Contemporary Clinical Trials

BACKGROUND: Midlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults...

INTRODUCTION: Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings...

BACKGROUND: Although modestly effective treatments exist for alcohol use disorder (AUD), many individuals return to heavy drinking after treatment, suggesting the need for better understanding of factors that contribute to maintaining abstinence or drinking reductions. Whereas past studies identified what treatments work for AUD, recent studies focus more on why particular treatments work, and the mechanisms by which treatment leads to change. This focus on mechanisms of behavior change (MOBC) may inform the process by which treatment leads to better outcomes, and also may lead to new treatments or modifications of existing treatments that target empirically supported mechanisms known to lead to change...

BACKGROUND: Colonoscopy is one of the primary methods of screening for colorectal cancer (CRC), a leading cause of cancer mortality in the United States. However, up to half of patients referred to colonoscopy fail to complete the procedure, and rates of adherence are lower in rural areas. OBJECTIVES: Colonoscopy Outreach for Rural Communities (CORC) is a randomized controlled trial to test the effectiveness of a centralized patient navigation program provided remotely by a community-based organization to six geographically distant primary care organizations serving rural patients, to improve colonoscopy completion for CRC...

BACKGROUND: Many post-9/11 U.S. combat Veterans experience difficulty readjusting to civilian life after military service, including relationship problems, reduced work productivity, substance misuse, and increased anger control problems. Mental health problems are frequently cited as causing these difficulties, driven by unparalleled rates of mild traumatic brain injury, posttraumatic stress, and other co-occurring emotional and physical conditions. Given the high prevalence of multimorbidity in this cohort, acceptable, non-stigmatizing, transdiagnostic interventions targeting reintegration are needed...

BACKGROUND: Leveraging military veterans' intimate relationships during treatment has the potential to concurrently improve posttraumatic stress disorder (PTSD) symptoms and relationship quality. Cognitive-Behavioral Conjoint Therapy (CBCT) and an 8-session Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) are manualized treatments designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among veterans...

BACKGROUND: Few clinical trials include a detailed protocol for stakeholder engagement in the design and execution of the clinical trial. Deliver-EE is a pragmatic clinical trial to assess how different types of home-delivered meals can affect older adults' health and well-being. We present the protocol for stakeholder engagement in this national, multi-site trial and initial findings from our efforts. METHODS: Twenty-nine participants were recruited to two stakeholder advisory panels...

INTRODUCTION: Intensive weight management programs are effective but often have low enrollment and high attrition. Lack of motivation is a key psychological barrier to enrollment, engagement, and weight loss. Mental Contrasting with Implementation Intentions (MCII) is a unique imagery technique that increases motivation for behavior change. We describe our study protocol to assess the efficacy and implementation of MCII to enhance the effectiveness of VA's MOVE! or TeleMOVE! weight management programs using a procedure called "WOOP" (Wish, Outcome, Obstacle, Plan) for Veterans...

BACKGROUND: Individuals with a history of moderate-severe traumatic brain injury (TBI) experience a significantly higher prevalence of insomnia compared to the general population. While individuals living with TBI have been shown to benefit from traditional insomnia interventions (e.g., face-to-face [F2F]), such as Cognitive Behavioral Therapy for Insomnia (CBTI), many barriers exist that limit access to F2F evidence-based treatments. Although computerized CBT-I (CCBT-I) is efficacious in terms of reducing insomnia symptoms, individuals with moderate-severe TBI may require support to engage in such treatment...

BACKGROUND: Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment. Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment...

No abstract text is available yet for this article.

BACKGROUND: Elevated depression symptoms have been associated with higher insulin resistance in adolescents, and consequently, greater risk for type 2 diabetes (T2D). Mindfulness-based intervention (MBI) may be suited for adolescents at risk for T2D given its potential to decrease depression and improve stress-related behavior/physiology underpinning insulin resistance. To prepare for a future multisite efficacy randomized controlled trial, a rigorous, multisite, pilot and feasibility study is needed to test this approach...

Anxiety sensitivity (AS), reflecting the fear of bodily sensations, is a transdiagnostic vulnerability factor that underpins both affective psychopathology and smoking. Phase II research supports the efficacy of a 15-week community-based intervention (STEP) that combines high-intensity exercise offered by the YMCA with standard smoking cessation treatment (tobacco quitline and nicotine replacement therapy) for sedentary smokers with elevated AS. This Phase III study aims to enroll 360 adults to evaluate whether STEP efficacy for achieving smoking abstinence generalizes to Black and Hispanic smokers with elevated AS...

No abstract text is available yet for this article.

BACKGROUND: There is need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing primary care teams. The goal of MAINTAIN PRIME (Promoting Real (World) IMplEmentation) is to evaluate whether a successful electronic health record (EHR)-based weight maintenance intervention can be adapted to a new clinical setting with primary care staff serving as coaches. METHODS: EHR tools include tracking tools, standardized surveys, and standardized "SmartPhrases" for coaching...

BACKGROUND: The minority of working-age Finns eat according to the national and Nordic nutritional guidelines and increasing numbers of health problems affect the Finnish workforce. Coincidently recruiting new workers in the more rural areas of Finland, such as Satakunta, has been problematic. To optimize the use of the existing workforce, health promotion interventions focusing on nutrition have been suggested to improve the health and well-being of the current working age Finns. METHODS AND ANALYSIS: The aim of this RCT study is to assess the effectiveness of a 12-month multifactorial nutritional guidance intervention to improve work ability (performance), work well-being, health-related quality of life, work productivity, sickness absence, dietary intake and eating habits...

BACKGROUND: Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education...

BACKGROUND: Weight reduction is a standard recommendation for obstructive sleep apnea (OSA) treatment in people with obesity or overweight; however, weight loss can be challenging to achieve and maintain without bariatric surgery. Currently, no approved anti-obesity medication has demonstrated effectiveness in OSA management. This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity. METHODS: SURMOUNT-OSA, a randomized, placebo -controlled, 52-week phase 3 trial, is investigating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA (apnea hypopnea- index ≥15 events/h) in participants with obesity (body mass index ≥30 kg/m2 ) and an established OSA diagnosis...

BACKGROUND: Supplemental oxygen is used during every general anesthesia. However, for the maintenance phase of a general anesthesia, in most cases the longest part of anesthesia, only scarce evidence of dosing supplemental oxygen exists. Oxygen is a well-known coronary vasoconstrictor and thus may contribute to cardiovascular complications especially in vulnerable high-risk patients with coronary artery disease undergoing major non-cardiac surgery. Myocardial biomarkers are early indicators of myocardial injury...

BACKGROUND: Pregnancy is a time of heightened risk for disordered eating behaviors, which are linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may be partially mediated by greater rates of deviation from recommended weight gain trajectories, especially in those who engage in binge and loss of control (LOC) eating. Food cravings are powerful and highly modifiable triggers of binge and LOC eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors in pregnancy as well...