Contemporary Clinical Trials Communications最新文献

{"title":"SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure with Reduced and Mildly-Reduced Ejection Fraction (SHINE-HF): rationale and design for a multicenter randomized controlled trial","authors":"Lina Feng ,&nbsp;Sizhen Chen ,&nbsp;Jiang Liu ,&nbsp;Chunyan Li ,&nbsp;Hongshuai Cao ,&nbsp;Liyuan Tao ,&nbsp;Fang Fang ,&nbsp;Feijiao Huo ,&nbsp;Lingling Liu ,&nbsp;Palidan Wubu'er ,&nbsp;Ming Wang ,&nbsp;Xiaohua Zhao ,&nbsp;Xiaojian Liu ,&nbsp;Hui Xin ,&nbsp;Ding Li ,&nbsp;Weisheng Mao ,&nbsp;Liang Gui ,&nbsp;Jianfei Guan ,&nbsp;Zhiyang Zhu ,&nbsp;Haijun Song ,&nbsp;Jingyi Ren","doi":"10.1016/j.conctc.2025.101497","DOIUrl":"10.1016/j.conctc.2025.101497","url":null,"abstract":"<div><h3>Background</h3><div>Although contemporary guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF) and heart failure with mildly-reduced ejection fraction (HFmrEF) has been shown to significantly improve prognosis, patients with these conditions still face considerable residual risk, and their quality of life (QoL) remains severely compromised. ShengXian-QuYu (SXQY) Decoction is a widely prescribed complementary and alternative medicine (CAM) therapy for HF in clinical practice. However, there is currently no robust evidence supporting its efficacy in HFrEF and HFmrEF, and its potential adverse effects have yet to be fully elucidated.</div></div><div><h3>Methods</h3><div>Patients with chronic HF, New York Heart Association (NYHA) class II–IV symptoms, elevated plasma natriuretic peptide levels, and a left ventricular ejection fraction (LVEF) of ≤50 % were enrolled in the ShengXian-QuYu Decoction in the Treatment of Heart Failure with Reduced and mildly reduced Ejection Fraction (SHINE-HF) trial. Patients eligibility entered a run-in period, followed by randomization in a 1:1 ratio to double-blind treatment with either 30 ml of SXQY or 30 ml of placebo, administered twice daily. The primary endpoint was the change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at week 12. Key secondary endpoints included the change from baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) and the 6-min walk test (6MWT) distance at week 12. Additionally, a safety analysis will be conducted.</div></div><div><h3>Conclusion</h3><div>SHINE-HF will determine the effects of SXQY on patient-reported outcomes (PROs) and symptom burden in patients with HFrEF and HFmrEF. This will shed light on the potential of SXQY as a novel treatment option in improving QoL of patients with HFrEF and HFmrEF.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101497"},"PeriodicalIF":1.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial","authors":"Jorge Diaz ,&nbsp;Allex Fonseca ,&nbsp;Lixin Yan ,&nbsp;Dongfang Liu ,&nbsp;Liangzhi Xie","doi":"10.1016/j.conctc.2025.101496","DOIUrl":"10.1016/j.conctc.2025.101496","url":null,"abstract":"<div><h3>Background/Objective</h3><div>The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19.<strong>:</strong> This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19.</div></div><div><h3>Methods</h3><div>The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29.</div></div><div><h3>Results</h3><div>109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction (<em>p</em> = 0.20) or symptom score reduction (<em>p</em> = 0.37) between the SCTA01 total and placebo groups. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported.</div></div><div><h3>Conclusions</h3><div>There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated.</div></div><div><h3>CLINICAL TRIAL</h3><div>The trial was registered at ClinicalTrial.gov (NCT04709328).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101496"},"PeriodicalIF":1.4,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic Yoga: A feasible complementary approach for glycemic control in individuals with impaired fasting glucose and elevated HbA1c","authors":"Gitika Bhasin ,&nbsp;Rucha S. Dafale ,&nbsp;Annapoorna K. ,&nbsp;Shobha U. Kamath ,&nbsp;Divya Matlani ,&nbsp;Raju Rana ,&nbsp;Mukhyaprana M. Prabhu ,&nbsp;Akhilesh K. Pandey ,&nbsp;Sahana Shetty ,&nbsp;Lavya Shetty ,&nbsp;Vasanthalaxmi K. ,&nbsp;Manjula S.D.","doi":"10.1016/j.conctc.2025.101493","DOIUrl":"10.1016/j.conctc.2025.101493","url":null,"abstract":"<div><h3>Background</h3><div>Impaired Fasting Glucose (IFG) with elevated glycated hemoglobin (HbA1c) is a key precursor to type 2 diabetes mellitus (T2DM). Although asymptomatic, IFG significantly raises the risk of developing T2DM and cardiovascular complications, emphasizing the need for early intervention. The Therapeutic Yoga Module (TYM) was designed to offer a feasible and effective remedy for improving glycemic control.