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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Improving stress management, anxiety, and mental well-being in medical students through an online Mindfulness-Based Intervention: a randomized study.
Fazia, T, Bubbico, F, Nova, A, Buizza, C, Cela, H, Iozzi, D, Calgan, B, Maggi, F, Floris, V, Sutti, I, et al
Scientific reports. 2023;13(1):8214
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Medical students commonly experience anxiety, depression, burnout and emotional discomfort due to the pressures of medical school. This randomised, controlled study of 362 medical students at Italian Universities evaluated the effectiveness of a 5-week online mindfulness-based intervention (MBI), consisting of an introductory session, 8 sessions of 35 min integral meditation and 10 min yoga, and one dietary advice/question and answer session with a nutritionist. The control group received no intervention. Effectiveness was measured through a variety of validated questionnaires for perceived stress, anxiety, wellbeing, emotional health, resilience and cognition. Overall, at baseline, participants of this study fared worse for stress than other studies had shown for general populations. The MBI was effective in improving perceived stress, mental wellbeing, emotional regulation, resilience, tendency to mind-wandering, ability to maintain attention and overall distress, although effect sizes for all outcomes were small. No statistically significant effect was seen for the anxiety rating. Interestingly, two cohorts were included in this study and whilst one benefitted from the programme, the other did not, one explanation of which may be that they were done during different phases of the COVID pandemic. The authors conclude that adopting MBI may help improve students’ wellbeing.
Abstract
Pressures and responsibilities of medical school put a strain on medical student's personal wellbeing, leading among all to high rates of anxiety, emotional discomfort and stress. In this work we evaluated the effectiveness of a comprehensive Mindfulness-Based Intervention (MBI) in reducing this load. The intervention comprised 10 twice-a-week Integral Meditation classes, dietary advice, and brief yoga sessions. We performed a randomized trial on two cohort of medical students from Italian universities: 239 in cohort 1 (106 treated and 133 controls), and 123 in cohort 2 (68 treated and 55 control) for a total sample of 362 students. Nine questionnaires for evaluating the effectiveness of our intervention on stress (PSS), state anxiety (STAIX-1), well-being (WEMWBS), mind-wandering (MW-S), overall distress (PANAS), emotion regulation (DERS), resilience (RS-14), and attentional control (ACS-C and ACS-D) were collected both pre and post intervention. Linear mixed effect models were run on the whole sample showing that, after multiple testing correction, our intervention was effective in reducing perceived stress (β = - 2.57 [- 4.02; - 1.12], p = 0.004), improving mental well-being (β = 2.82 [1.02; 4.63], p = 0.008) and emotional regulation (β = - 8.24 [- 12.98; - 3.51], p = 0.004), resilience (β = 3.79 [1.32; 6.26], p = 0.008), reducing the tendency to wander with the mind (β = - 0.70 [- 0.99; - 0.39], p = 0.0001), ameliorating the ability to maintain attention (AC-S (β = - 0.23 [- 0.44; - 0.02], p = 0.04) and AC-D (β = - 0.19 [- 0.36; - 0.01], p = 0.04)), and the overall distress (β = 1.84 [0.45; 3.23], p = 0.02).
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Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial.
Schmidt, LI, Neubauer, AB, Stoffel, M, Ditzen, B, Schirmaier, J, Farrenkopf, C, Sieverding, M
Journal of health psychology. 2023;28(11):1057-1071
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Insufficient sleep is a widespread problem. For adults between 18 and 64 years, the National Sleep Foundation generally recommends a range of nightly sleep duration from 7 to 9 hours. The aim of this study was to test a self-regulatory intervention based on mental contrasting with implementation intentions (MCII) against the effects of sleep hygiene information only. This study was a single-blinded, randomised controlled trial with daily/nightly assessments in a baseline-week and analog daily/nightly assessments in a post-intervention week. Participants were randomly assigned to one of the two groups. Results indicated an increase in sleep quality and subjective (but not objective) sleep duration from baseline to post-intervention period. Additionally, regarding subjective stress, associations with daily sleep parameters were largely confirmed. Authors conclude that future research should include booster sessions and evaluate MCII effects in the longer run. Furthermore, a better understanding of the causes regarding insufficient sleep among specific target groups and their degree of controllability is required to develop individually targeted interventions.
