Pub Date : 2026-03-01Epub Date: 2026-01-17DOI: 10.1016/j.cct.2026.108217
Jinghua An , Maisha Huq , Erin Speiser , Sherry Grumet , Beth N. Peshkin , Emily Heidt , Lucile Adams-Campbell , Christopher Grisham , Samuel Tundealao , Rose Yesha , Deborah Toppmeyer , Claudine Isaacs , Lia Sorgen , Naomi Tan , Anupama Hooda-Nehra , Melanie A. Nix , Dorothy J. Reed , Jimmie Staton , Marc D. Schwartz , Anita Y. Kinney
Background
Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.
Methods
Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.
Discussion
This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.
Trial registration number: The trial is registered on clinicaltrials.gov (NCT06073626).
{"title":"Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing","authors":"Jinghua An , Maisha Huq , Erin Speiser , Sherry Grumet , Beth N. Peshkin , Emily Heidt , Lucile Adams-Campbell , Christopher Grisham , Samuel Tundealao , Rose Yesha , Deborah Toppmeyer , Claudine Isaacs , Lia Sorgen , Naomi Tan , Anupama Hooda-Nehra , Melanie A. Nix , Dorothy J. Reed , Jimmie Staton , Marc D. Schwartz , Anita Y. Kinney","doi":"10.1016/j.cct.2026.108217","DOIUrl":"10.1016/j.cct.2026.108217","url":null,"abstract":"<div><h3>Background</h3><div>Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.</div></div><div><h3>Methods</h3><div>Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.</div></div><div><h3>Discussion</h3><div>This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.</div><div>Trial registration number: The trial is registered on <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06073626</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108217"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003198","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}
Pub Date : 2026-03-01Epub Date: 2026-01-18DOI: 10.1016/j.cct.2026.108231
Jennifer Erdrich , Melissa M. Carton , Adriena Hernandez , Dominique Nosie-Romo , Amanda Huber , Trevor Chapman , Colter Sanchez , William R. Montfort , Jennifer W. Bea , Angela Yung , Cynthia A. Thomson
Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.
{"title":"A reservation-based clinical trial on inflammatory biomarkers in American Indian/Alaska Native cancer patients: Rationale and design of the adaptive prehab approaches in cancer healing and education (APACHE) program","authors":"Jennifer Erdrich , Melissa M. Carton , Adriena Hernandez , Dominique Nosie-Romo , Amanda Huber , Trevor Chapman , Colter Sanchez , William R. Montfort , Jennifer W. Bea , Angela Yung , Cynthia A. Thomson","doi":"10.1016/j.cct.2026.108231","DOIUrl":"10.1016/j.cct.2026.108231","url":null,"abstract":"<div><div>Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108231"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008681","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}
Pub Date : 2026-03-01Epub Date: 2026-01-13DOI: 10.1016/j.cct.2026.108224
Hannah E. Reese , W. Alan Brown , Yaerin H. Wallenberger , Kesley A. Ramsey , Lauren E. Browning , Joshua Rooks , Neda F. Gould , Jeannie-Marie Leoutsakos , Tamar Mendelson , Alexandria H. Chang , Joseph F. McGuire
Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments—including behavior therapy and pharmacotherapy—are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.
{"title":"Remote delivery of a mindfulness-based intervention for adults with tics: Protocol of a randomized controlled trial","authors":"Hannah E. Reese , W. Alan Brown , Yaerin H. Wallenberger , Kesley A. Ramsey , Lauren E. Browning , Joshua Rooks , Neda F. Gould , Jeannie-Marie Leoutsakos , Tamar Mendelson , Alexandria H. Chang , Joseph F. McGuire","doi":"10.1016/j.cct.2026.108224","DOIUrl":"10.1016/j.cct.2026.108224","url":null,"abstract":"<div><div>Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments—including behavior therapy and pharmacotherapy—are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108224"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988542","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}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108207
Amy Gawad , Jessica Mendoza , Megan Singleton , Ryan Majkowski , Erica Hopkins , Jordyn Carll , Cindy MacInnis , Daniel Amirault , Bahiyyah Jackson , Nichol McBee , Andrew Mould , Lindsay M. Eyzaguirre , Cecilia Pessoa-Gingerich , Shmuel Shoham , David Sullivan , Karen Lane
We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12–15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.
