Contemporary clinical trials最新文献

{"title":"Recruitment feasibility and dietary and behavioral patterns in toddlers with ASD: Preliminary results from the Autism Eats program","authors":"Heewon L. Gray ,&nbsp;Claudia Jimenez ,&nbsp;Tiantian Pang ,&nbsp;Eunsook Kim ,&nbsp;Emily Shaffer-Hudkins ,&nbsp;Heather Agazzi ,&nbsp;Alanis Rosado ,&nbsp;Ankeeta Klinger ,&nbsp;Carissa Young ,&nbsp;Jana Kandil ,&nbsp;Samuel Won ,&nbsp;Amanda Perez ,&nbsp;William D. Sayre ,&nbsp;Karah A. Waters ,&nbsp;Raymond G. Miltenberger ,&nbsp;Marilyn Stern","doi":"10.1016/j.cct.2024.107688","DOIUrl":"10.1016/j.cct.2024.107688","url":null,"abstract":"<div><h3>Background</h3><p>Problematic mealtime behaviors and inadequate diet quality are pressing concerns for children with autism spectrum disorder (ASD). This study aimed to evaluate recruitment feasibility and baseline outcomes of the <em>Autism Eats</em> program for children under 3 years with ASD.</p></div><div><h3>Methods</h3><p>Recruitment feasibility was assessed through reach and participation rates. The Healthy Eating Index (HEI-2015) scores were calculated from 3-day food records. Problematic mealtime behaviors were assessed with the Brief Autism Mealtime Behavior Inventory. Parental feeding practices were assessed using the Child Feeding Questionnaire. Anthropometric measurements of children and parents were taken. Weight-for-length percentiles were calculated based on the CDC growth charts. Descriptive statistics, one-sample <em>t</em>-tests, and Spearman's rho correlations were used for data analysis.</p></div><div><h3>Results</h3><p>Of the contacted dyads, 74 % agreed to participate. All 51 enrolled dyads completed baseline survey (100 %), and 98 % completed 3-day food records and anthropometric measurements. Significantly higher problematic mealtime behaviors were observed, compared to the reference (e.g., Total score 55.7 vs. 32.5; <em>p</em> &lt; .001). Children with ASD exhibited lower HEI-2015 scores than national data (e.g., Total score 59 vs. 62). A large proportion of the children (29 %) had a weight-for-length ≥ 95th percentile. Several significant associations were found among mealtime behaviors, diet quality, parental feeding practices, and weight status.</p></div><div><h3>Conclusion</h3><p>Recruitment was highly feasible, and the findings suggest that early nutrition intervention may hold promise in addressing problematic mealtime behaviors and promoting healthier dietary habits in young children with ASD.</p><p>Clinical Trial Registration: This trial has been registered at <span><span>www.ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05194345</span><svg><path></path></svg></span>).</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107688"},"PeriodicalIF":2.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142239601","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":"Implementing changing behaviour towards aerobic and strength exercise: Results of a randomised, phase I study determining the safety, feasibility, and consumer-evaluation of an online exercise program in persons with multiple sclerosis","authors":"I. Kaur ,&nbsp;S.L. Baynton ,&nbsp;S. Teo ,&nbsp;A. White-Kiely ,&nbsp;L. Paul ,&nbsp;B.A. Wall ,&nbsp;F. van Rens ,&nbsp;T.J. Fairchild ,&nbsp;Y.C. Learmonth","doi":"10.1016/j.cct.2024.107686","DOIUrl":"10.1016/j.cct.2024.107686","url":null,"abstract":"<div><h3>Background</h3><p>Many people with MS do not meet the recommended exercise regime to elicit health benefits. This study aimed to determine the feasibility, safety, acceptability, and appropriateness of an exercise intervention delivered online to persons with MS that meets current exercise recommendations and behaviour change principles.</p></div><div><h3>Methods</h3><p>Seventy-two participants (age: 43.3 ± 13.3 years) with mild to moderate MS were stratified according to previous exercise behaviour and block-randomised into one of three groups: Control (CON; <em>n</em> = 24), General Exercise (GE; <em>n</em> = 24) who at screening did not meet current exercise recommendations, and Advanced Exercise, (AE; <em>n</em> = 24) who at screening met the current exercise recommendations. GE and AE groups received a four-month online-supervised, behaviour change theory-based exercise program and were assessed at baseline, four-months, five-months, and eleven-months for physical activity participation. The feasibility of process, resources, management, and scientific outcomes was assessed.