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BackgroundGrowing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. ObjectiveThe aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. MethodsA total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. ResultsActivities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. ConclusionsFindings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial RegistrationClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057 International Registered Report Identifier (IRRID)PRR1-10.2196/17721

BackgroundAdolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs. ObjectiveThe aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being. MethodsThe intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test. ResultsThe project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020. ConclusionsIf this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being. Trial RegistrationClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154. International Registered Report Identifier (IRRID)DERR1-10.2196/17078

ObjectivesWhen experiencing negative mood, people often eat to improve their mood. A learned association between mood and eating may cultivate frequent food cravings, detracting from health goals. Training in mindful eating may target this cycle of emotion-craving-eating by teaching individuals to manage urges when experiencing negative mood. We examined the impact of a mobile mindful eating intervention on the link between negative mood and food cravings among overweight women.MethodsIn a single-arm trial, participants (n = 64, M age = 46.1 years, M BMI = 31.5 kg/m2) completed ecological momentary assessments of negative mood and food cravings 3 times/day for 3 days pre- and post-intervention, as well as 1-month post-intervention. Using multilevel linear regression, we compared associations between negative mood and food craving strength at pre- vs. post-intervention (model 1) and post-intervention vs. 1-month follow-up (model 2).ResultsIn model 1, negative mood interacted with time point (β =  - .20, SE = .09, p = .02, 95% CI [- .38, - .03]) to predict craving strength, indicating that the within-person association between negative mood and craving strength was significantly weaker at post-intervention (β = 0.18) relative to pre-intervention (β = 0.38). In model 2, negative mood did not interact with time point to predict craving strength (β = .13, SE = .09, p = .10, 95% CI - .03, .31]); the association did not significantly differ between post-intervention and 1-month follow-up.ConclusionsTraining in mindful eating weakened the mood-craving association from pre- to post-intervention. The weakened association remained at follow-up. Our findings highlight the mood-craving link as a target-worthy mechanism of mindful eating that should be assessed in clinical trials.Trial registrationNCT02694731.Supplementary informationThe online version contains supplementary material available at 10.1007/s12671-021-01760-z.

BackgroundEnvironmental and behavioral interventions hold promise to reduce sugar-sweetened beverage (SSBs) consumption.PurposeTo test, among frequent SSB consumers, whether motivations to consume SSBs moderated the effects of (a) a workplace SSB sales ban (environmental intervention) alone, and (b) a "brief motivational intervention" (BI) in addition to the sales ban, on changes in SSB consumption.MethodsWe assessed whether (1) baseline motivations to consume SSBs (craving, psychological stress, or taste enjoyment) impacted changes in daily SSB consumption at 6-month follow-up among frequent (>12oz of SSBs/day) SSB consumers (N = 214); (2) participants randomized to the BI (n = 109) versus to the sales ban only (n = 105) reported greater reductions in SSB consumption at follow-up; and (3) motivations to consume SSBs moderated any changes in SSB consumption.ResultsIn response to the sales ban alone, individuals with stronger SSB cravings (+1 SD) at baseline showed significantly smaller reductions in daily SSB consumption at 6-month follow-up relative to individuals with weaker (-1 SD) SSB cravings (2.5 oz vs. 22.5 oz), p < .01. Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) = -19.2 (2.74) oz] than those who did not [M(SE) = -2.5 (2.3) oz, p < .001], a difference of 16.72 oz.ConclusionsFrequent SSB consumers with stronger SSB cravings report minimal reductions in daily SSB consumption with a sales ban only, but report greater reductions if they also receive a motivational intervention. Future multilevel interventions for institutions should consider both environmental and individualized multi-level interventions.Clinical trial informationNCT02585336.

ImportanceReductions in sugar-sweetened beverage (SSB) intake can improve health, but are difficult for individuals to achieve on their own.ObjectivesTo evaluate whether a workplace SSB sales ban was associated with SSB intake and cardiometabolic health among employees and whether a brief motivational intervention provides added benefits to the sales ban.Design, setting, and participantsThis before-after study and additional randomized trial conducted from July 28, 2015, to October 16, 2016, at a Northern California university and hospital assessed SSB intake, anthropometrics, and cardiometabolic biomarkers among 214 full-time English-speaking employees who were frequent SSB consumers (≥360 mL [≥12 fl oz] per day) before and 10 months after implementation of an SSB sales ban in a large workplace, with half the employees randomized to receive a brief motivational intervention targeting SSB reduction.InterventionsThe employer stopped selling SSBs in all workplace venues, and half the sample was randomized to receive a brief motivational intervention and the other half was a control group that did not receive the intervention. This intervention was modeled on standard brief motivational interventions for alcohol used in the workplace that promote health knowledge and goal setting.Main outcomes and measuresOutcomes included changes in SSB intake, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), and measures of abdominal adiposity. The primary associations tested were the correlation between changes in SSB intake and changes in HOMA-IR.ResultsAmong the 214 study participants, 124 (57.9%) were women, with a mean (SD) age of 41.2 (11.0) years and a baseline mean (SD) body mass index of 29.4 (6.5). They reported a mean daily intake of 1050 mL (35 fl oz) of SSBs at baseline and 540 mL (18 fl oz) at follow-up-a 510-mL (17-fl oz) (48.6%) decrease (P

