Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study
Chronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 13, 2018 Category: Radiology Authors: Jeanne M. Hoffman, Dawn M. Ehde, Sureyya Dikmen, Tiara Dillworth, Kevin Gertz, Carrie Kincaid, Sylvia Lucas, Nancy Temkin, Kate Sawyer, Rhonda Williams Source Type: research

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors
Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health and contraception. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 13, 2018 Category: Radiology Authors: Shaylyn S. Stark, Loki Natarajan, Diana Chingos, Jennifer Ehren, Jessica R. Gorman, Michael Krychman, Brian Kwan, Jun J. Mao, Emily Myers, Tom Walpole, John P. Pierce, H. Irene Su Source Type: research

Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE)
Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children. This manuscript describes the design and methodology of Sustainability via Active Garden Education (SAGE), a 12-session cluster-randomized controlled crossover design trial using community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention for young children aged 3 –5 years in 20 sites. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 11, 2018 Category: Radiology Authors: Rebecca E. Lee, Elizabeth Lorenzo, Jacob Szeszulski, Anel Arriola, Meg Bruening, Paul A. Estabrooks, Jennie Hill, Flavio Marsiglia, Teresia O'Connor, Kim Sellers Pollins, Gabriel Q. Shaibi, Erica Soltero, Michael Todd Source Type: research

Diabetes sleep treatment trial: Premise, design, and methodology
The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, the study design, and the methodology used in this on-going trial. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 2, 2018 Category: Radiology Authors: Eileen R. Chasens, Charles W. Atwood, Lora E. Burke, Mary Korytkowski, Robert Stansbury, Patrick J. Strollo, Susan M. Sereika Source Type: research

The weWomen and ourCircle randomized controlled trial protocol: A web-based intervention for immigrant, refugee and indigenous women with intimate partner violence experiences
Intimate partner violence (IPV), including homicides is a widespread and significant public health problem, disproportionately affecting immigrant, refugee and indigenous women in the United States (US). This paper describes the protocol of a randomized control trial testing the utility of administering culturally tailored versions of the danger assessment (DA, measure to assess risk of homicide, near lethality and potentially lethal injury by an intimate partner) along with culturally adapted versions of the safety planning (myPlan) intervention: a) weWomen (designed for immigrant and refugee women) and b) ourCircle (desi...
Source: Contemporary Clinical Trials - December 2, 2018 Category: Radiology Authors: Bushra Sabri, Veronica P.S. Njie-Carr, Jill T. Messing, Nancy Glass, Teresa Brockie, Ginger Hanson, James Case, Jacquelyn C. Campbell Source Type: research

Remission from chronic opioid use —Studying environmental and socio-economic factors on recovery (RECOVER): Study design and participant characteristics
Few opioid use disorder (OUD) treatment studies measure meaningful life changes during long-term recovery, focusing instead on retention and abstinence. Here, we report on the design and participant characteristics of the RECOVER Study, a study exploring life changes in persons with OUD for up to 24  months following participation in a Phase III trial evaluating buprenorphine extended-release monthly injection for subcutaneous use (known as RBP-6000 during development). This multisite, observational, cohort study tracks clinical, environmental, and socio-economic changes using self-administer ed assessments, urine drug s...
Source: Contemporary Clinical Trials - November 30, 2018 Category: Radiology Authors: W. Ling, V. Nadipelli, N. Ronquest, V. Albright, A. Aldridge, S. Learned, V. Mehra, C. Heidbreder Source Type: research

Shake Rattle & Roll – Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension
In Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle& Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 27, 2018 Category: Radiology Authors: Mai N. Nguyen-Huynh, Joseph D. Young, Stacey Alexeeff, Meghan K. Hatfield, Stephen Sidney Source Type: research

Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET)
Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 22, 2018 Category: Radiology Authors: Rebecca A. Shelby, Caroline S. Dorfman, Hayden B. Bosworth, Francis Keefe, Linda Sutton, Lynda Owen, Alaattin Erkanli, Shelby D. Reed, Sarah S. Arthur, Tamara Somers, Nadine Barrett, Scott Huettel, Juan Marcos Gonzalez, Gretchen Kimmick Source Type: research