</p></div><div><h3>Results</h3><p>Of 198 potential participants, 143 met the eligibility criteria (72 %), and 72 were randomised. Fifty-three participants completed the intervention (74 % immediate retention), and 44 were retained at the six-month follow-up (61 %). Personnel time was 369 h, and total per-participant cost was Au$1036.20. Adherence rate to ≥70 % of exercise sessions was 73 % (GE) and 38 % (AE). The GE group observed a small magnitude of improvement in physical activity (d = −0.23).</p></div><div><h3>Conclusions</h3><p>An online exercise program embedded with behaviour interventions for either GE or AE appears feasible, acceptable, appropriate and safe and may show long-term efficacy in increased exercise behaviours for persons with mild to moderate MS.</p><p>Trial registration: ANZCRT number ACTRN12619000228189p.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107686"},"PeriodicalIF":2.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002696/pdfft?md5=d72ef8636af836e613e91db480b61922&pid=1-s2.0-S1551714424002696-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274844","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":"Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol","authors":"Jesus Orellana-Jaén ,&nbsp;Matilde Mora-Fernández ,&nbsp;Luis Carrasco-Páez","doi":"10.1016/j.cct.2024.107672","DOIUrl":"10.1016/j.cct.2024.107672","url":null,"abstract":"<div><h3>Introduction</h3><p>Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.</p></div><div><h3>Methods</h3><p>The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T₁), after completing the interventions (5 months after baseline; T₂), and after completing the follow-up period (8 months after baseline; T₃).</p></div><div><h3>Discussion</h3><p>Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.</p><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT06073717</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107672"},"PeriodicalIF":2.0,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274849","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 clinical drug trial monitoring with blockchain technology","authors":"Poonam Kushwaha ,&nbsp;Nidhi Srivastava ,&nbsp;Shom Prakash Kushwaha","doi":"10.1016/j.cct.2024.107684","DOIUrl":"10.1016/j.cct.2024.107684","url":null,"abstract":"<div><h3>Background</h3><p>Clinical drug trials are intricate, involving numerous stakeholders, substantial data, and stringent regulations. Traditional systems for recording, storing, and sharing trial data often face data integrity, transparency, security, and interoperability challenges. The utilization of blockchain technology has emerged as a transformative influence in various industries, and its potential within healthcare, particularly in clinical drug trials, is increasingly gaining recognition.</p></div><div><h3>Methods</h3><p>Blockchain technology presents a decentralized and immutable ledger system that holds promise in effectively addressing these challenges. As the healthcare industry continues its journey of digital transformation, the incorporation of blockchain technology for monitoring clinical drug trials represents a paradigm shift that can result in more reliable, efficient, and transparent trials.</p></div><div><h3>Results and conclusion</h3><p>This review explores the innovative application of blockchain technology in transforming the monitoring and management of clinical drug trials and provides a comprehensive overview of the possibilities, challenges, and future directions of blockchain-based monitoring in the context of clinical drug trials, contributing to the progress of both blockchain technology and healthcare research practices.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107684"},"PeriodicalIF":2.0,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139548","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":"Methods to characterize lactate turnover in aging and Alzheimer's disease; The LEAN study","authors":"Riley E. Kemna ,&nbsp;Paul J. Kueck ,&nbsp;Anneka E. Blankenship ,&nbsp;Casey S. John ,&nbsp;Chelsea N. Johnson ,&nbsp;Zachary D. Green ,&nbsp;Tyler Chamberlain ,&nbsp;John P. Thyfault ,&nbsp;Jonathan D. Mahnken ,&nbsp;Benjamin F. Miller ,&nbsp;Jill K. Morris","doi":"10.1016/j.cct.2024.107682","DOIUrl":"10.1016/j.cct.2024.107682","url":null,"abstract":"<div><h3>Background</h3><p>There is evidence