Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
Addressing challenges in outreach and recruitment: A case study of an NIH-funded randomized controlled trial.
Waselewski M, Eazer LA, Farrell K … +2 more , Jones J, Chang T
Contemp Clin Trials · 2026 Jun · PMID 42229795 · Publisher ↗
Success of randomized controlled trials depends on effective recruitment and retention to ensure adequate power and generalizability. Historically underrepresented populations continue to face logistical, psychological,...
Success of randomized controlled trials depends on effective recruitment and retention to ensure adequate power and generalizability. Historically underrepresented populations continue to face logistical, psychological, and socioeconomic barriers to participation despite movement toward pragmatic study design. This paper describes the multifaceted recruitment approaches used to identify and engage young pregnant women with low-income in a behavioral intervention study. Adaptive recruitment strategies employed in this study led to recruitment of 341 individuals in 49 months, with 84% of individuals with a first contact completing enrollment. Building community and clinical relationships alongside social media recruitment and establising participant rapport were used in tandem to achieve recruitment goals. Fully remote procedures enabled reduced participant burden, flexibility, and statewide study reach to increase engagement. Outreach templates, text message communications, advertising language, and images are all provided to support adaptation of our recruitment processes by other researchers.
Rationale and study design for a randomized clinical trial of HOPE-Genomics, a web-based intervention to improve cancer patients' understanding of genomic testing results.
Solomon IB, Luong M, Currey M … +22 more , Labib S, Tang S, Martinez J, Suarez C, Qiao R, Mak A, Cheung F, Manookian R, Xiao Y, Garcia M, Seshadri A, Jinadu J, Kim M, Martinez R, White P, Martinez F, Rout R, Sharifara A, Zhou C, Boyd P, Davey S, Gray SW
Contemp Clin Trials · 2026 May · PMID 42217668 · Publisher ↗
BACKGROUND: Genomic testing is rapidly being incorporated into cancer care. The results of somatic (tumor) and germline (normal) DNA testing can have implications for treatment, management of future cancer risk, and the...
BACKGROUND: Genomic testing is rapidly being incorporated into cancer care. The results of somatic (tumor) and germline (normal) DNA testing can have implications for treatment, management of future cancer risk, and the health of family members. Despite these benefits, many patients fail to understand genomic concepts and their testing results. To address these knowledge gaps, we developed Helping Oncology Patients Explore (HOPE) Genomics. HOPE-Genomics is an interactive, web-based tool that 1) educates patients about genomics, 2) enables direct-to-patient return-of-results (ROR), and 3) facilitates sharing of genomic results within families. Herein we describe an NIH-funded randomized clinical trial (RCT) to test the intervention efficacy. METHODS: We will conduct a prospective, three-arm, RCT of HOPE-Genomics among cancer patients (n = 435) who have received somatic, germline or paired sequencing. Patients will be randomized into one of three arms: (1) Control (i.e., Usual Care), (2) return of results (ROR) through HOPE-Genomics and (3) pre-test genetic education and ROR through HOPE-Genomics. We will survey patients at 5 timepoints over 12 months. The primary study outcome will be patients' genetic testing recall at 10-day post-disclosure. Secondary outcome will be receipt of genomically-informed, guideline concordant care. Exploratory outcomes will include recall of genetic testing at 3-month post-disclosure, and general and cancer genetic knowledge. CONCLUSION: Our hypothesis is that the use of HOPE-Genomics will result in higher rates of recalling genetic testing, better understanding of general genomic knowledge and higher uptake of evidence-based genetically guided care. If effective, HOPE-Genomics could serve as a scalable model for genomics education and care delivery. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04905082.
Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors study protocol.
Baudier RL, Mosack KE, Lapidus JA … +19 more , Porter LS, Anderson A, Hope AA, Johnson A, Johnson K, Lesowski K, Avallone Mantelli R, Marentes Ruiz CJ, McDougal M, Mejia-Flores L, Mitchell J, Moss M, Neville TH, Estela Vasquez Guzman C, Vu A, Wolwowicz EL, Hough CL, Morris CD, Cox CE
Contemp Clin Trials · 2026 Jul · PMID 42217309 · Publisher ↗
INTRODUCTION: Persistent psychological distress including symptoms of depression, anxiety, and posttraumatic stress disorder (PTSD) occur in as many as 70% of intensive care unit (ICU) survivors. However, few therapies e...