Pediatric continuity care intensivist: A randomized controlled trial
This article describes the development and evaluation of an intervention designed to improve continuity and communication delivered by continuity PICU attendings. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 20, 2018 Category: Radiology Authors: Vanessa Madrigal, Jennifer K. Walter, Emily Sachs, Adam S. Himebach, Sherri Kubis, Chris Feudtner Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 18, 2018 Category: Radiology Source Type: research

Rationale and design for eHealth Familias Unidas Primary Care: A drug use, sexual risk behavior, and sti preventive intervention for hispanic youth in Pediatric primary care clinics
Family-based behavioral interventions are efficacious and effective in preventing drug use and sexual risk behaviors; unfortunately, they have not been evaluated and disseminated in pediatric primary care practice, where they can have a significant impact. There is an increased focus on integrating parenting interventions into primary care to reduce health disparities among ethnic minorities such as Hispanics. Although Hispanic youth demonstrate higher levels of drug use and sexual risk behaviors than their non-Hispanic counterparts, few parenting interventions are available for Hispanic youth, and none have been delivered...
Source: Contemporary Clinical Trials - November 16, 2018 Category: Radiology Authors: Guillermo Prado, Yannine Estrada, Lourdes M. Rojas, Monica Bahamon, Hilda Pantin, Meera Nagarsheth, Lisa Gwynn, Audrey Y. Ofir, Lourdes Q. Forster, Nicole Torres, C. Hendricks Brown Source Type: research

Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions
While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7  kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Fit& Quit is a randomized, controlled efficacy trial that aims to examine the ability of a weight stability intervention and a weight loss intervention to reduce post-cessation weight gain. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 13, 2018 Category: Radiology Authors: Francisco I. Salgado Garc ía, Karen J. Derefinko, Zoran Bursac, Robert C. Klesges, Jon O. Ebbert, Catherine R. Womack, Rebecca A. Krukowski Source Type: research

Rationale and design of the Hepatocellular carcinoma Early Detection Strategy study: A multi-center longitudinal initiative of the National Cancer Institute ’s early Detection Research Network
Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6  months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 12, 2018 Category: Radiology Authors: Kelly A. Borges, Jianliang Dai, Neehar D. Parikh, Myron Schwartz, Mindie H. Nguyen, Lewis R. Roberts, Alex S. Befeler, Sudhir Srivastava, Jo Ann Rinaudo, Ziding Feng, Jorge A. Marrero, K. Rajender Reddy Source Type: research

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials
The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 8, 2018 Category: Radiology Authors: Dustin C. Krutsinger, Jacqueline McMahon, Alisa J. Stephens-Shields, Brian Bayes, Steven Brooks, Brian L. Hitsman, Su Fen Lubitz, Celine Reyes, Robert A. Schnoll, S. Ryan Greysen, Ashley Mercede, Mitesh S. Patel, Catherine Reale, Fran Barg, Jason Karlawis Source Type: research

Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain
Behavioral nudges in the food environment increase healthy choices, but it is unknown if they improve diet and health. The ChooseWell 365 study will determine if an automated, personalized worksite intervention to nudge healthier choices improves overall diet and cardiometabolic health. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 7, 2018 Category: Radiology Authors: Douglas E. Levy, Emily D. Gelsomin, Eric B. Rimm, Mark Pachucki, Jenny Sanford, Emma Anderson, Charles Johnson, Rose Schutzberg, Anne N. Thorndike Source Type: research

European paediatric non-alcoholic fatty liver disease registry (EU-PNAFLD): Design and rationale
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in children and has the potential to progress to advanced fibrosis/cirrhosis, end-stage liver disease and hepatocellular carcinoma. However, the natural history of the condition is poorly understood and there are no approved treatments. The European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD) is a multi-centre registry of paediatric NAFLD that will serve as a prospective, observational, natural history study and provide a tractable back-bone to support recruitment into subsequent interventional trials. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 5, 2018 Category: Radiology Authors: Jake P. Mann, Anita Vreugdenhil, Piotr Socha, Wojciech Ja ńczyk, Ulrich Baumann, Sanjay Rajwal, Thomas Casswall, Claude Marcus, Indra van Mourik, Stephen O'Rahilly, David B. Savage, Gabriele Noble-Jamieson, Florence Lacaille, Myriam Dabbas, Béatrice Dub Source Type: research