</div></div><div><h3>Methods</h3><div>The TYM was designed by combining different yoga practices including asanas, pranayama, relaxation, and dhyana. After validating the module, a feasibility study was carried out on 12 individuals. Subsequently, the preliminary impact was assessed on 29 individuals (intervention group = 14 and control group = 15) with IFG. The study evaluated practicality, participant acceptance, and changes in Fasting Blood Glucose (FBG) and HbA1c levels over 12 weeks.</div></div><div><h3>Results</h3><div>The TYM achieved a content validity index (CVI) of 0.75, with 15 out of 20 practices deemed effective by the expert panel. The Intra-Class Correlation (ICC) coefficient of 0.864 indicated strong reliability. Feasibility testing revealed high participant acceptance, with an average attendance rate of 84.9 %. The intervention group showed significant improvements in FBG (from 108.79 mg/dL to 91.00 mg/dL, P &lt; 0.001) and HbA1c (from 6.00 % to 5.73 %, P &lt; 0.001), compared to the control group, which had more modest improvements. The analysis of covariance (ANCOVA) analysis confirmed that these improvements were primarily attributable to TYM.</div></div><div><h3>Conclusion</h3><div>Preliminary findings suggest that TYM may be a promising complementary intervention for individuals with IFG or at risk of T2DM.</div></div><div><h3>Trial registration</h3><div>Clinical Trials Registry - India (CTRI); Registration number: CTRI/2022/04/042307; Registration Date: April 29, 2022.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101493"},"PeriodicalIF":1.4,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144106226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Undiagnosed Liver Cirrhosis via Artificial Intelligence-Enabled Electrocardiogram (DULCE): Rationale and design of a pragmatic cluster randomized clinical trial","authors":"Amy Olofson ,&nbsp;Ryan Lennon ,&nbsp;Blake Kassmeyer ,&nbsp;Kan Liu ,&nbsp;Zacchi I. Attia ,&nbsp;David Rushlow ,&nbsp;Puru Rattan ,&nbsp;Joseph C. Ahn ,&nbsp;Paul A. Friedman ,&nbsp;Alina Allen ,&nbsp;Patrick S. Kamath ,&nbsp;Vijay H. Shah ,&nbsp;Peter A. Noseworthy ,&nbsp;Douglas A. Simonetto","doi":"10.1016/j.conctc.2025.101494","DOIUrl":"10.1016/j.conctc.2025.101494","url":null,"abstract":"<div><h3>Background</h3><div>Cirrhosis is a leading cause of morbidity and mortality worldwide, yet preventable at early stages. Currently, effective approaches for early diagnosis are lacking. A novel electrocardiogram (ECG)-enabled deep learning model trained for detection of advanced chronic liver disease (CLD) has demonstrated promising results and it may be used for screening of advanced CLD in primary care.</div></div><div><h3>Design</h3><div>A pragmatic, cluster randomized trial (<strong>NCT05782283</strong>) in 45 Mayo Clinic primary care practices will be conducted over a period of 6 months with 6 months of follow up. Care teams will be randomized 1:1 to intervention or usual care, stratified by region and patient volume. Patients from providers enrolled in the trial who undergo an ECG during the study period will be included. In the intervention arm, consenting providers to patients identified as higher risk of advanced CLD based on their ECG will be notified with a recommendation for noninvasive fibrosis assessment. The primary endpoint will be detection of advanced CLD (defined as stage 3–4 on blood- or imaging-based noninvasive liver disease assessment or liver biopsy). Secondary outcomes will include completion of fibrosis assessment tests within 180 days of ECG, new diagnosis of liver disease stratified by etiology and risk factors for CLD, and detection of any liver fibrosis (stages 1–4). Post-study surveys to participating clinicians will be conducted.</div></div><div><h3>Summary</h3><div>Preliminary findings suggest outstanding potential for the use of an ECG-enabled machine learning algorithm for detection of advanced CLD in the primary care community.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101494"},"PeriodicalIF":1.