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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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6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records.
Taquet, M, Geddes, JR, Husain, M, Luciano, S, Harrison, PJ
The lancet. Psychiatry. 2021;8(5):416-427
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Recent literature shows that COVID-19 survivors might be at an increased risk of neurological and psychiatric disorders. The aim of this study was to investigate the incidence of neurological and psychiatric diagnoses in survivors in the 6 months after documented clinical COVID-19 infection. This study is a retrospective cohort study with the primary cohort comprised of 236,379 patients diagnosed with COVID-19 and two propensity-score-matched control cohorts. The primary cohort was divided into one of the four subgroups. Results indicate that the severity of COVID-19 had a clear effect on subsequent neurological diagnoses. In fact, COVID-19 was associated with an increased risk of neurological and psychiatric outcomes. However, the incidences and hazard ratio of these were greater in patients who had required hospitalisation, and particularly those who required ITU admission or developed encephalopathy, even after extensive propensity score matching for other factors. Authors conclude that COVID-19 is followed by significant rates of neurological and psychiatric diagnoses over the subsequent 6 months.
Abstract
BACKGROUND Neurological and psychiatric sequelae of COVID-19 have been reported, but more data are needed to adequately assess the effects of COVID-19 on brain health. We aimed to provide robust estimates of incidence rates and relative risks of neurological and psychiatric diagnoses in patients in the 6 months following a COVID-19 diagnosis. METHODS For this retrospective cohort study and time-to-event analysis, we used data obtained from the TriNetX electronic health records network (with over 81 million patients). Our primary cohort comprised patients who had a COVID-19 diagnosis; one matched control cohort included patients diagnosed with influenza, and the other matched control cohort included patients diagnosed with any respiratory tract infection including influenza in the same period. Patients with a diagnosis of COVID-19 or a positive test for SARS-CoV-2 were excluded from the control cohorts. All cohorts included patients older than 10 years who had an index event on or after Jan 20, 2020, and who were still alive on Dec 13, 2020. We estimated the incidence of 14 neurological and psychiatric outcomes in the 6 months after a confirmed diagnosis of COVID-19: intracranial haemorrhage; ischaemic stroke; parkinsonism; Guillain-Barré syndrome; nerve, nerve root, and plexus disorders; myoneural junction and muscle disease; encephalitis; dementia; psychotic, mood, and anxiety disorders (grouped and separately); substance use disorder; and insomnia. Using a Cox model, we compared incidences with those in propensity score-matched cohorts of patients with influenza or other respiratory tract infections. We investigated how these estimates were affected by COVID-19 severity, as proxied by hospitalisation, intensive therapy unit (ITU) admission, and encephalopathy (delirium and related disorders). We assessed the robustness of the differences in outcomes between cohorts by repeating the analysis in different scenarios. To provide benchmarking for the incidence and risk of neurological and psychiatric sequelae, we compared our primary cohort with four cohorts of patients diagnosed in the same period with additional index events: skin infection, urolithiasis, fracture of a large bone, and pulmonary embolism. FINDINGS Among 236 379 patients diagnosed with COVID-19, the estimated incidence of a neurological or psychiatric diagnosis in the following 6 months was 33·62% (95% CI 33·17-34·07), with 12·84% (12·36-13·33) receiving their first such diagnosis. For patients who had been admitted to an ITU, the estimated incidence of a diagnosis was 46·42% (44·78-48·09) and for a first diagnosis was 25·79% (23·50-28·25). Regarding individual diagnoses of the study outcomes, the whole COVID-19 cohort had estimated incidences of 0·56% (0·50-0·63) for intracranial haemorrhage, 2·10% (1·97-2·23) for ischaemic stroke, 0·11% (0·08-0·14) for parkinsonism, 0·67% (0·59-0·75) for dementia, 17·39% (17·04-17·74) for anxiety disorder, and 1·40% (1·30-1·51) for psychotic disorder, among others. In the group with ITU admission, estimated incidences were 2·66% (2·24-3·16) for intracranial haemorrhage, 6·92% (6·17-7·76) for