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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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Effect of aerobic exercise, slow deep breathing and mindfulness meditation on cortisol and glucose levels in women with type 2 diabetes mellitus: a randomized controlled trial.
Obaya, HE, Abdeen, HA, Salem, AA, Shehata, MA, Aldhahi, MI, Muka, T, Marques-Sule, E, Taha, MM, Gaber, M, Atef, H
Frontiers in physiology. 2023;14:1186546
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Stress is considered to be an important factor in type 2 diabetes mellitus (T2DM) and aerobic exercise can help modulate the stress response as well as being important in the management of diabetes. Mindfulness meditation and deep breathing have also been shown to have positive effects on both stress and T2DM. This 6-week single-blind, randomised, controlled trial evaluated the effect of 10 min slow deep breathing and 10 min mindfulness meditation following a 40 min aerobic exercise programme, compared to the 40 min aerobic exercise alone, on fasting blood glucose (FBG) and cortisol levels in 58 stressed women with T2DM. FBG and cortisol levels improved in both groups but more so in the group who received the deep breathing and mindfulness meditation in addition to the exercise intervention: 20% vs 30% reduction in cortisol and 10% vs 15% reduction in FBG. The authors conclude that adding slow deep breathing and mindfulness meditation to an exercise programme may be useful in the management of stressed women with T2DM and reduce their cardiometabolic risk.
Expert Review
Conflicts of interest:
None
Take Home Message:
Practitioners could consider slow deep breathing and mindfulness meditation, added to aerobic exercise, as potentially useful components of the T2DM management program for stressed women.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
Stress, a key factor for Type 2 diabetes mellitus (T2DM), stimulates the hypothalamus-pituitary-adrenal gland (HPA) and triggers parasympathetic nerve withdrawal, leading to increased circulating cortisol levels and higher levels of blood glucose. Exercise is a key intervention that can modulate the HPA axis and help manage stress.
Methods
Fifty-eight women (aged between 40-50), diagnosed with T2DM for at least 5 years but medically stable with moderate to high stress scores were randomised to either aerobic training (AT) or aerobic exercise combined with slow deep breathing and mindfulness meditation (DMM) training three times weekly over 6-weeks.
AT group performed aerobic exercise on a treadmill at an intensity of 60%– 75% of the maximum heart rate for a total of 40 min, including a 5 minute warm up and 5 min cool down.
AT + DMM group performed a combination of aerobic exercise as per the AT group followed by a total of 10 minutes of diaphragmatic slow, deep breathing; and mindfulness meditation.
Results
Both groups showed a change from baseline in serum cortisol to p<0.0001
At 6 weeks in the AT + DMM group, the primary outcome of serum cortisol (nmol/L) levels was 12.59 nmol/L [95% CI 4.45-6.52] a decrease of 30.29% and the fasting blood glucose levels (secondary outcome) was 136.37mg/dl (95% CI: 9.19–2.6) a decrease of 14.54%
In the AT group performing only aerobic exercise decreased serum cortisol levels by 20.16% and FBG levels decreased by 9.97%.
Conclusion
This study showed that combining slow deep breathing and mindfulness meditation with aerobic exercise reduced the serum cortisol (p = 0.01) and FBG levels (p = 0.001) in women with T2DM compared to when only aerobic training was performed.
Clinical practice applications:
Consider a combined therapy approach with diaphragmatic breathing exercises and aerobic exercises that targets both the endocrine and autonomic nervous systems, as this may have a synergistic effect to assist with maintaining normal blood sugar levels and cortisol levels in individuals with T2DM.
Considerations for future research:
Future research is needed to determine the most effective combination of therapies for managing both FBG and serum cortisol levels in individuals with T2DM.