Abstract
Mental contrasting with implementation intentions (MCII) has been successfully applied to improve health-related behaviors (e.g. exercise). We explored its effectiveness to improve sleep outcomes beyond effects of sleep hygiene (SH) information, and investigated associations with stress. Eighty university employees (mean age: 29.6, SD = 4.5) were randomized to either a MCII + SH or a SH-only condition. During a baseline-week and a post-intervention week, sleep duration (Fitbit Alta and self-report), sleep quality, and stress were assessed daily and saliva was collected to assess the cortisol awakening response (CAR). In total, self-reported sleep quality and duration increased, but there was no meaningful condition*week interaction for sleep parameters or CAR. Higher average stress was associated with shorter sleep duration and lower sleep quality. Within-person, days with higher stress were followed by nights with lower sleep quality. Despite overall improvements, effects of MCII were not confirmed. MCII might be less effective to improve behaviors which are less controllable.
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A randomized trial of probiotic supplementation in nurses to reduce stress and viral illness.
Slykerman, RF, Li, E
Scientific reports. 2022;12(1):14742
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Dynamic communication occurs between the gut microbiota and the central nervous system along multiple physiological pathways. Stress increases glucocorticoid production and activation of the hypothalamic–pituitary–adrenal axis, affecting immunological function and neuronal changes. The aim of this study was to investigate whether supplementation with the probiotic Lactobacillus rhamnosus HN001 could reduce symptoms of stress and anxiety and improve psychological wellbeing in nurses working during the COVID19 pandemic. This study was a large double-blind, placebo-controlled randomised trial of probiotic supplementation with two parallel arms and a ratio of allocation to probiotic or placebo of 1:1. Results showed that following the intervention, stress, anxiety, and psychological wellbeing were not significantly different between nurses supplemented with the probiotic and those who received the placebo. Furthermore, the average number of days per week that nurses reported symptoms of cold or flu-like illness did not significantly differ between the probiotic and placebo supplemented groups. Authors conclude that there weren’t significant differences in outcomes between the probiotic and placebo groups.
Abstract
Animal studies demonstrate how the gut microbiota influence psychological health and immunity to viral infections through their actions along multiple dynamic pathways in the body. Considerable interest exists in probiotics to reduce stress and illness symptoms through beneficial effects in the gut, but translating pre-clinical evidence from animal models into humans remains challenging. We conducted a large trial in nurses working during the 2020 COVID19 pandemic year to establish whether daily ingestion of the probiotic Lactobacillus rhamnosus HN001 reduced perceived stress and the number of days participants reported symptoms of a viral illness. Our results showed no significant difference in perceived stress or the average number of illness days between probiotic supplemented nurses and the placebo group. Stress and viral illness symptoms reduced during the study for all participants, a trajectory likely influenced by societal-level factors. The powerful effect of a well-managed public health response to the COVID19 pandemic and the elimination of COVID19 from the community in 2020 may have altered the trajectory of stress levels and reduced circulating viral infections making it difficult to detect any effect of probiotic supplementation. Our study highlights the challenge in controlling environmental factors in human trials.
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Effects of sandplay therapy in reducing emotional and behavioural problems in school-age children with chronic diseases: A randomized controlled trial.
Tan, J, Yin, H, Meng, T, Guo, X
Nursing open. 2021;8(6):3099-3110
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Children with chronic diseases are more likely to suffer emotional-behavioural problems than healthy children, which can also impact the family. Sandplay has successfully been used as a therapy in children with autism spectrum disorder and this randomised control trial aimed to determine the effect of sandplay therapy in 62 children with chronic diseases and their caregivers. The results showed that sandplay reduced anxiety, depression, withdrawal and social behavioural problems and improved behaviour in children with chronic diseases. Depression and anxiety were also improved in the caregivers of those children who participated in sandplay. It was concluded that sandplay therapy is an effective clinical tool to improve several psychological domains in children with chronic diseases.