INTRODUCTION: Persistent psychological distress including symptoms of depression, anxiety, and posttraumatic stress disorder (PTSD) occur in as many as 70% of intensive care unit (ICU) survivors. However, few therapies exist that target this population's unique symptoms and needs. To address this, we developed the Blueprint adaptive coping skills mobile app, which was found to be feasible and reduce psychological distress symptoms in a recent single-center pilot randomized control trial (RCT). OBJECTIVE: To describe the methods of the Blueprint 2 multi-center RCT (clinicaltrials.gov ID NCT06538246) being conducted to test the efficacy of the Blueprint app in reducing psychological distress among ICU survivors compared to an education control in a geographically and sociodemographically diverse population, including Spanish-language speakers. METHODS AND ANALYSIS: In this RCT, 400 participants with a baseline Hospital Anxiety and Depression Scale (HADS) total score ≥ 8 will be randomized in a 1:1 ratio to intervention or control. The HADS total score at one month post-randomization is the primary outcome. Secondary outcomes include HADS anxiety and depression subscales, posttraumatic stress scale (PTSS), and the quality-of-life EQ-5D 100-point visual analog scale (VAS) at 1, 3, and 6 months. Select subgroup analyses including users of the Spanish-language version of the app will be used to evaluate consistency of effects across patient populations. Constrained longitudinal data analyses will compare outcomes across intervention groups and timepoints.
Practical considerations when designing an online learning algorithm for an app-based mHealth intervention.
Gonzalez RT, Abbott MR, Nallamothu B … +3 more , Hummel S, Dorsch M, Dempsey W
Contemp Clin Trials · 2026 Jul · PMID 42214461 · Publisher ↗
The ubiquitous nature of mobile health (mHealth) technology has expanded opportunities for the integration of reinforcement learning into traditional clinical trial designs, allowing researchers to learn individualized t...
The ubiquitous nature of mobile health (mHealth) technology has expanded opportunities for the integration of reinforcement learning into traditional clinical trial designs, allowing researchers to learn individualized treatment policies during the study. LOWSALT4LIFE 2 (LS4L2) is a recent trial aimed at reducing sodium intake among hypertensive individuals through an app-based intervention. A reinforcement learning algorithm, which was deployed in one of the trial arms, was designed to send reminder notifications to promote app engagement in contexts where the notification would be effective, i.e., when a participant was likely to open the app in the next 30-minutes and not when prior data suggested reduced effectiveness. Such an algorithm can improve app-based mHealth interventions by reducing participant burden and more effectively promoting behavior change. We encountered various challenges during the implementation of the learning algorithm, which we present as a template to solving challenges in future trials that deploy reinforcement learning algorithms. We provide template solutions based on LS4L2 for solving the key challenges of (i) defining a relevant reward, (ii) determining a meaningful timescale for optimization, (iii) specifying a robust statistical model that allows for automation, (iv) balancing model flexibility with computational cost, and (v) addressing missing values in gradually collected data.
The prevention of sexual violence in school settings with adolescents: A study protocol for the cluster randomized trial of the SUN (stand up now against sexual violence) program.
Carmo E, Brazão N, Costa P … +2 more , Moreira B, Carvalho J
Contemp Clin Trials · 2026 Jul · PMID 42208729 · Publisher ↗
INTRODUCTION: Sexual violence (SV) is a global public health concern that impacts adolescents worldwide. This project aims to develop, deliver, and assess the efficacy of a new SV bystander prevention program for adolesc...
INTRODUCTION: Sexual violence (SV) is a global public health concern that impacts adolescents worldwide. This project aims to develop, deliver, and assess the efficacy of a new SV bystander prevention program for adolescents: the SUN (Stand Up Now against sexual violence) Program. This manualized bystander program, specifically targeting SV, will be implemented by psychologists in Portuguese schools. The SUN combines psychoeducation with skills training exercises, targeting social norms, attitudes, emotions, and behaviors. Program contents include sexual and reproductive rights, SV, sexual consent, bystander attitudes and behaviors, and empathy. METHODS: This mixed-method study will involve a pragmatic parallel-arm cluster randomized controlled trial, conducted with the following goals: to assess the program's efficacy regarding bystander attitudes and behaviors (as primary outcomes), and SV myths, sexism, and empathy (as secondary outcomes); to examine the maintenance of changes three, six, and nine months after the program's completion; to assess mechanisms of change; to investigate whether age, gender, sexual orientation, and personal history of victimization will influence participants' responsivity to the program; to assess the program's acceptability and to document contextual factors influencing implementation. The sample will include adolescents from high schools in the North and Centre of Portugal, enrolled in 10th and 11th grades. Participants will be assessed at five time-points using self-report questionnaires and focus groups will be conducted to gather their perceptions regarding the Program. CONCLUSIONS: This will be the first primary prevention program for SV to be assessed in a cluster randomized trial in Portugal, and one of the first to do so in Europe, particularly using a bystander approach. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov (Identifier: NCT06830278) on 17 February 2025, after trial commencement and completion of baseline and post-intervention assessments, and prior to completion of follow-up assessments.
The glucose monitoring comparison in primary care study (GluCoCare): Study design, methods, recruitment success, and baseline characteristics of study participants.
Martens TW, Asche SE, JaKa MM … +16 more , Johnson ML, Dunnigan S, Haven AL, Morris C, Barnaby D, Maciosek MV, Dinh JM, Kaiser SJ, Trower NK, Gustafson SK, Leet K, Krizka SK, Zimmerman SH, Castellanos VG, Forrester KR, Bergenstal RM
Contemp Clin Trials · 2026 Jul · PMID 42191110 · Publisher ↗
BACKGROUND: While both fingerstick blood glucose monitoring (BGM) and continuous glucose monitoring (CGM) are currently available for people managing type 2 diabetes (T2D) with insulin, it is not currently known which is...
