Contemporary Clinical Trials[JOURNAL]
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200 papers
Remotely-delivered exercise training program among older adults with multiple sclerosis: Feasibility results of a randomized controlled trial.
Zheng P, DeJonge SR, DuBose NG … +6 more , Kidwell-Chandler A, Martin TB, Huynh TLT, Phillips SA, Duffecy J, Motl RW
Contemp Clin Trials · 2026 Feb · PMID 41419055 · Full text
BACKGROUND: Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training. O...
BACKGROUND: Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training. OBJECTIVES: We conducted a phase-Ib, randomized controlled trial (RCT) that examined the feasibility and initial efficacy of a 16-week remotely-delivered, home-based exercise training program in older adults with MS who had moderate mobility disability. METHODS: This study utilized a parallel-group RCT design. Participants (n = 51; mean age = 60.5 years, 78 % females) were randomized into exercise training (aerobic and resistance) or active control (stretching) conditions. Both conditions were undertaken within a participant's home/community and remotely supported by a behavioral coach. Participants received training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and social cognitive theory-based newsletters. Feasibility was assessed across process, resource, management, and scientific domains. Scientific outcomes focused on physical function, cognition, and physical activity, with data collected by treatment-blinded assessors. RESULTS: The intervention was cost-effective, accessible, well-received, and safe based on formative evaluation. Forty-one (80.4 %) participants completed the conditions, with adherence and compliance rates across conditions exceeding 80 %. There were moderate-to-large improvements in walking speed, functional mobility, lower-extremity function, and verbal learning and memory (p < 0.05, |d| = 0.58-0.80) in the exercise condition, but not in control (p > 0.05). CONCLUSIONS: This study established the feasibility and initial efficacy of a theory-based, remotely-delivered exercise training intervention for older adults with MS. The promising results support the design and implementation of a subsequent, phase-II RCT for improving physical and cognitive functions in the older MS population.
Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol.
Ozieh MN, Patterson CG, Williams JS … +2 more , Walker RJ, Egede LE
Contemp Clin Trials · 2026 Feb · PMID 41419054 · Full text
BACKGROUND: Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more li...
BACKGROUND: Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more likely to progress to ESKD compared to non-Hispanic whites. The presence of social adversities impacts the complex self-management of DKD and negatively impacts health outcomes. Patient navigation interventions offer a promising strategy to improve health outcomes in individuals with chronic disease. However, it is not known whether a basic needs navigation intervention that addresses social adversities in combination with patient education and lifestyle coaching leads to improved clinical and patient-centered outcomes. METHODS AND ANALYSIS: This ongoing 3-year two-arm pilot randomized clinical trial will test the feasibility of a basic needs navigation intervention in African American adults with DKD experiencing multidimensional adversity (having one or more social adversity). Fifty African American adults with DKD experiencing one or more social adversity and who have uncontrolled diabetes (HbA1c 8 % or more) will be randomized into one of two arms: 1) basic needs navigation intervention arm or 2) enhanced usual care arm. The primary clinical outcome is feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention. DISCUSSION: The results of this study will serve as a first step in addressing current gaps in knowledge and will provide feasibility data for a large-scale appropriately powered, randomized clinical trial focused on addressing social adversity in African American adults with DKD. ETHICS AND DISSEMINATION: This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675. TRIAL REGISTRATION NUMBER: Registration for this trial can be found under ID: NCT05357742 and online (https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&draw=2&rank=1) on the NIH U.S. National Library of Medicine Clinical Trials Database.
Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial.
Mehta SJ, Shaw PA, Reitz C … +13 more , Brophy C, Okorie E, Williams K, Segura A, Tao J, Snider CK, Wollack C, Friday S, Rendle KA, Klaiman T, Glanz K, Rhodes C, Asch DA
Contemp Clin Trials · 2026 Feb · PMID 41412475 · Full text
BACKGROUND: Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of seque...
BACKGROUND: Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR). METHODS: In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year. ANALYSIS: For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b). CONCLUSION: This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design. CLINICAL TRIALS IDENTIFIER: NCT05693649.
Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families.
Boutelle KN, Eichen DM, Manzano M … +8 more , Crespo NC, Rivera-Iñiguez I, Castro E, Strong DR, Newell I, Reed K, Marquez B, Rhee KE
Contemp Clin Trials · 2026 Feb · PMID 41412474 · Publisher ↗
Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a c...
Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB. Clinical trials # NCT05437406.
Corrigendum to "Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial," [Contemp Clin Trials 101 (2021) 106253].
Whooten RC, Kwete GM, Farrar-Muir H … +4 more , Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM
Contemp Clin Trials · 2026 Jan · PMID 41412096 · Publisher ↗
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Evaluating missing outcome data methods for the analysis of the MEL-SELF trial of patient-led surveillance for early-stage melanoma: A simulation study.
Medcalf E, Turner RM, Espinoza D … +2 more , Zhu L, Bell KJL
Contemp Clin Trials · 2026 Feb · PMID 41407102 · Publisher ↗
BACKGROUND: Complete case analysis (CCA) is the most common method used to handle missing outcome data in trials but may often lead to biased estimates. Newer methods that address missing not at random data are infrequen...
BACKGROUND: Complete case analysis (CCA) is the most common method used to handle missing outcome data in trials but may often lead to biased estimates. Newer methods that address missing not at random data are infrequently used. OBJECTIVE: We evaluated six missing data methods in a simulation study based on a melanoma surveillance trial. METHODS: We used the MEL-SELF pilot of patient-led surveillance for patients with early-stage melanoma as the empirical basis of our simulated study. We evaluated three commonly used methods (CCA, mixed models for repeated measurements (MMRM), multiple imputation (MI)), and three recently developed methods (retrieved dropout (RD) imputation, jump to reference (J2R) imputation and trimmed means (TM)), under 48 scenarios where treatment effect size, missingness percentage and missingness assumptions were varied. RESULTS: Under scenarios with small or small-moderate treatment effects and missing not at random outcome data, all methods produced some bias, with TM and CCA the most biased towards and away from the null, respectively. Both also had low precision and power. J2R performed best of methods that were biased towards the null (JR, TM), with small bias for small and small-moderate treatment effects, high precision and high coverage. RD performed best of methods that were biased away from the null (RD, CCA, MMRM, MI) with small bias, good precision and good coverage. CONCLUSION: In this simulation of a melanoma surveillance trial with non-random missing outcomes, RD produced the least bias away from the null and J2R produced the least bias towards the null.
A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol.
Pallin ND, Algeo N, O'Connor ME … +10 more , Connolly H, Lowry M, Bennett K, Gillespie P, Hobbins A, Gallagher P, Mullen L, Lyons KD, McHugh SM, Connolly D
Contemp Clin Trials · 2026 Feb · PMID 41407101 · Publisher ↗
INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for t...
INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment. METHODS: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires. DISCUSSION: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work. TRIAL REGISTRATION NUMBER: NCT06723899.
Effects of auricular vagus nerve stimulation and aerobic training in individuals with hypertension - Protocol for a controlled, randomized, and blind clinical trial.
Souza PHL, Consolim-Colombo FM, Venancio BP … +5 more , de Angelis K, Corrêa JCF, de Sousa MG, Dias RMR, Corrêa FI
Contemp Clin Trials · 2026 Feb · PMID 41407100 · Publisher ↗
INTRODUCTION: Hypertensive individuals experience chronic inflammation, higher sympathetic nervous system activity, and decreased functional capacity. While Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and ae...
