,&nbsp;Freya Nezir ,&nbsp;Dylan Small ,&nbsp;Karen Glanz","doi":"10.1016/j.cct.2025.107909","DOIUrl":"10.1016/j.cct.2025.107909","url":null,"abstract":"<div><h3>Background</h3><div>The majority of people in the United States do not achieve recommended levels of physical activity. Even small, daily increases can have health benefits. Wearable devices paired with social incentives increased daily steps in pilot studies but have not been tested for long-term effectiveness in community settings. This paper describes the study design and baseline participant characteristics of a trial testing these approaches to increase physical activity among families in the Philadelphia area.</div></div><div><h3>Methods</h3><div>The trial, called STEP Together, is a Hybrid Type 1 effectiveness-implementation study. Participants enroll on family teams of 2–10 people, including at least one person 60 years old or older. Each participant receives a Fitbit device, establishes a baseline daily step count, and selects a daily step goal 1500 to 3000 steps greater than their baseline. Family teams are stratified based on family size and randomized to Control, Social Incentive Gamification, or Social Goals through Incentives to Charity. Participation is 18-months: a 12-month intervention and 6-month follow up.</div></div><div><h3>Results</h3><div>779 participants on 285 family teams were randomized. Recruitment was more difficult than anticipated due to the COVID-19 pandemic and higher-than expected numbers of participants who were already physically active and therefore ineligible. Changes to the eligibility criteria that did not impact the underlying intent or conceptual basis for the trial improved recruitment feasibility.</div></div><div><h3>Conclusion</h3><div>The results from this study will contribute to the growing body of evidence about scalable, effective strategies to motivate individuals and families to increase their daily physical activity.</div><div>Clinical trial registration number: <span><span>NCT04942535</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107909"},"PeriodicalIF":2.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143848217","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":"Efficient stage-wise allocation ratios in multi-arm multi-stage designs","authors":"Ruqayya A. Azher ,&nbsp;Michael J. Grayling ,&nbsp;James M.S. Wason","doi":"10.1016/j.cct.2025.107908","DOIUrl":"10.1016/j.cct.2025.107908","url":null,"abstract":"<div><h3>Background</h3><div>Multi-arm multi-stage (MAMS) designs allow the simultaneous evaluation of multiple treatments across several stages. Due to their potential to accelerate drug development, researchers are continuously seeking ways to improve MAMS designs. This study focuses on the impact of varying allocation ratios at each stage on statistical power and the expected sample size (ESS).</div></div><div><h3>Methods</h3><div>We present a methodology for calculating the operating characteristics of MAMS designs with varying stage-wise allocation ratios, where the maximum sample size is fixed. We evaluate the impact of various common allocation ratio combinations on three types of power: marginal, disjunctive, and conjunctive, assuming equal sample size across stages. The allocation ratio at any stage is assumed to be equal for all experimental arms, and outcomes are assumed to follow a normal distribution. The parameters used in our evaluation, such as sample size and treatment effects, are derived from a real trial.</div></div><div><h3>Results</h3><div>Our results demonstrate that efficient stage-wise allocation ratios vary by power type. Both marginal and disjunctive power increase when more patients are allocated to the control arm, but the efficient stage-wise allocation ratio differs for each. Conversely, conjunctive power benefits from a more balanced allocation between control and experimental arms. Variations in allocation ratios resulted in minor changes to ESS.</div></div><div><h3>Conclusions</h3><div>Our findings highlight the importance of considering stage-wise allocation ratios to align with the specific objectives of a trial. Stage-wise allocation ratios can enhance power and efficiency in MAMS trials, facilitating better decision-making and minimising resource use.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107908"},"PeriodicalIF":2.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143815939","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":"Targeted EHR-based communication of diagnostic uncertainty (TECU) in the emergency department: Protocol for an effectiveness implementation trial","authors":"Danielle M. McCarthy ,&nbsp;Sara Malone ,&nbsp;Dimitrios Papanagnou ,&nbsp;Benjamin E. Leiby ,&nbsp;Amandy M.B. Doty ,&nbsp;Phillip Watts ,&nbsp;Rahul Yadav ,&nbsp;Julia K. Pugliese ,&nbsp;Jonathan Woodworth ,&nbsp;Tracy Esteves Camacho ,&nbsp;Efrat Kean ,&nbsp;Kristin L. Rising","doi":"10.1016/j.cct.2025.107910","DOIUrl":"10.1016/j.cct.2025.107910","url":null,"abstract":"<div><h3>Background</h3><div>At least 37 % emergency department (ED) patients are discharged without a definitive diagnosis, resulting in diagnostic uncertainty. Transitions of care are high-risk periods for patient safety, especially for patients discharged with diagnostic uncertainty. Effective communication between clinicians and patients improves these care transitions. Previous research developed tools to support high quality discharge in the setting of diagnostic uncertainty, including: a communication checklist, a physician training program, and a patient-facing information sheet.