BACKGROUND: While both fingerstick blood glucose monitoring (BGM) and continuous glucose monitoring (CGM) are currently available for people managing type 2 diabetes (T2D) with insulin, it is not currently known which is more effective in optimizing glycemia and decreasing disease burden in this population in real-world settings. OBJECTIVES: This two-arm cluster-randomized trial will compare use of BGM versus CGM in individuals with T2D using insulin not meeting A1C goals. We will compare change in hemoglobin A1c (A1C) (primary outcome measure) and Diabetes Distress Scale score (DDS) (secondary outcome measure) in individuals attending primary care clinics randomized to either BGM or CGM monitoring over 12 months. MATERIALS AND METHODS: Fifty clinics in a large healthcare system in Minnesota and Wisconsin were randomized to enroll individuals to monitor with BGM (25 clinics) or CGM (25 clinics). Adults aged 18-75 with T2D using insulin, A1C 7.5-12%, were recruited from these clinics to be managed by their primary care clinician in a fundamentally pragmatic intervention over 12 months. A1C, DDS, and blinded CGM along with patient reported outcome (PRO) measures will be compared between 0 and 12 months. RESULTS: GluCoCare met its enrollment goals, enrolling 360 individuals from 42 primary care clinics between September 2022 and June 2024, age (mean ± SD) 60.5 ± 10.3 years, diabetes duration 14.3 ± 8.2 years, A1C 8.8% ± 1.1%, and DDS 2.2 ± 0.9. CONCLUSIONS: We have successfully enrolled participants with T2D using insulin, to test in a real-world primary care setting, whether BGM versus CGM improves A1c or decreases Diabetes Distress Scale score more.
Rationale and protocol for time-based energy intake goals within an obesity care lifestyle intervention: Daily eating patterns for total health study.
Raynor HA, Berlin KS, Bond DS … +6 more , Cardoso C, Carskadon M, Ehrlich S, Holloway E, Thomas JG, Wu Y
Contemp Clin Trials · 2026 Jul · PMID 42184900 · Full text
This publication outlines the rationale and protocol for the Daily Eating Patterns for Total Health (DEPTH) trial, detailing its motivation, aims, design, intervention, and measures. This randomized clinical trial examin...
This publication outlines the rationale and protocol for the Daily Eating Patterns for Total Health (DEPTH) trial, detailing its motivation, aims, design, intervention, and measures. This randomized clinical trial examines how time-based energy goals applied within a 12-month obesity care lifestyle intervention influences percent weight loss, dietary temporal patterns, sleep regularity, and appetite regulation. One hundred seventy-four adults (ages: 25-60 y; BMI: 27-45 kg/m) will be randomized to one of three interventions: DEPTH-Morning, DEPTH-Evening, or DEPTH. All participants will receive 33 sessions of an obesity care lifestyle intervention that includes five separate dietary goals: (1) 1200-1500 kcal/day, (2) ≤ 30% energy from fat, (3) a 12-h eating window, (4) first eating occasion within 60 min of awakening, and (5) 3 meals and 1 snack per day. They will also aim for 200 min/wk. of moderate- to vigorous-intensity physical activity. DEPTH-Morning participants will be given the goals to consume 70% of energy in two meals and one snack during the first six hours of the 12-h eating window, and 30% of energy in one meal in the last six hours of the eating window (morning-loaded distribution). DEPTH-Evening will be given goals to adopt the opposite pattern (afternoon/evening-loaded distribution). DEPTH participants will have no specific time-based energy intake goals. Measures of anthropometrics, dietary intake, sleep, and appetite regulation will be assessed at 0, 3, 6, and 12-months. This study will provide insights into the role of time-based energy intake goals, a form of chrononutrition, on obesity care outcomes.
Micro-randomization trial design under operational constraints.
Bunning B, Ritter V, Bishop FK … +9 more , Chen JH, Ding V, Johari R, Shaw B, Scheinker D, Prahalad P, Thapa I, Maahs DM, Desai M
Contemp Clin Trials · 2026 Jul · PMID 42184899 · Publisher ↗
BACKGROUND: Micro-randomization is a common method used to design and tailor AI-driven digital health interventions. However, applying it in real-world clinical settings can be challenging particularly when there are ope...
