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Feasibility, Acceptability, and Preliminary Effects of “Mindful Moms”: A Mindful Physical Activity Intervention for Pregnant Women with Depression

imageBackground Nonpharmacological and accessible therapies that engage individuals in self-management are needed to address depressive symptoms in pregnancy. The 12-week “Mindful Moms” intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful physical activity using prenatal yoga. Objectives This longitudinal pilot study evaluated the feasibility, acceptability, and preliminary effects of the “Mindful Moms” intervention in pregnant women with depressive symptoms. Methods We evaluated enrollment and retention data (feasibility) and conducted semistructured interviews (acceptability). We evaluated the intervention’s effects over time on participants’ depressive symptoms, anxiety, perceived stress, self-efficacy, and maternal–child attachment, and we compared findings to an archival comparison group, also assessed longitudinally. Results Enrollment and retention rates and positive feedback from participants support the intervention’s acceptability and feasibility. “Mindful Moms” participants experienced decreases in depressive symptoms, perceived stress, anxiety, ruminations, and maternal–child attachment and no change in physical activity self-efficacy from baseline to postintervention. Comparisons of the “Mindful Moms” intervention to the comparison groups over time indicated differences in depressive symptoms between all groups and a trend in differences in perceived stress. Discussion Results support the feasibility and acceptability of “Mindful Moms” for pregnant women with depressive symptoms and suggest that further research is warranted to evaluate this intervention for reducing depressive and related symptoms. Lack of a concurrent control group, with equivalent attention from study staff, and no randomization limit the generalizability of this study; yet, these preliminary findings support future large-scale randomized controlled trials to further evaluate this promising intervention.

Transition From Acute to Chronic Pain in Lower Extremity Fracture Patients: A Pain Phenotyping Protocol

imageBackground Traumatic injury is a major source of chronic pain, particularly for individuals with traumatic fracture of the fibula and/or tibia (lower extremity fracture [LEFx]). Although several factors (e.g., older age, being female, high pain intensity at time of initial injury) have been identified as risk factors for chronic pain associated with LEFx. Comprehensive biopsychosical models to predict the odds of transitioning from acute to chronic pain after LEFx are needed to better understand the underlying processes, predict risk for chronic pain, and develop personalized therapies for individuals at higher risk for developing chronic pain. Objective The aim of the study was to outline the study design that will be used to examine the physiological, psychological, and genetic/genomic variables—models that predict the transition from acute to chronic pain after LEFx. Method This prospective descriptive cohort study will enroll 240 participants with a fibula and/or tibia fracture and 40 controls with no LEFx. Data will be collected during an in-hospital baseline visit, five in-person clinic visits (6 weeks, 12 weeks, 24 weeks, 52 weeks, and 24 months), and seven online between-visit surveys (2 weeks, 4 weeks, 8 weeks, 10 weeks, 16 weeks, 20 weeks, and 18 months) from participants with LEFx and at concordant intervals from controls. Measures will consist of 19 questionnaires characterizing pain and psychological status, neurophysiological testing for peripheral sensory nerve function, and peripheral blood samples collections for RNA sequencing. Illumina standard protocols will be used to sequence RNA, and read counts will be used to measure gene expression. Analysis Direct-entry, multiple logistic regression will be used to produce odds ratios expressing the relative risk on each explanatory variable when controlling for other predictors/covariates in the model. Conclusion This study is one of the first to longitudinally characterize the biopsychosocial variables associated with a clinically relevant problem of the transition from acute to chronic posttraumatic fracture pain in individuals with LEFx. Results from this study will be used to construct predictive risk models of physiological, psychological, and genetic/genomic variables associated with increased risk for transitioning from acute to chronic pain status after LEFx. This work will lead to a better understanding of the trajectory of pain and relevant variables over time; initiate a better understanding of variables associated with risk for transitioning from acute to chronic pain; and, in the future, could provide a foundation for the identification of novel therapeutic targets to improve the outcomes of individuals with LEFx.

Protocol for Pilot Study on Self-Management of Depressive Symptoms in Pregnancy

imageBackground Pregnant women with depressive symptoms face significant treatment challenges and are in great need of safe, effective, accessible, inexpensive, and nonpharmacological self-management therapies to enhance well-being, reduce the burden of symptoms both during their pregnancy and postpartum, and prevent chronic sequelae. Objectives In this article, we describe the protocol for our pilot study testing a self-management intervention entitled, “Mindful Moms,” designed to foster women’s ability to address current depressive symptoms and enhance resilience to prevent recurrence. Methods We will conduct a longitudinal pilot trial of the 12-week intervention with pregnant women with depressive symptoms (n = 40); the primary aim is to determine the feasibility and acceptability of the intervention. The secondary aim is to examine preliminary effects of the intervention on maternal psychobehavioral outcomes in pregnancy and 6 weeks postpartum. The third aim will quantify genome-wide and gene-specific DNA methylation patterns associated with depressive symptoms during pregnancy and investigate whether intervention participation influences these patterns. Results This study is currently ongoing. Discussion Findings from this study will inform future research addressing the need for nonpharmacological self-management interventions for pregnant women with depressive symptoms.