</div></div><div><h3>Methods</h3><div>This study aims to enhance transitions for patients leaving the ED with diagnostic uncertainty through an electronic health record (EHR)-based strategy. The intervention, the Targeted EHR-based Communication about Uncertainty strategy, integrates use of an Uncertainty Communication Checklist and an Uncertainty Discharge Document into routine ED discharge workflows. The checklist aids clinicians in addressing topics of chief concern for ED patients discharged with diagnostic uncertainty. The patient-centered discharge document explains the concept of diagnostic uncertainty to patients. The pre-post trial seeks to test the intervention's effectiveness in reducing patient uncertainty and return ED visits compared to standard of care with 300 participants. It also aims to evaluate the intervention's adoption and implementation barriers and facilitators.</div></div><div><h3>Discussion</h3><div>This trial builds on previous research to establish a communication strategy that equips patients with essential information for safe transitions amidst diagnostic uncertainty. The EHR-based strategy seeks to standardize communication and minimize bias and variation. Findings will be disseminated, to inform future trials and improve understanding of patient experiences with diagnostic uncertainty.</div></div><div><h3>Trial registration</h3><div>This trial was prospectively registered on 10/9/2024 with ClinicalTrials.gov (# NCT06638021).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107910"},"PeriodicalIF":2.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143829320","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":"System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial","authors":"L. Ebony Boulware MD, MPH, FACP ,&nbsp;Patti L. Ephraim MPH ,&nbsp;Tariq Shafi MD, MHS ,&nbsp;Jamie A. Green MD, MS ,&nbsp;Teri Browne PhD, MSW ,&nbsp;Tara S. Strigo MPH, BS ,&nbsp;Sarah Peskoe PhD ,&nbsp;Jonathan Wilson MS ,&nbsp;Yuliya Lokhnygina PhD ,&nbsp;Aviel Alkon BS ,&nbsp;George L. Jackson PhD, MHA ,&nbsp;Matthew J. Ellis MD ,&nbsp;Debra Sudan MD ,&nbsp;Blake Cameron MD ,&nbsp;Pradeep K. Vaitla MD ,&nbsp;Ashley Cabacungan BS ,&nbsp;Lauren Brubaker MLS, ASCP, MPH ,&nbsp;Emily L. Obermiller MEd ,&nbsp;Clarissa J. Diamantidis MD, MHS","doi":"10.1016/j.cct.2025.107911","DOIUrl":"10.1016/j.cct.2025.107911","url":null,"abstract":"<div><div>The System Interventions to Achieve Early and Equitable Kidney Transplants Study (STEPS) is an ongoing pragmatic clinical trial investigating the effectiveness of an equitable and patient-centered approach to kidney care on equitable access to early kidney transplants for individuals with chronic kidney disease not on dialysis. The STEPS intervention combines active electronic health record surveillance to equitably identify all potentially eligible kidney transplant candidates in three health systems (‘STEPS Surveillance’) with a ‘STEPS Outreach Program’ (comprised of equity-conscious patient-centered transplant social worker and transplant coordinator outreach and navigation activities). Identified eligible participants are randomly assigned to receive either (a) Augmented Usual Kidney Care (routine care plus electronic surveillance and best practice alerts), or (b) the STEPS Health System Surveillance and Outreach Intervention plus Augmented Usual Kidney Care to improve access to kidney transplants overall as well as among Black and rural residing individuals. STEPS recruited all planned 1168 participants from March 2022 to March 2024. Outcomes will quantify differences between the study arms in progress toward and completion of kidney transplant evaluations, assessed via medical records, and patient-reported outcomes.</div><div><strong>Registration of clinical trials</strong></div><div>This study is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> under the identifier <span><span>NCT05014256</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107911"},"PeriodicalIF":2.0,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810615","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":"Design and methods of a cluster-randomized pragmatic trial of post-discharge stroke care","authors":"Patricia Commiskey ,&nbsp;D. Leann Long ,&nbsp;Virginia J. Howard ,&nbsp;Jeri Braunlin ,&nbsp;George Howard ,&nbsp;David Cochran ,&nbsp;Barry Jackson ,&nbsp;Desiree Bell ,&nbsp;Debbie Hill ,&nbsp;Amy E. Callahan ,&nbsp;Kenneth Gaines","doi":"10.1016/j.cct.2025.107890","DOIUrl":"10.1016/j.cct.2025.107890","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Stroke is the 5th leading cause of death and a leading cause of adult disability in the