Design of the rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling
Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 5, 2018 Category: Radiology Authors: Michael G. Perri, Aviva H. Ariel-Donges, Meena N. Shankar, Marian C. Limacher, Michael J. Daniels, David M. Janicke, Kathryn M. Ross, Linda B. Bobroff, A. Daniel Martin, Tiffany A. Radcliff, Christie A. Befort Source Type: research

Improving quality of life among latino cancer survivors: Design of a randomized trial of patient navigation
Latino cancer survivors have lower survival rates for most cancers relative to non-Latino whites, including, colorectal, prostate, and breast. In addition, Latinos experience health disparities in both access to care and quality of care. Experts recommend providing psychosocial services as an integral part of quality cancer care; however, there continues to be a paucity of information on the efficacy of Patient Navigators (PNs) in linking Latino cancer survivors to appropriate psychosocial services. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 3, 2018 Category: Radiology Authors: Amelie G. Ramirez, Kipling J. Gallion, Arely Perez, Edgar Munoz, Dorothy Long Parma, Patricia I. Moreno, Frank J. Penedo Source Type: research

Enrollment and assessment of a first-year college class social network for a controlled trial of the indirect effect of a brief motivational intervention
Heavy drinking and its consequences among college students represent a serious public health problem, and peer social networks are a robust predictor of drinking-related risk behaviors. In a recent trial, we administered a Brief Motivational Intervention (BMI) to a small number of first-year college students to assess the indirect effects of the intervention on peers not receiving the intervention. Objectives: To present the research design, describe the methods used to successfully enroll a high proportion of a first-year college class network, and document participant characteristics. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 1, 2018 Category: Radiology Authors: Nancy P. Barnett, Melissa A. Clark, Shannon R. Kenney, Graham DiGuiseppi, Matthew K. Meisel, Sara Balestrieri, Miles Q. Ott, John Light Source Type: research

Attentional bias modification treatment for depression: Study protocol for a randomized controlled trial
Theoretical models and empirical research point to negatively biased attention as a maintaining factor in depression. Although preliminary studies suggest experimentally modifying attentional biases (i.e., attentional bias modification; ABM) reduces depression symptoms and depression risk, relatively few rigorous studies with clinical samples have been completed. This clinical trial examines the impact of ABM on a sample of adults (N  = 123) with elevated depression severity who also exhibit at least modest levels of negatively biased attention prior to treatment. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 26, 2018 Category: Radiology Authors: Kean J. Hsu, Kayla Caffey, Derek Pisner, Jason Shumake, Semeon Risom, Kimberly L. Ray, Jasper A.J. Smits, David M. Schnyer, Christopher G. Beevers Source Type: research

Methods to improve the noninvasive diagnosis and assessment of disease severity in children with suspected nonalcoholic fatty liver disease (NAFLD): Study design
Nonalcoholic fatty liver disease (NAFLD) is strongly associated with obesity and is the most common liver disease in the developed world. In children with suspected NAFLD, present guidelines suggest consideration of alternative diagnoses via extensive blood testing, though the yield of this work up is unknown. Furthermore, the gold standard diagnostic test for NAFLD remains liver biopsy, making the development of non-invasive tests critically important. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 26, 2018 Category: Radiology Authors: Bryan Rudolph, Nicole Bjorklund, Nadia Ovchinsky, Debora Kogan-Liberman, Adriana Perez, Mark Liszewski, Terry Levin, Michelle Ewart, Qiang Liu, Xiaonan Xue, Shankar Viswanathan, Howard D. Strickler Source Type: research

The healthy weigh study of lottery-based incentives and environmental strategies for weight loss: Design and baseline characteristics
Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese urban employee populations. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 26, 2018 Category: Radiology Authors: Karen Glanz, Pamela A. Shaw, Karen Hoffer, Annie Chung, Jingsan Zhu, Ruoming Wu, Qian (Erin) Huang, Ji (Rebekah) Choi, Kevin G. Volpp Source Type: research

The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study: Protocol for a point-of-care randomized controlled trial of statin pharmacogenetics in primary care
The association between the SLCO1B1 rs4149056 variant and statin-associated muscle symptoms (SAMS) is well validated, but the clinical utility of its implementation in patient care is unknown. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 24, 2018 Category: Radiology Authors: Jason L. Vassy, Charles A. Brunette, Nilla Majahalme, Sanjay Advani, Lauren MacMullen, Cynthia Hau, Andrew J. Zimolzak, Stephen J. Miller Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2018 Category: Radiology Source Type: research