Abstract
Background: Aerobic exercise combined with breathing exercise can be an integral part of diabetes mellitus treatment. This single-center, randomized, parallel-group study investigated the effect of the combination of aerobic exercise with slow deep breathing and mindfulness meditation on the glucose and cortisol levels of women with type 2 diabetes mellitus (T2DM). Materials and Methods: Fifty-eight middle-aged women with T2DM (mean age: 45.67 ± 2.92 years) were randomly assigned to either the aerobic training group (AT: n = 29; mean age [46.1 ± 2.7 years]) or the aerobic exercise combined with slow deep breathing and mindfulness meditation (AT + DMM: n = 29; mean age [45.24 ± 3.14 years]). Aerobic exercise was performed at 60%-75% of the maximum heart rate. The women in each group were asked to perform the training three times weekly over a 6-week period. The duration of each session was 40 min for the AT group and 60 min for the AT + DMM group. The two groups were asked to perform aerobic exercise at 60%-75% of the maximum heart rate. Their fasting blood glucose (FBG) and serum cortisol levels were measured at the baseline and after the 6 weeks. Results: Compared with the AT group, the group undertaking 6 weeks of aerobic training combined with slow, deep breathing exercises and mindfulness meditation showed significantly lower levels of FBG (p = 0.001) and cortisol levels (p = 0.01) than the AT group. Conclusion: The addition of slow deep breathing and mindfulness meditation to aerobic exercise can better control the glucose and cortisol levels of women with T2DM and thereby improve their outcomes and decrease their cardiometabolic risk.
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Efficacy of mindfulness-based intervention for the treatment of chronic headaches: A systematic review and meta-analysis.
Aemaz Ur Rehman, M, Waseem, R, Habiba, U, Fahad Wasim, M, Alam Rehmani, S, Alam Rehmani, M, Abdullah, M, Khabir, Y, Rehan Hashmi, M, Almas, T, et al
Annals of medicine and surgery (2012). 2022;78:103862
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The International Headache Society defines chronic daily headache (CDH) as headaches occurring on 15 or more days in a month for at least three months. Many pharmacological treatments are available to minimize the functional disability caused by headaches. However, meditation-based mindfulness techniques have gained popularity in recent years. The main aim of this study was to determine the efficacy of mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in improving headache frequency, duration, and intensity in patients suffering from chronic headaches. This study is an updated systematic review and meta-analysis which included 10 full-text articles (4 from previous meta-analysis and 6 recently published). Results provide limited evidence that MBSR/MBCT intervention may be effective in reducing the frequency, duration, and pain intensity of headaches, in patients with chronic headaches including tension-type and migraine compared with the usual care but it demonstrated a significant difference between groups in achieving mindfulness. Authors conclude that since their findings are inconclusive, MBSR/MBCT interventions for the treatment of migraine and/or tension-type headaches cannot be recommended.
Abstract
Background: Mindfulness-based stress reduction/cognitive therapy has attained popularity as an adjunctive treatment for a plethora of medical and psychiatric conditions, however, its impact on chronic headaches is inconclusive. This review aims to assess the impact of MBSR/MBCT in alleviating the symptoms of chronic headaches. Data sources and data selection: PubMed and Cochrane CENTRAL were searched from inception till 1st May 2021. Randomized Control Trials evaluating mindfulness-based stress reduction/cognitive therapy with either passive comparators (usual care) or active comparators (e.g., Health education or cognitive behavioral therapy) for chronic headaches (Migraine, Tension-type, or cluster headaches), which evaluated either headache frequency, pain intensity or headache duration as primary outcome were eligible for inclusion. The Risk of Bias was evaluated using the Cochrane Collaboration's Risk of Bias Tool. Results: A total of ten Randomized Controlled Trials (five on migraine; three on tension-type; two with mixed samples) were evaluated. In comparison to usual care, mindfulness-based stress reduction/cognitive therapy did not illustrate significant changes in headache frequency (MD = -0.14; 95% CI -1.26 to 0.97; P = 0.80; Moderate Certainty), headache duration (MD = -0.27; 95% CI -3.51 to 2.97, P = 0.87; Low Certainty) or pain intensity (MD = -0.19; 95% CI -0.46 to 0.07; P = 0.15; Moderate Certainty). Conclusion: The results found are insignificant for the three primary outcomes, which may be due to the low number of participants and often a high or unclear risk of bias in the randomized control trials included. Perhaps more aggressive clinical trials with a larger sample size effectively demonstrate differences in outcomes before and after therapy for MBSR/MBCT could provide a more significant change.
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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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Practitioner review: health anxiety in children and young people in the context of the COVID-19 pandemic.
