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Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.
Daumit, GL, Dalcin, AT, Dickerson, FB, Miller, ER, Evins, AE, Cather, C, Jerome, GJ, Young, DR, Charleston, JB, Gennusa, JV, et al
JAMA network open. 2020;3(6):e207247
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Heart disease death rates in individuals with serious mental illness are double that of the general population, indicating a concerted effort is needed to help this group of people. However, previous studies on interventions have failed to show improvements indicating a requirement to identify effective solutions. This randomised control trial of 269 individuals with mental illness aimed to determine the effectiveness of an 18-month management plan to reduce heart disease risk. The results showed that heart disease risk was significantly decreased when individuals with mental illness were in a closely monitored management programme. This programme consisted of behavioural counselling and care coordination. It was concluded that a multi-faceted care management plan can significantly reduce the risk of heart disease in individuals with serious mental illness. This study could be used by health care professionals to understand that individuals with mental illness are at a higher risk of death from heart disease and that they need to consider enrolling them into a closely monitored management plan.
Abstract
Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.
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A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED).
Parletta, N, Zarnowiecki, D, Cho, J, Wilson, A, Bogomolova, S, Villani, A, Itsiopoulos, C, Niyonsenga, T, Blunden, S, Meyer, B, et al
Nutritional neuroscience. 2019;22(7):474-487
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Observational studies have shown that a healthy diet is associated with a reduced risk for depression. This study investigated whether a Mediterranean-style diet supplemented with fish oil can improve mental health in adults suffering depression. Adults with self-reported depression were randomised to receive fortnightly food hampers and Mediterranean diet cooking workshops for 3 months and fish oil supplements for 6 months, or attend social groups fortnightly for 3 months. Assessments at baseline, 3 and 6 months included mental health, quality of life and dietary questionnaires, and blood samples for fatty acid analysis. Both groups experienced in improvements in their mental health. The Mediterranean diet group had greater reduction in depression and improved mental health quality of life scores at 3 months and 6 months. Reduced depression was correlated with an increased Mediterranean diet score, nuts and vegetable diversity. Other mental health improvements were associated with increased vegetable diversity and legumes. There were some correlations between increased omega-3, decreased omega-6 and improved mental health. The authors suggest that getting back to basics by promoting cooking skills and family/group meals could be a simple yet powerful and empowering approach to healthcare and prevention.
Abstract
OBJECTIVES We investigated whether a Mediterranean-style diet (MedDiet) supplemented with fish oil can improve mental health in adults suffering depression. METHODS Adults with self-reported depression were randomized to receive fortnightly food hampers and MedDiet cooking workshops for 3 months and fish oil supplements for 6 months, or attend social groups fortnightly for 3 months. Assessments at baseline, 3 and 6 months included mental health, quality of life (QoL) and dietary questionnaires, and blood samples for erythrocyte fatty acid analysis. RESULTS n = 152 eligible adults aged 18-65 were recruited (n = 95 completed 3-month and n = 85 completed 6-month assessments). At 3 months, the MedDiet group had a higher MedDiet score (t = 3.95, P < 0.01), consumed more vegetables (t = 3.95, P < 0.01), fruit (t = 2.10, P = 0.04), nuts (t = 2.29, P = 0.02), legumes (t = 2.41, P = 0.02) wholegrains (t = 2.63, P = 0.01), and vegetable diversity (t = 3.27, P < 0.01); less unhealthy snacks (t = -2.10, P = 0.04) and red meat/chicken (t = -2.13, P = 0.04). The MedDiet group had greater reduction in depression (t = -2.24, P = 0.03) and improved mental health QoL scores (t = 2.10, P = 0.04) at 3 months. Improved diet and mental health were sustained at 6 months. Reduced depression was correlated with an increased MedDiet score (r = -0.298, P = 0.01), nuts (r = -0.264, P = 0.01), and vegetable diversity (r = -0.303, P = 0.01). Other mental health improvements had similar correlations, most notably for increased vegetable diversity and legumes. There were some correlations between increased omega-3, decreased omega-6 and improved mental health. DISCUSSION This is one of the first randomized controlled trials to show that healthy dietary changes are achievable and, supplemented with fish oil, can improve mental health in people with depression.
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Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial.
Villar-García, J, Güerri-Fernández, R, Moya, A, González, A, Hernández, JJ, Lerma, E, Guelar, A, Sorli, L, Horcajada, JP, Artacho, A, et al
PloS one. 2017;12(4):e0173802
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Recent studies have shown that HIV severely damages the gastrointestinal (GI) mucosal barrier, resulting in microbes passing from the GI tract to the circulatory system leading to chronic inflammation. The aim of this randomised double blind study was to analyse the beneficial effects of probiotic supplementation on the gut microbiome composition. 44 chronic HIV infected patients were treated with 12 weeks of specific strain of probiotic called Saccharomyces Boulardii. The authors found that supplementation with the probiotic changed the composition of gut microbiome, with a decrease in pathogenic bacteria observed in the study group. However, no correlation could be established with regard to inflammation. The authors concluded that identifying the pro inflammatory species in the gut can be the markers of poor immune response.
Abstract
Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immunologic non-response to antiretroviral therapy (<270 CD4+Tcells/μL despite long-term suppressed viral load). The aim of the present study was to investigate if this beneficial effect of the probiotic Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples) in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14) and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria). Thus, in this work, we propose a new therapeutic strategy using the probiotic yeast S. boulardii to modify gut microbiome composition. Identifying pro-inflammatory species in the gut microbiome could also be a useful new marker of poor immune response and a new therapeutic target.