Association between Cerebrospinal Fluid and Serum Biomarker Levels and Diagnosis, Injury Severity, and Short-Term Outcomes in Patients with Acute Traumatic Spinal Cord Injury.

Acute traumatic spinal cord injury (SCI) is recognized as a global problem that can lead to a range of acute and secondary complications impacting morbidity and mortality. There is still a lack of reliable diagnostic and prognostic biomarkers in patients with SCI that could help guide clinical care and identify novel therapeutic targets for future drug discovery. The aim of this prospective controlled study was to determine the cerebral spinal fluid (CSF) and serum profiles of 10 biomarkers as indicators of SCI diagnosis, severity, and prognosis to aid in assessing appropriate treatment modalities. CSF and serum samples of 15 SCI and ten healthy participants were included in the study. The neurological assessments were scored on admission and at discharge from the hospital using the American Spinal Injury Association Impairment Score (AIS) grades. The CSF and serum concentrations of SBDP150, S100B, GFAP, NF-L, UCHL-1, Tau, and IL-6 were significantly higher in SCI patients when compared with the control group. The CSF GBDP 38/44K, UCHL-L1, S100B, GFAP, and Tau levels were significantly higher in the AIS A patients. This study demonstrated a strong correlation between biomarker levels in the diagnosis and injury severity of SCI but no association with short-term outcomes. Future prospective controlled studies need to be done to support the results of this study.

An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial.

BACKGROUND: Young adult (YA) cancer survivors experience clinically significant distress and have limited access to psychosocial support. Given growing evidence for unique adaptive benefits of positive emotion in the context of health-related and other life stress, we developed an eHealth positive emotion skills intervention for post-treatment survivors called EMPOWER (Enhancing Management of Psychological Outcomes With Emotion Regulation) and evaluated feasibility and proof of concept for reducing distress and enhancing well-being. METHOD: In this single-arm pilot feasibility trial, post-treatment YA cancer survivors (ages 18-39) participated in the EMPOWER intervention which included 8 skills (e.g., gratitude, mindfulness, acts of kindness). Participants completed surveys at baseline (pre-intervention), 8 weeks (post-intervention), and 12 weeks (1-month follow-up). Primary outcomes included feasibility (assessed by participation percentage) and acceptability (would recommend EMPOWER skills to a friend). Secondary outcomes included psychological well-being (mental health, positive affect, life satisfaction, meaning/purpose, general self-efficacy) and distress (depression, anxiety, anger). RESULTS: We assessed 220 YAs for eligibility; 77% declined. Of those screened, 44 (88%) were eligible and consented, 33 began the intervention, and 26 (79%) completed the intervention. Overall retention was 61% at 12 weeks. Average acceptability ratings were high (8.8/10). Participants (M = 30.8 years, SD = 6.6) were 77% women, 18% racial/ethnic minorities, and 34% breast cancer survivors. At 12 weeks, EMPOWER was associated with improved mental health, positive affect, life satisfaction, meaning/purpose, and general self-efficacy (ps < .05, ds = .45 to .63) and decreased anger (p < .05, d = - 0.41). CONCLUSION: EMPOWER demonstrated evidence of feasibility and acceptability as well as proof of concept for enhancing well-being and reducing distress. Self-guided, eHealth interventions show promise for addressing YA cancer survivors' needs and warrant additional research to optimize survivorship care. TRIAL REGISTRATION: ClinicalTrials .gov NCT02832154,  https://clinicaltrials.gov/ct2/show/NCT02832154.

Negative Mood and Food Craving Strength Among Women with Overweight: Implications for Targeting Mechanisms Using a Mindful Eating Intervention.

OBJECTIVES: When 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. METHODS: In 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). RESULTS: In model 1, negative mood interacted with time point (ß = - .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 (ß = 0.18) relative to pre-intervention (ß = 0.38). In model 2, negative mood did not interact with time point to predict craving strength (ß = .13, SE = .09, p = .10, 95% CI - .03, .31]); the association did not significantly differ between post-intervention and 1-month follow-up. CONCLUSIONS: Training 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 REGISTRATION: NCT02694731. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12671-021-01760-z.

Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial.