BACKGROUND: Micro-randomization is a common method used to design and tailor AI-driven digital health interventions. However, applying it in real-world clinical settings can be challenging particularly when there are operational or resource constraints. We propose a novel design that integrates micro-randomization with treatment allocation policies to address such constraints, inspired by a pediatric type 1 diabetes (T1D) program. METHODS: We evaluated the design's properties through an extensive simulation study and developed a simulation-based power calculator, MRThreshold, to support such trial designs. RESULTS: Operational constraints that led to imbalance in treatment assignment affected efficiency. However, increasing resources had less impact relative to increases in study length (i.e., opportunities for micro-randomization). We observed a > 50% increase in power when lengthening a 16-week study to a 40-week study. Using our power calculator, we demonstrated that a 40-week study with 100 patients provides 84.0% power to detect a 2% change in time spent in glucose control, providing design considerations for our study. CONCLUSIONS: Careful consideration of study length, sample size, and operational capacity is essential for thoughtful design. Our novel design and tool balance micro-randomization and treatment allocation under operational constraints.
Hybrid type 1 randomized controlled trial of technology-assisted stepped care behavioral health intervention for caregivers and children following pediatric traumatic injury.
Ridings LE, Thomsen KN, Prentice MA … +11 more , Powell E, Becerra G, Mueller M, Hanson R, Streck CJ, Ehrlich P, Ewing-Cobbs L, Marsac ML, Spurrier R, Davidson T, Ruggiero KJ
Contemp Clin Trials · 2026 Jul · PMID 42178019 · Publisher ↗
Pediatric traumatic injury (PTI) has substantial physical and emotional health impacts, sometimes resulting in hospitalization and/or the development of posttraumatic stress disorder (PTSD) and depression in children. Ca...
Pediatric traumatic injury (PTI) has substantial physical and emotional health impacts, sometimes resulting in hospitalization and/or the development of posttraumatic stress disorder (PTSD) and depression in children. Caregivers are a key source of support for children following PTI; however, many caregivers experience their own distress and psychological reactions following injury. The CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) model is a technology-assisted, stepped care intervention to support the emotional and behavioral recovery of preadolescent children hospitalized after PTI and their caregivers. The CAARE model seeks to provide a systematic, evidence-based screening and intervention procedure that is feasible to implement within pediatric trauma centers. This protocol paper describes a study to evaluate the effectiveness of the CAARE model in improving quality of life, clinical and functional outcomes, and treatment engagement in children and their caregivers following PTI. We also aim to explore potential inequities regarding race, ethnicity, and injury type. This hybrid type 1 effectiveness-implementation trial design allows for the examination of contextual factors related to implementation of CAARE. This paper includes a description of the intervention and control conditions, participant selection and recruitment procedures, assessment measures, and planned quantitative and qualitative methodologies. Potential implications and future directions are discussed. This study was registered in ClinicalTrials.gov (NCT04579198).
Rationale and study protocol for a randomized controlled MIND diet feeding trial for breast cancer-related cognitive impairment.
Crowder SL, Hu B, Hoogland AI … +10 more , Li X, Rodriguez Y, Bryant C, Varghese DM, Simon DF, Reese SA, Carson TL, Han HS, Small BJ, Jim HSL
Contemp Clin Trials · 2026 Jul · PMID 42173439 · Full text
BACKGROUND: Despite well-documented cancer-related cognitive impairment (CRCI) burden, few efficacious interventions exist to mitigate CRCI. Biological mechanisms include inflammation and oxidative stress, which may be i...
BACKGROUND: Despite well-documented cancer-related cognitive impairment (CRCI) burden, few efficacious interventions exist to mitigate CRCI. Biological mechanisms include inflammation and oxidative stress, which may be influenced by diet. Dietary interventions could be highly disseminable and acceptable, but have not been evaluated for CRCI. This study will examine the efficacy of a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet on CRCI. METHODS: Breast cancer survivors will be eligible if they have completed adjuvant treatment 6 months to three years previously, self-reported CRCI, and low adherence to the MIND diet. Participants (N = 200) will be randomized 1:1 to a 12-week feeding trial of the MIND diet versus their usual diet. To achieve maximal effect, the study consists of two 12-week phases: 1) intervention phase, MIND diet meals will be provided with skill coaching, and 2) maintenance phase, determine the extent of the diet in maintaining cognition to determine efficacy and future scalability. Subjective cognition will be evaluated as the primary outcome. Secondary outcomes include objective CRCI, self-reported fatigue, mood, and quality of life. Assessments will occur immediately before the intervention (baseline), at the end of the intervention phase (first 12-week phase), and end of the maintenance phase (second 12-week phase). DISCUSSION: Findings will describe the relationship between diet and CRCI and provide a novel examination of the MIND diet as a strategy to mitigate CRCI. Results have potential to influence clinical practice, translational research, and public health efforts aimed at developing medical nutrition therapy guidelines tailored to this population. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT07018986, on 2025-06-13.
Supporting tailored adaptive change and reinforcement for medication adherence program (STAR-MAP): Rationale and design of a randomized controlled clinical trial.
Peacock E, Mohundro B, Li J … +5 more , Bazzano L, Shankar A, Petty R, Kegan R, Krousel-Wood M
Contemp Clin Trials · 2026 Jul · PMID 42173438 · Publisher ↗
BACKGROUND: Low antihypertensive medication adherence remains a clinical challenge, leading to uncontrolled blood pressure (BP) and increased cardiovascular risk. Traditional adherence interventions targeting patients' c...
