Search

BackgroundA very low-carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain.ObjectiveThis study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring.MethodsThe study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5).ResultsOverall, the VLC intervention led to statistically significant improvements in glycemic control (-0.70%, 95% CI -1.04% to -0.35%; P

Psychological well-being, characterized by feelings, cognitions, and strategies that are associated with positive functioning (including hedonic and eudaimonic well-being), has been linked with better physical health and greater longevity. Importantly, psychological well-being can be strengthened with interventions, providing a strategy for improving population health. But are the effects of well-being interventions meaningful, durable, and scalable enough to improve health at a population-level? To assess this possibility, a cross-disciplinary group of scholars convened to review current knowledge and develop a research agenda. Here we summarize and build on the key insights from this convening, which were: (1) existing interventions should continue to be adapted to achieve a large-enough effect to result in downstream improvements in psychological functioning and health, (2) research should determine the durability of interventions needed to drive population-level and lasting changes, (3) a shift from individual-level care and treatment to a public-health model of population-level prevention is needed and will require new infrastructure that can deliver interventions at scale, (4) interventions should be accessible and effective in racially, ethnically, and geographically diverse samples. A discussion examining the key future research questions follows.

Dementia caregiving, besides encompassing various challenges in tandem to the diagnosis of the care recipient, is associated with decreased psychological well-being and mental health. Accordingly, caregivers' wellbeing has an impact on the quality of care they provide and on the relationship quality with the person in their care. The aim of the present study is to examine the effectiveness of a mindfulness-based intervention on relational and psychological wellbeing, tailored to the needs of dementia caregivers. This clinical trial (NCT04977245) will apply a randomized controlled mixed method design. Caregivers will be randomly allocated to either the mindfulness intervention or the active control group. The intervention arm is based on experiential learning and is targeted to promote caregivers' well-being and empowerment. Assessments will include, standardized self-report questionnaires, task performance measures, and qualitative measures. All assessments will be held at three time points (baseline; t0, 0 months, post-intervention; t1, 2 months, and after maintenance; t2, 3 months) focused on three core domains (1. relational well-being, 2. psychological well-being, and 3. dementia patient's lifestyle/activities). The primary outcome will be relational well-being, and data will be analyzed using linear mixed modelling.

There has been extensive discussion about gender gaps in representation and career advancement in the sciences. However, psychological science itself has yet to be the focus of discussion or systematic review, despite our field's investment in questions of equity, status, well-being, gender bias, and gender disparities. In the present article, we consider 10 topics relevant for women's career advancement in psychological science. We focus on issues that have been the subject of empirical study, discuss relevant evidence within and outside of psychological science, and draw on established psychological theory and social-science research to begin to chart a path forward. We hope that better understanding of these issues within the field will shed light on areas of existing gender gaps in the discipline and areas where positive change has happened, and spark conversation within our field about how to create lasting change to mitigate remaining gender differences in psychological science.

PurposePositive affect has demonstrated unique benefits in the context of health-related stress and is emerging as an important target for psychosocial interventions. The primary objective of this meta-analysis was to determine whether psychosocial interventions increase positive affect in cancer survivors.MethodsWe coded 28 randomized controlled trials of psychosocial interventions assessing 2082 cancer survivors from six electronic databases. We calculated 76 effect sizes for positive affect and conducted synthesis using random effects models with robust variance estimation. Tests for moderation included demographic, clinical, and intervention characteristics.ResultsInterventions had a modest effect on positive affect (g = 0.35, 95% CI [0.16, 0.54]) with substantial heterogeneity of effects across studies ([Formula: see text]; I2 = 78%). Three significant moderators were identified: in-person interventions outperformed remote interventions (P = .046), effects were larger when evaluated against standard of care or wait list control conditions versus attentional, educational, or component controls (P = .009), and trials with survivors of early-stage cancer diagnoses yielded larger effects than those with advanced-stage diagnoses (P = .046). We did not detect differential benefits of psychosocial interventions across samples varying in sex, age, on-treatment versus off-treatment status, or cancer type. Although no conclusive evidence suggested outcome reporting biases (P = .370), effects were smaller in studies with lower risk of bias.ConclusionsIn-person interventions with survivors of early-stage cancers hold promise for enhancing positive affect, but more methodological rigor is needed.Implications for cancer survivorsPositive affect strategies can be an explicit target in evidence-based medicine and have a role in patient-centered survivorship care, providing tools to uniquely mobilize human strengths.

IntroductionIn the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine.MethodsConducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures.ResultsMen randomized to the positive affect intervention displayed significantly lower log10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months.ConclusionsDelivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.