BACKGROUND: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another. OBJECTIVE: The aim of our study is to test whether 3 enhancements-facilitator contact (FC), an online discussion board, and virtual badges (VB)-alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence. METHODS: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions-the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed. RESULTS: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline. CONCLUSIONS: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755.

A Brief Motivational Intervention Differentially Reduces Sugar-sweetened Beverage (SSB) Consumption.

BACKGROUND: Environmental and behavioral interventions hold promise to reduce sugar-sweetened beverage (SSBs) consumption. PURPOSE: To 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. METHODS: We 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. RESULTS: In 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. CONCLUSIONS: Frequent 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 INFORMATION: NCT02585336.

A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial.

BACKGROUND: Growing 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. OBJECTIVE: The 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. METHODS: A 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. RESULTS: Activities 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. CONCLUSIONS: Findings 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 REGISTRATION: ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17721.

Tryptophan degradation is associated with risk-taking propensity in methamphetamine users with treated HIV infection.

Few studies have examined neuroimmune pathways that could contribute to impulsivity in people living with HIV who use substances. Eighty-four methamphetamine-using, sexual minority men with an undetectable HIV viral load were administered the Balloon Analogue Risk Task (BART), a behavioral measure of risk-taking propensity. We examined the associations between kynurenine/tryptophan ratio and phenylalanine/tyrosine ratio with BART scores using multiple linear regression. A higher kynurenine/tryptophan ratio was independently associated with greater BART scores (beta = 0.25; 95% CI = 0.05-1.23; p = 0.034). The phenylalanine/tyrosine ratio was not significantly associated with BART scores. Findings support the need for further research to elucidate the neuroimmune mechanisms linking tryptophan degradation with impulsivity to catalyze the development novel pharmacologic treatments for people living with HIV who use methamphetamine.

A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial.

BACKGROUND: Adolescent 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. OBJECTIVE: The 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: If 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 REGISTRATION: ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17078.

Association of a Workplace Sales Ban on Sugar-Sweetened Beverages With Employee Consumption of Sugar-Sweetened Beverages and Health.

Importance: Reductions in sugar-sweetened beverage (SSB) intake can improve health, but are difficult for individuals to achieve on their own. Objectives: To 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 Participants: This 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. Interventions: The 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 Measures: Outcomes 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. Results: Among 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 < .001). Reductions in SSB intake correlated with improvements in HOMA-IR (r = 0.16; P = .03). Those not randomized to receive the brief intervention reduced their SSB intake by a mean (SD) of 246.0 (84.0) mL (8.2 [2.8] fl oz), while those also receiving the brief intervention reduced SSB intake by 762.0 (84.0) mL (25.4 [2.8] fl oz). From baseline to follow-up, there were significant reductions in mean (SE) waist circumference (2.1 [2.8] cm; P < .001). Conclusions and Relevance: This study's findings suggest that the workplace sales ban was associated with a reduction in SSB intake and a significant reduction in waist circumference among employees within 10 months. The randomized clinical trial portion of this study found that targeting those at high risk with a brief motivational intervention led to additional improvements. Workplace sales bans may offer a promising new private-sector strategy for reducing the health harms of SSB intake. Trial Registration: ClinicalTrials.gov identifier: NCT02585336.

A novel technology-enhanced internalized stigma and shame intervention for HIV-positive persons with substance use disorders.

Internalized stigma, shame, and other negative self-conscious emotions are inadequately addressed barriers to HIV-related self-care, particularly among people actively using substances. Innovative approaches are needed to optimize antiretroviral treatment (ART) adherence as well as engagement in HIV care among people living with HIV and substance use disorders. Based on qualitative feedback from providers and patients, we iteratively developed and conducted a proof-of-concept study of a relatively brief transdiagnostic emotion regulation intervention designed to improve ART adherence care by addressing behavioral and psychological barriers, including internalized stigma and shame, among people living with HIV and active substance use disorders. The final intervention included 5 individual sessions focused on metacognitive awareness of emotions and thoughts, cognitive reframing of dysfunctional thoughts about the self using concepts such as self-compassion, and identifying and reaching the participants' personalized HIV-self-care goal(s). All participants received daily texts querying current emotion and weekly texts querying ART adherence and substance use. To extend the effects of the intervention, we developed a personalized bi-directional text component through which participants received their personalized compassionate self-statements, informed by the intervention content, in response to their answers to emotion queries for 8 weeks after the 5 sessions. The texts modeled using compassionate self-statements as a form of cognitive reframing, consistent with cognitive restructuring of distorted core beliefs. We consented 10 participants living with HIV and problematic substance use in the proof-of-concept pilot. Of the 8 participants who completed all intervention sessions, participants replied to 70% of all text messages sent. All 8 reported strong acceptability of the intervention content. This emotion-focused, technology-enhanced intervention demonstrated proof-of-concept, in that this patient population would participate in this intervention. A larger randomized controlled pilot is needed to determine feasibility and acceptability among people living with HIV and substance use disorders, a hard-to-reach and underserved population.