INTRODUCTION: Hypertensive individuals experience chronic inflammation, higher sympathetic nervous system activity, and decreased functional capacity. While Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and aerobic training have shown benefits for hypertension, their combined effects have not been explored. OBJECTIVE: To evaluate the effects of taVNS combined with aerobic training on blood pressure, cardiac autonomic modulation, inflammation, oxidative stress, and functional capacity in individuals with hypertension. METHODS: This protocol outlines a randomized, controlled, single-blind clinical trial involving hypertensive adults. Participants will be randomly assigned to one of three groups: aerobic training with taVNS, aerobic training alone, or taVNS alone. Aerobic training will consist of 50 min of stationary cycling, while taVNS will be applied using a neuromuscular stimulator with an electrode placed on the left ear for 30 min. The intervention will be administered three times per week for 8 weeks, totaling 24 sessions. The primary outcome is blood pressure measurement, while secondary outcomes include heart rate variability, functional capacity, serum inflammatory mediators, and biomarkers of systemic oxidative stress. Assessments will be conducted before the intervention, after 24 sessions, and 30 days of post-treatment. RESULTS: The groups will be compared to the outcome measures to determine the taVNS benefits combined with aerobic training for hypertensive individuals. CONCLUSION: This is the first clinical trial to assess the taVNS effects combined with physical exercise in hypertensive individuals. The study will provide data on this approach's efficacy for improving blood pressure, cardiac autonomic modulation, oxidative stress, and functional capacity in hypertensive people.
Study protocol for a type I hybrid effectiveness trial of strategies to prevent suicide attempts among adults recently released from jail.
Wisnieski DM, Rossom RC, Weinstock LM … +20 more , Johnson J, Miley K, Gaudiano BA, Benz MB, Borgert-Spaniol C, Graves HR, Norwood R, Kazan R, Starkey C, Kim H, Fletcher L, Kane S, Hu Y, Farrell Z, Strong S, Yeh HH, Miller T, Jones R, Morey K, Ahmedani BK
Contemp Clin Trials · 2026 Feb · PMID 41407099 · Publisher ↗
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 stres...
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. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT06506344.
Improving diagnostic safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial.
McCarthy DM, VanWagner LB, Rafferty MR … +5 more , Cameron KA, Lee J, Dong S, Fellner A, Kontrick AV
Contemp Clin Trials · 2026 Feb · PMID 41407098 · Full text
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...
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).
Development and implementation of standardized study enrollment metrics for a VA healthcare system clinical research consortium: A 6-year follow-up assessment.
Johnson MR, Raitt M, Asghar A … +2 more , Beck D, Huang GD
Contemp Clin Trials · 2026 Jan · PMID 41380766 · Publisher ↗
Participant enrollment remains a leading indicator of the validity and generalizability of clinical trial results in the population at large. Establishing standardized and structured enrollment metrics can offer valuable...
Participant enrollment remains a leading indicator of the validity and generalizability of clinical trial results in the population at large. Establishing standardized and structured enrollment metrics can offer valuable information on clinical research performance (site and network level). The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) evaluated its performance against standardized study and network enrollment metrics over a 6-year timeframe from implementation of the metrics (VA Fiscal Year (FY) 2019) through FY 2024. Our findings demonstrate a positive trend in the ability of network sites to achieve NODES-specific enrollment metrics, comparing FY 2019 (55 %) to FY 2024 (73 %). Additionally, we identified improvement in study participant enrollment more broadly based on CSP study-specific enrollment metrics, as evidenced by an increase in the percentage that Node sites achieved ≥50 % of their expected enrollment targets in FY 2019 (64.7 %) on average compared to FY 2024 (69.5 %), and sustained performance as it relates to the percentage that network sites were in the "Top 1/3 of Study Sites Overall" comparing FY 2019 (36.9 %) to FY 2024 (36.1 %). Lastly, CSP Node sites enrolled study participants at a higher percentage than non-Node CSP study sites when comparing enrollment (actual/expected) by margins of 28.4 % (FY 2019) and 21.6 % (FY 2024), respectively. It is our hope that our experiences of navigating challenges associated with this effort, understanding lessons learned, and achieving successes might serve as a useful template for other clinical research consortiums that aim to evaluate their performance.
Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care.
El Zein A, Garla V, Hall ME … +8 more , Nawshin T, Hays D, John T, Delaney E, Wallace E, Hearld L, Cherrington AL, Mehta T
Contemp Clin Trials · 2026 Feb · PMID 41354173 · Publisher ↗
BACKGROUND: In the U.S. Deep South, Black adults experience disproportionate rates of type 2 diabetes (T2D) and associated complications, driven in part by adverse social determinants of health (SDoH). Addressing these d...