{"title":"Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency","authors":"Amy Gawad , Jessica Mendoza , Megan Singleton , Ryan Majkowski , Erica Hopkins , Jordyn Carll , Cindy MacInnis , Daniel Amirault , Bahiyyah Jackson , Nichol McBee , Andrew Mould , Lindsay M. Eyzaguirre , Cecilia Pessoa-Gingerich , Shmuel Shoham , David Sullivan , Karen Lane","doi":"10.1016/j.cct.2025.108207","DOIUrl":"10.1016/j.cct.2025.108207","url":null,"abstract":"<div><div>We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12–15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108207"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838279","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}
Pub Date : 2026-02-01Epub Date: 2025-12-15DOI: 10.1016/j.cct.2025.108184
Diane M. Wisnieski , Rebecca C. Rossom , Lauren M. Weinstock , Jennifer Johnson , Kathleen Miley , Brandon A. Gaudiano , Madeline B. Benz , Caitlin Borgert-Spaniol , Hannah R. Graves , Rachael Norwood , Rowyda Kazan , Colleen Starkey , Hanmin Kim , Linda Fletcher , Sheryl Kane , Yong Hu , Zachary Farrell , Sarah Strong , Hsueh-Han Yeh , Ted Miller , Brian K. Ahmedani
Background
Over 20 % of all adult suicide deaths in the U.S. occur within one year following jail release. Individuals may have increased access to lethal means, be faced with numerous financial, legal, and social stressors, and encounter a resurgence of legal problems. Suicide prevention interventions have demonstrated effects. Widespread implementation of these interventions for individuals leaving jail detention could have a significant impact on national suicide rates.
Methods
The 5S Study (Syncing, Screening, and Services for Suicide Prevention among Health & Jail Systems) aims to prevent suicide attempts among adults aged 18+ who are recently released from jail. Data from public jail release reports are synced with electronic health record (EHR) systems to enable proactive health system outreach. Those randomized to the intervention are contacted and consented, undergo a suicide risk screening and create a safety plan. Care Coordinators connect participants to health services. High risk participants, identified by the Patient Health Questionnaire (PHQ-9), are offered the Coping Long Term with Active Suicide Program (CLASP), an evidence-based suicide prevention intervention. Those randomized to control are never contacted and receive usual care. There is a waiver of consent for the control condition and a waiver of written consent for the intervention condition.
Discussion
The 5S Study uses data linkage between EHRs and jails to identify and connect with those recently released from jail, a population historically at high risk. Trial results will highlight best practices for syncing these data and offering support during the transition back to the community.