that chronic exercise can benefit the brain, but the effects vary markedly between studies. One potential mechanism for exercise-related benefit is the increase in systemic lactate concentration that is well-characterized to occur during exercise. Lactate is known to cross the blood brain barrier and can be used readily as a fuel for neurons. This may be particularly important in Alzheimer's Disease, which is characterized by cerebral hypometabolism. However, little is known about how whole-body lactate metabolism differs between older adults and individuals with cognitive impairment. This information is critical when considering potential differences in responses to exercise in various cognitive diagnosis groups.</p></div><div><h3>Methods</h3><p>Here we describe the use of a “lactate clamp” procedure to adjust blood lactate levels to approximate those achieved during exercise, but while at rest. This trial will compare lactate oxidation between cognitively healthy older adults and cognitively impaired participants. We will further evaluate the effect of acute lactate infusion on cognitive performance.</p></div><div><h3>Discussion</h3><p>The findings of the study described here, the Lactate for Energy and Neurocognition trial (<span><span>clinicaltrials.gov</span><svg><path></path></svg></span> # <span><span>NCT05207397</span><svg><path></path></svg></span>) will add to our understanding of systemic lactate mechanics in cognitively healthy older adults and individuals with Alzheimer's Disease. These findings will be applicable to ongoing exercise trials and to future studies aimed at modulating systemic bioenergetic function in aging and Alzheimer's Disease.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107682"},"PeriodicalIF":2.0,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139549","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":"Multiphase optimization strategy to establish optimal delivery of nutrition-related services in healthcare settings: A step towards clinical trial","authors":"Jennifer L. Lemacks ,&nbsp;Tammy Greer ,&nbsp;Sermin Aras ,&nbsp;Shantoni Holbrook ,&nbsp;June Gipson","doi":"10.1016/j.cct.2024.107683","DOIUrl":"10.1016/j.cct.2024.107683","url":null,"abstract":"<div><h3>Background</h3><p>Minorities living in the Southern US generally have greater incidence and prevalence of cardiometabolic diseases compared to other groups. Cardiometabolic disease prevalence and risk can be reduced by focusing on diet and lifestyle modifications. There is need for holistic and integrated care models for community-based healthcare organizations who are already working with minorities. This research aimed to select and optimize essential psychosocial and structural components to address diet behaviors among racial/ethnic minorities, and/or disadvantaged background young to middle aged adult populations in Mississippi.</p></div><div><h3>Methods</h3><p>Nutrition360 was guided by a community-academic team using a participatory approach and included a preparation and two optimization phases to examine different approaches to dietary interventions utilizing the multiphase optimization strategy. Each intervention arm included three different modalities to identify the most feasible delivery method. The intervention was conducted at a community-based, outpatient healthcare center located in Jackson, MS. Eligible participants were between 25 and 50 years old, residents of Jackson metropolitan area, at risk for cardiovascular disease-related premature mortality, and had internet access. Individuals who completed baseline surveys were randomly assigned to an intervention group and then to modality order. Co-primary outcomes were research participant burden and cost-effectiveness and secondary outcomes were attendance, and dietary measures.</p></div><div><h3>Results</h3><p>Thirty-one, African American individuals with a mean age of 40.5 years completed baseline surveys and were randomized to an intervention program.</p></div><div><h3>Conclusion</h3><p>The two most feasible and cost-effective interventions will be combined to further test this model's delivery in the real-world setting as part of the next optimization phase.