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings","authors":"Marisa E. Hilliard ,&nbsp;Wendy Levy ,&nbsp;Ruth S. Weinstock ,&nbsp;Korey K. Hood ,&nbsp;Paula M. Trief ,&nbsp;Daniel J. DeSalvo ,&nbsp;Yuliana Rojas ,&nbsp;Kyrah Holland ,&nbsp;Aika K. Schneider-Utaka ,&nbsp;Selma A. Alamarie ,&nbsp;Lynn Agostini ,&nbsp;Se-Kang Kim ,&nbsp;Maartje de Wit ,&nbsp;Meghan E. McGrady ,&nbsp;Laurel H. Messer ,&nbsp;Barbara J. Anderson","doi":"10.1016/j.conctc.2025.101491","DOIUrl":"10.1016/j.conctc.2025.101491","url":null,"abstract":"<div><h3>Background</h3><div>Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited potential for implementation in routine care. This trial is piloting a brief behavioral intervention that targets health-related quality of life (HRQOL), which can be implemented with PWDs of all ages in a range of clinical care settings. The aims are to (1) evaluate intervention feasibility and acceptability, (2) explore pre-post change in psychosocial and clinical outcomes, and (3) explore costs related to intervention development and implementation.</div></div><div><h3>Methods</h3><div>Participants are PWD of all ages who receive T1D care in pediatric subspecialty, adult specialty, and primary care settings (target n = 120, 40/site) and a parent (for children) or partner (for adults). Certified diabetes care and education specialists deliver the intervention during two ∼30-45-min remote sessions over 6 months. In the sessions, interventionists review a “quality of life profile” generated from participants’ pre-session responses to a measure of T1D-specific HRQOL, and provide behavioral strategies and resources tailored to their individual strengths and challenges. Feasibility and acceptability data include recruitment/enrollment/retention rates, intervention fidelity, satisfaction surveys, and qualitative interviews. Pre-post measures of psychosocial and clinical outcomes are collected at baseline and 6 months.</div></div><div><h3>Conclusion</h3><div>This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members, designed for implementation across a range of care settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101491"},"PeriodicalIF":1.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Links between self-monitoring data collected through smartphones and smartwatches and the individual disease trajectories of adult patients with depressive disorders: Study protocol of a one-year observational trial","authors":"Hanna Reich ,&nbsp;Simon Schreynemackers ,&nbsp;Rebeka Amin ,&nbsp;Sascha Ludwig ,&nbsp;Jil Zippelius ,&nbsp;Johannes Leimhofer ,&nbsp;Tobias Dunker ,&nbsp;Elisabeth Schriewer ,&nbsp;Angela Carell ,&nbsp;Yvonne Weber ,&nbsp;Ulrich Hegerl ,&nbsp;the MONDY consortium","doi":"10.1016/j.conctc.2025.101492","DOIUrl":"10.1016/j.conctc.2025.101492","url":null,"abstract":"<div><div>Depression is highly recurrent and heterogenous in its individual course, requiring a personalized treatment approach. Patients today can collect large volumes of personal data via smartphones and smartwatches and may utilize them for their treatment and self-management. We aim to provide proof-of-concept that these data can (i) serve as an objective marker of and (ii) predict the daily and weekly self-reported depression severity within individuals with depressive disorders.</div><div>In this exploratory study, 15 adult patients with depressive disorders will collect self-report and biosensor data over the course of one year. Participants will (a) attend three in-person appointments (at baseline, 6 months, and 12 months), (b) self-report daily and weekly depressive symptoms, (c) continuously collect sensor data via the “iTrackDepression” app on their Android smartphone (app usage, phone calls, phonetic parameters from voice recordings), and (d) wear a Samsung Galaxy Watch 5® to record data from the accelerometer, step sensor, light sensor, and heart rate sensor. We will apply multilevel correlations, vector-autoregressive models, and Machine Learning approaches to identify individual patterns in the data, particularly in the relationships between biosensor data and self-reported depressive symptoms.</div><div>Enhancing the understanding of individual disease trajectories through data from smartphones and smartwatches could allow for classical, digital, and self-management interventions for depression to be delivered in a manner and at a time specifically tailored to the individual's needs.