Applications of general multistage gatekeeping and graphical multiple testing strategies in a clinical trial setting
Multiplicity adjustment plays a critical role for testing multiple endpoints and/or multiple doses in clinical trials. Under the clinical trial setting, multiple hypotheses are usually grouped into primary and secondary families and hierarchically ordered between and within families. The determination of the order and grouping of the hypotheses depends on the objectives of the trial. In such scenarios, strong control of the family-wise error rate (FWER) can be achieved via either gatekeeping procedures or the graphical approach to sequential testing procedures. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 18, 2018 Category: Radiology Authors: Yihan Li, Xin Wang, Deli Wang, Walter Offen Source Type: research

School-based secondary prevention of overweight and obesity among 8- to 12-year old children: Design and sample characteristics of the SNAPSHOT trial
Rising levels of severe obesity among children, worsening disparities by race and ethnicity and reluctance of primary care clinicians' to provide obesity management to children are compelling reasons to consider alternatives to primary care management of childhood obesity. The Students Nurses and Parents Seeking Healthy Options Together (SNAPSHOT) trial will test the efficacy of an elementary school-based, school nurse-led, healthy weight management program to reduce excess weight gain among children, 8- to 12-years old with a body mass index (BMI) ≥75th percentile, by increasing healthy dietary practices and physical a...
Source: Contemporary Clinical Trials - October 17, 2018 Category: Radiology Authors: Martha Y. Kubik, Jayne A. Fulkerson, John R. Sirard, Ann Garwick, Judy Temple, Olga Gurvich, Jiwoo Lee, Bonnie Dudovitz Source Type: research

Results of a feasibility study of a patient informed, racially tailored home-based exercise program for black persons with multiple sclerosis
Exercise training is a promising approach for managing multiple sclerosis (MS), but existing research has not focused on black individuals with MS. This is important as black individuals with MS may experience a more aggressive disease course, increased comorbidities, and have a poorer prognosis with disease modifying therapies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2018 Category: Radiology Authors: Dominique Kinnett-Hopkins, Robert Motl Source Type: research

Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: mood and insulin sensitivity to prevent diabetes (MIND)
Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2018 Category: Radiology Authors: Lauren B. Shomaker, Lauren Gulley, Allison M. Hilkin, Emma Clark, Shelly Annameier, Sangeeta Rao, Bonny Rockette-Wagner, Andrea Kriska, Kenneth P. Wright, Eric Stice, Kristen J. Nadeau, Megan M. Kelsey Source Type: research

“Wellness Champions for Change,” a multi-level intervention to improve school-level implementation of local wellness policies: Study protocol for a cluster randomized trial
Schools are a recommended place for childhood obesity prevention. Local Wellness Policies (LWPs) establish guidelines for schools to provide opportunities for students to access nutritious foods and be physically active. Little is known about the impact of LWPs, when implemented, on students' behavior and body mass index (BMI). The Wellness Champions for Change trial assesses the student-level impact of providing theory-based training and technical assistance to help schools implement LWPs. This 3-arm, cluster randomized controlled trial will take place in 30 low- or middle-income schools (15 elementary and 15 middle) in f...
Source: Contemporary Clinical Trials - October 17, 2018 Category: Radiology Authors: Hannah G. Lane, Rachel Deitch, Yan Wang, Maureen M. Black, Genevieve F. Dunton, Linda Aldoory, Lindsey Turner, Elizabeth A. Parker, Shauna C. Henley, Brit Saksvig, Hee-Jung Song, Erin R. Hager Source Type: research

iCanCope with Sickle Cell Pain: Design of a randomized controlled trial of a smartphone and web-based pain self-management program for youth with sickle cell disease
Many adolescents with sickle cell disease (SCD) experience recurrent and chronic pain, which has a negative impact on their health-related quality of life (HRQL). Cognitive-behavioral therapy (CBT) interventions can lead to improvement in pain and HRQL, yet due to barriers to care, most youth with SCD will not receive these interventions. To address this need for innovative programs targeting youth with SCD pain, we developed iCanCope, a tailored smartphone and web-based program that delivers a pain self-management intervention to youth with SCD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 11, 2018 Category: Radiology Authors: Tonya M. Palermo, William T. Zempsky, Carlton D. Dampier, Chitra Lalloo, Amos S. Hundert, Lexa K. Murphy, Nitya Bakshi, Jennifer N. Stinson Source Type: research