ischaemic stroke, 0·26% (0·15-0·45) for parkinsonism, 1·74% (1·31-2·30) for dementia, 19·15% (17·90-20·48) for anxiety disorder, and 2·77% (2·31-3·33) for psychotic disorder. Most diagnostic categories were more common in patients who had COVID-19 than in those who had influenza (hazard ratio [HR] 1·44, 95% CI 1·40-1·47, for any diagnosis; 1·78, 1·68-1·89, for any first diagnosis) and those who had other respiratory tract infections (1·16, 1·14-1·17, for any diagnosis; 1·32, 1·27-1·36, for any first diagnosis). As with incidences, HRs were higher in patients who had more severe COVID-19 (eg, those admitted to ITU compared with those who were not: 1·58, 1·50-1·67, for any diagnosis; 2·87, 2·45-3·35, for any first diagnosis). Results were robust to various sensitivity analyses and benchmarking against the four additional index health events. INTERPRETATION Our study provides evidence for substantial neurological and psychiatric morbidity in the 6 months after COVID-19 infection. Risks were greatest in, but not limited to, patients who had severe COVID-19. This information could help in service planning and identification of research priorities. Complementary study designs, including prospective cohorts, are needed to corroborate and explain these findings. FUNDING National Institute for Health Research (NIHR) Oxford Health Biomedical Research Centre.
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Comparing eating behaviours, and symptoms of depression and anxiety between Spain and Greece during the COVID-19 outbreak: Cross-sectional analysis of two different confinement strategies.
Papandreou, C, Arija, V, Aretouli, E, Tsilidis, KK, Bulló, M
European eating disorders review : the journal of the Eating Disorders Association. 2020;28(6):836-846
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Stress and mental health problems which may be induced by restrictions imposed during the Covid-19 pandemic can lead to unhealthy eating habits. Restrictions have varied amongst countries and this cross-sectional analysis aimed to compare eating behaviours and symptoms of stress experienced by 1841 individuals in countries with differing lockdown measures. The results showed that individuals in the country with higher lockdown measures showed lower restraint in eating, they were more likely to overeat if they saw or smelt food and reported increased anxiety. However, they did not display depression or overeating when experiencing negative feelings. It was concluded that both countries had a high frequency of depression and anxiety. Higher restrictions were associated with greater anxiety, lower restraint and overeating when confronted with food. This paper could be used by healthcare professionals to recognise the need to include dietary advice when dealing with patients who are reporting anxiety during the current Covid-19 pandemic.
Abstract
OBJECTIVE We compared eating behaviours, and depressive and anxiety symptoms in two countries with different confinement strictness strategies and different levels of COVID-19 pandemic. METHOD A web-based cross-sectional survey was administered during and shortly after the COVID-19 related lockdown in Spain and Greece. Multivariable linear regression analyses were performed to identify country differences associated with eating behaviour, and symptoms of depression and anxiety. RESULTS This study included 1,002 responders in Spain and 839 in Greece. The mean ± SD of restraint, emotional and external eating was 2.5 ± 0.79, 2.1 ± 0.81 and 2.6 ± 0.65 in Spain, whereas 2.7 ± 0.85, 2.3 ± 0.99 and 2.9 ± 0.74 in Greece. Spanish participants had lower average scores of restraint and external eating compared to Greek participants (p < .001), but no difference was seen for emotional eating. In Spain, 13.6%, and 12.3% of the survey respondents reported moderate to severe depressive and anxiety symptoms, respectively, whereas in Greece the respective values were 18.8 and 13.2%. After adjusting for several risk factors, a higher prevalence of anxiety symptoms was observed in Spain compared to Greece (p = .001), but no difference was seen for depressive symptoms. CONCLUSIONS This study demonstrated high scores of inappropriate eating behaviours and a high frequency of depressive and anxiety symptoms in two Mediterranean countries during the COVID-19 outbreak. Our findings revealed that compared to Greek participants, Spanish participants, that faced more severe COVID-19 pandemic and stricter lockdown measures, were associated with lower restraint and external eating and increased anxiety symptoms, but not with depressive symptoms or emotional eating.
