Jo Lynne W. Robins

Control Group Design: Enhancing Rigor in Research of Mind-Body Therapies for Depression

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.

Psychoneuroimmunology-Based Stress Management during Adjuvant Chemotherapy for Early Breast Cancer

Objective. In a randomized trial of women with early stage breast cancer undergoing adjuvant chemotherapy, two stress management interventions, tai chi training and spiritual growth groups, were compared to a usual care control group, to evaluate psychosocial functioning, quality of life (QOL), and biological markers thought to reflect cancer- and treatment-specific mechanisms. Method. The sample consisted of 145 women aged 27–75 years; 75% were Caucasian and 25% African American. A total of 109 participants completed the study, yielding a 75% retention rate. Grounded in a psychoneuroimmunology framework, the overarching hypothesis was that both interventions would reduce perceived stress, enhance QOL and psychosocial functioning, normalize levels of stress-related neuroendocrine mediators, and attenuate immunosuppression. Results. While interesting patterns were seen across the sample and over time, the interventions had no appreciable effects when delivered during the period of chemotherapy. Conclusions. Findings highlight the complex nature of biobehavioral interventions in relation to treatment trajectories and potential outcomes. Psychosocial interventions like these may lack sufficient power to overcome the psychosocial or physiological stress experienced during the chemotherapy treatment period. It may be that interventions requiring less activity and/or group attendance would have enhanced therapeutic effects, and more active interventions need to be tested prior to and following recovery from chemotherapy.

The Effects of Tai Chi on Cardiovascular Risk in Women

Purpose. This study examined the effects of tai chi (TC) on biobehavioral factors associated with cardiovascular disease (CVD) risk in women. Design. A randomized trial used a wait-list control group, pretest-posttest design. Data were collected immediately before, immediately after, and 2 months following the intervention. Setting. The study was community based in central Virginia. Subjects. Women aged 35 to 50 years at increased risk for CVD. Intervention. The 8-week intervention built on prior work and was designed to impact biobehavioral factors associated with CVD risk in women. Measures. Biological measures included fasting glucose, insulin, and lipids as well as C-reactive protein and cytokines. Behavioral measures included fatigue, perceived stress, depressive symptoms, social support, mindfulness, self-compassion, and spiritual thoughts and behaviors. Analysis. A mixed effects linear model was used to test for differences between groups across time. Results. In 63 women, TC was shown to decrease fatigue (∂ [difference in group means] = 9.38, p = .001) and granulocyte colony stimulating factor (∂ = 12.61, p = .052). Consistent with the study model and intervention design, significant changes observed 2 months post intervention indicated that TC may help down-regulate proinflammatory cytokines associated with underlying CVD risk, including interferon gamma (∂ = 149.90, p = .002), tumor necrosis factor (∂ = 16.78, p = .002), interleukin (IL) 8 (∂ = 6.47, p = .026), and IL-4 (∂ = 2.13, p = .001), and may increase mindfulness (∂ = .54, p = .021), spiritual thoughts and behaviors (∂ = 8.30, p = .009), and self-compassion (∂ = .44, p = .045). Conclusion. This study contributes important insights into the potential benefits and mechanisms of TC and, with further research, may ultimately lead to effective strategies for reducing CVD risk in women earlier in the CVD trajectory.

Text Messaging as Adjunct to Community-Based Weight Management Program

Increasing obesity rates are still a public health priority. The primary aim of this study was to evaluate the effect of tailored text messages on body weight change in overweight and obese adults in a community-based weight management program. A secondary aim was to detect behavioral changes in the same population. The study design was quasi-experimental with pretest and posttest analysis, conducted over 12 weeks. A total of 28 participants were included in the analysis. Body weight, eating behaviors, exercise and nutrition self-efficacy, attitude toward mobile technology, social support, and physical activity were assessed at baseline and at 12 weeks. Text messages were sent biweekly to the intervention but not to the control group. At 12 weeks, the intervention group had lost significant weight as compared with the control group. There was a trend toward an improvement in eating behaviors, exercise, and nutrition self-efficacy in the intervention group, with no significant difference between groups. A total of 79% of participants stated that text messages helped in adopting healthy behaviors. Tailored text messages appear to enhance weight loss in a weight management program at a community setting. Large-scale and long-term intervention studies are needed to confirm these findings.