ObjectiveDysfunction in positive affect is a defining symptom of bipolar I disorder (BD), both during and between mood episodes. We hypothesize that helping people with BD learn skills to create balance in their affective experiences by engaging in strategies that increase low activation positive emotion (LAP; e.g., relaxation) could help to improve well-being during periods of symptom remission. We discuss the development and preliminary outcomes of a positive emotion regulation (PER) group treatment for people with BD, designed as a supplement to pharmacological treatment.MethodThe Learning Affective Understanding for a Rich Emotional Life (LAUREL) intervention is a group-based intervention covering 10 empirically supported skills designed to increase LAP. Sixteen people with BD enrolled in the LAUREL intervention and twelve completed baseline and post-intervention assessments.ResultsParticipants who completed the study (n = 12) attended the majority of groups (87.96%) and reported practicing skills, on average, 16 times a week. We were unable to detect significant differences in mania symptoms following engagement in this PER intervention. Finally, participants reported increases in several areas associated with well-being post-intervention, including mindfulness, reappraisal, and self-compassion.ConclusionThis study provides a theoretical framework and preliminary support for a PER intervention for BD.

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.

ObjectiveTo test the effects of Life Enhancing Activities for Family Caregivers (LEAF), a 6-week positive emotion regulation intervention, on outcomes of positive emotion, depression, anxiety, and physical health as measured by the Patient-Reported Outcomes Measurement Information System® (PROMIS®).MethodA randomized controlled trial (N = 170) comparing LEAF (N = 86) to an emotion reporting/waitlist condition (N = 84) in dementia caregivers. LEAF was individually delivered online by trained facilitators. Participants in the control condition completed daily online emotion reports and then crossed over into the intervention condition after 6 weeks. The study was registered with Clinicaltrials.gov (NCT01825681) and funded by R01NR014435.ResultsAnalyses of difference in change from baseline to 6 weeks demonstrated significantly greater decreases in PROMIS® depression (d = -.25; p = .02) and Quality of Life in Neurological Disorders (NeuroQOL) anxiety (d = -.33; p < .01), as well as improvements in PROMIS® physical health (d = .24; p = .02) in the intervention condition compared to the emotion reporting/waitlist control. The intervention also showed greater improvements in positive emotion (d = .58; p < .01) and positive aspects of caregiving (d = .36; p < .01). Increases in positive emotion significantly mediated the effect of LEAF on depression over time.ConclusionsThis randomized controlled trial of the online-facilitated positive emotion regulation intervention in dementia caregivers demonstrated small to medium effect sizes on caregiver well-being and shows promise for remotely delivered programs to improve psychological well-being in caregivers of people with dementia and other chronic illnesses. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Positive affect (PA) is associated with better health across a wide range of physical health outcomes. This review reflects on why the study of PA is an essential component of our understanding of physical health and expands on pathways that connect these two variables. To encourage forward movement in this burgeoning research area, measurement and design issues in the study of PA and health are discussed, as are the connections between PA and a range of different health outcomes. Plausible biological, social, and behavioral pathways that allow for positive feelings to get under the skin and influence physical wellness are detailed and framed in the context of several theoretical models. Finally, new directions for the field and important methodological and interpretative considerations that are essential to moving this important research area forward are explored.

Background: Mindfulness meditation is ubiquitous in health care, education, and communities at large. Mindfulness-Based Interventions (MBIs) are the focus of hundreds of NIH-funded trials given the myriad health benefits associated with this practice across multiple populations. Notwithstanding, significant gaps exist in how mindfulness concepts are measured using currently available self-report instruments. Due to the number of available mindfulness measurement tools, each measuring different aspects, it is difficult to determine the extent to which individuals develop comparable mindfulness skills and attitudes and which health benefits can be attributed to which gains in mindfulness. The Patient-Reported Outcomes Measurement Information System (Puerto RicoOMIS®) has established a rigorous instrument development methodology to create brief, precise, and clinically relevant outcomes tools. Objective: This is the first of 4 papers representing an NCCIH-funded initiative (R01AT009539), which has applied Puerto RicoOMIS® instrument development methodologies to mindfulness measurement to improve the rigor, relevance, and reproducibility of MBI research results. Methods/Results: This introductory paper sets the stage for why improved mindfulness measurement tools are needed and briefly describes the Puerto RicoOMIS® development approach. The second 2 papers highlight results from a national survey, focus groups, and expert interviews to identify and organize relevant mindfulness concepts, domains, and items for eventual item bank creation. The fourth paper reviews the item writing and development process of these new instruments, including results from stakeholder cognitive interviews and a translatability review. Conclusion: Together these papers feature the rigorous development approach, rationale, logic, and significance that supports the development, calibration, and validation of new Puerto RicoOMIS® measures of mindfulness and related concepts. [ABSTRACT FROM AUTHOR]

