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The association of diabetes-related self-care activities with perceived stress, anxiety, and fatigue: a cross-sectional study.
Zhao, FF, Suhonen, R, Katajisto, J, Leino-Kilpi, H
Patient preference and adherence. 2018;12:1677-1686
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Diabetes treatments rely on the individual’s ability to perform diabetes-related self-care activities (DRSCA), which involves tasks such as medication adherence, regulating diet, physical activity, blood glucose monitoring and foot care, however it appears that many individuals do not perform one or all of these tasks. Reasons why have been investigated, but remain insufficient. In this cross-sectional study of 248 individuals with type 2 diabetes (T2D) DRSCA was investigated in relation to stress, anxiety, and fatigue. The results showed that there was evidence of mid-level performance of DRSCA activities and performing DRSCA activities was likely to reduce stress levels but was not related to anxiety or fatigue. Individuals who had T2D for more than 5 years and women were more likely to have anxiety. Interestingly in contradiction to previous studies, support from outside sources did not affect levels of stress, anxiety and fatigue. It was concluded that improving the level of DRSCA may reduce stress. The fact that the performance of DRSCA was not related to anxiety may be because these activities impose restrictions on patients’ lives. This study could be used by healthcare professionals to understand that the performance of DRSCA may reduce stress levels, however as this study was an observational study, direct causal relationships are hard to determine.
Abstract
PURPOSE Many people with type 2 diabetes (T2DM) do not sustain sufficient diabetes-related self-care activities (DRSCA) in their daily lives. To provide additional information about the positive influence of DRSCA, this study was conducted to examine whether DRSCA were associated with reduced perceived stress, anxiety, and fatigue among people with T2DM and to explore the level of DRSCA, perceived stress, anxiety, and fatigue and their association with background information. PATIENTS AND METHODS This study was a cross-sectional survey including 251 participants aged 18 years and older recruited from two hospitals in the eastern part of China. The study utilized self-report questionnaires that consisted of background information, DRSCA, perceived stress, anxiety, and fatigue. Hierarchical multiple regression analysis was conducted to explore the association of DRSCA with perceived stress, anxiety, and fatigue while adjusting for background information. RESULTS The results indicated that the level of self-care activities, stress, and fatigue was around middle level. The prevalence of anxiety was 19%. A high level of DRSCA was likely to reduce perceived stress but was not linked to anxiety and fatigue. Women were more susceptible to stress and anxiety, and people who had diabetes for >5 years were more likely to have anxiety. The background information included diabetes duration, standardized diabetes education, and high social support, all of which are factors that may influence DRSCA. CONCLUSION The findings suggest that improving the level of DRSCA might effectively reduce perceived stress. The potential benefits of DRSCA can provide both motivational and evaluative data for self-care programs. In addition, the findings show that DRSCA were not linked to anxiety and fatigue, which implies that their positive influence on anxiety and fatigue may be offset by the load of frequent DRSCA. It is suggested that helping patients to make tailored plans to integrate DRSCA into their daily lives is needed. Meanwhile, in the background information, it is suggested that standardized diabetes education and high social support can benefit DRSCA; in improving psychological health, more attention should be paid to women and patients with diabetes duration <5 years.
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Effectiveness of plant-based diets in promoting well-being in the management of type 2 diabetes: a systematic review.
Toumpanakis, A, Turnbull, T, Alba-Barba, I
BMJ open diabetes research & care. 2018;6(1):e000534
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Diabetes can cause a number of health complications if not well managed and treated and has the potential to have a huge impact on people’s physical and psychological wellbeing. The aims of this review are to systematically analyse the available literature on plant-based diet interventions targeting and/or including adults with diabetes and to clearly define the benefits on well-being of such interventions. This study is a systemic review of 11 controlled trials, of which 7 were randomised. Results demonstrate that a plant-based diet can significantly improve psychological well-being, quality of life, control of type 2 diabetes measured by glycated haemoglobin [is a form of haemoglobin that is measured primarily to know the average plasma glucose concentration over a three-month period] and a number of physical characteristics in people with type 2 diabetes. Authors conclude that future studies could explore ways of delivering proper nutritional education in order to support participants to follow healthier dietary patterns.