Mindfulness: An effective coaching tool for improving physical and mental health

Purpose: This article provides an overview of the mechanisms of action, evidence base, and practice of mindfulness, with an emphasis on how to easily incorporate this valuable skill into practice. Data sources: PubMed, CINAHL, PsychInfo Databases. Conclusions: Conscious attention to the present moment in a receptive way is known as mindfulness. A growing body of research indicates that mindfulness can be taught and cultivated to improve physical and mental health. Implications for practice: Accordingly, as part of the coaching competency, mindfulness can be practiced and taught by advanced practice nurses to support lifestyle and behavioral changes, decrease perceived stress, enhance quality of life, and, ultimately, improve health and health outcomes.

The Story of the Evolution of a Unique Tai Chi Form Origins, Philosophy, and Research

The purpose of this article is to introduce a unique tai chi form that has been successfully implemented in two large randomized clinical trials. The intervention is composed of a series of tai chi movements chosen for their particular meanings, thus adding a cognitive component to the practice of a moving meditation. Over the last decade, the intervention has continued to evolve as it has been used in different populations. Most recently, medical qigong has been integrated to strengthen its potential impact on a variety of biobehavioral measures associated with cardiometabolic risk in women. Following an appraisal of the authors’ process as well as the philosophy, practice, and research of tai chi and qigong, the authors share the story of their intervention to contribute to the evolving research of these safe, well-received, low-cost, and beneficial practices.

Exploring the Complexity of Cardiometabolic Risk in Women

Cardiovascular disease (CVD) is the leading cause of death in the United States. Women are more likely than men to present with advanced disease and experience higher CVD-related morbidity and mortality. Metabolic syndrome is a constellation of risk factors for Type 2 diabetes mellitus (T2DM) and CVD. Abdominal adiposity, a component of metabolic syndrome, is associated with insulin resistance and promotes an atherogenic inflammatory milieu. Cardiometabolic risk (CMR) encompasses metabolic syndrome and incorporates other risk factors such as lifestyle choices, gender, and genetics as risk factors for CVD yet still does not include more recently recognized physiological risk factors such as vitamin D deficiency or psychosocial risk factors such as perceived stress and lack of social support. Because a more comprehensive view of CVD risk factors may facilitate earlier identification and risk reduction, we undertook this exploratory pilot study to answer the question, How do healthy women with and without abdominal adiposity differ physiologically and psychosocially?. We recruited a total of 41 women for a single study visit and assessed a battery of baseline physiological and psychological measures. While the women in this study were free of any diagnoses associated with increased CMR, women with increased waist circumference (WC) exhibited significantly altered levels of several measures associated with impending CMR including insulin sensitivity, lipids, and adiponectin as well as lower social support. These findings suggest that a more comprehensive conceptualization of and refinement of measures for CMR may be useful for identifying and reducing CMR and ultimately CVD in women.

Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.

Background The need for reliable, valid tools to measure patient-reported outcomes (PROs) is critical both for research and for evaluating treatment effects in practice. The Patient-Reported Outcomes Measurement Information System Fatigue-Short Form v1.0-Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations. Objectives The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations. Methods Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia, sickle cell disease, cardiometabolic risk, pregnancy, and healthy controls were used. Reliability was estimated using Cronbach’s alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson’s correlations between scores from the PROMIS F-SF, the Multidimensional Fatigue Symptom Inventory-Short Form, and the Brief Fatigue Inventory. Discriminant validity was evaluated by examining Pearson’s correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SF scores in the clinical samples to healthy controls. Results Reliability of PROMIS F-SF scores was adequate across samples, ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups, correlations with scores on the Multidimensional Fatigue Symptom Inventory-Short Form and Brief Fatigue Inventory ranged from .60 to .85. Correlations of the PROMIS F-SF with measures of stress and depressive mood were moderate to strong, ranging from .37 to .64. PROMIS F-SF scores were significantly higher in clinical samples compared to healthy controls. Discussion Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis.