{"title":"Study protocol for a type I hybrid effectiveness trial of strategies to prevent suicide attempts among adults recently released from jail","authors":"Diane M. Wisnieski , Rebecca C. Rossom , Lauren M. Weinstock , Jennifer Johnson , Kathleen Miley , Brandon A. Gaudiano , Madeline B. Benz , Caitlin Borgert-Spaniol , Hannah R. Graves , Rachael Norwood , Rowyda Kazan , Colleen Starkey , Hanmin Kim , Linda Fletcher , Sheryl Kane , Yong Hu , Zachary Farrell , Sarah Strong , Hsueh-Han Yeh , Ted Miller , Brian K. Ahmedani","doi":"10.1016/j.cct.2025.108184","DOIUrl":"10.1016/j.cct.2025.108184","url":null,"abstract":"<div><h3>Background</h3><div>Over 20 % of all adult suicide deaths in the U.S. occur within one year following jail release. Individuals may have increased access to lethal means, be faced with numerous financial, legal, and social stressors, and encounter a resurgence of legal problems. Suicide prevention interventions have demonstrated effects. Widespread implementation of these interventions for individuals leaving jail detention could have a significant impact on national suicide rates.</div></div><div><h3>Methods</h3><div>The 5S Study (Syncing, Screening, and Services for Suicide Prevention among Health & Jail Systems) aims to prevent suicide attempts among adults aged 18+ who are recently released from jail. Data from public jail release reports are synced with electronic health record (EHR) systems to enable proactive health system outreach. Those randomized to the intervention are contacted and consented, undergo a suicide risk screening and create a safety plan. Care Coordinators connect participants to health services. High risk participants, identified by the Patient Health Questionnaire (PHQ-9), are offered the Coping Long Term with Active Suicide Program (CLASP), an evidence-based suicide prevention intervention. Those randomized to control are never contacted and receive usual care. There is a waiver of consent for the control condition and a waiver of written consent for the intervention condition.</div></div><div><h3>Discussion</h3><div>The 5S Study uses data linkage between EHRs and jails to identify and connect with those recently released from jail, a population historically at high risk. Trial results will highlight best practices for syncing these data and offering support during the transition back to the community.</div><div><strong>Trial Registration</strong>: <span><span>https://clinicaltrials.gov/study/NCT06506344</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108184"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760862","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}
Pub Date : 2026-02-01Epub Date: 2026-01-03DOI: 10.1016/j.cct.2025.108212
Iris Dalhuisen , Marloes Wurkum , Chris Bervoets , Eric Constant , Eric van Exel , Mickaël Hiligsmann , Alexander Sack , Teresa Schuhmann , Indira Tendolkar , Thierry Verplancke , Ben Wijnen , Chris Baeken , Philip van Eijndhoven
Introduction
Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), yet some patients only show partial or no response. Recent efforts to enhance rTMS efficacy have focused on combining rTMS with adjunctive interventions, such as psychotherapy, which may yield synergistic effects rather than merely additive effects. Cognitive control training (CCT) activates similar underlying neural circuits as rTMS and has demonstrated antidepressant potential. Given the time-intensive nature of rTMS, augmenting it with CCT may offer a pragmatic, time-efficient and potentially cost-effective solution to increase the therapeutic response of rTMS. This study aims to investigate whether rTMS augmented with CCT is more (cost-) effective in reducing depressive symptoms as opposed to rTMS alone.
Methods
In this international multicenter clinical trial, 132 adult patients with depression will be randomized to receive rTMS either augmented with CCT or placebo task. The trial consists 30 rTMS sessions over eight weeks, followed by a follow-up period up to one year. The primary outcome is the change in depressive severity, assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17) after eight weeks of treatment. Secondary outcomes include an economic evaluation and response and remission after 8 weeks of treatment as well as during follow-up.
Discussion
The present study aims to improve the (cost-)effectiveness of rTMS by concurrently combining rTMS with CCT. Findings may support the development of more cost-effective, personalized interventions for the treatment of depression.
Trial registration
This trial is registered within the Overview of medical research in the Netherlands, OMON (code: NL-OMON57187, date: 18 December 2024).