BACKGROUND: Low antihypertensive medication adherence remains a clinical challenge, leading to uncontrolled blood pressure (BP) and increased cardiovascular risk. Traditional adherence interventions targeting patients' conscious processes have shown limited success. This study will determine the efficacy and sustainability of a novel intervention targeting subconscious implicit attitudes as the mechanism on improving adherence, BP control, and quality of life (QOL). METHODS: The Medication Adherence Program (MAP) is a randomized controlled trial among adults aged ≥40 years with hypertension, fully insured by a statewide insurer, with low antihypertensive medication adherence (pharmacy fill: proportion of days covered [PDC] <0.8 and self-report: Krousel-Wood Medication Adherence Scale [K-Wood-MAS-4] ≥1) and uncontrolled BP (≥130/80 mmHg). Participants are randomized to either the STAR-MAP intervention (eleven 30-50-min virtual health coaching sessions over one year, a pillbox, and adherence app) or the Medication Adherence Reminder System-MAP enhanced usual care (pillbox and adherence app only). The primary outcome is between-group difference in proportion with PDC ≥0.8 at 12 months. Secondary outcomes include between-group differences in change in PDC, K-Wood-MAS-4, BP control, and QOL at 12 and 24 months. Mediation by changes in implicit attitudes will be examined. The planned sample size of 402 participants (50% women; 30% Black) has 90% power to detect a 15% between-group difference in the primary outcome (two-sided α = 0.05, 80% follow-up). CONCLUSION: MAP will generate critical data on the efficacy of the novel STAR-MAP intervention for improving medication adherence and BP control, which could improve BP-related disease and healthy aging among adults with uncontrolled hypertension. CLINICAL TRIAL REGISTRATION: The trial has been registered with ClinicalTrials.gov: NCT05183763.
Integrated Childhood Activity and Nutrition (ICAN) study: Protocol for a randomized controlled trial to prevent summer learning loss and promote child health.
Kinder CJ, Liu R, McCabe E … +5 more , Madson J, Keye S, Hodge K, Richards KA, Khan NA
Contemp Clin Trials · 2026 Jul · PMID 42140347 · Publisher ↗
BACKGROUND: Children from communities affected by poverty face disproportionate risks of summer learning loss, physical inactivity, and poor diet, contributing to widening disparities in academic and health outcomes. The...
BACKGROUND: Children from communities affected by poverty face disproportionate risks of summer learning loss, physical inactivity, and poor diet, contributing to widening disparities in academic and health outcomes. These inequities are further compounded by limited access to high-quality foods and structured opportunities for physical activity during the summer months. Lutein, a xanthophyll carotenoid that accumulates in neural tissue, has been associated with cognitive and visual function. Physical activity and social-emotional learning (SEL) interventions independently improve executive function, self-regulation, and academic readiness. The Integrated Childhood Activity and Nutrition (ICAN) clinical trial (ClinicalTrials.gov: NCT07011602) is a randomized controlled trial evaluating an 8-week summer program integrating daily physical activity, nutrition education, SEL instruction, and lutein-rich foods for elementary-aged children. METHODS: Children (aged 6-11 years) eligible for the Supplemental Nutrition Assistance Program will be randomized to an intervention group (Illinois Physical Activity and Life Skills program) or waitlist control. Primary outcomes include academic achievement, behavioral and neuroelectric measures of cognitive functioning, carotenoid status, physical activity, and physical fitness. Secondary outcomes include dietary intake, plate waste, growth, body composition, and nutrition- and SEL-literacy. DISCUSSION: We hypothesize that intervention participants will maintain or improve academic and cognitive performance, show greater increases in carotenoid status and fitness, and exhibit gains in SEL and nutrition literacy versus controls. CONCLUSION: The ICAN clinical trial will provide evidence on the efficacy of an SEL-framed multicomponent intervention to mitigate summer learning loss, promote healthy behaviors, and support child health and development.
Integration of Cognitive Processing Therapy for PTSD and cognitive-behavioral therapy for co-occurring alcohol use disorder: Design and methodology of a randomized controlled trial.
Vujanovic AA, Back SE, Kaysen DL … +9 more , Jarnecke AM, Roberts K, Ruiz F, Hall KE, Flanagan JC, Schmitz JM, Norman SB, Zoller L, Resick PA
Contemp Clin Trials · 2026 Jul · PMID 42140346 · Publisher ↗
BACKGROUND: The prevalent comorbidity of alcohol use disorder (AUD) with posttraumatic stress disorder (PTSD) is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poo...