</p></div><div><h3>Registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT06286618</span><svg><path></path></svg></span>. <span><span>https://clinicaltrials.gov/study/NCT06286618</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107683"},"PeriodicalIF":2.0,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139550","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":"EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial","authors":"Jashalynn German ,&nbsp;Qing Yang ,&nbsp;Daniel Hatch ,&nbsp;Allison Lewinski ,&nbsp;Hayden B. Bosworth ,&nbsp;Brystana G. Kaufman ,&nbsp;Ranee Chatterjee ,&nbsp;Gina Pennington ,&nbsp;Doreen Matters ,&nbsp;Donghwan Lee ,&nbsp;Diana Urlichich ,&nbsp;Sarah Kokosa ,&nbsp;Holly Canupp ,&nbsp;Patrick Gregory ,&nbsp;Cindy Leslie Roberson ,&nbsp;Benjamin Smith ,&nbsp;Sherry Huber ,&nbsp;Katheryn Doukellis ,&nbsp;Tammi Deal ,&nbsp;Rose Burns ,&nbsp;Ryan J. Shaw","doi":"10.1016/j.cct.2024.107673","DOIUrl":"10.1016/j.cct.2024.107673","url":null,"abstract":"<div><h3>Background</h3><p>Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.</p></div><div><h3>Methods</h3><p>Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.</p></div><div><h3>Results</h3><p>Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.</p></div><div><h3>Conclusion</h3><p>The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107673"},"PeriodicalIF":2.0,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105121","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":"Acceptance and commitment therapy versus progressive relaxation training for misophonia: Randomized controlled trial protocol, interventions, and audiological assessments","authors":"Emily M. Bowers ,&nbsp;Mercedes G. Woolley ,&nbsp;Karen Muñoz ,&nbsp;Julie M. Petersen ,&nbsp;Michael P. Twohig","doi":"10.1016/j.cct.2024.107671","DOIUrl":"10.1016/j.cct.2024.107671","url":null,"abstract":"<div><h3>Background</h3><p>Misophonia is a disorder characterized by an intense emotional reaction to specific sounds, often leading to significant distress and impairment in daily functioning. Acceptance and commitment therapy (ACT) is a promising psychotherapy for treating misophonia, but has only been previously tested in case studies. This paper presents a protocol for the first randomized controlled trial (RCT) assessing the efficacy and feasibility of ACT supplemented by audiological interventions for misophonia versus progressive relaxation training (PRT).</p></div><div><h3>Methods</h3><p>The outlined protocol is a RCT with 60 adults with misophonia. After undergoing a comprehensive psychological and audiological evaluation, participants were randomly assigned to ACT (<em>n</em> = 30) or PRT (<em>n</em> = 30). All participants completed clinician-administered and self-report assessments at baseline, post-intervention, 3-month follow-up, and 6-month follow-up. The primary outcome was misophonia severity and impairment measured via clinical interview. Secondary outcomes included disgust, anger, sensory sensitivities, well-being, distress, and psychological flexibility.</p></div><div><h3>Discussion</h3><p>This paper outlines the rationale of using ACT supplemented by audiological methods for misophonia with the novel therapeutic target of enhancing psychological flexibility. The results of this randomized controlled trial will help determine if ACT is an efficacious and acceptable treatment for misophonia. This trial will also help clarify active psychological mechanisms of misophonia, and assess whether this combination of psychological and audiological services can effectively help individuals with misophonia.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107671"},"PeriodicalIF":2.0,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055136","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":"Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial","authors":"Shannon M. Blakey ,&nbsp;Amber K. Alsobrooks ,&nbsp;Antonio A. Morgan-López ,&nbsp;Nicholas Kruskamp ,&nbsp;Tracy L. Simpson ,&nbsp;Stacey B. Daughters ,&nbsp;Chase M. DuBois ,&nbsp;Jovin S. Huang ,&nbsp;Janequia Evans ,&nbsp;Bethzaida N. Serrano ,&nbsp;Patrick S. Calhoun ,&nbsp;Jean C. Beckham ,&nbsp;Eric B. Elbogen","doi":"10.1016/j.cct.2024.107670","DOIUrl":"10.1016/j.cct.2024.107670","url":null,"abstract":"<div><h3>Background</h3><p>Nearly 2 million U.S. veterans live with co-occurring alcohol use disorder and posttraumatic stress disorder (AUD/PTSD). Extant AUD/PTSD treatments emphasize symptom reduction, sometimes overlooking psychosocial functioning improvements, and have dropout rates as high as 50 %. Additionally, current approaches to measuring psychosocial functioning are limited to self-report. This study protocol describes a 1:1 parallel, two-arm, pilot randomized controlled trial comparing Behavioral Activation (BA) psychotherapy to Relapse Prevention (RP) psychotherapy for veterans with AUD/PTSD.