{"title":"Enhancing effect of cognitive control training on rTMS treatment in depression: A study protocol for a multicenter randomized controlled trial","authors":"Iris Dalhuisen , Marloes Wurkum , Chris Bervoets , Eric Constant , Eric van Exel , Mickaël Hiligsmann , Alexander Sack , Teresa Schuhmann , Indira Tendolkar , Thierry Verplancke , Ben Wijnen , Chris Baeken , Philip van Eijndhoven","doi":"10.1016/j.cct.2025.108212","DOIUrl":"10.1016/j.cct.2025.108212","url":null,"abstract":"<div><h3>Introduction</h3><div>Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), yet some patients only show partial or no response. Recent efforts to enhance rTMS efficacy have focused on combining rTMS with adjunctive interventions, such as psychotherapy, which may yield synergistic effects rather than merely additive effects. Cognitive control training (CCT) activates similar underlying neural circuits as rTMS and has demonstrated antidepressant potential. Given the time-intensive nature of rTMS, augmenting it with CCT may offer a pragmatic, time-efficient and potentially cost-effective solution to increase the therapeutic response of rTMS. This study aims to investigate whether rTMS augmented with CCT is more (cost-) effective in reducing depressive symptoms as opposed to rTMS alone.</div></div><div><h3>Methods</h3><div>In this international multicenter clinical trial, 132 adult patients with depression will be randomized to receive rTMS either augmented with CCT or placebo task. The trial consists 30 rTMS sessions over eight weeks, followed by a follow-up period up to one year. The primary outcome is the change in depressive severity, assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17) after eight weeks of treatment. Secondary outcomes include an economic evaluation and response and remission after 8 weeks of treatment as well as during follow-up.</div></div><div><h3>Discussion</h3><div>The present study aims to improve the (cost-)effectiveness of rTMS by concurrently combining rTMS with CCT. Findings may support the development of more cost-effective, personalized interventions for the treatment of depression.</div></div><div><h3>Trial registration</h3><div>This trial is registered within the Overview of medical research in the Netherlands, OMON (code: NL-OMON57187, date: 18 December 2024).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108212"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905728","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}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108206
Shannon K. Runge , Elizabeth M. Hudak , Jade A. Sutfin , Victor R. Dobrovolskiy , Jerri D. Edwards
Background/Purpose
Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators – former study participants – enhanced intervention adherence or study retention in a clinical trial among healthy older adults.
Methods
We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (N = 268) by assigning a subsample of participants to peer navigators (n = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention.
Results
Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (SD = 5) with 16 years of education (SD = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, t(134.2) = −6.0, p < .001; participants with a navigator completed an average of 5 more sessions (M = 20, SD = 3) compared to those without a navigator (M = 15, SD = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), X2 (1, N = 261) = 10.0, p = .002.
Conclusions
Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed.
The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, https://clinicaltrials.gov/study/NCT03528486
{"title":"The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT","authors":"Shannon K. Runge , Elizabeth M. Hudak , Jade A. Sutfin , Victor R. Dobrovolskiy , Jerri D. Edwards","doi":"10.1016/j.cct.2025.108206","DOIUrl":"10.1016/j.cct.2025.108206","url":null,"abstract":"<div><h3>Background/Purpose</h3><div>Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators – former study participants – enhanced intervention adherence or study retention in a clinical trial among healthy older adults.</div></div><div><h3>Methods</h3><div>We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (<em>N</em> = 268) by assigning a subsample of participants to peer navigators (<em>n</em> = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention.</div></div><div><h3>Results</h3><div>Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (<em>SD</em> = 5) with 16 years of education (<em>SD</em> = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, <em>t</em>(134.2) = −6.0, <em>p</em> < .001; participants with a navigator completed an average of 5 more sessions (<em>M</em> = 20, <em>SD</em> = 3) compared to those without a navigator (<em>M</em> = 15, <em>SD</em> = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), <em>X</em><sup>2</sup> (1, <em>N</em> = 261) = 10.0, <em>p</em> = .002.</div></div><div><h3>Conclusions</h3><div>Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed.</div><div>The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, <span><span>https://clinicaltrials.gov/study/NCT03528486</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108206"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843537","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}
Pub Date : 2026-02-01Epub Date: 2026-01-02DOI: 10.1016/j.cct.2025.108214
Jaime Perales-Puchalt , Mariana Ramírez-Mantilla , Henry P. Moore , Idaly Velez-Uribe , Vanessa Sepulveda-Rivera , Rachel Ruiz , Mónica Fracachán-Cabrera , Yesenia Herrera , Christina Baker , Antonio Miras-Neira , Becky Bothwell , Heidi Anderson , Tina Lewandowski , Francisco J. Diaz , K. Allen Greiner , Kristine Williams , Eric D. Vidoni , Edward Ellerbeck , Jeffrey M. Burns
Background
Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention on depression and distress among informal Latino dementia caregivers. We will also assess mechanisms of action.