BACKGROUND: The prevalent comorbidity of alcohol use disorder (AUD) with posttraumatic stress disorder (PTSD) is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poorer treatment outcomes as compared to either disorder alone. Trauma-focused, cognitive-behavioral interventions delivered alongside interventions for substance use disorders are recommended to reduce PTSD severity and substance use. Cognitive Processing Therapy (CPT) for PTSD and cognitive-behavioral therapy (i.e., Relapse Prevention [RP]) for AUD are two of the most widely used and efficacious treatments for these conditions. There are few effective integrated treatments available for PTSD/AUD comorbidity. The present study addresses this critical gap by further developing and evaluating a 12-session, manualized treatment that integrates CPT and RP for the treatment of co-occurring PTSD/AUD. Primary outcomes include reduction in alcohol use frequency and quantity and reduction in PTSD symptom severity at the end of treatment (session 12). Secondary outcomes are evaluated using ecological momentary assessment (EMA) to elucidate underlying mechanisms of change, including daily alcohol related cognitions and behaviors, PTSD symptoms, and distress tolerance. METHOD: This paper describes the rationale, design, and methodology of a Stage II randomized controlled trial that compares a novel integrated CPT + RP intervention to RP-alone among adults (N = 200) with comorbid PTSD/AUD. CONCLUSION: This study will provide new information to advance the field of PTSD/AUD comorbidity and innovate clinical practice, which may lead to improved treatment outcomes for co-occurring PTSD/AUD.
Let's Talk Birth Control: Study protocol for a cluster randomized trial of a clinic-based contraceptive intervention for adolescents and young adults.
Welti K, Manlove J, Watkins R … +3 more , Whitfield B, Harper CC, Steiner RJ
Contemp Clin Trials · 2026 Jul · PMID 42134686 · Publisher ↗
BACKGROUND: Adolescents and young adults (AYA) often lack sufficient information to make informed contraceptive choices, and many are not using their preferred method. Clinical decision aids (CDAs) improve contraceptive...
BACKGROUND: Adolescents and young adults (AYA) often lack sufficient information to make informed contraceptive choices, and many are not using their preferred method. Clinical decision aids (CDAs) improve contraceptive knowledge, self-efficacy, and decision-making, but few have been designed for or evaluated with AYA. Let's Talk Birth Control (Let's Talk) is a clinic-based intervention that combines a printed CDA and the digital Bedsider.org Method Explorer with a provider training on person-centered contraceptive counseling. This study evaluates the effectiveness of Let's Talk in improving contraceptive behaviors and related outcomes among AYA. METHODS: We are conducting a cluster-randomized controlled trial across 30 U.S. community health centers. Eligible participants are females ages 15-24, sexually active or interested in contraception, not pregnant or intending pregnancy within one year. Health centers are randomized by block design, stratified by Title X funding and school-based status. At intervention sites, participants review the CDA prior to their appointment and discuss contraceptive priorities with their provider using the tool; controls receive standard of care. Primary outcomes, measured at 9 months, are consistent contraceptive use and preferred method use. Secondary outcomes, assessed at 1 week and 9 months, include contraceptive self-efficacy, decision-making confidence, intentions, and knowledge. Multilevel regression models will account for clustering at the health center level. CONCLUSION: Delivering person-centered contraceptive counseling with CDA support is a promising strategy to improve sexual and reproductive health outcomes among AYA. Let's Talk has the potential to strengthen contraceptive counseling for young people and to address gaps in evidence-based sexual health programming.
Increasing physical activity in rural Pennsylvanians: The PA moves trial study protocol for a cluster randomized controlled trial.
West SM, Meyer MRU, Patterson C … +10 more , Ruffin MT, Calo W, Pagoto S, Conroy D, Doerksen S, Sciamanna CN, Gordon B, Garrow G, Werts-Pelter SJ, Schmitz KH
Contemp Clin Trials · 2026 Jul · PMID 42134685 · Publisher ↗
BACKGROUND: Approximately 20% of Americans live in rural communities. For several cancers, incidence rates for rural residents are over 8% higher than for urban residents. Increased physical activity (PA) can reduce risk...
BACKGROUND: Approximately 20% of Americans live in rural communities. For several cancers, incidence rates for rural residents are over 8% higher than for urban residents. Increased physical activity (PA) can reduce risk for several cancers, but rural residents report lower PA than their urban counterparts. Multiple service delivery models have shown success with primary care providers (PCPs) promoting PA. We propose a cluster randomized controlled trial combining PCP PA counseling with telephone coaching to help rural adults increase their PA and reduce their cancer risk. METHODS: 800-880 patients seeing 32-48 PCPs in 17 clinics will be enrolled in cohorts using a wait list control cluster parallel randomized design. Randomization occurs at the clinic level with the intervention offered either immediately or delayed until the final year of the study in a 1:1 ratio. PCPs receive training in evidence-based strategies through Project Extension for Community Healthcare Outcomes, a case-based learning model commonly used to deliver best practices to PCPs. After referral from PCPs, patients receive PA coaching from the MoveLine, a telephone-based coaching service grounded in evidence-based behavior change techniques. Feedback from MoveLine is provided to the PCP about patient progress through the program. An implementation evaluation occurs annually using rapid assessment procedures and qualitative interviews to suggest intervention delivery improvements. To examine contextual factors, clinic communities' PA environments and opportunities are assessed using established rural-specific methods. CONCLUSION: The PA Moves trial is a multilevel randomized trial to address rural health disparities by intervening on PA to reduce cancer risk. CLINICALTRIALS: gov reference numbers: NCT05319821 and NCT05227105.