United States (US). One in four strokes are recurrent events. Stroke patients experience persisting physical and cognitive impairments long-term, and their caregivers/family also experience psychological and health quality impacts. The current standard for stroke care in the US utilizes hospital certifications based on level of available care and includes proven acute and in-hospital care processes and offers limited post-discharge care coordination of risk factor management, secondary prevention, and early and continued rehabilitation that have been shown beneficial for recovery. The Joint Commission (TJC) Comprehensive Stroke Care (CSC) certification is awarded to hospitals that provide the most advanced level of stroke care. Another model of care in use in the US is a patient-centered, technology-enabled Integrated Stroke Practice Unit (ISPU) that incorporates team-based care components across the continuum. While risk factor management and early rehabilitation occur during hospitalization, these become the focus and are facilitated in the ISPU post-discharge. While both models have shown effectiveness, understanding which model yields better outcomes is critical scientific information for the stroke community.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This paper reports the protocol for the &lt;em&gt;Coordinated, Collaborative, Comprehensive, Family-Based, Integrated, and Technology-Enabled Stroke Care (C3FIT)&lt;/em&gt;, including rationale, design, and methodology for the study. C3FIT is a pragmatic, multicenter, single masked, Phase III, cluster randomized clinical trial designed to determine effectiveness of two US stroke care models - TJC CSC care (CSC-Only; active control) compared to a model that layers the ISPU model on top of CSC care (ISPU+CSC; intervention). Up to 23 clinical sites were stratified by geographic region and patient admission volume and randomized at the site level. Participants included patients (or their Legally Authorized Representative) and their caregiver (if available). Participants in each treatment group were followed through in-person, virtual, or phone contact at 3-, 6-, and 12-months post-discharge; participants in the ISPU+CSC arm were also seen at 1-, 2-, 4-, 5-, 7-, 8-, 9-, 10- and 11-months post-discharge. Patient-centered primary outcomes were patient function and quality of life (measured using the simplified modified Rankin Scale and Stroke Impact Scale respectively) at 12-months post-stroke. Treatment differences were assessed using generalized linear mixed models incorporating assessments at 0, 3, 6 and 12 months, with the primary treatment differences evaluated by a contrast statement assessing the 12-month difference.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Results from C3FIT will help to determine which model of care yields better outcomes for patients and their caregivers, which will build scient","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107890"},"PeriodicalIF":2.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794951","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":"Unpacking the chain of change in group CBT and ACT for depression: A protocol for a randomized clinical trial","authors":"Anh Dao,&nbsp;Rachel A. Bernstein,&nbsp;Francisco N. Ramos,&nbsp;Brittany Beasley,&nbsp;Iony D. Ezawa","doi":"10.1016/j.cct.2025.107907","DOIUrl":"10.1016/j.cct.2025.107907","url":null,"abstract":"<div><h3>Background</h3><div>Cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) are among our most effective treatments for depression, yet their efficacy remains modest. Prior research has not been able to improve these efficacy rates in part due to the limited insight into the processes of change in these treatments and which individuals may benefit more or less from different therapeutic processes.</div></div><div><h3>Method</h3><div>One hundred adults with a diagnosis of major depressive disorder will be randomized to receive eight weeks of group CBT (<em>n</em> = 50) or ACT (<em>n</em> = 50). We will use intensive longitudinal sampling methods to examine therapeutic skills use, theorized treatment mechanisms, and treatment outcomes throughout the course of treatment. The primary aim is to examine the mediational effect of theorized treatment mechanisms on the association between therapeutic skills use and treatment outcomes. Our secondary aim is to examine the combined moderating effects of treatment modality and client characteristics on the association between therapeutic skills use and activation of mechanisms of change.</div></div><div><h3>Conclusion</h3><div>This work has the potential to inform precision mental health care by closing in on the question of “what works and for whom” as it relates to data-driven psychotherapeutic interventions for depression.</div></div><div><h3>Trial registration number</h3><div>The study is registered at <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06245096</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107907"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787781","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}