Methods
We are enrolling 288 Latino dementia informal caregivers 18 or older into a parallel group RCT. Participants randomized to the intervention group receive a remote, asynchronous, bilingual, bi-directional, 6-month texting program focused on dementia education, skill-building and community resources. The control group enters a 7-month waitlist after which they are offered the same intervention as the intervention group. Randomization is stratified by each of the four recruitment sites at a 1:1 ratio. Outcomes (e.g., caregiver depressive symptomatology, distress) are measured via surveys at baseline, 3, 6 and 7 months.
Conclusions
This RCT addresses two priority areas: eliminating dementia disparities and optimizing caregiver support. Findings have the potential to make clinical and policy-relevant contributions by providing appropriate caregiver support to Latinos in a highly scalable way.
{"title":"Testing the effects of a text message intervention on depression and distress among Latino dementia caregivers: A randomized controlled trial protocol","authors":"Jaime Perales-Puchalt , Mariana Ramírez-Mantilla , Henry P. Moore , Idaly Velez-Uribe , Vanessa Sepulveda-Rivera , Rachel Ruiz , Mónica Fracachán-Cabrera , Yesenia Herrera , Christina Baker , Antonio Miras-Neira , Becky Bothwell , Heidi Anderson , Tina Lewandowski , Francisco J. Diaz , K. Allen Greiner , Kristine Williams , Eric D. Vidoni , Edward Ellerbeck , Jeffrey M. Burns","doi":"10.1016/j.cct.2025.108214","DOIUrl":"10.1016/j.cct.2025.108214","url":null,"abstract":"<div><h3>Background</h3><div>Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention on depression and distress among informal Latino dementia caregivers. We will also assess mechanisms of action.</div></div><div><h3>Methods</h3><div>We are enrolling 288 Latino dementia informal caregivers 18 or older into a parallel group RCT. Participants randomized to the intervention group receive a remote, asynchronous, bilingual, bi-directional, 6-month texting program focused on dementia education, skill-building and community resources. The control group enters a 7-month waitlist after which they are offered the same intervention as the intervention group. Randomization is stratified by each of the four recruitment sites at a 1:1 ratio. Outcomes (e.g., caregiver depressive symptomatology, distress) are measured via surveys at baseline, 3, 6 and 7 months.</div></div><div><h3>Conclusions</h3><div>This RCT addresses two priority areas: eliminating dementia disparities and optimizing caregiver support. Findings have the potential to make clinical and policy-relevant contributions by providing appropriate caregiver support to Latinos in a highly scalable way.</div><div>Protocol version/date: 1/14/2025.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108214"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899342","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}
Pub Date : 2026-02-01Epub Date: 2025-12-15DOI: 10.1016/j.cct.2025.108187
Danielle M. McCarthy , Lisa B. VanWagner , Miriam R. Rafferty , Kenzie A. Cameron , Jungwha Lee , Siyuan Dong , Anuva Fellner , Amy V. Kontrick
Background
Up to a quarter of emergency department (ED) patients have incidental hepatic steatosis (fatty liver) noted on imaging studies; however, patients are infrequently notified about this new finding. This lack of communication may have consequences including delayed diagnosis of metabolic associated steatotic liver disease (MASLD) and disease progression.
Methods
This type-2 hybrid effectiveness-implementation study uses a Stepped Wedge-Cluster Randomized Trial design across 11 EDs to evaluate an electronic health record (EHR) delivered intervention. The STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED) clinical decision support system leverages the EHR to identify cases of hepatic steatosis and deliver risk-stratified communication to clinicians supporting patient notification about hepatic steatosis in the ED. The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days post-ED discharge; the primary implementation outcome is fidelity, defined as the degree to which STIRRED was delivered as intended. Over the study period, ∼4700 patients with incidental hepatic steatosis will be analyzed, including 616 high-risk patients, providing 80 % power to detect a risk difference of 5.6 % (odds ratio of 3.5) between STIRRED and usual care in the receipt of a new steatotic liver disease-related diagnosis.
