OBJECTIVES: Adequate relief (AR) of irritable bowel syndrome (IBS) symptoms (IBS-AR) has been used as a primary end point in many randomized controlled trials of IBS and is considered by the Rome III committee to be an acceptable primary end point. However, controversy exists on whether baseline severity confounds the effect of the treatment outcome. The aim (1) is to compare a subjective report of IBS-AR with global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS), and IBS quality of life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the ability of these outcome measures to detect differences post treatment; and (3) to determine whether psychological symptoms influence the sensitivity of these measures, in a randomized controlled treatment trial.
METHODS: A total of 289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<175), moderate (175–300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or wait-list control.
RESULTS: IBS baseline severity (IBS-SSS) significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (P<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant effect on patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (P=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity.
CONCLUSIONS: These data suggest that IBS-AR as an end point is inversely related to baseline symptom severity. However, if patients who report AR at screening were excluded from study participation, baseline symptom severity was no longer confounded with a report of AR at the study end point.
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Background: Chronic pelvic pain in adolescents accounts for 10% of outpatient gynecology visits, and 70% of adolescent patients whose pelvic pain is unresponsive to initial therapy have endometriosis. To date, there has been no published research investigating the use of acupuncture for adolescents with chronic pelvic pain and/or endometriosis. Methods: This paper presents two case reports describing the impact of a course of acupuncture on adolescent girls with endometriosis-related chronic pelvic pain of more than 1 year. Results: Both patients, undergoing between 9 and 15 treatments over a 7- to 12-week period, experienced modest improvement in pain as measured by oral self-reports of pain on a scale from 1 to 10, as well as selfor family-reported improvement in headaches, nausea and fatigue. No adverse effects were reported. Conclusions: These case reports provide preliminary evidence that acupuncture may be an acceptable and safe adjunct treatment therapy for some adolescents with endometriosis-related pelvic pain refractory to standard antiendometriosis therapies. These observations suggest that a prospective, randomized controlled trial of the safety and efficacy of acupuncture for this population may be warranted.
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<p>Enhancing body awareness has been described as a key element or a mechanism of action for therapeutic approaches often categorized as mind-body approaches, such as yoga, TaiChi, Body-Oriented Psychotherapy, Body Awareness Therapy, mindfulness based therapies/meditation, Feldenkrais, Alexander Method, Breath Therapy and others with reported benefits for a variety of health conditions. To better understand the conceptualization of body awareness in mind-body therapies, leading practitioners and teaching faculty of these approaches were invited as well as their patients to participate in focus groups. The qualitative analysis of these focus groups with representative practitioners of body awareness practices, and the perspectives of their patients, elucidated the common ground of their understanding of body awareness. For them body awareness is an inseparable aspect of embodied self awareness realized in action and interaction with the environment and world. It is the awareness of embodiment as an innate tendency of our organism for emergent self-organization and wholeness. The process that patients undergo in these therapies was seen as a progression towards greater unity between body and self, very similar to the conceptualization of embodiment as dialectic of body and self described by some philosophers as being experienced in distinct developmental levels.</p>
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A recently published analysis by Lewis and Maslin (Lewis SL and Maslin MA (2015) Defining the Anthropocene. Nature 519: 171–180) has identified two new potential horizons for the Holocene−Anthropocene boundary: 1610 (associated with European colonization of the Americas), or 1964 (the peak of the excess radiocarbon signal arising from atom bomb tests). We discuss both of these novel suggestions, and consider that there is insufficient stratigraphic basis for the former, whereas placing the latter at the peak of the signal rather than at its inception does not follow normal stratigraphical practice. Wherever the boundary is eventually placed, it should be optimized to reflect stratigraphical evidence with the least possible ambiguity.
Parochial schools are assumed to provide better social and academic experiences; however, few studies account for selection bias when comparing with public schools. This study contrasted public versus parochial schools using propensity score matching across a range of outcomes (e.g., perceptions of school, emotional symptoms, substance use, bullying). Using a sample of 58 public and 5 parochial high schools, the nonmatched analyses suggested a significant advantage for parochial schools students (e.g., better on 23 of 32 indicators). However, the propensity score matched analyses revealed nine differences (e.g., weapon carrying, smoking), two of which (i.e., stress and cyberbullying) favored public schools. While at first glance parochial schools generally appear to be healthier and safer learning environments, accounting for selection bias, the gap was narrowed. Students in parochial schools may struggle with issues related to social, emotional, and behavioral health risk, and thus prevention programs should also be implemented in these settings.
Objective To investigate whether placebo effects can experimentally be separated into the response to three components—assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship—and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.