Peer support and mobile health technology targeting obesity-related cardiovascular risk in young adults with serious mental illness: Protocol for a randomized controlled trial
Individuals with serious mental illness (SMI) such as schizophrenia and bipolar disorder face a higher risk of early death due to cardiovascular disease and other preventable chronic illnesses. Young adulthood is a critical window of development for lifestyle interventions to improve the long-term health and quality of life in this population. Fit Forward is an NIH-funded randomized clinical trial examining the effectiveness of a group lifestyle intervention (PeerFIT) enhanced with mobile health technology compared to one-on-one mobile lifestyle coaching with Basic Education in fitness and nutrition supported by a wearable...
Source: Contemporary Clinical Trials - October 11, 2018 Category: Radiology Authors: Kelly A. Aschbrenner, John A. Naslund, Amy A. Gorin, Kim T. Mueser, Emily A. Scherer, Mark Viron, Allison Kinney, Stephen J. Bartels Source Type: research

Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET): A comparative effectiveness trial of a transdiagnostic treatment and a measurement feedback system
This article describes the protocol for a comparative effectiveness study of two novel interventions designed to address these challenges. The first intervention is a transdiagnostic treatment (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents, UP-A), a promising new approach that uses a small number of common strategies to treat a broad range of emotional disorders, and their underlying shared emotional vulnerabilities. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 4, 2018 Category: Radiology Authors: Amanda Jensen-Doss, Jill Ehrenreich-May, Monica M. Nanda, Colleen A. Maxwell, Jamie LoCurto, Ashley M. Shaw, Heather Souer, David Rosenfield, Golda S. Ginsburg Source Type: research

Vitamin D and omega-3 trial to prevent and treat diabetic kidney disease: Rationale, design, and baseline characteristics
Diabetic kidney disease (DKD), defined as reduced glomerular filtration rate (GFR), elevated urine albumin excretion, or both that is clinically attributable to diabetes, is a common and morbid diabetes complication. Animal-experimental data, observational human studies, and short-term clinical trials suggest that vitamin D and omega-3 fatty acid supplements may be safe and inexpensive interventions to reduce the incidence and progression of DKD. The Vitamin D and Omega-3 Trial to Prevent and Treat DKD (VITAL-DKD) was designed as an ancillary study to the VITAL trial of 25,871 US adults. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: Ian H. de Boer, Leila R. Zelnick, Julie Lin, Debra Schaumberg, Lu Wang, John Ruzinski, Georgina Friedenberg, Julie Duszlak, Vadim Y. Bubes, Andrew N. Hoofnagle, Ravi Thadhani, Robert J. Glynn, Julie E. Buring, Howard D. Sesso, JoAnn E. Manson Source Type: research

Moms fit 2 fight: Rationale, design, and analysis plan of a behavioral weight management intervention for pregnant and postpartum women in the U.S. military
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: Margaret C. Fahey, G. Wayne Talcott, Callie M. Cox Bauer, Zoran Bursac, Leslie Gladney, Marion E. Hare, Jean Harvey, Melissa Little, Deirdre McCullough, Ann S. Hryshko-Mullen, Robert C. Klesges, Mehmet Kocak, Teresa M. Waters, Rebecca A. Krukowski Source Type: research

Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial
Approximately 5 –8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-managem ent program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate...
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: Tonya M. Palermo, Rocio de la Vega, Joanne Dudeney, Caitlin Murray, Emily Law Source Type: research

A web-based program to improve treatment adherence in patients with type 2 diabetes: Development and study protocol
Many patients with type 2 diabetes mellitus (T2DM) sub-optimally adhere to core treatment recommendations, such as healthy diets, sufficient physical activity and pharmacological support. This paper describes the development of the web-based computer-tailored program My Diabetes Profile (MDP), incorporating identified success factors of web-based interventions, and the protocol for testing the effectiveness of this program in a randomized multicentre trial. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: S. Vluggen, C. Hoving, N.C. Schaper, H. de Vries Source Type: research

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol
Real-time video communication technology (e.g. Skype) may be an effective mode for delivering smoking cessation treatment to regional and remote residents. This randomised trial examines the effectiveness of real-time video counselling compared to: 1) telephone counselling; and 2) written materials (control) in achieving smoking abstinence in regional and remote residents. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: Flora Tzelepis, John Wiggers, Christine L. Paul, Judith Byaruhanga, Emma Byrnes, Jennifer Bowman, Karen Gillham, Elizabeth Campbell, Rod Ling, Andrew Searles Source Type: research