Discussion
This trial uses the electronic health record to deliver an evidence-based risk stratification score and referral recommendation to the bedside clinician in patients with incidentally noted hepatic steatosis. Rigorous implementation science methodology used in both the intervention development and assessment will increase the usability of the intervention and future scalability.
Trial Registration: This trial was prospectively registered on 10/9/2024 with ClinicalTrials.gov (# NCT06944353).
{"title":"Improving diagnostic safety through steatosis identification, risk stratification, and referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial","authors":"Danielle M. McCarthy , Lisa B. VanWagner , Miriam R. Rafferty , Kenzie A. Cameron , Jungwha Lee , Siyuan Dong , Anuva Fellner , Amy V. Kontrick","doi":"10.1016/j.cct.2025.108187","DOIUrl":"10.1016/j.cct.2025.108187","url":null,"abstract":"<div><h3>Background</h3><div>Up to a quarter of emergency department (ED) patients have incidental hepatic steatosis (fatty liver) noted on imaging studies; however, patients are infrequently notified about this new finding. This lack of communication may have consequences including delayed diagnosis of metabolic associated steatotic liver disease (MASLD) and disease progression.</div></div><div><h3>Methods</h3><div>This type-2 hybrid effectiveness-implementation study uses a Stepped Wedge-Cluster Randomized Trial design across 11 EDs to evaluate an electronic health record (EHR) delivered intervention. The STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED) clinical decision support system leverages the EHR to identify cases of hepatic steatosis and deliver risk-stratified communication to clinicians supporting patient notification about hepatic steatosis in the ED. The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days post-ED discharge; the primary implementation outcome is fidelity, defined as the degree to which STIRRED was delivered as intended. Over the study period, ∼4700 patients with incidental hepatic steatosis will be analyzed, including 616 high-risk patients, providing 80 % power to detect a risk difference of 5.6 % (odds ratio of 3.5) between STIRRED and usual care in the receipt of a new steatotic liver disease-related diagnosis.</div></div><div><h3>Discussion</h3><div>This trial uses the electronic health record to deliver an evidence-based risk stratification score and referral recommendation to the bedside clinician in patients with incidentally noted hepatic steatosis. Rigorous implementation science methodology used in both the intervention development and assessment will increase the usability of the intervention and future scalability.</div><div>Trial Registration: This trial was prospectively registered on 10/9/2024 with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (# <span><span>NCT06944353</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108187"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773884","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}
Pub Date : 2026-02-01Epub Date: 2025-12-19DOI: 10.1016/j.cct.2025.108189
Paola Palombo , Nicole Akana , Abigail Bowen , Alex Schmidt , Rachel Ryan , Sean Hovland , B. Connor Stark , Nicole Rodin , Naomi Chaytor , Michael G. McDonell , Ekaterina Burduli , Matthew Layton , John M. Roll , Crystal L. Smith , André Q. Miguel , Sterling M. McPherson
Background
Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.
Methods
Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.
Conclusions
If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.
{"title":"The pharmaceutically enhanced reinforcement for reduced alcohol and smoking (PERRAS) study: Protocol for a randomized clinical trial","authors":"Paola Palombo , Nicole Akana , Abigail Bowen , Alex Schmidt , Rachel Ryan , Sean Hovland , B. Connor Stark , Nicole Rodin , Naomi Chaytor , Michael G. McDonell , Ekaterina Burduli , Matthew Layton , John M. Roll , Crystal L. Smith , André Q. Miguel , Sterling M. McPherson","doi":"10.1016/j.cct.2025.108189","DOIUrl":"10.1016/j.cct.2025.108189","url":null,"abstract":"<div><h3>Background</h3><div>Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.</div></div><div><h3>Methods</h3><div>Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.</div></div><div><h3>Conclusions</h3><div>If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108189"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803361","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}
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