Although increasing emotional well-being has been proposed as a potential pathway to drive cardiac health, emotional well-being interventions for people with cardiac risk are underdeveloped, particularly among Hispanic/Latino adults. Our objective was to pilot a well-being intervention drawing on positive psychology concepts to determine feasibility and acceptability in Hispanics/Latinos at risk for cardiovascular disease (CVD). We developed a Spanish-language positive psychological intervention, with cultural tailoring informed by formative qualitative work, to promote emotional well-being and its antecedents in Hispanics/Latinos. Hispanic/Latino adults (n = 19) self-reporting two or more CVD risk factors were enrolled in our single-arm 8-week pilot trial. The group intervention consisted of 8 weekly 90-min sessions delivered by a bilingual licensed clinical social worker. Mean age was 54.1 years, 68.8% were female, and 50% had ≤eighth-grade education. Eleven of 19 Hispanic/Latino adults completed the 8-week program for a 57.89% retention rate, with a majority of factors leading to dropout unrelated to program content or mode of delivery. Most participants felt satisfied overall with each session (97.1%). Largest increases relative to baseline after receiving the intervention were found in engagement in happiness-inducing behaviors (e.g., meditation), emotional vitality, and subjective happiness using metrics of reliable change and effect sizes. This single-arm trial documented adequate feasibility and acceptability, although strategies to increase retention are warranted. Future studies should test our intervention using a randomized trial design with a larger sample size and inclusion of biomarkers (e.g., C-reactive protein) to document impact of our intervention on cardiac-related health.

BackgroundContingency management (CM) is an evidence-based intervention providing rewards in exchange for biomarkers that confirm abstinence from stimulants such as methamphetamine. We tested the efficacy of a positive affect intervention designed to boost the effectiveness of CM with HIV-positive, methamphetamine-using sexual minority men.MethodsThis attention-matched, randomized controlled trial of a positive affect intervention delivered during CM was registered on www.clinicaltrials.gov (NCT01926184). In total, 110 HIV-positive sexual minority men with biologically confirmed, recent methamphetamine use were enrolled. Five individual sessions of a positive affect intervention (n = 55) or an attention-control condition (n = 55) were delivered during three months of CM. Secondary outcomes examined over the 3-month intervention period included: 1) psychological processes relevant to affect regulation (i.e., positive affect, negative affect, and mindfulness); 2) methamphetamine craving; 3) self-reported stimulant use (past 3 months); and 4) cumulative number of urine samples that were non-reactive for stimulants (i.e., methamphetamine and cocaine) during CM.ResultsThose randomized to the positive affect intervention reported significant increases in positive affect during individual sessions and increases in mindfulness over the 3-month intervention period. Intervention-related improvements in these psychological processes relevant to affect regulation were paralleled by concurrent decreases in methamphetamine craving and self-reported stimulant use over the 3-month intervention period.ConclusionsDelivering a positive affect intervention may improve affect regulation as well as reduce methamphetamine craving and stimulant use during CM with HIV-positive, methamphetamine-using sexual minority men.

BackgroundText messaging is a promising strategy to support human immunodeficiency virus (HIV) care engagement, but little is known about its efficacy in urban safety-net HIV clinics.MethodsWe conducted a randomized controlled trial of a supportive and motivational text messaging intervention, Connect4Care (C4C), among viremic patients who had a history of poor retention or were new to the clinic. Participants were randomized (stratified by new or established HIV diagnosis status) to receive either of the following for 12 months: (1) thrice-weekly intervention messages, plus texted primary care appointment reminders and a monthly text message requesting confirmation of study participation or (2) texted reminders and monthly messages alone. Viral load was assessed at 6 and 12 months. The primary outcome was virologic suppression (