Implementing community health worker-patient pairings at the time of hospital discharge: A randomized control trial
In 2011, there were approximately 3.3 million adult 30-day all-cause hospital readmissions in the US generating $41.3 billion in hospital costs. Community health worker (CHW) care delivery is one of very few interventions demonstrated to reduce health care utilization among populations with chronic disease. While there are a number of studies demonstrating improved disease-specific outcomes with CHW interventions, studies examining the effect of CHW care delivery on 30-day readmission rates are rare. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 3, 2018 Category: Radiology Authors: Jocelyn Carter, Anne Walton, Karen Donelan, Anne Thorndike Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 1, 2018 Category: Radiology Source Type: research

The anorexia nervosa genetics initiative (ANGI): Overview and methods
We describe methods and procedures for the Anorexia Nervosa Genetics Initiative (ANGI), an international collaboration designed to rapidly recruit 13,000 individuals with AN as well as ancestrally matched controls. We present sample characteristics and the utility of an online eating disorder diagnostic questionnaire suitable for large-scale genetic and population research. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 1, 2018 Category: Radiology Authors: Laura M. Thornton, Melissa A. Munn-Chernoff, Jessica H. Baker, Anders Jur éus, Richard Parker, Anjali K. Henders, Janne T. Larsen, Liselotte Petersen, Hunna J. Watson, Zeynep Yilmaz, Katherine M. Kirk, Scott Gordon, Virpi M. Leppä, Felicity C. Martin, D Source Type: research

Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries
Approximately one-third of older adults fall each year and fall-related injuries are a leading cause of death and disability among this rapidly expanding age group. Despite the availability of bisphosphonates to reduce fractures, concerns over side effects have dramatically reduced use, suggesting that other treatment options are needed. Though many smaller studies have shown that physical activity programs can reduce falls, no study has been adequately powered to detect a reduction in fall-related injuries. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 24, 2018 Category: Radiology Authors: Christopher Sciamanna, Noel H. Ballentine, Melissa Bopp, Jennifer S. Brach, Vernon M. Chinchilli, Joseph T. Ciccolo, Molly B. Conroy, Abigail Fisher, Edward J. Fox, Susan L. Greenspan, M. Jan De Beur, Suzanne, Kalen Kearcher, Jennifer L. Kraschnewski, Kat Source Type: research

The LURN research network neuroimaging and sensory testing (NIST) study: Design, protocols, and operations
The Neuroimaging and Sensory Testing (NIST) Study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a cross-sectional, case-control study designed to investigate whether disrupted brain connectivity and sensory processing are associated with abnormal lower urinary tract symptoms (LUTS) in patients with overactive bladder syndrome (OAB). The NIST Study tests the hypotheses that patients with urinary urgency will demonstrate: (1) abnormal functional and structural connectivity of brain regions involved in urinary sensation on magnetic resonance imaging (MRI), and (2) hypersensitivity to painful (p...
Source: Contemporary Clinical Trials - September 21, 2018 Category: Radiology Authors: H. Henry Lai, Bruce Naliboff, Alice B. Liu, Cindy L. Amundsen, Joshua S. Shimony, Vincent A. Magnotta, Joseph J. Shaffer, Robin L. Gilliam, Jonathan B. Wiseman, Margaret E. Helmuth, Victor P. Andreev, Ziya Kirkali, Steven E. Harte, The LURN Study Group Source Type: research

Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients
Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower pati...
Source: Contemporary Clinical Trials - September 19, 2018 Category: Radiology Authors: Kristie B. Hadden, Connie L. Arnold, Laura M. Curtis, Jennifer M. Gan, Scott Hur, Mary Kwasny, Jean C. McSweeney, Latrina Y. Prince, Michael S. Wolf, Terry C. Davis Source Type: research