</p></div><div><h3>Methods</h3><p>Forty-six veterans with AUD/PTSD will be block-randomized to eight weekly, virtual, hour-long individual sessions of BA or RP. Clinical interview, self-report, and geospatial assessments will be administered at pre- and post-treatment. Select outcome and exploratory measures will be administered during treatment. Analyses will focus on trial feasibility, BA acceptability, and preliminary efficacy. Geospatial analyses will explore whether pre- to post-treatment changes in geospatial movement can be used to objectively measure treatment response. The study site and an independent Data and Safety Monitoring Board will monitor trial progress, safety, and quality. De-identified data from consenting participants will be submitted to a sponsor-designated data repository.</p></div><div><h3>Conclusion</h3><p>If successful, this trial could help to provide veterans with AUD/PTSD with a more acceptable treatment option. Positive findings would also lay groundwork for testing BA in civilians with AUD/PTSD. Finally, by incorporating novel geospatial methods and technologies, this study could potentially yield a new approach to objectively measuring AUD/PTSD recovery that could be used in other clinical trials. This study was registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06249386</span><svg><path></path></svg></span>).</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107670"},"PeriodicalIF":2.0,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072234","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":"Empathic communication skills training to reduce lung cancer stigma: Study protocol of a cluster randomized control trial","authors":"Smita C. Banerjee ,&nbsp;Charlotte D. Malling ,&nbsp;Elizabeth A. Schofield ,&nbsp;Lisa Carter-Bawa ,&nbsp;Carma L. Bylund ,&nbsp;Heidi A. Hamann ,&nbsp;Patricia A. Parker ,&nbsp;Megan J. Shen ,&nbsp;Jamie L. Studts ,&nbsp;Timothy J. Williamson ,&nbsp;Jamie S. Ostroff","doi":"10.1016/j.cct.2024.107669","DOIUrl":"10.1016/j.cct.2024.107669","url":null,"abstract":"<div><h3>Background</h3><p>Prior research demonstrates that nearly all (95 %) people with lung cancer (PwLC) report stigma, and approximately half (48 %) PwLC experience stigma during clinical encounters with oncology care providers (OCPs). When stigma is experienced in a medical context, it can have undesirable consequences including patients' delaying and underreporting of symptoms, misreporting of smoking behavior, and avoiding help-seeking such as psychosocial support and cessation counseling. Multi-level interventions are needed to prevent and mitigate lung cancer stigma. One promising intervention for reducing patient perception and experience of stigma is to train OCPs in responding empathically to patient emotions and promoting empathic communication within clinical encounters.</p></div><div><h3>Methods</h3><p>This paper describes the study protocol for a cluster randomized trial comparing Usual Care (waitlist control group) with Empathic Communication Skills (ECS) training (intervention group). For this study, we will recruit 16 community oncology practice sites, 9–11 OCPs per site, and 6 PwLCs per OCP.</p></div><div><h3>Results</h3><p>The goal of this trial is to investigate the effect of the ECS training on (a) OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal – relevance, novelty, clarity; self-efficacy, attitude towards communication with patients); and (b) patient-reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with OCP communication, psychological distress, social isolation, and appraisal of care).</p></div><div><h3>Conclusion</h3><p>Findings from this trial will advance understanding of the effectiveness of the ECS training intervention and inform future provider-level training interventions that may reduce lung cancer stigma and improve cancer care delivery.</p><p><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Identifier</strong>: <span><span>NCT05456841</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107669"},"PeriodicalIF":2.0,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055137","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}