Design A six week single blind three arm randomised controlled trial.
Setting Academic medical centre.
Participants 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale.
Interventions For three weeks either waiting list (observation), placebo acupuncture alone (“limited”), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence (“augmented”). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.
Main outcome measures Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.
Results At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus “limited” versus “augmented,” respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01).Results were similar at six week follow-up.
Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.
Trial registration Clinical Trials NCT00065403.
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Touch Healing (TH) therapies, defined here as treatments whose primary route of administration is tactile contact and/or active guiding of somatic attention, are ubiquitous across cultures. Despite increasing integration of TH into mainstream medicine through therapies such as Reiki, Therapeutic Touch,TM and somatically focused meditation practices such as Mindfulness-Based Stress Reduction, relatively little is known about potential underlying mechanisms. Here, we present a neuroscientific explanation for the prevalence and effectiveness of TH therapies for relieving chronic pain. We begin with a cross-cultural review of several different types of TH treatments and identify common characteristics, including: light tactile contact and/or a somatosensory attention directed toward the body, a behaviorally relevant context, a relaxed context and repeated treatment sessions. These cardinal features are also key elements of established mechanisms of neural plasticity in somatosensory cortical maps, suggesting that sensory reorganization is a mechanism for the healing observed. Consideration of the potential health benefits of meditation practice specifically suggests that these practices provide training in the regulation of neural and perceptual dynamics that provide ongoing resistance to the development of maladaptive somatic representations. This model provides several direct predictions for investigating ways that TH may induce cortical plasticity and dynamics in pain remediation.
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How does our identity affect the teaching and learning processes? As we teach, what paths are we following intellectually, emotionally, or even spiritually? How do these paths influence our relationship to our content and to our students? With an engaging honesty, Parker Palmer pursues these questions.
How does our identity affect the teaching and learning processes? As we teach, what paths are we following intellectually, emotionally, or even spiritually? How do these paths influence our relationship to our content and to our students? With an engaging honesty, Parker Palmer pursues these questions.
Cued spatial attention modulates functionally relevant alpha rhythms in visual cortices in humans. Here, we present evidence for analogous phenomena in primary somatosensory neocortex (SI). Using magnetoencephalography, we measured changes in the SI mu rhythm containing mu-alpha (7–14 Hz) and mu-beta (15–29 Hz) components. We found that cued attention impacted mu-alpha in the somatopically localized hand representation in SI, showing decreased power after attention was cued to the hand and increased power after attention was cued to the foot, with significant differences observed 500–1100 ms after cue. Mu-beta showed differences in a time window 800–850 ms after cue. The visual cue also drove an early evoked response beginning ∼70 ms after cue with distinct peaks modulated with cued attention. Distinct components of the tactile stimulus-evoked response were also modulated with cued attention. Analysis of a second dataset showed that, on a trial-by-trial basis, tactile detection probabilities decreased linearly with prestimulus mu-alpha and mu-beta power. These results support the growing consensus that cue-induced alpha modulation is a functionally relevant sensory gating mechanism deployed by attention. Further, while cued attention had a weaker effect on the allocation of mu-beta, oscillations in this band also predicted tactile detection.
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Mindfulness-based stress reduction (MBSR) is an 8-week training that is designed to teach participants mindful awareness of the present moment. In randomized clinical trials (RCTs), MBSR has demonstrated efficacy in various conditions including reducing chronic pain-related distress and improving quality of life in healthy individuals. There have, however, been no qualitative studies investigating participants' descriptions of changes experienced over multiple time points during the course of the programme. This qualitative study of an MBSR cohort (N = 8 healthy individuals) in a larger RCT examined participants' daily diary descriptions of their home-practice experiences. The study used a two-part method, combining grounded theory with a close-ended coding approach. The grounded theory analysis revealed that during the trial, all participants, to varying degrees, described moments of distress related to practice; at the end of the course, all participants who completed the training demonstrated greater detail and clarity in their descriptions, improved affect, and the emergence of an observing self. The closed-ended coding schema, carried out to shed light on the development of an observing self, revealed that the emergence of an observing self was not related to the valence of participants' experiential descriptions: even participants whose diaries contained predominantly negative characterizations of their experience throughout the trial were able, by the end of the trial, to demonstrate an observing, witnessing attitude towards their own distress. Progress in MBSR may rely less on the valence of participants' experiences and more on the way participants describe and relate to their own inner experience. Copyright © 2010 John Wiley & Sons, Ltd. Key Practitioner Message: This article • Analyses the ways in which participants in a mindfulness-based stress reduction (MBSR) clinical trial describe their experiences with mindfulness practice. • Carries out qualitative analysis of the ways in which participants' descriptions of home-based meditation practice contained in their practice diaries change over the course of an 8-week MBSR trial. • Demonstrates that the participants who successfully completed the 8-week course show a common developmental trajectory, as each participant used less reactive, judgemental language to describe their home meditative practice-based experiences by the end of the trial, even when, in the case of some participants, that experience was perceived as negative or distressing. • Suggests that progress in MBSR may rely less on the valence of participants' experience and more on the way participants describe and relate to their own inner experience.