BackgroundThis manuscript describes the first two phases of pilot testing MARIGOLD, an online self-guided positive emotion skills intervention for adults with elevated depressive symptoms, along with enhancements to overcome retention and adherence problems reported in previous research.MethodsAdults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up. Phase 1 participants (n = 58) were randomized to MARIGOLD, daily emotion reporting, or waitlist. Phase 2 participants (n = 79) were randomized to MARIGOLD plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC). Post-intervention interviews assessed acceptability. Intention-to-treat analyses examined retention, adherence, and preliminary efficacy.ResultsIn both phases, retention and adherence did not differ between groups. MARIGOLD skills were highly acceptable, but qualitative results indicate web-based features (e.g., log-in, ODB, VB) require refinement prior to larger testing. Neither phase demonstrated between-group differences in preliminary efficacy. In Phase 1 within-group analyses, MARIGOLD and emotion reporting control demonstrated a similar pattern of findings (stable depressive symptoms, increased positive emotion, decreased negative emotion and stress), whereas the waitlist group significantly increased in depressive mood. Most Phase 2 within-group analyses demonstrated the expected pattern of results (i.e., decreases in PHQ-8 and negative emotion, increases in positive emotion). However, CES-D scores were stable in FC; perceived stress was stable in FC and ODB.LimitationsThis pilot study is not powered to evaluate efficacy.ConclusionPositive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.

Theoretically driven smartphone-delivered behavioral interventions that target mechanisms underlying eating behavior are lacking. In this study, we administered a 28-day self-paced smartphone-delivered intervention rooted in an operant conditioning theoretical framework that targets craving-related eating using mindful eating practices. At pre-intervention and 1-month post-intervention, we assessed food cravings among adult overweight or obese women (N = 104; M age = 46.2 ± 14.1 years; M BMI = 31.5 ± 4.5) using ecological momentary assessment via text message (SMS), self-reported eating behavior (e.g., trait food craving), and in-person weight. Seventy-eight participants (75.0%) completed the intervention within 7 months ('all completers'), and of these, 64 completed the intervention within 3 months ('timely completers'). Participants experienced significant reductions in craving-related eating (40.21% reduction; p

BackgroundChildbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education.MethodsThis study, the Prenatal Education About Reducing Labor Stress (PEARLS) study, is a randomized controlled trial (RCT; n = 30) of a short, time-intensive, 2.5-day mindfulness-based childbirth preparation course offered as a weekend workshop, the Mind in Labor (MIL): Working with Pain in Childbirth, based on Mindfulness-Based Childbirth and Parenting (MBCP) education. First-time mothers in the late 3rd trimester of pregnancy were randomized to attend either the MIL course or a standard childbirth preparation course with no mind-body focus. Participants completed self-report assessments pre-intervention, post-intervention, and post-birth, and medical record data were collected.ResultsIn a demographically diverse sample, this small RCT demonstrated mindfulness-based childbirth education improved women's childbirth-related appraisals and psychological functioning in comparison to standard childbirth education. MIL program participants showed greater childbirth self-efficacy and mindful body awareness (but no changes in dispositional mindfulness), lower post-course depression symptoms that were maintained through postpartum follow-up, and a trend toward a lower rate of opioid analgesia use in labor. They did not, however, retrospectively report lower perceived labor pain or use epidural less frequently than controls.ConclusionsThis study suggests mindfulness training carefully tailored to address fear and pain of childbirth may lead to important maternal mental health benefits, including improvements in childbirth-related appraisals and the prevention of postpartum depression symptoms. There is also some indication that MIL participants may use mindfulness coping in lieu of systemic opioid pain medication. A large-scale RCT that captures real-time pain perceptions during labor and length of labor is warranted to provide a more definitive test of these effects.Trial registrationThe ClinicalTrials.gov identifier for the PEARLS  study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.

ObjectiveWe conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV.MethodOne-hundred and fifty-nine participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually delivered positive affect skills intervention or an attention-matched control condition.ResultsFor the primary outcome of past-day positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12, d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months postdiagnosis compared with an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006, d = -.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048, d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes.ConclusionsThis comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. (PsycINFO Database Record

Purpose To determine if high lung shunt fraction (LSF) is an independent prognostic indicator of poor survival in patients who undergo yttrium 90 radioembolization for unresectable liver-dominant metastatic colorectal cancer. Materials and Methods Retrospective data were analyzed from 606 patients (62% men; mean age, 62 years) who underwent radioembolization to treat liver metastases from colorectal adenocarcinoma between July 2002 and December 2011 at 11 U.S. centers. Institutional review board exemptions were granted prior to the collection of data at each site. Overall survival was estimated by using Kaplan-Meier survival and univariate Cox proportional hazards models to examine the effect of LSF on survival and to compare this to other potential prognostic indicators. Multivariate analysis was also performed to determine whether LSF is an independent risk factor for poor survival. Results LSF higher than 10% was predictive of significantly decreased survival (median, 6.9 months vs 10.0 months; hazard ratio, 1.60; P < .001) and demonstrated a mild but significant correlation to serum carcinoembryonic antigen levels and tumor-to-liver volume ratio (Pearson correlation coefficients, 0.105 and 0.113, respectively; P < .05). A progressive decrease in survival was observed as LSF increased from less than 5% to more than 20% (P < .05). LSF did not correlate with the presence of extrahepatic metastases or prior administration of bevacizumab. Conclusion Increased LSF is an independent prognostic indicator of worse survival in patients undergoing radioembolization for liver-dominant metastatic colorectal adenocarcinoma. High LSF correlates poorly to other potential markers of tumor size, such as tumor-to-liver volume ratio or serum carcinoembryonic antigen level, and does not correlate to the presence of extrahepatic metastases. © RSNA, 2016 Online supplemental material is available for this article.

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414).