Effects of Cognitive Behavioral Therapy for Insomnia on Sleep, Symptoms, Stress, and Autonomic Function Among Patients With Heart Failure.

Background: Insomnia is common among patients with stable heart failure (HF) and associated with inflammation and altered autonomic function. Purpose: The purposes of this study were to examine the effects of cognitive behavioral therapy for insomnia (CBT-I) on the Hypothalamic Pituitary (HPA) Axis, autonomic function, inflammation, and circadian rhythmicity and the associations between these biomarkers and insomnia, sleep characteristics, symptoms, functional performance, and sleep-related cognitions. Methods: We conducted a subanalysis of a pilot randomized controlled trial (RCT, NCT02827799) whose primary aim was to test the effects of CBT-I on insomnia. We randomized 51 patients with stable Class II-IV HF to CBT-I (n = 30) or attention control (n = 21). Participants completed wrist actigraphy and self-reported insomnia severity, sleep characteristics, sleep-related cognitions, daytime symptoms, and functional performance. We measured day and nighttime urinary free cortisol, melatonin sulfate, epinephrine, and norepinephrine at baseline, and two weeks after CBT-I and computed general linear models and partial correlations. Results: CBT-I had no effects on the biomarkers, but there were statistically significant negative cross-sectional correlations between the ratio of day and night urinary free cortisol and sleep disturbance, anxiety, fatigue, depression, and negative sleep cognitions. Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions. Conclusions: Biomarkers of stress and autonomic function are associated with sleep, sleep-related symptoms, and cognitions among people with chronic HF. Future studies are needed to identify potential causal relationships and the impact of sleep interventions.

Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure.

OBJECTIVE/BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) improves insomnia and fatigue among chronic heart failure (HF) patients, but the extent to which sleep-related cognitions explain CBT-I outcomes in these patients is unknown. We examined the effects of CBT-I on sleep-related cognitions, associations between changes in sleep-related cognitions and changes in sleep and symptoms after CBT-I, and the extent to which cognitions mediated the effects of CBT-I. PARTICIPANTS: Stable New York Heart Association Class II-III HF patients (total n = 51; n = 26 or 51.0% women; M age = 59.1 ± 15.1 years). METHODS: HF patients were randomized in groups to group CBT-I (n = 30) or attention control (HF self-management education, n = 21) and completed actigraphy, the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Dysfunctional Beliefs and Attitudes about Sleep (DBAS) and Sleep Disturbance Questionnaires (SDQ), and self-reported fatigue, depression, anxiety, and sleepiness (baseline, immediately after treatment, six months). We used mixed-effects modeling, mediation analysis with a bootstrapping approach, and Pearson correlations. RESULTS: There was a statistically significant group × mult time effect on DBAS. DBAS mediated the effects of CBT-I on insomnia severity and partially mediated CBT-I effects on fatigue. Improvements in dysfunctional cognitions were associated with improved sleep quality, insomnia severity, sleep latency and decreased fatigue, depression, and anxiety, with sustained effects at six months. CONCLUSIONS: Improvement in dysfunctional sleep-related cognitions is an important mechanism for CBT-I effects among HF patients who are especially vulnerable to poor sleep and high symptom burden.

Post-Irradiation Treatment with a Superoxide Dismutase Mimic, MnTnHex-2-PyP5+, Mitigates Radiation Injury in the Lungs of Non-Human Primates after Whole-Thorax Exposure to Ionizing Radiation.

Radiation injury to the lung is the result of acute and chronic free radical formation, and there are currently few effective means of mitigating such injury. Studies in rodents indicate that superoxide dismutase mimetics may be effective in this regard; however, studies in humans or large animals are lacking. We hypothesized that post-exposure treatment with the lipophilic mitochondrial superoxide dismutase mimetic, MnTnHex-2-PyP5+ (hexyl), would reduce radiation-induced pneumonitis and fibrosis in the lungs of nonhuman primates. Rhesus monkeys (Macaca mulatta) received 10 Gy whole thorax irradiation, 10 Gy + hexyl treatment, sham irradiation, or sham irradiation + hexyl. Hexyl was given twice daily, subcutaneously, at 0.05 mg/kg, for 2 months. Animals were monitored daily, and respiratory rates, pulse oximetry, hematology and serum chemistry panels were performed weekly. Computed tomography scans were performed at 0, 2, and 4 months after irradiation. Supportive fluid therapy, corticosteroids, analgesics, and antibiotics were given as needed. All animals were humanely euthanized 4.5 months after irradiation, and pathologic assessments were made. Multifocal, progressive lung lesions were seen at 2 and 4 months in both irradiated groups. Hexyl treatment delayed the onset of radiation-induced lung lesions, reduced elevations of respiratory rate, and reduced pathologic increases in lung weight. No adverse effects of hexyl treatment were found. These results demonstrate (1) development of a nonhuman primate model of radiation-induced lung injury, (2) a significant mitigating effect of hexyl treatment on lung pathology in this model, and (3) no evidence for toxicity of hexyl at the dose studied.

Universal screening for intimate partner and sexual violence in trauma patients-What about the men? An Eastern Association for the Surgery of Trauma Multicenter Trial.