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Mindfulness-based stress reduction (MBSR) is an 8-week training that is designed to teach participants mindful awareness of the present moment. In randomized clinical trials (RCTs), MBSR has demonstrated efficacy in various conditions including reducing chronic pain-related distress and improving quality of life in healthy individuals. There have, however, been no qualitative studies investigating participants' descriptions of changes experienced over multiple time points during the course of the programme. This qualitative study of an MBSR cohort (N = 8 healthy individuals) in a larger RCT examined participants' daily diary descriptions of their home-practice experiences. The study used a two-part method, combining grounded theory with a close-ended coding approach. The grounded theory analysis revealed that during the trial, all participants, to varying degrees, described moments of distress related to practice; at the end of the course, all participants who completed the training demonstrated greater detail and clarity in their descriptions, improved affect, and the emergence of an observing self. The closed-ended coding schema, carried out to shed light on the development of an observing self, revealed that the emergence of an observing self was not related to the valence of participants' experiential descriptions: even participants whose diaries contained predominantly negative characterizations of their experience throughout the trial were able, by the end of the trial, to demonstrate an observing, witnessing attitude towards their own distress. Progress in MBSR may rely less on the valence of participants' experiences and more on the way participants describe and relate to their own inner experience.
Background: The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes. Objectives: As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies. Study design: To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. Results: Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD. Conclusions: The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.
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Conditional goal setting (CGS, the tendency to regard high order goals such as happiness, as conditional upon the achievement of lower order goals) is observed in individuals with depression and recent research has suggested a link between levels of dispositional mindfulness and conditional goal setting in depressed patients. Since interventions which aim to increase mindfulness through training in meditation are used with patients suffering from depression it is of interest to examine whether such interventions might alter CGS. Study 1 examined the correlation between changes in dispositional mindfulness and changes in CGS over a 3-4 month period in patients participating in a pilot randomised controlled trial of Mindfulness-Based Cognitive Therapy (MBCT). Results indicated that increases in dispositional mindfulness were significantly associated with decreases in CGS, although this effect could not be attributed specifically to the group who had received training in meditation. Study 2 explored the impact of brief periods of either breathing or loving kindness meditation on CGS in 55 healthy participants. Contrary to expectation, a brief period of meditation increased CGS. Further analyses indicated that this effect was restricted to participants low in goal re-engagement ability who were allocated to loving kindness meditation. Longer term changes in dispositional mindfulness are associated with reductions in CGS in patients with depressed mood. However initial reactions to meditation, and in particular loving kindness meditation, may be counterintuitive and further research is required in order to determine the relationship between initial reactions and longer-term benefits of meditation practice.
Conditional goal setting (CGS, the tendency to regard high order goals such as happiness, as conditional upon the achievement of lower order goals) is observed in individuals with depression and recent research has suggested a link between levels of dispositional mindfulness and conditional goal setting in depressed patients. Since interventions which aim to increase mindfulness through training in meditation are used with patients suffering from depression it is of interest to examine whether such interventions might alter CGS. Study 1 examined the correlation between changes in dispositional mindfulness and changes in CGS over a 3-4 month period in patients participating in a pilot randomised controlled trial of Mindfulness-Based Cognitive Therapy (MBCT). Results indicated that increases in dispositional mindfulness were significantly associated with decreases in CGS, although this effect could not be attributed specifically to the group who had received training in meditation. Study 2 explored the impact of brief periods of either breathing or loving kindness meditation on CGS in 55 healthy participants. Contrary to expectation, a brief period of meditation increased CGS. Further analyses indicated that this effect was restricted to participants low in goal re-engagement ability who were allocated to loving kindness meditation. Longer term changes in dispositional mindfulness are associated with reductions in CGS in patients with depressed mood. However initial reactions to meditation, and in particular loving kindness meditation, may be counterintuitive and further research is required in order to determine the relationship between initial reactions and longer-term benefits of meditation practice.