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Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial.
Lycett, D, Aveyard, P, Farmer, A, Lewis, A, Munafò, M
BMJ open. 2020;10(1):e032271
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Weight gain is a well-known consequence of smoking cessation. The aim of this study was to compare standard stop smoking behavioural support with an intervention that, in addition to providing standard stop smoking support, included personalised weight management support, provided by Slimming World. This study is a parallel group, individually randomised controlled trial. Participants were randomised (1:1) to usual care or Slimming World with usual care. Stop smoking advisors were unaware of the randomisation sequence. Results showed that referral to the Slimming World programme plus usual stop smoking support achieved significantly less weight gain than usual stop smoking support alone. Furthermore, percentage quit was no worse in the treatment than the control group. Authors conclude that referral to a behavioural weight loss programme may be a pragmatic option within stop smoking clinics.
Abstract
INTRODUCTION Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse. TRIAL DESIGN An unblinded parallel randomised controlled trial. METHODS Participants were adult smokers with a body mass index greater or equal to 23 kg/m2. Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation. RESULTS Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported. CONCLUSION In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme. TRIAL REGISTRATION NUMBER ISRCTN65705512.
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Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.
Wang, C, Schmid, CH, Fielding, RA, Harvey, WF, Reid, KF, Price, LL, Driban, JB, Kalish, R, Rones, R, McAlindon, T
BMJ (Clinical research ed.). 2018;360:k851
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Fibromyalgia is a complex disorder, characterised by chronic widespread musculoskeletal pain, fatigue, sleep problems and depression. Conventional treatment is multidisciplinary, including medication, exercise and CBT. This randomised, single-blinded trial aimed to determine the effectiveness of regular Tai Chi practice when compared to the standard recommended exercise, aerobic training. 226 adults diagnosed with fibromyalgia were randomly assigned to either 24 weeks of supervised aerobic exercise or 12 or 24 weeks of Tai Chi classes. A standard fibromyalgia impact questionnaire was used to assess changes in pain and quality of life measures, along with patient perception of various aspects of their condition. The study found that Fibromyalgia Impact Questionnaire scores improved across all treatment groups, however the 24-week Tai Chi group saw a statistically significant greater improvement than the aerobic group. In addition, those patients on the 24-week Tai Chi programme experienced greater improvement than those on the 12-week Tai Chi programme. There was also higher attendance and fewer drop-outs in the Tai Chi groups in comparison to the aerobic exercise group. Tai Chi could therefore be considered as an alternative to aerobic exercise in a multi-disciplinary approach to fibromyalgia treatment.
Abstract
OBJECTIVES To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION ClinicalTrials.gov NCT01420640.
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Does adapted physical activity‑based rehabilitation improve mental and physical functioning? A randomized trial.
Røe, C, Preede, L, Dalen, H, Bautz-Holter, E, Nyquist, A, Sandvik, L, Saebu, M
European journal of physical and rehabilitation medicine. 2018;54(3):419-427
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Physical and mental functioning is reduced in people with chronic disability. Adapted physical activity (APA) programmes have been developed to facilitate physical activity in this population, but the mental effects have not yet been addressed. The aim of this study was to determine both the physical and mental effects of an APA programme in 202 patients with chronic disability. Participants were randomised to either join an in-patient APA rehabilitation programme or a waitlist control group. Those in the APA programme received 2-5 hours of guided activity every day for 6 days a week, as well as 1-3 hours of a social or cultural activities. Various questionnaires were completed at baseline and at the end of the intervention. This study found participants receiving the APA rehabilitation programme showed improvements in physical functioning, motivation, self-efficacy (a feeling that 'I can do' an action), pain and fatigue compared with the waitlist group. Based on these results, the authors conclude physical activity should be considered during the development of rehabilitation strategies for people with chronic disabilities.