</div><div>Clinical trial registration number: DRKS00032618 (<span><span>https://drks.de/search/en/trial/DRKS00032618</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101492"},"PeriodicalIF":1.4,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lessons learned in recruiting and retaining Black men in behavioral diabetes intervention research","authors":"Jaclynn M. Hawkins ,&nbsp;Alana M. Ewen ,&nbsp;Martha Funnell ,&nbsp;Robin Nwankwo ,&nbsp;Gretchen Piatt","doi":"10.1016/j.conctc.2025.101487","DOIUrl":"10.1016/j.conctc.2025.101487","url":null,"abstract":"<div><div>Black men experience disproportionately high rates of type 2 diabetes (T2D) and its complications, yet remain underrepresented in diabetes intervention research. Culturally tailored, community-based interventions that prioritize trust and address structural barriers are essential for improving recruitment and retention in this population. This article provides insights from the Michigan Men's Diabetes (MenD I and II) Projects, a peer-led diabetes self-management intervention tailored to Black men with T2D. MenD I and MenD II used Diabetes Self-Management Education (DSME) and Peer-Led Diabetes Self-Management Support (PLDSMS) sessions delivered virtually to meet participants' needs. Recruitment efforts engaged trusted community organizations, healthcare providers, and targeted outreach. Retention strategies emphasized trust-building, flexible scheduling, and culturally resonant support mechanisms, such as fostering a sense of community, providing personalized check-ins, and incorporating time for informal interactions and relationship-building. Data collected from pre- and post-intervention assessments and participant feedback illustrate the effectiveness of these approaches in addressing barriers and sustaining engagement. Despite challenges like medical mistrust, systemic inequities, and competing responsibilities, the MenD studies demonstrate that well-designed peer-led interventions can effectively engage Black men. These findings highlight the importance of culturally tailored adaptations and strong community partnerships in overcoming barriers to participation. Insights from MenD I and II offer valuable guidance for reducing health disparities and improving diabetes outcomes for Black men.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101487"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143899919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care","authors":"Tiffany M. Rybak ,&nbsp;Sarah E. Francis ,&nbsp;Constance A. Mara ,&nbsp;Cynthia Zion ,&nbsp;Avani C. Modi ,&nbsp;Lori E. Crosby ,&nbsp;Rachel B. Herbst ,&nbsp;Brea A. Lauer ,&nbsp;Bridget N. Murphy ,&nbsp;Kasey R. Harry ,&nbsp;Devanshi J. Patel ,&nbsp;Mary Carol Burkhardt","doi":"10.1016/j.conctc.2025.101488","DOIUrl":"10.1016/j.conctc.2025.101488","url":null,"abstract":"<div><h3>Background</h3><div>Unprecedented rates of overweight and obesity are seen in childhood with evidence suggesting that infancy may be a critical period for the development of this elevated-weight trajectory. The impact of rapid growth in infancy on later obesity may differ by social stratification factors such as race/ethnicity and family income and be mediated by infant feeding and sleeping practices. This paper outlines the protocol for the Teaching Healthy Responsive Parenting during Infancy to promote Vital growth and rEgulation (THRIVE 2.0) intervention.</div></div><div><h3>Methods/design</h3><div>This Phase 2b pilot randomized controlled trial will determine the feasibility, acceptability, satisfaction, and preliminary efficacy of the THRIVE 2.0 intervention compared with primary care treatment as usual (control). Caregiver-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to THRIVE 2.0 (obesity prevention) or Control (usual pediatric care). Feasibility, acceptability, satisfaction, infant growth, feeding, and sleep will be assessed throughout the study period. Intervention will take place at regularly scheduled well-child visits at ages 1, 2, 4, and 6 months. Efficacy measures will be assessed at baseline, and 9 and 12 months of age. THRIVE is hypothesized to demonstrate efficacy for primary (e.g., conditional weight gain scores calculated from weight-for-length z-scores) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies when it is not time for a feeding, and good infant sleep hygiene).</div></div><div><h3>Discussion</h3><div>This paper outlines the planned procedures for the THRIVE 2.0 Phase 2b randomized controlled trial.