Effects of Physical Activity on Neurophysiological and Gene Expression Profiles in Chronic Back Pain: Study Protocol

imageBackground Despite the emphasis on exercise to reduce pain and improve function among people with chronic low back pain (cLBP), little is known about the underlying mechanism of the impact of exercise on the neurophysiological and gene transcription alterations that characterize cLBP. Objectives To present a study protocol to examine the feasibility, acceptability, and initial efficacy of Problem-Solving Pain to Enhance Living Well (PROPEL) with the support of nurse consultations and wearable activity-tracking technology on self-management (SM) knowledge, skills, physical activity, and pain and to examine the differential neurophysiological and gene expression profiles in cLBP participants from pre- to post-PROPEL. Methods A pretest and posttest study is employed on 40 adults ages 18–60 years with cLBP who do not have serious complications and/or comorbidities that affect sensorimotor function. Participants will receive video modules focused on SM and biweekly phone consultations to facilitate symptom monitoring and problem-solving while increasing physical activity frequency and duration. Participants will be assessed for outcomes including SM skills, physical activity, and pain every 2 weeks for 12 weeks. We will examine the participants’ differential neurophysiological and gene expression profiles at 12 weeks postintervention and correlate these outcomes with the total duration of physical activity. Results The study began in September 2018. Of the 99 subjects that were screened, 23 were enrolled and 8 completed data collection. Discussion Comparing the neurophysiological and gene expression profiles of people with cLBP exposed to PROPEL could inform the development of interventions that offer personalized physical activity dosage along with general SM support. Web-based programs such as PROPEL have the potential to enhance accessibility of evidence-based interventions that improve functionality and quality of life among people living with cLBP.

Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial

imageBackground Over 90% of women experience pain during breastfeeding initiation and lack strategies to self-manage breast and nipple pain. Guided by the Individual and Family Self-Management Theory, a breastfeeding self-management (BSM) intervention targeted women's knowledge, beliefs, and social facilitation to manage their breast and nipple pain and achieve their breastfeeding goals. Objectives The purpose of this longitudinal pilot randomized control trial (RCT) was to test the preliminary efficacy of the BSM intervention on general and specific pain related to breastfeeding. Methods Sixty women intending to breastfeed were approached within 48 hours of delivery to participate in this pilot RCT (30 randomized to the BSM intervention and 30 randomized to the control group). All participants provided baseline data before discharge and pain and breastfeeding measures at 1, 2, and 6 weeks. Participants in the BSM intervention group received educational modules addressing breast and nipple pain and biweekly, text-based nurse coaching and completed a daily breastfeeding journal. Results Women in the BSM intervention group reported significantly less breast and nipple pain at 1 and 2 weeks using a visual analog scale (p

Association of CTRP13 With Liver Enzymes and Cognitive Symptoms in Nonalcoholic Fatty Liver Disease

imageBackground Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease in which patients present with metabolic dysregulation and obesity as well as fat accumulation in the liver. Those with NAFLD frequently have symptoms of fatigue, sleep disturbance, depression, and cognitive dysfunction. C1q/TNF-related protein 13 (CTRP13) regulates glucose metabolism and obesity in mice, yet the role of CTRP13 in human NAFLD has not been elucidated. Aims Our aims were to examine whether the plasma levels of CTRP13 are (a) increased in patients with NAFLD; (b) associated with metabolic dysregulation, obesity, liver enzymes, and dyslipidemia; and (c) associated with putative symptoms of NAFLD. Methods An observational study was conducted with 23 adults with confirmed NAFLD. Plasma levels of CTRP13, insulin resistance, insulin sensitivity, HbA1C, lipid profile, and liver enzymes were collected. Anthropometric analysis (body mass index, waist–hip circumference ratio) and bioelectrical impedance analysis of body composition were used to assess obesity. Symptom questionnaires were used to assess putative symptoms of NAFLD. Plasma levels of CTRP13 were measured in 21 age- and sex-matched control samples from a biobank. Paired t test was used for comparison of the CTRP13 between NAFLD and controls. Pearson’s correlation coefficients were used to examine associations among variables. Results Plasma levels of CTRP13 were significantly higher in patients with NAFLD than in normal controls (p