ObjectivesMounting evidence links positive psychological functioning to restorative health processes and favourable medical outcomes. However, very little is known about the relationship between optimism, an indicator of psychological functioning and the American Heart Association (AHA)-defined concept of cardiovascular health (CVH), particularly in Hispanics/Latinos of diverse backgrounds. To address limitations of existing literature, this study investigated the association between dispositional optimism and CVH in a heterogeneous sample of Hispanics/Latinos residing in the USA.DesignCross-sectional study.Participants and settingData were analysed from 4919 adults ages 18-75 of the Hispanic Community Health Study/Study of Latinos parent study and the Sociocultural Ancillary Study.Main outcome measuresOptimism was assessed using the 6-item Life Orientation Test-Revised (range from 6 to 30). AHA classification standards were used to derive an additive CVH score with operationalisation of indicators as Ideal, Intermediate and Poor. The overall CVH score included indicators of diet, body mass index, physical activity, cholesterol, blood pressure, fasting glucose and smoking status. Multivariate linear and logistic regressions were used to examine associations of optimism with CVH (Life's Simple 7), after adjusting for sociodemographic factors and depressive symptoms.ResultsEach increase in the optimism total score was associated with a greater CVH score (β=0.03 per unit increase, 95% CI 0.01 to 0.05). When modelling tertiles of optimism, participants with moderate (β=0.24 to 95% CI 0.06 to 0.42) and high (β=0.12, 95% CI 0.01 to 0.24) levels of optimism displayed greater CVH scores when compared with their least optimistic peers.ConclusionThis study offers preliminary evidence for an association between optimism and CVH in a large heterogeneous group of Hispanic/Latino adults. Our study adds scientific knowledge of psychological assets that may promote CVH and suggests a novel therapeutic target for consideration. Future studies are needed to explore causality and potential mechanism underlying the relationship between positive emotion and heart health.

Given the increasing number of family caregivers of persons with dementia (PWD) and the associated burden and detriments to both physical and mental health, interventions that aim to improve such outcomes are important. Studies are increasingly demonstrating the unique importance of positive emotions in coping with stress, independent from the impact of negative emotions. However, none have examined the benefits of interventions that target positive emotions for caregivers of individuals with a chronic and debilitating disease such as dementia. This paper presents the design and methods for a randomized controlled trial (RCT) of a positive affect skills intervention for family caregivers of PWD. The RCT is of a skills-based intervention that seeks to increase the frequency and intensity of positive affect in order to improve outcomes such as well-being, coping, and physical and mental health. The skills are delivered by trained facilitators via five one-to-one Internet video sessions with family caregivers of persons diagnosed with dementia (eg, Alzheimer's disease, vascular dementia, unspecified). The control group is an emotion reporting/waitlist control. Follow-up assessments are conducted post-intervention and at 1, 3, and 6 months post-completion of the intervention. This study promises to be an important and needed step toward improving the lives of caregivers of PWD.

Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n = 34) with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25) to a very low-carbohydrate ketogenic (LCK) diet (n = 16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n = 18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%) than participants in MCCR group (EMM at baseline = 6.9%, at 12 mos = 6.7%), p = .007. Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p

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

BackgroundContingency management (CM) is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts.Methods/designThis randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM) is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention - Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior.DiscussionImplementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018.Trial registrationThis trial was registered on clinicaltrials.gov ( NCT01926184 ) on August 16, 2013.

BackgroundPeople with prehypertension (120-130/80-90 mmHg) are at increased risk of progressing to hypertension. Recommendations for prehypertension include engaging in regular physical activity. We aimed to assess feasibility and acceptability and collect preliminary outcome data on ChiRunning for people with elevated blood pressure. ChiRunning is a commercially available running program based on the mindful movements of Tai Chi, which is aimed at decreasing injury by both increasing body awareness and modifying running form.MethodsWe enrolled adults with elevated systolic (130-150 mmHg) or diastolic (80-100 mmHg) blood pressure in a 12-week pilot trial. Participants were randomized 2:1:1 to 8 weeks of: 1) intervention-a trainer-led ChiRunning group (n = 10); 2) active control-a trainer-led running group (n = 6); or 3) educational control-a self-directed running group (n = 6) and followed for 4 more weeks. The active control and educational control groups were combined for analysis.ResultsThis study was feasible, meeting recruitment, retention and adherence goals, and acceptable to participants. Systolic and diastolic blood pressure did not change significantly over the study for either the ChiRunning or control groups. Changes in BMI over time were significantly different from zero in the ChiRunning group (p = 0.04) but not in the control group (slope for ChiRunning -0.05 [-0.1 to -0.002] vs. control -0.01 [-0.06 to 0.04], between slope difference, p = 0.22). Self-reported running-related injury (i.e. discomfort leading to a decrease in running) was similar between groups (ChiRunning, 4 [1.2 to 8.4] vs. control, 3 [0.7 to 7.1] injuries per 100 h of running, p = 0.72) although self-reported running-related discomfort (i.e. discomfort that does not lead to changes in running) trended higher in the ChiRunning group (ChiRunning, 10 [5.4 to 16.8] vs. control, 4 [1.5 to 9] reports of discomfort per 100 h of running, p = 0.06).ConclusionChiRunning appears to be a feasible and acceptable exercise program for people with elevated blood pressure. We did not find that ChiRunning had a significant impact on blood pressure or self reported injury, but did see a positive change in BMI over time. ChiRunning warrants further investigation in a larger trial.Trial registrationClinicalTrials.gov Identifier: NCT01587183.