BACKGROUND: In the U.S. Deep South, Black adults experience disproportionate rates of type 2 diabetes (T2D) and associated complications, driven in part by adverse social determinants of health (SDoH). Addressing these disparities requires multilevel interventions that can be optimized for both effectiveness and cost. The Food Delivery, Remote Monitoring, & Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) trial aims to identify an optimized, scalable intervention package that improves glycemic control among Black adults with T2D. METHODS: FREEDOM is a multicenter, hybrid type 1 optimization-implementation trial uses a 2 × 2 × 2 factorial design to test three intervention components-digital health coaching, food box delivery, and remote patient monitoring (RPM)-among 304 adults recruited from three health systems in Alabama and Mississippi. Interventions are delivered over six months with follow-up assessments through 12 months. The primary clinical outcome is change in HbA1c at 12 months. Secondary outcomes include within-trial cost-utility using net monetary benefit, RE-AIM outcomes, and CFIR-guided qualitative assessment of contextual determinants. Mixed methods will evaluate fidelity and context. Optimization will be determined using the net monetary benefit framework based on quality-adjusted life years (QALYs). DISCUSSION: This protocol describes the design and methods of the FREEDOM trial, which seeks to address key gaps in optimizing multilevel interventions for adults with T2D in underserved regions of the Deep South. Findings will guide the selection of scalable, cost-effective intervention strategies to improve glycemic control among adults with T2D. REGISTRATION: ClinicalTrials.gov identifier: NCT05288452; first posted December 29, 2022.
The Investigation of Vitamin D and Menstrual Cycles Trial (the inVitD Trial): A clinical trial of vitamin D supplementation on the hypothalamic-pituitary-ovarian axis.
Klawans MR, Kohrman O, Braxton Jackson W … +8 more , Jackson CL, Metz CN, Wegienka G, Motsinger-Reif A, Steiner AZ, Baird DD, Sandler DP, Jukic AMZ
Contemp Clin Trials · 2026 Jan · PMID 41352534 · Full text
BACKGROUND: While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cy...
BACKGROUND: While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis. METHODS: This two-site RCT (NCT05050916) required participants to be aged 19-40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml ("low") received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone. DISCUSSION: Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.
Study protocol for a randomized controlled trial of the Let's Connect® intervention: A trauma-responsive, emotion-focused parenting skills program.
Pauletic MT, Shipman K, Steeger CM … +2 more , Holton M, Trammell J
Contemp Clin Trials · 2026 Jan · PMID 41352533 · Publisher ↗
BACKGROUND: This paper outlines the study protocol for an evaluation of the Let's Connect® (LC) parenting program. LC is a trauma-responsive, emotion-focused parenting program that teaches parents/caregivers to identify...
BACKGROUND: This paper outlines the study protocol for an evaluation of the Let's Connect® (LC) parenting program. LC is a trauma-responsive, emotion-focused parenting program that teaches parents/caregivers to identify and respond to children's emotional needs and behaviors in a way that builds connection and warmth and promotes children's emotional competence, mental and behavioral health, and overall well-being. In a randomized controlled trial (RCT), this project will evaluate the efficacy of LC in a virtual delivery format with families who are at-risk for or have experienced trauma, violence, and/or other adverse life events. METHODS: We will recruit up to 200 parent-child dyads (children ages 4-14 years) and randomize them to the 14-week LC intervention condition or waitlist control condition. Primary outcomes include parent well-being, parenting practices, child well-being, and child social-emotional competencies. Outcomes will be assessed using parent and child report questionnaires, parent interview, and observational data at three time points: baseline (T1), posttest (T2; ∼14 weeks after baseline), and follow-up (T3; 6-months after posttest). Intent-to-treat analyses will be used to estimate intervention effects across the three assessment points. CONCLUSION: This study is the first RCT of the LC parenting intervention that will evaluate its efficacy and will contribute to evidence of innovative and culturally responsive, emotion-focused parenting interventions in a sustainable delivery format. This trial is preregistered on the Open Science Framework (https://osf.io/xd5he/).