Abstract
BACKGROUND Persons with chronic disabilities face a wide variety of problems with functioning that affect their level of physical activity and participation. We have limited knowledge about the effect of adapted physical activity (APA)-based rehabilitation on perceived mental and physical functioning. AIM: The main aim of this study was to evaluate the effect of APA‑based rehabilitation compared to waiting‑list on perceived mental and physical functioning. Secondly, we wanted to assess whether improvement in self‑efficacy, motivation, pain and fatigue during rehabilitation was related to the effect of the intervention. DESIGN Randomized controlled trial. SETTING In‑patient rehabilitation Center. POPULATION All subjects above 17 years who were referred by their physician to BHC between July 1, 2010 and August 1, 2012 without major cognitive or language problems were eligible for the study (N.=321). METHODS Persons above 17 years (men and women) with chronic disabilities who applied for a rehabilitation stay, were randomized to an adapted physical activity‑based rehabilitation intervention (N.=304) or waiting‑list with delayed rehabilitation. A total of 246 consented and were allocated to four week intervention or a waiting‑list control group. The main outcome was physical and mental functioning evaluated four weeks after rehabilitation using the Medical Outcomes Study 12-Item Short‑Form Health Survey (SF-12). RESULTS Compared to waiting‑list the adapted physical activity‑based intervention improved physical and mental functioning. Improvement in physical functioning during rehabilitation was related to reduced pain, improved motivation and self‑efficacy. CONCLUSIONS The results indicate that an adapted physical activity‑based rehabilitation program improves functioning. Improved efficacy for managing disability may mediate the improvement in mental functioning. CLINICAL REHABILITATION IMPACT Adapted physical activity‑based rehabilitation should be considered during the development of rehabilitation strategies for people with chronic disabilities. Motivational and self‑efficacy aspects must be addressed when organizing and evaluating rehabilitation programs.
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Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey.
Paterson, C
BMJ (Clinical research ed.). 1996;312(7037):1016-20
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The patient's personal experience of illness, as well as the influence of the wide variety of help and treatments they seek, needs to be incorporated into the measurement process. The aim of the study was to test the instrument, the "measure yourself medical outcome profile"—MYMOP—alongside the SF-36 health survey for responsiveness, validity, and clinical usefulness in primary care. The study’s sample consisted of 265 patients, of whom 218 were recruited by general practitioners and 47 by complementary practitioners. MYMOP was designed and piloted in the practice over four months. It consists of four items, each scored by the patient on a seven-point scale. Results indicate that the instrument was applicable to all patients presenting with symptoms to conventional and complementary practitioners, and it elicited high response and completion rates. Responsiveness to change of the SF-36 health survey was poor no matter what the method of assessment. Authors conclude that the MYMOP questionnaire and chart can be used to visually chart progress and quantify outcomes in case studies.
Abstract
OBJECTIVE To assess the sensitivity to within person change over time of an outcome measure for practitioners in primary care that is applicable to a wide range of illness. DESIGN Comparison of a new patient generated instrument, the measure yourself medical outcome profile (MYMOP), with the SF-36 health profile and a five point change score; all scales were completed during the consultation with' practitioners and repeated after four weeks. 103 patients were followed up for 16 weeks and their results charted; seven practitioners were interviewed. SETTING Established practice of the four NHS general practitioners and four of the private complementary practitioners working in one medical centre. SUBJECTS Systematic sample of 218 patients from general practice and all 47 patients of complementary practitioners; patients had had symptoms for more than seven days. OUTCOME MEASURES Standardised response mean and index of responsiveness; view of practitioners. RESULTS The index of responsiveness, relating to the minimal clinically important difference, was high for MYMOP 1.4 for the first symptom, 1.33 for activity, and 0.85 for the profile compared with < 0.45 for SF-36. MYMOP's validity was supported by significant correlation between the change score and the change in the MYMOP score and the ability of this instrument to detect more improvement in acute than in chronic conditions. Practitioners found that MYMOP was practical and applicable to all patients with symptoms and that its use increased their awareness of patients' priorities. CONCLUSION MYMOP shows promise as an outcome measure for primary care and for complementary treatment. It is more sensitive to change than the SF-36 and has the added bonus of improving patient-practitioner communication.