The MARIGOLD study: Feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms.

BACKGROUND: This 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. METHODS: Adults 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. RESULTS: In 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. LIMITATIONS: This pilot study is not powered to evaluate efficacy. CONCLUSION: Positive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.

Feasibility of an Internet-based positive psychological intervention for hemodialysis patients with symptoms of depression.

BACKGROUND: Depression is a pervasive psychological issue facing hemodialysis (HD) patients. Novel technology-based treatment strategies that deploy psychology-based interventions have not been the focus for therapy and few published studies exist. The aim of the current trial is to determine the feasibility and acceptability of an Internet-based positive psychological intervention in HD patients with comorbid depressive symptoms. METHODS: HD patients (n = 14) with elevated symptoms of depression were enrolled in a single-arm pre-post trial with clinical assessments at baseline and immediately post intervention. Chairside during regularly scheduled HD treatment, patients utilized a web browser to complete online modules promoting skills for increasing positive emotion over a 5-week period using Apple IPads. Targeted skills included noting of daily positive events, gratitude, positive reappraisal, acts of kindness, and mindfulness/meditation. RESULTS: Twelve of 14 patients completed the program for an 85.7% retention rate. Participants felt satisfied with each session and offered consistently positive feedback. On average, participants visited the website 3.5 times per week. Significant improvements were evident for depressive symptoms (15.3 vs. 10.9; p = 0.04), as per the Center for Epidemiological Studies Depression Scale. CONCLUSIONS: An innovative Internet-based positive psychological intervention represents a feasible and useful therapeutic option for HD patients with depressive symptoms.

A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD.

BACKGROUND: Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE: The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS: This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS: The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS: Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION: ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10494.

Erratum to updated survival outcomes and analysis of long-term survivors from the MORE study on safety and efficacy of radioembolization in patients with unresectable colorectal cancer liver metastases.

[This corrects the article DOI: 10.21037/jgo.2017.03.10.].

Testing a mobile mindful eating intervention targeting craving-related eating: feasibility and proof of concept.

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 < .001) and self-reported overeating behavior (trait food craving, p < .001; other measures ps < .01). Reductions in trait food craving were significantly correlated with weight loss for timely completers (r = .30, p = .020), this pattern of results was also evident in all completers (r = .22, p = .065). Taken together, results suggest that smartphone-delivered mindful eating training targeting craving-related eating may (1) target behavior that impacts a relative metabolic pathway, and (2) represent a low-burden and highly disseminable method to reduce problematic overeating among overweight individuals. ClinicalTrials.gov registration: NCT02694731.

Updated survival outcomes and analysis of long-term survivors from the MORE study on safety and efficacy of radioembolization in patients with unresectable colorectal cancer liver metastases.