Efficacy and safety of the stellate ganglion block for posttraumatic stress disorder in veterans: Rationale for and methods of a multisite trial.
Hollifield M, Brock C, Lim K … +10 more , Holtzheimer P, Alkire M, Macedo F, Bovin MJ, Smith T, Romesser J, Messina M, Jovanovic T, Norrholm S, Krajec A
Contemp Clin Trials · 2026 Jan · PMID 41352532 · Publisher ↗
Posttraumatic Stress Disorder (PTSD) is a debilitating disorder characterized by re-experiencing aspects of the original trauma, avoidance of trauma reminders, negative alterations in cognition and mood, and hyperarousal...
Posttraumatic Stress Disorder (PTSD) is a debilitating disorder characterized by re-experiencing aspects of the original trauma, avoidance of trauma reminders, negative alterations in cognition and mood, and hyperarousal. Current evidence-based treatments for PTSD have both value and limitations, most notably slow response and high withdrawal rates. The field is searching for more rapid and highly effective interventions. The Stellate Ganglion Block (SGB), which has historically been used to treat regional pain syndromes, causalgia (nerve injury), and intractable angina, has support for being a rapid and highly effective intervention from multiple case series. However, one of two published RCTs was negative and the other had limitations. A larger more definitive study is necessary to provide the evidence needed to determine if SGB is an effective intervention. This paper describes the background, theory and methods of a multi-site triple-blind placebo-controlled trial about the efficacy and safety of the SGB for PTSD. Elements that make this a more definitive study include using and describing a reliably conducted sham, using a standard dose of anesthetic, including an untreated group, rigorously assessing side-effects and safety, and evaluating durability, enhanced dosing, and an objective physiological outcome measure (fear-potentiated startle) to evaluate treatment response in addition to the clinical effect. The strengths and limitations of this research are also presented. CLINICAL TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov ID NCT05169190.
Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial.
Sripada RK, Garlick J, Hemphill N … +8 more , Walters HM, Ganoczy D, Kim HM, Zivin K, Nevedal AL, Avallone KM, Cigrang JA, Rauch SAM
Contemp Clin Trials · 2026 Jan · PMID 41352531 · Publisher ↗
BACKGROUND: Healthcare workers and first responders are frequently exposed to traumatic events and subsequently are more susceptible to posttraumatic stress disorder (PTSD), but few receive treatment. Although Employee A...
BACKGROUND: Healthcare workers and first responders are frequently exposed to traumatic events and subsequently are more susceptible to posttraumatic stress disorder (PTSD), but few receive treatment. Although Employee Assistance Programs (EAPs) are available at almost all large-sized companies, they lack the capacity to provide time-intensive first-line treatments for PTSD. To address this problem, our study team adapted a standard first-line PTSD treatment into a brief, 4-6 session format (Processing Emotions in Primary Care; PE-PC) and demonstrated its efficacy in military and veteran populations. This paper describes a study protocol to leverage the existing resource of the EAP to test intervention effectiveness among healthcare workers and first responders with treatment need. METHOD: We are currently conducting a Hybrid Type 1 Effectiveness-Implementation trial to test the effectiveness of PE-PC, delivered by EAP counselors, versus EAP treatment as usual (TAU) in 360 healthcare workers and first responders with PTSD, and gather data regarding implementation. The specific aims are to compare the effectiveness of PE-PC versus EAP TAU in reducing PTSD symptoms at 6-week (post-treatment), 3-, and 6-month follow-ups, and prepare for future implementation through process evaluation and implementation mapping. We expect the study to yield an implementation strategy that is targeted to address EAP-specific implementation barriers. CONCLUSIONS: This project will contribute a point-of-care intervention for frontline healthcare workers and first responders with PTSD, thus improving clinical practice for populations vulnerable to PTSD and increasing preparedness for public health emergencies. CLINICALTRIALS: gov Identifier: NCT05751473.
Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial.
Malpeddi T, Poongulali S, Shuter J … +9 more , Rigotti NA, An LC, Kumarasamy N, Reddy KP, Shergina E, Colborn K, Faith B, Sierra YL, Kruse GR
Contemp Clin Trials · 2026 Jan · PMID 41352530 · Full text
INTRODUCTION: The use of tobacco remains a significant health concern among people with HIV (PWH) in India, exacerbating comorbidities, increasing the risk of HIV-related complications and reducing the effectiveness of a...
INTRODUCTION: The use of tobacco remains a significant health concern among people with HIV (PWH) in India, exacerbating comorbidities, increasing the risk of HIV-related complications and reducing the effectiveness of antiretroviral therapy. This protocol outlines a randomized trial designed to evaluate the effectiveness, cost and implementation of a tobacco cessation intervention for PWH in India. METHODS: This is a type 1 hybrid implementation effectiveness study including a clinical trial (n = 400) randomizing adults who smoke 1:1 to varenicline and Positively Smoke Free Mobile (PSF-M), a theory-based, digital, behavioral intervention versus a standard care control of brief cessation advice and Quitline referral. The primary outcome is cotinine-validated 7-day point prevalence abstinence from tobacco at 24 weeks post-randomization. Implementation outcomes of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability will be measured by survey and interviews. Cost-effectiveness of the intervention will be calculated using a simulation model of tobacco and nicotine outcomes. CONCLUSION: This study will test the effectiveness of a scalable and comprehensive tobacco use treatment approach with medication plus digital behavioral support in a low- and middle-income country setting, paired with examination of implementation and cost-effectiveness. This research has the potential to improve the health of PWH by demonstrating the health effects of a tobacco cessation treatment package that aims to reduce the morbidity and mortality associated with smoking. Trial Registration clinicaltrials.gov #NCT05786547, Registered 27 March 2023.
Personalising the management of obesity-related asthma using medical nutrition therapy and physical activity prescription: The IDEAL study protocol.
Blickisdorf T, Wood LG, Valkenborghs SR … +18 more , Dixon AE, Horvat JC, Weaver NA, Yoong S, Berthon BS, Williams EJ, Brown AC, Jenkins CR, Morrissey ML, Wark PA, Wynne K, Grainge CL, El-Omar EM, Williams LM, Brannan JD, De Wang L, Wong SL, Scott HA
Contemp Clin Trials · 2026 Jan · PMID 41352529 · Publisher ↗
BACKGROUND: Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of...
BACKGROUND: Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of obesity varies between individuals, a one-size-fits-all approach to obesity management will not address the underlying cause(s), increasing the risk of treatment failure. We hypothesise that obesity-related asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health, while an individualised obesity management intervention, utilising medical nutrition therapy and personalised physical activity prescription, will result in better asthma control. METHODS: The Individualised Diet and Exercise Intervention for Optimising Asthma Control and Lung Function (IDEAL) Study will test the first individualised obesity management approach for people with asthma. In this 16-week randomised controlled trial with 12-month follow-up, 102 adults with obesity and uncontrolled asthma will be randomised to either the IDEAL program or control group. Participants will be assessed for outcomes at baseline, 16 and 52 weeks. Participants randomised to the IDEAL Program will attend five sessions with a dietitian and physiotherapist/exercise physiologist during the 16-week intervention period. We will test the intervention effect on asthma (asthma control, lung function), inflammatory (e.g. sputum cell counts, plasma IL-6) and non-asthma outcomes (e.g. diet quality, physical activity levels, metabolic health), as well as the acceptability and cost of the intervention. CONCLUSION: This trial aims to provide people living with asthma and obesity an effective and sustainable way to help control their asthma symptoms and will assess mechanisms responsible for any improvements observed. ETHICS/REGISTRATIONS: NSW REGIS ETHICS Reference: 2023/ETH00833. UoN IBC Reference No: SP-23-92. ANZCTR Reference No: ACTRN12623000979651. Universal Trial Number: U1111-1291-8501.