Home-based, square-stepping exercise program among older adults with multiple sclerosis: results of a feasibility randomized controlled study
There is very little known about exercise rehabilitation approaches for older adults with multiple sclerosis (MS), yet this growing segment of the MS population experiences declines in cognition and mobility associated with disease progression and aging. We conducted a RCT examining the feasibility of a 12-week, home-based Square-Stepping Exercise (SSE) program in older adults with MS. Older adults with MS (N  = 26) with mild-to-moderate levels of disability were recruited and randomized into the intervention (i.e., SSE) or a minimal activity, attention-control conditions. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 19, 2018 Category: Radiology Authors: Emerson Sebasti ão, Edward McAuley, Ryosuke Shigematsu, Brynn C. Adamson, Rachel E. Bollaert, Robert W. Motl Source Type: research

Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial
Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 19, 2018 Category: Radiology Authors: Kurt T. Barnhart, Mary D. Sammel, Mary Stephenson, Jared Robins, Karl R. Hansen, Wahid A. Youssef, Nanette Santoro, Esther Eisenberg, Heping Zhang, for the NICHD Cooperative Reproductive Medicine Network Source Type: research

Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial
Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 17, 2018 Category: Radiology Authors: Anita Y. Kinney, Rachel Howell, Rachel Ruckman, Jean A. McDougall, Tawny W. Boyce, Belinda Vicu ña, Ji-Hyun Lee, Dolores D. Guest, Randi Rycroft, Patricia A. Valverde, Kristina M. Gallegos, Angela Meisner, Charles L. Wiggins, Antoinette Stroup, Lisa E. P Source Type: research

Putting patients at the center of kidney care transitions: prepare now, a cluster randomized controlled trial
Care for patients transitioning from chronic kidney disease to kidney failure often falls short of meeting patients' needs. The PREPARE NOW study is a cluster randomized controlled trial studying the effectiveness of a pragmatic health system intervention, ‘Patient Centered Kidney Transition Care,’ a multi-component health system intervention designed to improve patients' preparation for kidney failure treatment. Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and ri sk prediction tools) to help providers recognize patients in nee...
Source: Contemporary Clinical Trials - September 12, 2018 Category: Radiology Authors: Jamie A. Green, Patti L. Ephraim, Felicia F. Hill-Briggs, Teri Browne, Tara S. Strigo, Chelsie L. Hauer, Rebecca A. Stametz, Jonathan D. Darer, Uptal D. Patel, Katina Lang-Lindsey, Brian L. Bankes, Shakur A. Bolden, Patricia Danielson, Suzanne Ruff, Lana Source Type: research

Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (T ĀCcare trial)
Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 9, 2018 Category: Radiology Authors: Maria-Eleni Roumelioti, Jennifer L. Steel, Jonathan Yabes, Kevin E. Vowles, Yoram Vodovotz, Scott Beach, Bruce Rollman, Steven D. Weisbord, Mark L. Unruh, Manisha Jhamb Source Type: research

Improving the cardiometabolic health of people with psychosis: A protocol for a randomised controlled trial of the Physical Health Nurse Consultant service
Over 690,000 Australians experience psychosis annually, significantly impacting cardiometabolic illness and healthcare costs. Current models of care are fragmented and a critical implementation gap exists regarding the delivery of coordinated physical healthcare for Australians with psychosis. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 9, 2018 Category: Radiology Authors: Brenda Happell, Jackie Curtis, Michelle Banfield, John Goss, Theophile Niyonsenga, Andrew Watkins, Chris Platania-Phung, Lynelle Moon, Philip Batterham, Brett Scholz, Vanessa Prescott, Robert Stanton Source Type: research

Evaluating the clinical implementation of structured exercise: A randomized controlled trial among non-insulin dependent type II diabetics
The American Diabetes Association (ADA) currently recommends 150  min of moderate-intensity aerobic exercise per week and resistance exercise at least twice per week in individuals with type 2 diabetes (T2DM) to improve overall health.1 However, approximately 38% of patients with T2DM do not exercise at recommended levels and 31% do not exercise at all.2 The ef ficacy of structured exercise interventions has been proven effective in reducing glycosylated hemoglobin A1c (HbA1c) levels in patients, but practical approaches are needed to translate these findings into the clinical setting. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 8, 2018 Category: Radiology Authors: Lida Faroqi DPM, Myo Wong, Saniya Bonde, Chi Wai Wong, Khalil Walai, Wendy West, Daniella Tatianna Goni, Saron Araya, Sayed Azamey, Carla Nacif-Coelho, Sonia Sunita Raghuram, Katherine Vera, Anuva Mittal, Leah Groppo CDE, Mary Christensen, Neil Johannsen, Source Type: research