BACKGROUND: The Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) study was a retrospective analysis of 606 patients with unresectable colorectal liver metastases treated with radioembolization (RE) using 90Y-labeled resin microspheres. The first analysis of this study was completed with a last patient follow-up of 77.7 months. We now provide an updated survival analysis through September 15, 2016, with a last patient follow-up of 125 months. METHODS: 90Y-RE was considered for patients with advanced liver-only or liver-dominant metastatic colorectal cancer which was deemed not suitable for surgery, ablation, or systemic therapy, and which had progressed or become refractory to at least one line of systemic therapy. All patients with a diagnosis of metastatic colorectal cancer who had received at least 1 RE treatment and 1 follow-up visit were included in the analysis. Patients were treated between July 2002 and December 2011 at one of 11 U.S. tertiary care centers. Data were collected at baseline, on the day of the first 90Y-RE treatment (day 0), and at all subsequent visits or until death. Patient medical charts and/or public records were accessed to obtain dates of death. RESULTS: Dates of death were obtained for 574 out of a total of 606 patients, and overall survival (OS) data analyzed. Updated median OS was 10.0 months (95% CI: 9.2-11.8 months) at a median follow-up of 9.5 months versus the originally reported median OS of 9.6 months (95% CI: 9.0-11.1 months) at a follow-up of 8.6 months in the first MORE analysis. Patients received a median (range) of 2 (0 to 6) lines of chemotherapy. Baseline characteristics and factors significantly associated with patient survival (P<0.01) are consistent with those reported in the first safety analysis of the MORE study. These factors include poor ECOG performance status, markers of advanced disease such as increased extent of tumor-to-target liver involvement, poor baseline liver function, pre-treatment anemia, lung shunt fraction, and number of lines of prior chemotherapy. Patient age did not significantly affect survival outcomes. CONCLUSIONS: Long-term follow-up confirms that 90Y-RE treatment offers favorable survival benefits for patients with unresectable metastatic colorectal cancer, even among patients who received 3 or more prior lines of chemotherapy. Our analysis also supports earlier reported prognostic factors for survival after 90Y-RE. Overall, our updated analysis confirms that 90Y-RE treatment provided a meaningful response and survival advantage for MORE patients across all ages and across diverse community and academic centers in the U.S.

Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison.

BACKGROUND: Childbirth 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. METHODS: This 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. RESULTS: In 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. CONCLUSIONS: This 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 REGISTRATION: The ClinicalTrials.gov identifier for the PEARLS  study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.

Baseline hemoglobin and liver function predict tolerability and overall survival of patients receiving radioembolization for chemotherapy-refractory metastatic colorectal cancer.

BACKGROUND: Patients with liver metastatic colorectal cancer (mCRC) often benefit from receiving 90Y-microsphere radioembolization (RE) administered via the hepatic arteries. Prior to delivery of liver-directed radiation, standard laboratory tests may assist in improving outcome by identifying correctable pre-radiation abnormalities. METHODS: A database containing retrospective review of consecutively treated patients of mCRC from July 2002 to December 2011 at 11 US institutions was used. Data collected included background characteristics, prior chemotherapy, surgery/ablation, radiotherapy, vascular procedures, 90Y treatment, subsequent adverse events and survival. Kaplan-Meier estimates compared the survival of patients across lines of chemotherapy. The following values were obtained within 10 days prior to each RE treatment: haemoglobin (HGB), albumin, alkaline phosphatase (Alk phosph), aspartate aminotransferase (AST), alanine transaminase (ALT), total bilirubin and creatinine. Common Terminology Criteria Adverse Events (CTCAEs) 3.0 grade was assigned to each parameter and analysed for impact on survival by line of chemotherapy. Consensus Guidelines were used to categorize the parameter grades as either within or outside guidelines for treatment. RESULTS: A total of 606 patients (370 male; 236 female) were studied with a median follow-up was 8.5 mo. (IQR 4.3-15.6) after RE. Fewer than 11% of patients were treated outside recommended RE guidelines, with albumin being the most common, 10.5% grade 2 (<3-2.0 g/dL) at time of RE. All seven parameters showed statistically significant decreased median survivals with any grade >0 (P<0.001) across all lines of prior chemotherapy. Compared to grade 0, grade 2 albumin decreased overall survival 67%; for grade 2 total bilirubin a 63% drop occurred, and grade 1 HGB resulted in 66% lower median survival. CONCLUSIONS: Review of pre-RE laboratory parameters may aid in improving median survivals if correctable grade >0 values are addressed prior to radiation delivery. HGB <10 g/dL is a well-known negative factor in radiation response and is easily corrected. Improving other parameters is more challenging. These efforts are important in optimizing treatment response to liver radiotherapy.

Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV.

OBJECTIVE: We 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. METHOD: One-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. RESULTS: For 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. CONCLUSIONS: This 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