Abstract
PURPOSE Children with chronic diseases exhibit a higher incidence of emotional-behavioural problems. Though sandplay therapy is a universally recognized psychological treatment method, experimental evidence for this form of therapy is lacking. Our aims were to examine the effectiveness of sandplay therapy in reducing emotional and behavioural problems in school-age children with chronic diseases as well as anxiety and depression in their caregivers. DESIGN AND METHODS A total of 60 children and their caregivers were enrolled in the present study between January and October 2019. A randomized controlled trial was conducted at the Children's Hospital of Chongqing Medical University, China. Participants were divided into an intervention and a control group. Both groups received regular treatment, and the intervention group received additional sandplay therapy. Four behavioural rating scales were used to evaluate the differences between the two groups. The children's scores on the Child Behavior Checklist (CBCL), Eysenck Personality Questionnaire (EPQ), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) before and after the intervention were compared using the Mann-Whitney test. The Wilcoxon signed rank test was also employed to compare the median results before and after treatment. RESULTS The total scores for CBCL, anxiety and depression, withdrawal, and social behavioural problems for children in the intervention group were all lower than the corresponding scores for those in the control group (p < .05). The EPQ scores for emotional stability and psychosis in the intervention group were both lower than those in the control group (p < .05). The SAS and SDS scores for the caregivers of children in the intervention group were also lower than the corresponding scores for those in the control group (p < .05). CONCLUSION Sandplay therapy can reduce anxiety, withdrawal, and social behavioural problems in school-age children with chronic diseases, as well as relieve anxiety and depression symptoms in their caregivers. Our study provided evidence for the clinical application of sandplay therapy and highlights the importance of offering and integrating psychological treatment in clinical nursing care.
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Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial.
Wells, RE, O'Connell, N, Pierce, CR, Estave, P, Penzien, DB, Loder, E, Zeidan, F, Houle, TT
JAMA internal medicine. 2021;181(3):317-328
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Mindfulness-based stress reduction (MBSR), a standardized mind-body treatment that teaches momentary awareness with decreased sensory percept judgment, is associated with improvements in many chronic pain conditions. Mindfulness may be particularly helpful for migraine, as it diminishes affective responses to stress, the most common migraine trigger. This study is a double-blinded, randomized clinical trial of MBSR vs headache education for adults with migraine. The study enrolled 96 participants out of which 89 participants attended at least 1 class and completed at least 1 headache log (MBSR, 45; headache education, 44) across 7 cohorts. Participants were randomly assigned to one of the two arms. Results indicate that participants in both groups demonstrated a reduction of migraine days per month from baseline at 12 weeks. Furthermore, both groups sustained reductions in frequency of migraine and headache without group differences. Compared with headache education, MBSR participants had improvements in headache-related disability, quality of life, depression scores, self-efficacy, pain catastrophizing, and decreased experimentally induced pain intensity and unpleasantness out to 36 weeks. Authors conclude that mindfulness may help treat the total burden of migraine. However, a larger, more definitive study is needed to understand the impact of mindfulness on migraine.
Abstract
Importance: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit. Objective: To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education. Design, Setting, and Participants: This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment). Interventions: Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks. Main Outcomes and Measures: The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks). Results: Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days per month; 95% CI, -0.7 to -2.5; headache education: -2.0 migraine days per month; 95% CI, -1.1 to -2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, -9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, -8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol. Conclusions and Relevance: Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, MBSR improved disability, quality of life, self-efficacy, pain catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results. Trial Registration: ClinicalTrials.gov Identifier: NCT02695498.
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Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.
Cheng, P, Casement, MD, Kalmbach, DA, Castelan, AC, Drake, CL
Sleep. 2021;44(4)
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The 2019 coronavirus disease (COVID-19) pandemic has had health consequences that extend well-beyond symptoms of the virus. Mental health problems are already being observed in the context of COVID-19 and have also been documented during previous epidemics. The aim of this study was to evaluate the effect of prior digital cognitive-behavioural therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. This study is a follow up study based on a previous randomised controlled trial [SPREAD trial] for which the enrolled participants were divided into two groups: 358 in the dCBT-I condition and 300 in the control condition. For this follow-up study 208 participants (dCBT-I: n = 102; control: n = 106) out of the total 658 participants were enrolled. Results indicate that 67.3% of the sample reported direct impact from the coronavirus, and 26.4% reported living alone during the shelter-in-place orders. Furthermore, those who received dCBT-I reported less insomnia, stress, depression, and better global physical health compared to those who received a sleep education control. Authors conclude that future research should examine the mechanisms by which insomnia treatment may enhance resilience, and the role of dCBT-I in mitigating the adverse health consequences of the COVID-19 pandemic.
Abstract
STUDY OBJECTIVES Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. METHODS COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016-2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic. RESULTS Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition. CONCLUSIONS Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic. CLINICAL TRIAL REGISTRATION NCT02988375.
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Anxiety reduction through art therapy in women. Exploring stress regulation and executive functioning as underlying neurocognitive mechanisms.