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov Identifier: NCT06028113 (October 10, 2023)</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101488"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143870581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations","authors":"Huynh-Nhu Le ,&nbsp;Nickie Andescavage ,&nbsp;Jennifer M. Keller ,&nbsp;Maariya M. Bassa ,&nbsp;Aimee L. Danielson ,&nbsp;Diedtra Henderson ,&nbsp;Shanae Bond ,&nbsp;Nandi Mjenga ,&nbsp;Stephanie Wells ,&nbsp;Patricia Quinn ,&nbsp;Catherine Limperopoulos","doi":"10.1016/j.conctc.2025.101489","DOIUrl":"10.1016/j.conctc.2025.101489","url":null,"abstract":"<div><h3>Background</h3><div>Mental health disorders, including stress, anxiety, and depression, are the most common complications during pregnancy, with significant racial disparities in prevalence and access to care. Low-income Black/African American/of African descent (Black) individuals are at greater risk for perinatal mental health issues and face more obstacles to care due to a variety of barriers, including poor implementation of screening protocols, stigma, adverse experiences of social determinants of health, and distrust of healthcare systems. These disparities are particularly striking in Washington, DC, and worsened during the COVID-19 pandemic.</div></div><div><h3>Methods</h3><div>This study has two aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) prevention and treatment intervention for low-income Black pregnant women; and (2) to determine the effectiveness of multiple interventions: patient navigation, culturally adapted CBT, and/or peer support groups versus usual care for pregnant individuals at subthreshold and threshold risk for prenatal stress, depression and/or anxiety in a two-arm prospective longitudinal randomized controlled study. Outcomes will be tracked from pregnancy through 12 months postpartum, assessing maternal mental health, engagement with the intervention, healthcare experiences and utilization, and infant outcomes.</div></div><div><h3>Conclusions</h3><div>If found to be efficacious, results will help develop scalable, culturally relevant interventions aimed at reducing racial disparities in maternal mental health care and improving health outcomes for both mothers and infants. Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID NCT05345834.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101489"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143876715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol of Brief Behavioral Treatment for insomnia intervention for adult patients with cancer and their sleep-partner caregivers","authors":"Youngmee Kim ,&nbsp;Thomas C. Tsai ,&nbsp;Wendy M. Troxel","doi":"10.1016/j.conctc.2025.101486","DOIUrl":"10.1016/j.conctc.2025.101486","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbance is common and problematic among both patients with cancer and their sleep-partner caregivers. Although one's sleep affects the partner's sleep, existing psychobehavioral interventions have targeted patients' and caregivers' sleep problems independently.</div></div><div><h3>Methods</h3><div>We adapt the Brief Behavioral Treatment for Insomnia (BBTI) for both adult patients and their sleep-partner caregivers in the context of cancer. This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the BBTI for Couples with Cancer (BBTI-CC) intervention, which is to reduce sleep disturbance and improving sleep quality of both adults with cancer and their sleep-partner caregivers. The intervention will be delivered weekly for 4 weeks. Questionnaire and daily sleep logs will be collected at baseline (T1) and one-week after conclusion of the intervention (T2). Satisfaction with the intervention will be assessed weekly for 4 weeks.</div></div><div><h3>Results</h3><div>We estimate 18 dyads will be enrolled (18 patients and 18 caregivers). We expect &gt;75 % of eligible and screened dyads will enroll within the enrollment period, &gt;80 % of enrolled dyads will complete the intervention, and &gt;80 % of participants will report satisfaction across all acceptability measures. We also expect BBTI-CC will reveal a small-to-medium effect on sleep efficiency (primary outcome), overall sleep disturbance, subjective sleep quality, and insomnia severity (secondary outcomes).</div></div><div><h3>Conclusions</h3><div>Results will inform the feasibility and acceptability of conducting a dyadic sleep behavioral intervention, and provide preliminary efficacy data to guide further refinement of intervention content and procedure for adult patients with cancer and their sleep-partner caregivers.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101486"},"PeriodicalIF":1.4,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143852341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}