Haig-Ferguson, A, Cooper, K, Cartwright, E, Loades, ME, Daniels, J
Behavioural and cognitive psychotherapy. 2021;49(2):129-143
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In response to the Covid-19 pandemic, many individuals have health-related fear of contracting the disease. In some, this has developed into health anxiety (HA) whereby the sufferer is obsessed with contracting or developing a serious illness, impairing their day-to-day functioning. HA is commonplace in adulthood and most research is in adults; however, it is now thought that it can develop in children. This review on HA in adults aimed to identify adaptations needed to ensure diagnosis and interventions are appropriate for children. The review discussed that children may not be diagnosed with HA, as the criteria used for diagnosis may not be age appropriate; HA symptoms in adults may not be the same in children and adolescents. Health-related worries are relatively common in children but may not be diagnosed as HA. The authors then went on to discuss HA in children in the context of Covid-19 and outlined that limited brain development, pre-existing mental health or physical problems and the influence of parent or carer mental health may contribute to its development. Finally, the paper discussed how diagnosis and treatment in adults could be adapted for children, with a strong focus on cognitive behavioural therapy. It was concluded that HA can develop in children and for those individuals an adapted multi-pronged approach to diagnosis and treatment may be of benefit, however more research is needed. This study could be used by healthcare professionals to understand that children can suffer from HA, how it presents itself and possible treatments for children.
Abstract
Health-related fear is a normal and common response in the face of the global pandemic of COVID-19. Children and young people are frequently being exposed to messages about the threat to health, including from the media and authorities. Whilst for most, their anxiety will be proportionate to the threat, for some, existing pre-occupation with physical symptoms and illness will become more problematic. There is a growing body of evidence that health anxiety may occur in childhood, however much of the literature is taken from research using adult samples. This practitioner review aims to give an overview of the assessment and treatment of health-related worries in children and young people in the context of the COVID-19 pandemic. This review is based on the limited existing evidence in this population and the more substantial evidence base for treating health anxiety in adults. We consider the adaptations needed to ensure such interventions are developmentally appropriate.
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Brain Neurotransmitter Modulation by Gut Microbiota in Anxiety and Depression.
Huang, F, Wu, X
Frontiers in cell and developmental biology. 2021;9:649103
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The causes of anxiety and depression are unclear, but growing evidence points to a role of the gut microbiota. One possible way that the gut microbiota may have an influence on mental health is through a group of chemical messengers in the brain, known as neurotransmitters. This review summarised the research surrounding neurotransmitters and gut microbiota. The review began by looking at research in animal models and the roles of various neurotransmitters and how they may be influenced by the gut microbiota. The neurotransmitters outlined were serotonin, dopamine, and noradrenaline and it was stated that there is evidence that gut microbiota may be able to influence them alleviating anxiety and/or depression, however there was limited evidence with noradrenaline. It was concluded that there is a close connection between the gut microbiota and anxiety and depression. There is more research needed in humans, as most work has been completed in animal models. This paper could be used by healthcare professionals to understand the role of the gut microbiota in mental health disorders and the importance of gut health in individuals suffering from these.
Abstract
Anxiety and depression are highly prevalent mental illnesses worldwide and have long been thought to be closely associated to neurotransmitter modulation. There is growing evidence indicating that changes in the composition of the gut microbiota are related to mental health including anxiety and depression. In this review, we focus on combining the intestinal microbiota with serotonergic, dopaminergic, and noradrenergic neurotransmission in brain, with special emphasis on the anxiety- and depression-like behaviors in stress-related rodent models. Therefore, we reviewed studies conducted on germ-free rodents, or in animals subjected to microbiota absence using antibiotics, as well as via the usage of probiotics. All the results strongly support that the brain neurotransmitter modulation by gut microbiota is indispensable to the physiopathology of anxiety and depression. However, a lot of work is needed to determine how gut microbiota mediated neurotransmission in human brain has any physiological significance and, if any, how it can be used in therapy. Overall, the gut microbiota provides a novel way to alter neurotransmitter modulation in the brain and treat gut-brain axis diseases, such as anxiety and depression.
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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.