BACKGROUND: A recent Eastern Association for the Surgery of Trauma-supported multicenter trial demonstrated a similar rate of intimate partner and sexual violence (IPSV) between male and female trauma patients, regardless of mechanism. Our objective was to perform a subgroup analysis of our affected male cohort because this remains an understudied group in the trauma literature. METHODS: We conducted a recent Eastern Association for the Surgery of Trauma-supported, cross-sectional, multicenter trial over one year (March 2015 to April 2016) involving four Level I trauma centers throughout the United States. We performed universal screening of adult trauma patients using the validated Hurt, Insult, Threaten, Scream and sexual violence screening surveys. Risk factors for male patients were identified. χ Test compared categorical variables with significance at p values less than 0.05. Parametric data are presented as mean ± standard deviation. RESULTS: A total of 2,034 trauma patients were screened, of which 1,281 (63%) were men. Of this cohort, 119 (9.3%) men screened positive for intimate partner violence, 14.1% for IPSV, and 6.5% for sexual violence. On categorical analysis of the Hurt, Insult, Threaten, Scream screen, the proportion of men that were physically hurt was 4.8% compared to 4.3% for women (p = 0.896). A total of 4.8% of men screened positive for both IPSV. The total proportion of men who presented with any history of intimate partner violence, sexual violence, or both (IPSV) was 15.8%. More men affected by penetrating trauma screened positive for IPSV (p < 0.00001). The IPSV positivity in men was associated with mental illness, substance abuse, and trauma recidivism. CONCLUSION: One of every 20 men that present to trauma centers is a survivor of both IPSV, with one of every six men experiencing some form of violence. Men are at similar risk for physical abuse as women when this intimate partner violence occurs. The IPSV is associated with penetrating trauma in men. Support programs for this population may potentially impact associated mental illness, substance abuse, trauma recidivism, and even societal-level violence. LEVEL OF EVIDENCE: Epidemiological study, level II.

Universal screening for intimate partner and sexual violence in trauma patients: An EAST multicenter trial.

BACKGROUND: A single-center trial recently demonstrated a prevalence of 14% of intimate partner and sexual violence (IPSV) among both male and female trauma patients, regardless of mechanism of injury. We aimed to determine if this phenomenon was similar to rates in other trauma centers by assessing the feasibility of universal screening and determining the prevalence and association of IPSV with other trauma-associated comorbidities. METHODS: We designed an Eastern Association for the Surgery of Trauma-supported multicenter, prospective observational cohort study involving four Level I trauma centers throughout the United States. Screening occurred from March 2015 to April 2016. We performed universal screening of adult trauma patients using the validated HITS (Hurt, Insult, Threaten, Scream) and SAVE (sexual violence) screening surveys. Trauma recidivism, substance use, and mental illness were also measured and were classified as "trauma-associated comorbidities." Chi-squared test compared categorical variables with significance at p <0.05. Parametric data is presented as mean ± standard deviation. RESULTS: A total of 2,034 eligible trauma patients were screened by clinical social workers at each site over 1 year. The mean age was 37.05 ± 20.32 with 63% men, 37% women, and one transgendered participant. The overall rate of IPSV was 11.4%. The proportion of positive screens for men was 9.3%, with variability between centers (3.8-72.7%), and for women was 16.1% (15.3-50.0%) (p < 0.001). The transgendered patient screened positive for IPSV. Of patients who screened positive for IPSV, 60.0% had one or more trauma-associated comorbidity compared to 15.1% of patients who screened negative (p < 0.001). CONCLUSION: More than one in nine trauma patients is at risk of IPSV, regardless of gender or mechanism of injury. IPSV may be a risk factor for other trauma-associated comorbidities. LEVEL OF EVIDENCE: Prognostic/Epidemiologic, level II; Care Management, level III.

Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial.

BACKGROUND: Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. OBJECTIVES: The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS). METHODS: Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis. DISCUSSION: The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings.

Nutritional aspects of detoxification in clinical practice.

Detoxification is a vital cellular task that, if lacking, can lead to early morbidity and mortality. The process of detoxification involves the mobilization, biotransformation, and elimination of toxicants of exogenous and endogenous origin. This article discusses the phase I and phase II detoxification and biotransformation pathways and promotes using food to support these highly complex processes. The author identifies the comprehensive elimination diet as a useful therapeutic tool for clinicians and patients to use to achieve detoxification. Using this diet, the patient removes the most common allergenic foods and beverages from the diet and replaces them with nonallergenic choices for a period of 4 wk, gradually adding back the eliminated foods and observing their effects. Another effective clinical tool that the author discusses is the detox-focused core food plan, which identifies the variety of foods required to supply key nutrients that can maximize the effectiveness of detoxification. Finally, the author provides a case study in which these tools were used to help a patient suffering from major, debilitating illnesses that resulted from exposure to malathion, including severe vomiting and diarrhea, headaches, night sweats, severe arthralgias and myalgias, episcleritis, and shortness of breath. The article details the interventions used and the clinical results (ie, successful resolution of most issues after 3 mo).

Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure.

BACKGROUND: Chronic insomnia is common among patients with heart failure (HF) and may contribute to fatigue and poor function. However, to date there have been no randomized controlled trials focused on treatment of insomnia or daytime symptoms in this population. OBJECTIVES: The purpose of this study was to examine the preliminary efficacy, feasibility, and acceptability of a self-management intervention (cognitive behavioral therapy [CBT-I]) for insomnia among patients with stable HF. METHODS: We conducted a pilot randomized controlled trial (RCT) in which patients with stable Class I-III HF (n = 25/52.1% women; mean age = 59 ± 14.8 years) were randomized in groups to CBT-I (n = 29) or an attention control condition (HF self-management with sleep hygiene; n = 19). Participants completed 2 weeks of wrist actigraphy, the insomnia severity index, and measures of fatigue, depression, sleepiness, and functional performance at baseline and follow-up. We computed the size of the effects on the dependent variables and used MANOVA to evaluate the effects of CBT-I on insomnia and fatigue. RESULTS: CBT-I was feasible and acceptable and had a statistically significant effect on insomnia and fatigue, while controlling for the effects of comorbidity and age. CONCLUSIONS: CBT-I has short-term efficacy as a treatment for chronic insomnia among patients with stable HF. Future studies are needed to address its sustained effects.