Abstract
Diet interventions have suggested an association between plant-based diets and improvements in psychological well-being, quality of life and glycated hemoglobin (HbA1c) control in populations with diabetes. The aims of this review are to systematically analyze the available literature on plant-based diet interventions targeting diabetes in adults and to clearly define the benefits on well-being of such interventions. This is a systematic review of controlled trials. A computerized systematic literature search was conducted in the following electronic databases: Allied and Complementary Medicine, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, E-Journals, Excerpta Medica Database, MEDLINE, Health Management Information Consortium, PsycARTICLES, PsycINFO, PubMed, SocINDEX and Web of Science. The search strategy retrieved 1240 articles, of which 11 met the inclusion criteria (n=433; mean sample age 54.8 years). Plant-based diets were associated with significant improvement in emotional well-being, physical well-being, depression, quality of life, general health, HbA1c levels, weight, total cholesterol and low-density lipoprotein cholesterol, compared with several diabetic associations' official guidelines and other comparator diets. Plant-based diets can significantly improve psychological health, quality of life, HbA1c levels and weight and therefore the management of diabetes.
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Zinc, Magnesium, Selenium and Depression: A Review of the Evidence, Potential Mechanisms and Implications.
Wang, J, Um, P, Dickerman, BA, Liu, J
Nutrients. 2018;10(5)
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Adequate micronutrient consumption and mental health are of major public health importance. Recent findings suggest micronutrient deficiencies may play a role in the development and progression of depression, yet the findings remain unclear. The aim of this review is to present the recent evidence on the association between several micronutrients and depression and discuss the potential mechanisms and clinical implications. Based on the current literature, evidence shows an association between both zinc and magnesium deficiency and the risk of depression, with stronger evidence supporting zinc. Studies on selenium are limited or inconclusive. According to these findings, the authors support the importance of adequate micronutrient consumption for promoting mental health. They suggest future research should investigate the safety and efficacy of micronutrient supplementation as an adjunct treatment for depression to better inform current prevention and treatment strategies.
Abstract
Micronutrient deficiency and depression are major global health problems. Here, we first review recent empirical evidence of the association between several micronutrients—zinc, magnesium, selenium—and depression. We then present potential mechanisms of action and discuss the clinical implications for each micronutrient. Collectively, empirical evidence most strongly supports a positive association between zinc deficiency and the risk of depression and an inverse association between zinc supplementation and depressive symptoms. Less evidence is available regarding the relationship between magnesium and selenium deficiency and depression, and studies have been inconclusive. Potential mechanisms of action involve the HPA axis, glutamate homeostasis and inflammatory pathways. Findings support the importance of adequate consumption of micronutrients in the promotion of mental health, and the most common dietary sources for zinc and other micronutrients are provided. Future research is needed to prospectively investigate the association between micronutrient levels and depression as well as the safety and efficacy of micronutrient supplementation as an adjunct treatment for depression.
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Metabolic and Microbiota Measures as Peripheral Biomarkers in Major Depressive Disorder.
Horne, R, Foster, JA
Frontiers in psychiatry. 2018;9:513
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Though the connection between the gut microbiome, physical health and mental health is becoming more established, there remains a lack of understanding around the underlying cause of major depressive disorder (MDD). There is a need to identify biomarkers in MDD in order to help identify individual differences and improve treatment outcomes. The aim of this review is to investigate the link between metabolic biomarkers and the gut microbiota in individuals experiencing MDD. The current literature points to two potential biomarkers, leptin and ghrelin, which play a role in both metabolic disease and depression. Based on these findings, the authors conclude these biomarkers may help researchers and clinicians establish subgroups in depressed individuals in order to better predict treatment responses and develop more targeted therapies.