<p>How do we, as humans, take in the feelings and thoughts of other people? Theory-of-Mind (ToM) and Embodied Simulation (ES) approaches hypothesize divergent neural and behavioral mechanisms underlying intersubjectivity. ToM investigators assert that humans take in the belief states and intentions of another person by holding "a theory of mind" that cognitively posits the other person's mental contents, with some experiments identifying the right temporo-parietal junction as a specific ToM brain region. ES theorists hypothesize that humans perceive the other's state of mind by simulating his/her actions, emotions, and goals in the "mirror neuron system" in the brain. A historical review suggests these understandings rely on opposing, dualist models of cognition and perception. William James's intervention on this earlier debate is informative in anticipating recent findings in low-level sensory neuroscience. Of specific interest are studies showing that intersubjectivity and low-level sensory attentional filtering are both processed in the same cortical area (the temporo-parietal junction) suggesting that the ability to entertain other minds may be related to the ability to perceive salient stimuli during attention-demanding tasks.</p>
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Background
Behavioral paradigms applied during human recordings in electro- and magneto- encephalography (EEG and MEG) typically require 1–2 hours of data collection. Over this time scale, the natural fluctuations in brain state or rapid learning effects could impact measured signals, but are seldom analyzed.
Methods and Findings
We investigated within-session dynamics of neocortical alpha (7–14 Hz) rhythms and their allocation with cued-attention using MEG recorded from primary somatosensory neocortex (SI) in humans. We found that there were significant and systematic changes across a single ∼1 hour recording session in several dimensions, including increased alpha power, increased differentiation in attention-induced alpha allocation, increased distinction in immediate time-locked post-cue evoked responses in SI to different visual cues, and enhanced power in the immediate cue-locked alpha band frequency response. Further, comparison of two commonly used baseline methods showed that conclusions on the evolution of alpha dynamics across a session were dependent on the normalization method used.
Conclusions
These findings are important not only as they relate to studies of oscillations in SI, they also provide a robust example of the type of dynamic changes in brain measures within a single session that are overlooked in most human brain imaging/recording studies.
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BackgroundMindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence.
Methods/design
To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years.
Discussion
The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence.
A growing body of literature has identified a range of beneficial physiological and psychological outcomes from the regular practice of mindfulness meditation. For healthcare professionals, mindfulness meditation is claimed to reduce stress, anxiety and burnout, and enhance resilience.
A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews. We also report the fraction of cost each method consumed and fraction of recruitment each method generated. Our cost per call from potential participants varied from $3–$103 and cost per enrollment participant varied from $12–$584. Using a novel metric, the efficacy index, we found that physician referrals and flyers were the most effective recruitment method in our trial. Despite some methods being more efficient than others, all methods contributed to the successful recruitment. The iterative use of the efficacy index during a recruitment campaign may be helpful to calibrate and focus on the most effective recruitment methods.
A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews. We also report the fraction of cost each method consumed and fraction of recruitment each method generated. Our cost per call from potential participants varied from $3–$103 and cost per enrollment participant varied from $12–$584. Using a novel metric, the efficacy index, we found that physician referrals and flyers were the most effective recruitment method in our trial. Despite some methods being more efficient than others, all methods contributed to the successful recruitment. The iterative use of the efficacy index during a recruitment campaign may be helpful to calibrate and focus on the most effective recruitment methods.
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Anxiety, depression and eating disorders show peak emergence during adolescence and share common risk factors. School-based prevention programs provide a unique opportunity to access a broad spectrum of the population during a key developmental window, but to date, no program targets all three conditions concurrently. Mindfulness has shown promising early results across each of these psychopathologies in a small number of controlled trials in schools, and therefore this study investigated its use in a randomised controlled design targeting anxiety, depression and eating disorder risk factors together for the first time. Students (M age 13.63; SD = .43) from a broad band of socioeconomic demographics received the eight lesson, once weekly.b ("Dot be") mindfulness in schools curriculum (N = 132) or normal lessons (N = 176). Anxiety, depression, weight/shape concerns and wellbeing were the primary outcome factors. Although acceptability measures were high, no significant improvements were found on any outcome at post-intervention or 3-month follow-up. Adjusted mean differences between groups at post-intervention were .03 (95% CI: -.06 to -.11) for depression, .01 (-.07 to -.09) for anxiety, .02 (-.05 to -.08) for weight/shape concerns, and .06 (-.08 to -.21) for wellbeing. Anxiety was higher in the mindfulness than the control group at follow-up for males, and those of both genders with low baseline levels of weight/shape concerns or depression. Factors that may be important to address for effective dissemination of mindfulness-based interventions in schools are discussed. Further research is required to identify active ingredients and optimal dose in mindfulness-based interventions in school settings.
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