Study protocol for a mobile app that delivers peer-led mental health support to adults with type 1 diabetes: The REACHOUT randomized wait-list controlled trial.
Tang TS, Klein G, Fisher L … +11 more , Davis JC, Li LC, Görges M, Yardley J, Polonsky WH, Hessler D, Taylor D, Jain A, Singer J, McLean L, Klassen T
Contemp Clin Trials · 2026 May · PMID 42107490 · Publisher ↗
Peer support and digital technology are two promising strategies to address psychosocial needs in type 1 diabetes (T1D). REACHOUT is a mobile app designed to deliver peer-led mental health support to adults with T1D livi...
Peer support and digital technology are two promising strategies to address psychosocial needs in type 1 diabetes (T1D). REACHOUT is a mobile app designed to deliver peer-led mental health support to adults with T1D living in British Columbia. This report describes the methodological design and recruitment for the REACHOUT randomized wait-list controlled (WLC) trial. The primary goal was to examine whether participation in the REACHOUT intervention was associated with reductions in diabetes distress compared to a WLC condition (eligible to receive the intervention after six months). Two-hundred twenty-five adults with T1D (age 19-81 years) completed a baseline survey;113 participants were randomized to the six-month REACHOUT intervention and 112 to the WLC condition. REACHOUT offers support that is choice-based, customizable, and just-in-time. Support delivery modalities include one-on-one support from a participant-selected peer supporter, group-based text support using a 24/7 chat room and topic-specific discussion boards, and small group virtual face-to-face support. The primary outcome of this trial was diabetes distress; secondary outcomes included depressive symptoms, perceived social support, diabetes-specific quality of life, and resilience; exploratory outcomes were A1c, time in range, health resource utilization, and cost-effectiveness. The goal of this research is to examine whether a mobile app that delivers peer-led and personalized mental health support can improve diabetes distress and other mental health outcomes among adults living with T1D.
Study protocol for weSIPsmarter: A cluster randomized-controlled trial to evaluate the efficacy of a digital health intervention aimed at reducing sugary drinks among rural Head Start preschoolers and their parents.
Zoellner JM, You W, Porter KJ … +6 more , Ritterband LM, Hayes T, Thomas T, Brock DP, Reid AL, Markwalter T
Contemp Clin Trials · 2026 Jul · PMID 42105939 · Publisher ↗
Despite the high prevalence of sugary drink consumption among preschool-aged children and strong evidence of risky sugary drink behaviors in rural communities, efficacious and scalable interventions remain limited. In pa...
Despite the high prevalence of sugary drink consumption among preschool-aged children and strong evidence of risky sugary drink behaviors in rural communities, efficacious and scalable interventions remain limited. In partnership with rural Head Starts in Appalachia and the southern Black Belt, this trial targets parents as agents of change to improve sugary drink behaviors among parent-child dyads. Guided by the RE-AIM (reach, efficacy/effectiveness, adoption, implementation, maintenance) framework, the study uses a two-group cluster randomized controlled trial design. Twelve Head Starts are recruited and randomized 1:1 to either the weSIPsmarter experimental condition, a highly interactive, digital, theory-based program incorporating self-monitoring, action planning, a resource help line, and drinking water vouchers for eligible families, or the weLearn2Read control condition, an attention-matched digital program focused on reading readiness. Assessments occur at pre, 9-week, and 12-month follow-up. weSIPsmarter is hypothesized to be more efficacious at reducing sugary drink consumption than the control. Secondary outcomes include parent-child dyad measures (e.g., diet quality, water intake, body mass index, quality of life, behavioral theory constructs) and maintenance at 12 months. Additional aims include examining reach, describing parent engagement, and using a mixed-methods process evaluation to understand adoption, implementation, and potential sustainability across Head Starts. Mediators and moderators of engagement and efficacy outcomes will also be explored. The long-term goal of this primary prevention research is to develop an efficacious, scalable sugary drink reduction intervention with broad reach among rural, low-socioeconomic-status preschool-aged children and their parents, suitable for sustained implementation within Head Start programs.
Conducting multicenter trials through the trial innovation network comprehensive consultation.
Hanley DF, Lane K, McBee N … +36 more , Eyzaguirre LM, Mould WA, Holthouse E, Baird JF, Casey JD, Wilkins CH, Waddy SP, Wiley KL, Hassani S, Hildreth M, Nanni A, Edwards TL, Thompson DD, Stroud M, Serdoz E, Kennedy N, Nelson SJ, Jones M, Boone LR, Lawrence C, Cook SK, Chen T, Cohen J, Dilts N, Cheng AC, Grout RW, Miller ER, Casella JF, Benjamin DK, Selker HP, Palm ME, Poole L, Burr JS, Ford DE, Bernard GR, Harris PA
Contemp Clin Trials · 2026 Jul · PMID 42086122 · Full text
Effective design and execution of multicenter clinical trials remain critical yet challenging for advancing clinical care. The Trial Innovation Network (TIN) Comprehensive Consultation process was established to improve...