Abstract
Advances in understanding the role of the microbiome in physical and mental health are at the forefront of medical research and hold potential to have a direct impact on precision medicine approaches. In the past 7 years, we have studied the role of microbiota-brain communication on behavior in mouse models using germ-free mice, mice exposed to antibiotics, and healthy specific pathogen free mice. Through our work and that of others, we have seen an amazing increase in our knowledge of how bacteria signal to the brain and the implications this has for psychiatry. Gut microbiota composition and function are influenced both by genetics, age, sex, diet, life experiences, and many other factors of psychiatric and bodily disorders and thus may act as potential biomarkers of the gut-brain axis that could be used in psychiatry and co-morbid conditions. There is a particular need in major depressive disorder and other mental illness to identify biomarkers that can stratify patients into more homogeneous groups to provide better treatment and for development of new therapeutic approaches. Peripheral outcome measures of host-microbe bidirectional communication have significant translational value as biomarkers. Enabling stratification of clinical populations, based on individual biological differences, to predict treatment response to pharmacological and non-pharmacological interventions. Here we consider the links between co-morbid metabolic syndrome and depression, focusing on biomarkers including leptin and ghrelin in combination with assessing gut microbiota composition, as a potential tool to help identify individual differences in depressed population.
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Lifestyle and vascular risk effects on MRI-based biomarkers of Alzheimer's disease: a cross-sectional study of middle-aged adults from the broader New York City area.
Mosconi, L, Walters, M, Sterling, J, Quinn, C, McHugh, P, Andrews, RE, Matthews, DC, Ganzer, C, Osorio, RS, Isaacson, RS, et al
BMJ open. 2018;8(3):e019362
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Alzheimer’s disease (AD) is the most common form of dementia, affecting nearly 34 million people worldwide. It has been estimated that one in every three cases of AD may be attributable to diet and lifestyle factors. The aim of this study was to investigate the effects of lifestyle and vascular-related risk factors for AD. Researchers studied the brain scans of 116 healthy adults aged 30-60 years. They collected information on factors related to lifestyle, such as diet, physical activity and intellectual enrichment. They also looked at markers for vascular risk such as body mass index (BMI), cholesterol and homocysteine, as well as cognitive function. The researchers found that a Mediterranean-style diet and good insulin sensitivity were both associated with a healthier brain structure. A better score for intellectual enrichment and lower BMI were both associated with better cognition. They concluded that adopting a Mediterranean-style diet and maintaining a healthy weight might reduce the risk of developing AD.
Abstract
OBJECTIVE To investigate the effects of lifestyle and vascular-related risk factors for Alzheimer's disease (AD) on in vivo MRI-based brain atrophy in asymptomatic young to middle-aged adults. DESIGN Cross-sectional, observational. SETTING Broader New York City area. Two research centres affiliated with the Alzheimer's disease Core Center at New York University School of Medicine. PARTICIPANTS We studied 116 cognitively normal healthy research participants aged 30-60 years, who completed a three-dimensional T1-weighted volumetric MRI and had lifestyle (diet, physical activity and intellectual enrichment), vascular risk (overweight, hypertension, insulin resistance, elevated cholesterol and homocysteine) and cognition (memory, executive function, language) data. Estimates of cortical thickness for entorhinal (EC), posterior cingulate, orbitofrontal, inferior and middle temporal cortex were obtained by use of automated segmentation tools. We applied confirmatory factor analysis and structural equation modelling to evaluate the associations between lifestyle, vascular risk, brain and cognition. RESULTS Adherence to a Mediterranean-style diet (MeDi) and insulin sensitivity were both positively associated with MRI-based cortical thickness (diet: βs≥0.26, insulin sensitivity βs≥0.58, P≤0.008). After accounting for vascular risk, EC in turn explained variance in memory (P≤0.001). None of the other lifestyle and vascular risk variables were associated with brain thickness. In addition, the path associations between intellectual enrichment and better cognition were significant (βs≥0.25 P≤0.001), as were those between overweight and lower cognition (βs≥-0.22, P≤0.01). CONCLUSIONS In cognitively normal middle-aged adults, MeDi and insulin sensitivity explained cortical thickness in key brain regions for AD, and EC thickness predicted memory performance in turn. Intellectual activity and overweight were associated with cognitive performance through different pathways. Our findings support further investigation of lifestyle and vascular risk factor modification against brain ageing and AD. More studies with larger samples are needed to replicate these research findings in more diverse, community-based settings.