Acceptance and commitment therapy for people with HIV who drink at unhealthy levels: Protocol for the ACCEPT randomized controlled trial.
Woolf-King SE, Presutti E, McKenna O … +6 more , Hahn JA, Abar B, Dahne J, Gump BB, Bendinskas KG, Maisto SA
Contemp Clin Trials · 2025 Dec · PMID 41326267 · Full text
BACKGROUND: Alcohol consumption at unhealthy levels is associated with negative consequences at nearly every step of the HIV care continuum. We describe the rationale, aims, and study design for the ACCEPT Trial, a rando...
BACKGROUND: Alcohol consumption at unhealthy levels is associated with negative consequences at nearly every step of the HIV care continuum. We describe the rationale, aims, and study design for the ACCEPT Trial, a randomized controlled comparative efficacy trial for Acceptance and Commitment Therapy (ACT) compared to a standard brief alcohol intervention (BI) for people living with HIV (PWH) who drink at unhealthy levels. METHODS: A total of 300 PWH who report drinking at unhealthy levels will be randomly assigned 1:1 to the two treatments conditions and assessed, via self-report and an alcohol biomarker, for alcohol use and comorbid symptoms of depression, anxiety, and stress at baseline, post-treatment, and 3-, 6-, and 12-months later. Symptoms of experiential avoidance, a proposed mechanism of change in the ACT condition, will also be assessed at all timepoints. We hypothesize that the two treatments will have significant, and statistically equivalent, effects on alcohol use at the post-treatment and 3-month timepoints and the ACT condition will have superior outcomes, mediated by changes to experiential avoidance, at the 6- and 12-month timepoints. CONCLUSIONS: Confirmation of the ACCEPT trial's hypotheses will provide an important tool for HIV care, treating not only unhealthy alcohol use, but also other psychiatric comorbidities seen in this population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06648629.
The DREAMERS-trial: A randomized controlled trial protocol addressing the use of perioperative music to prevent sleep disturbances in hospitalized surgical patients.
Stoop JM, Geensen R, Louter M … +4 more , Poley MJ, Verhoef C, Jeekel J, Klimek M
Contemp Clin Trials · 2025 Dec · PMID 41326266 · Publisher ↗
BACKGROUND: Sleep disturbances occur in up to 64 % of hospitalized surgical patients, whilst poor sleep impedes postoperative recovery, e.g. through prolonged immobilization due to fatigue. Common treatment with benzodia...
BACKGROUND: Sleep disturbances occur in up to 64 % of hospitalized surgical patients, whilst poor sleep impedes postoperative recovery, e.g. through prolonged immobilization due to fatigue. Common treatment with benzodiazepines, however, is associated with serious side effects, among which an increased risk of cognitive impairment, respiratory depression, agitation, and falls leading to fractures. Music is a potential non-pharmacological treatment option without such adverse events, that has already been proven to reduce pain, anxiety and stress. It is therefore investigated on its effectiveness in improving sleep quality in the perioperative period. We hypothesize that a music intervention is effective in improving perioperative sleep quality. METHODS: A single-center randomized controlled trial is conducted in adult patients, undergoing major gastro-intestinal oncological surgery. Patients in the music group will listen to patient-preferred music through headphones intra-operatively, and postoperatively until postoperative day 4. Patients in the control group will receive standard care. The primary outcome is subjective sleep quality, as assessed with the adapted Patient Reported Outcomes Measurements Information Questionnaire. Secondary outcomes include objective sleep quality, subjective sleep quantity, anxiety, subjective stress, and postoperative recovery. Furthermore, music quantity, patient satisfaction, and music importance and preference will be documented. Patient characteristics, information regarding the current hospital admission and physical parameters, including pain scores and the postoperative risk on delirium, are extracted from the electronic patient records, and cost-effectiveness questionnaires are conducted for economic evaluation of the intervention. TRIAL REGISTRATION NUMBER: NL78543.078.21, NCT06131034.
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