The Impact of Neutrophil Proteinase 3 on IGFBP-3 Proteolysis in Obesity

Obesity is a complex disorder and is a major risk factor associated with the incidence of insulin resistance (IR), diabetes, cardiovascular disease (CVD) and other metabolic disorders. The endocrine paradigm suggests that visceral fat in obesity, consisting primarily of adipocytes, secretes various pro-inflammatory adipokines such as tumor necrosis factor (TNF), leptin, visfatin, resistin, and IL-6 creating a state of local inflammation further resulting in chronic systemic inflammation and accelerating the events leading to systemic IR, diabetes and metabolic syndrome. The insulin-like growth factor (IGF) system plays a major role in growth, development and maintenance of homeostasis in normal cells. IGF binding protein-3 (IGFBP-3), the major binding protein in circulation, has been shown to be associated with obesity, IR, type II diabetes mellitus (T2DM) and CVD. Recent studies have demonstrated the IGFBP-3-specific receptor (IGFBP-3R) is a novel protein mediating the anti-inflammatory function of IGFBP-3. IGFBP-3 inhibits adipokine-induced insulin resistance and early manifestations of atherosclerosis via inhibition of NF-κB signaling in adipocytes. Furthermore, decreases in total IGFBP-3 levels and increases in proteolyzed IGFBP-3 in circulation have been documented in obese populations compared to their normal counterparts further establishing a positive correlation between IGFBP-3 proteolysis and adiposity parameters as well as IR. Conversely, our recent studies have identified that neutrophil serine protease (NSP) PR3, an IGFBP-3 specific protease in obesity, is positively correlated with IGFBP-3 proteolysis, IR, body mass index, TNF and IL-8. These findings strongly suggest that obesity-induced activation of PR3 abrogates the anti-inflammatory, insulin-sensitizing IGFBP-3/IGFBP-3R cascade, resulting in IR and its progression to T2DM. The complete characterization of the underlying mechanism and functional significance of the PR3-IGFBP-3/IGFBP-3R cascade in obesity will foster identification of the diagnostic and therapeutic potential of PR3 inhibition in insulin resistance and its sequelae.

Cumulative Risk and Physiological Stress Responses in African American Adolescents

Objective: To investigate associations between components of cumulative risk (CR) and physiological stress responses in African American adolescents and evaluate emotion regulation as a mediator and sex as a moderator of these associations. Methods: Cortisol and salivary alpha amylase (sAA) were collected in adolescents (N = 205; 55% female; 12.1 ± 1.6 years at baseline) as part of a longitudinal study of stress and adjustment in families. CR was assessed at baseline and emotion regulation was assessed at baseline and 2 years later at Wave 3 (W3) using caregiver and adolescent reports. Cortisol and sAA responses to the social competence interview were assessed at W3. Results: Repeated-measures analyses of variance predicting cortisol and controlling for time of day, adolescent age, medication usage, and pubertal status revealed significant interactions of time with both psychosocial and sociodemographic risk. In both analyses, youths with higher levels of risk showed a steeper decline in cortisol than youths with lower levels of risk. In parallel analyses predicting sAA, time interacted with psychosocial but not with sociodemographic risk. There were no interactions with sex in any of the analyses. Although CR was associated with changes in emotion regulation, there was no evidence that these changes accounted for the observed CR–stress response associations. Conclusions: These findings illustrate the potential importance of disentangling CR and suggest that additional work is needed to help explicate why and how CR is associated with specific physiological responses to stress.