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Comparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: a randomised clinical trial.
Watson, NA, Dyer, KA, Buckley, JD, Brinkworth, GD, Coates, AM, Parfitt, G, Howe, PRC, Noakes, M, Murphy, KJ
Nutrition journal. 2018;17(1):62
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The psychological burden of living with type 2 diabetes (T2D) has far reaching effects, negatively impacting quality of life, physical health and emotional wellbeing. It has been suggested that health-related quality of life (HRQoL) changes in response to weight status however this has not yet been explored in individuals with T2D. The aim of this randomised controlled study was to compare the effects of high protein and high carbohydrate diets, combined with moderate intensity exercise, on psychological wellbeing and HRQoL in 61 overweight adults with T2D. Participants enrolled in a 12-week weight loss period followed by a 12-week weight maintenance phase and blood glucose levels and various quality of life factors were assessed. This trial found in overweight adults with T2D, improvements in several psychological wellbeing and HRQoL were seen in response to modest weight loss and improvements in blood sugar levels. Improvements were seen in both high protein and high carbohydrate group, though a high protein diet may be better for maintaining control of blood glucose levels thus improving feelings of vitality. Based on this study, the authors conclude that it is imperative to address and support the psychological aspects of patients managing T2D.
Abstract
BACKGROUND Although higher-protein diets (HP) can assist with weight loss and glycemic control, their effect on psychological wellbeing has not been established. The objective of this study was to compare the effects of a HP and a higher-carbohydrate diet (HC), combined with regular exercise, on psychological wellbeing both during weight loss (WL) and weight maintenance phases (WM). METHODS In a parallel RCT, 61 adults with T2D (mean ± SD: BMI 34.3 ± 5.1 kg/m2, aged 55 ± 8 years) consumed a HP diet (29% protein, 34% carbohydrate, 31% fat) or an isocaloric HC diet (21%:48%:24%), with moderate intensity exercise, for 12 weeks of WL and 12 weeks of WM. Secondary data evaluating psychological wellbeing was assessed using: Problems Areas in Diabetes (PAID); Diabetes-39 Quality of Life (D-39); Short Form Health Survey (SF-36); Perceived Stress Scale-10 (PSS-10) and the Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 0, 12 and 24 and evaluated with mixed models analysis. RESULTS Independent of diet, improvements for PAID; D-39 diabetes control; D-39 severity of diabetes; SF-36 physical functioning and SF-36 general health were found following WL (d = 0.30 to 0.69, P ≤ 0.04 for all) which remained after 12 weeks of WM. SF-36 vitality improved more in the HP group (group x time interaction P = 0.03). Associations were seen between HbA1c and D-39 severity of diabetes rating (r = 0.30, P = 0.01) and SF-36 mental health (r = - 0.32, P = 0.003) and between weight loss and PAID (r = 0.30, P = 0.01). CONCLUSION Several improvements in diabetes-related and general psychological wellbeing were seen similarly for both diets following weight loss and a reduction in HbA1c with most of these improvements remaining when weight loss was sustained for 12 weeks. A HP diet may provide additional increases in vitality. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12613000008729 ) on 4 January 2013.
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Intestinal microbiome-gut-brain axis and irritable bowel syndrome.
Moser, G, Fournier, C, Peter, J
Wiener medizinische Wochenschrift (1946). 2018;168(3-4):62-66
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The gut-brain-microbiota axis connects the nervous system with the metabolic, hormonal and immune functions of the intestines. Irritable bowel syndrome (IBS) is a functional gut disorder that commonly presents with psychological co-morbidities, and while animal studies show strong associations between stress and gut microbiota, studies in humans are rare. This review assesses the current literature on intestinal microbiome and its association with stress, anxiety and depression in patients with IBS. Based on existing studies, the authors found the gut microbiota forms a crucial link between the intestine and nervous system. Therapies targeted at both modulating the gut microbiome and psychological interventions are recommended. The authors conclude further randomised clinical trials are needed to better understand which therapies work best for patients with IBS.