Effective design and execution of multicenter clinical trials remain critical yet challenging for advancing clinical care. The Trial Innovation Network (TIN) Comprehensive Consultation process was established to improve the feasibility and success of investigator-initiated trial proposals by offering structured, multidisciplinary support across 60+ Clinical and Translational Science Award (CTSA) institutions. We report outcomes from 75 trial proposals that underwent Comprehensive Consultation between 2016 and 2024. The process follows a phased Assess-Design-Compose model that integrates expertise in trial design, operations, recruitment, and informatics to generate robust, fundable grant applications. Here we demonstrate 66% of our submitted grants receive funding. This consultation framework demonstrates a scalable, high-impact approach to enhancing the rigor, efficiency, and success of multicenter clinical trials and offers a model for national and global networks seeking to improve clinical research translation.
Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients following hematopoietic stem cell transplant or CAR T-cell therapy: Protocol of a randomized controlled trial.
Pedreira PB, Somers TJ, Fisher HM … +11 more , Winger JG, Patterson E, Diachina A, Martinson E, Majestic C, Pittman AS, Cobb M, Sitlinger A, Lin C, Samsa G, Kelleher SA
Contemp Clin Trials · 2026 Jul · PMID 42070654 · Full text
BACKGROUND: Patients undergoing hematopoietic stem cell transplant (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy experience significant disability exacerbated by persistent fatigue, pain, and psychological d...
BACKGROUND: Patients undergoing hematopoietic stem cell transplant (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy experience significant disability exacerbated by persistent fatigue, pain, and psychological distress. These symptoms limit physical activity, one of the most effective and recommended strategies for reducing disability. Cognitive behavioral interventions improve cancer-related symptoms but have not been adapted for this unique patient population. METHODS/DESIGN: This randomized controlled trial will test Step Up, a hybrid-delivered (in-person and mobile health) intervention that integrates cognitive behavioral symptom management with occupational therapy (OT)-led activity coaching. Adults (N = 177) post-HCT or CAR-T who report ≥2 target symptoms (fatigue, pain, psychological distress) at moderate levels (≥3/10) will be randomized 1:1 to Step Up or Usual Care Plus. Step Up includes seven weekly sessions: three in-person during intensive outpatient care and four videoconferencing at home, supported by a mobile app with activity trackers and personalized feedback. Usual Care Plus provides seven educational videos and activity monitoring. The primary outcome is physical disability assessed post-intervention (10-14 weeks after baseline). Secondary outcomes include fatigue, pain, psychological distress, daily steps, self-efficacy for symptom management, and digital symptom biomarkers (e.g., sleep). Assessments occur at baseline, post-intervention, and 3- and 6-month follow-ups. CONCLUSION: This is the first trial to test a hybrid-delivered, theory-based intervention integrating symptom management and OT-led activity coaching for HCT and CAR-T patients. Step Up may reduce physical disability and improve clinical outcomes. If successful, it could lead to widespread implementation to improve recovery during the critical transition from intensive outpatient care to home.
Design of the FRESH-A study: A randomized controlled trial evaluating telehealth parent-only treatment for autistic youth with overweight/obesity.
Boutelle KN, Eichen DM, Martinez K … +6 more , Pinson CK, Strong DR, Reed KL, Akshoomoff N, Rhee KE, Brookman-Frazee L
Contemp Clin Trials · 2026 Jul · PMID 42061554 · Publisher ↗
Autistic children have higher rates of overweight and obesity (OW/OB) compared to nonautistic children. Family-based behavioral treatment (FBT) is the standard of care for children with obesity and is delivered to both t...
Autistic children have higher rates of overweight and obesity (OW/OB) compared to nonautistic children. Family-based behavioral treatment (FBT) is the standard of care for children with obesity and is delivered to both the parent and the child. Common autism characteristics, such as sensory sensitivities, social communication challenges, and behavioral rigidity, can limit the feasibility of providing FBT to both parent and child. Our team developed a parent-based treatment (PBT) model that is delivered only to the parent of an autistic child with OW/OB. Our published pilot data established the initial feasibility, acceptability and initial weight-loss efficacy of this program. This paper presents a protocol for an ongoing two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored for families with an autistic child (PBT-A) with a health education (HE) comparator on the child's weight over 18 months. We aim to recruit 150 families with an autistic child with OW/OB and randomize them to either six-months of telehealth PBT-A or HE treatment delivered to the parent only. The primary outcome is change in child body size, assessed by BMIz and percent of the 95th percentile, over the 18 months of the study. Secondary outcomes include parent BMI, dietary intake for both parent and child, child mealtime behavior, physical activity levels, parenting style, and parental self-efficacy. This ongoing study may provide a scalable, cost-effective intervention for families with an autistic child with OW/OB. Clinical trials # NCT05741840.
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