Abbing, A, de Sonneville, L, Baars, E, Bourne, D, Swaab, H
PloS one. 2019;14(12):e0225200
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Anxiety treatments currently involve medication and changing an individual’s beliefs through cognitive behavioural therapy (CBT). Art therapy (AT) is often used as a CBT treatment strategy, although little is known about its effectiveness. This randomised control trial of 47 adult women with anxiety aimed to understand the role of AT in anxiety treatment over three months. The results showed improvements in self-reported measures of anxiety, the ability to control emotions, memory and the ability to manage tasks with AT, however subjects were just as susceptible to stress following treatment. It was concluded that anxiety reduction was related to improvements in emotions, memory and task management and this was as a result of AT. This study could be used by healthcare professionals to recommend AT to individuals with symptoms of anxiety as part of their treatment management plan.
Abstract
OBJECTIVES To explore possible working mechanisms of anxiety reduction in women with anxiety disorders, treated with art therapy (AT). METHODS A RCT comparing AT versus waiting list (WL) condition on aspects of self-regulation. Stress regulation (heart rate and heart rate variability) and executive functioning (daily behavioural and cognitive performance aspects of executive functioning (EF)) were evaluated in a pre-post design. Participants were women, aged 18-65 years with moderate to severe anxiety symptoms. RESULTS Effectiveness of AT compared to WL was demonstrated in a higher resting HRV post treatment, improvements in aspects of self-reported daily EF (emotion control, working memory, plan/organize and task monitor), but not in cognitive performance of EF, stress responsiveness and down regulation of stress. The decrease in anxiety level was associated with improvements in self-reported daily EF. CONCLUSIONS AT improves resting HRV and aspects of EF, the latter was associated with art therapy-related anxiety reduction.
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A Large Randomized Trial: Effects of Mindfulness-Based Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6.
Lengacher, CA, Reich, RR, Paterson, CL, Shelton, M, Shivers, S, Ramesar, S, Pleasant, ML, Budhrani-Shani, P, Groer, M, Post-White, J, et al
Biological research for nursing. 2019;21(1):39-49
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Breast cancer survivors (BCS) often experience physiological and psychological stressors related to their diagnosis and treatment, and a disruption of cortisol function can affect cancer risk and progression. Increased levels of the stress hormone cortisol and interleukin-6 (IL-6), a pro-inflammatory immune mediator, have been associated with acute and chronic stress levels. Mindfulness-Based Stress Reduction (MBSR) is a clinical stress-reducing program, which has been found to decrease psychological and physical symptoms associated with stress. The purpose of this randomised study, involving 299 BCS, was to evaluate the efficacy of MBSR in reducing cortisol and IL-6 levels, compared to a usual-care control treatment. Statistically significant reductions in cortisol levels were seen after the delivery of the MBSR program at both time points (week 1 and 6), and at week 6 only for IL-6. There was no significant difference in change in cortisol or IL6 levels over time between the MBSR and the usual-care groups. An association was observed between levels of IL-6 and psychological and physical symptoms and quality of life, but not for cortisol. The authors conclude that MBSR can alleviate the stress response in the short term for breast cancer survivors.
Abstract
Breast cancer survivors (BCS) often experience psychological and physiological symptoms after cancer treatment. Mindfulness-based stress reduction (MBSR), a complementary and alternative therapy, has reduced subjective measures of stress, anxiety, and fatigue among BCS. Little is known, however, about how MBSR affects objective markers of stress, specifically the stress hormone cortisol and the pro-inflammatory cytokine interleukin-6 (IL-6). In the present study, BCS ( N = 322) were randomly assigned to a 6-week MBSR program for BC or usual-care control. Measurements of cortisol, IL-6, symptoms, and quality of life were obtained at orientation and 6 weeks. Cortisol and IL-6 were also measured prior to and after the MBSR(BC) class Weeks 1 and 6. The mean age of participants was 56.6 years and 69.4% were White non-Hispanic. Most had Stage I (33.8%) or II (35.7%) BC, and 35.7% had received chemotherapy and radiation. Cortisol levels were reduced immediately following MBSR(BC) class compared to before the class Weeks 1 and 6 (Wilcoxon-signed rank test; p < .01, d = .52-.56). IL-6 was significantly reduced from pre- to postclass at Week 6 (Wilcoxon-signed rank test; p < .01, d = .21). No differences were observed between the MBSR(BC) and control groups from baseline to Week 6 using linear mixed models. Significant relationships with small effect sizes were observed between IL-6 and both symptoms and quality of life in both groups. Results support the use of MBSR(BC) to reduce salivary cortisol and IL-6 levels in the short term in BCS.
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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.