Abstract
Psychological comorbidity is highly present in irritable bowel syndrome (IBS). Recent research points to a role of intestinal microbiota in visceral hypersensitivity, anxiety, and depression. Increased disease reactivity to psychological stress has been described too. A few clinical studies have attempted to identify features of dysbiosis in IBS. While animal studies revealed strong associations between stress and gut microbiota, studies in humans are rare. This review covers the most important studies on intestinal microbial correlates of psychological and clinical features in IBS, including stress, anxiety, and depression.
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A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial.
Schmidt, K, Weber, N, Steiner, M, Meyer, N, Dubberke, A, Rutenberg, D, Hellhammer, J
Clinical nutrition ESPEN. 2018;24:22-30
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PMS is characterized by a cluster of somatic and psychological symptoms of varying severity. These symptoms occur only during the luteal phase of the menstrual cycle and resolve during the first days of menses. Recent observational data suggest that supplementation with Lipogen's phosphatidylserine and phosphatidic acid complex (PAS) alleviates these PMS symptoms. The aim of this study was to observe the effects of PAS on PMS symptom severity. This study is a prospective, randomised, placebo-controlled, double-blind single centre study with two arms (PAS or placebo). Participants were randomly assigned to one of the two groups. Results show beneficial effects of a daily intake of PAS over 3 cycles on symptom levels as assessed by several well-recognized instruments for PMS evaluation. The PAS complex alleviated the PMS symptoms, providing a safe alternative to standard pharmacological treatment. Authors conclude that their findings merit consideration of developing the PAS complex as a botanical drug for treatment of PMS symptoms.
Abstract
BACKGROUND & AIMS Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest that supplementation with Lipogen's phosphatidylserine (PS) and phosphatidic acid (PA) complex (PAS) alleviates these PMS symptoms. The aim of this study was to confirm these observations on the effects of PAS on PMS symptom severity within a controlled clinical trial setting. METHODS Forty women aged 18-45 years with a diagnosis of PMS were assigned to either take PAS (containing 400 mg PS & 400 mg PA per day) or a matching placebo. The study comprised 5 on-site visits including 1 baseline menstrual cycle followed by 3 treatment cycles. Treatment intake was controlled for by using an electronic device, the Medication Event Monitoring System (MEMS®). Primary outcome of the study was the PMS symptoms severity as assessed by using the Daily Record of Severity of Problems (DRSP). Further, SIPS questionnaire (a German version of the Premenstrual Symptoms Screening Tool (PSST)), salivary hormone levels (cortisol awakening response (CAR) and evening cortisol levels) as well as serum levels (cortisol, estradiol, progesterone and corticosteroid binding globulin (CBG)) were assessed. RESULTS PMS symptoms as assessed by the DRSP Total score showed a significantly better improvement (p = 0.001) over a 3 cycles PAS intake as compared to placebo. In addition, PAS treated women reported a greater improvement in physical (p = 0.002) and depressive symptoms (p = 0.068). They also reported a lower reduction of productivity (p = 0.052) and a stronger decrease in interference with relationships with others (p = 0.099) compared to the placebo group. No other DRSP scale or item showed significant results. Likewise, the reduction in the number of subjects fulfilling PMS or premenstrual dysphoric disorder (PMDD) criteria as classified by the SIPS did not differ between the PAS and the placebo group. For the biomarkers, the salivary cortisol percentage increase of the CAR was significantly less pronounced in the follicular phase of cycle 4 than in the follicular phase of cycle 1 for subjects taking PAS when compared to subjects taking placebo (p = 0.018). Furthermore, the change of serum cortisol levels between visit 1 and visit 5 differed significantly between groups (p = 0.043). While serum cortisol levels of PAS treated females slightly decreased between visit 1 and visit 5, cortisol levels of females treated with placebo increased. For all other biomarkers, no treatment effects were observed over the 4 cycles study period. Overall, this study confirms that a daily intake of PAS, containing 400 mg PS and 400 mg PA, can be considered as safe. CONCLUSIONS Results substantiate the efficacy of PAS in reducing symptoms of PMS. In view of the recent inclusion of severe PMS symptoms (PMDD) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the positive results of this clinical study merits consideration of developing the PAS complex as a botanical drug for treatment of PMDD. CLINICAL TRIAL REGISTRATION The study is registered at Deutsches Register Klinischer Studien with the registration number DRKS00009005.
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Impact of Experimentally Induced Cognitive Dietary Restraint on Eating Behavior Traits, Appetite Sensations, and Markers of Stress during Energy Restriction in Overweight/Obese Women.
Morin, I, Bégin, C, Maltais-Giguère, J, Bédard, A, Tchernof, A, Lemieux, S
Journal of obesity. 2018;2018:4259389
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The treatment of obesity has become a public health priority given the negative impact of this condition on physical and mental health. The aim of this study was to compare the effects of energy restriction alone or in combination with induced cognitive dietary restraint (CDR) on eating behaviour traits, appetite sensations, and markers of stress in overweight and obese premenopausal women. The study is a single-blinded randomised clinical study which recruited premenopausal women aged between 26 and 50 years. The participants were randomised to either an energy-restriction-plus-induced CDR condition (CDR+group) or an energy-restriction-without induced CDR condition (CDR−group). Results indicate that inducing CDR in a context of energy restriction had no further effects on eating behaviour traits, appetite sensations, and markers of stress in the short term as well as in the longer term than energy restriction alone. Authors conclude that increasing CDR has no negative impact on factors regulating energy balance in the context of energy restriction.
Abstract
Weight loss has been associated with changes in eating behaviors and appetite sensations that favor a regain in body weight. Since traditional weight loss approaches emphasize the importance of increasing cognitive dietary restraint (CDR) to achieve negative energy imbalance, it is difficult to untangle the respective contributions of energy restriction and increases in CDR on factors that can eventually lead to body weight regain. The present study aimed at comparing the effects of energy restriction alone or in combination with experimentally induced CDR on eating behavior traits, appetite sensations, and markers of stress in overweight and obese women. We hypothesized that the combination of energy restriction and induced CDR would lead to more prevalent food cravings, increased appetite sensations, and higher cortisol concentrations than when energy restriction is not coupled with induced CDR. A total of 60 premenopausal women (mean BMI: 32.0 kg/m2; mean age: 39.4 y) were provided with a low energy density diet corresponding to 85% of their energy needs during a 4-week fully controlled period. At the same time, women were randomized to either a condition inducing an increase in CDR (CDR+ group) or a condition in which CDR was not induced (CRD- group). Eating behavior traits (Three-Factor Eating Questionnaire and Food Craving Questionnaire), appetite sensations (after standardized breakfast), and markers of stress (Perceived Stress Scale; postawakening salivary cortisol) were measured before (T = 0 week) and after (T = 4 weeks) the 4-week energy restriction, as well as 3 months later. There was an increase in CDR in the CDR+ group while no such change was observed in the CDR- group (p=0.0037). No between-group differences were observed for disinhibition, hunger, cravings, appetite sensations, perceived stress, and cortisol concentrations. These results suggest that a slight increase in CDR has no negative impact on factors regulating energy balance in the context of energy restriction.
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A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.
Galante, J, Dufour, G, Vainre, M, Wagner, AP, Stochl, J, Benton, A, Lathia, N, Howarth, E, Jones, PB
The Lancet. Public health. 2018;3(2):e72-e81
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There has been a recent increase in students accessing university counselling services, though the reasons for this are currently unclear. Mindfulness-based stress reduction has gained increased attention as evidence has shown mindfulness training can improve anxiety and depression. The aim of this trial was to therefore assess whether a mindfulness course, Mindfulness Skills for Students (MSS), would improve university students’ resilience to stress. Participants were randomly assigned to either enrol in the 8-week MSS course alongside mental health support or receive mental health support alone. A total of 449 participants completed the study and self-reported psychological distress was the primary outcome. Students enrolled in MSS showed reduced distress scores during the examination period compared with those receiving support as usual. Based on these results, the authors conclude that offering mindfulness training could be an effective, feasible component of a wider university mental health strategies. Further controlled studies are required to better understand preventative mental health interventions for students.
Abstract
BACKGROUND The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. METHODS We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. FINDINGS Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. INTERPRETATION Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. FUNDING University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England.