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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This uncontrolled pilot study examined the effects of a classroom-based yoga intervention on cortisol concentrations and perceived behavior in children. A 10-week Yoga 4 Classrooms intervention was implemented in one second-grade and one third-grade classroom. Students' salivary cortisol responses were assessed at 3 time points. Classroom teachers also documented their perceptions of the effects of the intervention on students' cognitive, social, and emotional skills. Second, but not third, graders showed a significant decrease in baseline cortisol from before to after the intervention. Second and third graders both showed significant decreases in cortisol from before to after a cognitive task, but neither grade showed additional decreases from before to after a single yoga class. The second-grade teacher perceived significant improvements in several aspects his/her students' behavior. The third-grade teacher perceived some, but fewer, improvements in his/her students' behavior. Results suggest that school-based yoga may be advantageous for stress management and behavior.
OBJECTIVE:Mindfulness-based interventions have been shown to have psychological benefits in college students. We explored the effects of an academic Seminar on Compassion on student psychological health.
PARTICIPANTS:
Forty-one participants (14 male, 27 female, mean age 19.8 ± 1.4 years) were assessed pre- and post- spring semesters 2013 and 2014.
METHODS:
Students were randomized to the Seminar on Compassion or a wait-list control group. Participants completed self-report measures on anxiety, depression, perceived stress, self-compassion, compassion and mindfulness. Salivary alpha-amylase was also assessed.
RESULTS:
At baseline, self-compassion and mindfulness were negatively correlated with depression, anxiety, and perceived stress. There were significant changes between the intervention and control group from Time 1 to Time 2 in mindfulness, self-compassion, compassion, and salivary alpha-amylase; however, there were no significant changes in depression, anxiety, and perceived stress.
CONCLUSIONS:
The course was effective in increasing mindfulness, self-compassion and compassion, and decreasing a salivary marker of stress.
Objective: Evidence is accumulating, predominantly among clinical trials in adults, that yoga improves blood pressure (BP) control, with downregulation of the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS) projected as underlying mechanisms. This pilot study assessed whether Hatha yoga has the potential to reduce BP among youth and whether dampening of the SNS and/or HPA activity is a likely pathway of change. Design: Thirty-one seventh graders were randomly assigned to a Hatha yoga program (HYP) or attention control (AC) music or art class. Baseline and 3-month evaluations included resting BP; overnight urine samples; and saliva collected at bedtime, upon awakening, and at 30 and 60 minutes after awakening for α-amylase and cortisol assays. Results: Twenty-eight (14 in the HYP group and 14 in the AC group) students were assessed both before and after the intervention. BP changes from pre- to post-intervention were −3.0/−2.0 mmHg for the HYP group and −0.07/−0.79 mmHg for the AC group ( p=0.30 and 0.57, respectively). Changes in systolic BP (SBP)/diastolic BP (DBP) for the prehypertensive (75th-94th percentiles for SBP) subgroup analyses were −10.75/−8.25 mmHg for the HYP group ( n=4) versus 1.8/1.0 mmHg for the AC group ( n=5) ( p for SBP=0.02; p for DBP=0.09). Although no statistically significant group differences were observed with changes in SNS or HPA awakening curves (area under curve for α-amylase and cortisol, respectively), a small to moderate effect size was seen favoring a reduction of α-amylase activation for the HYP group (Cohen d=0.34; prehypertensive d=0.20). Conclusions: A school-based Hatha yoga program demonstrated potential to decrease resting BP, particularly among prehypertensive youth. Reduced SNS drive may be an underlying neurohormonal pathway beneficially affected by the program. A large-scale efficacy/effectiveness randomized clinical trial is warranted.
<p>A school-based program of mindful awareness practices (MAPs) was evaluated in a randomized control study of 64 second- and third-grade children ages 7–9 years. The program was delivered for 30 minutes, twice per week, for 8 weeks. Teachers and parents completed questionnaires assessing children's executive function immediately before and following the 8-week period. Multivariate analysis of covariance on teacher and parent reports of executive function (EF) indicated an interaction effect between baseline EF score and group status on posttest EF. That is, children in the MAPs group who were less well regulated showed greater improvement in EF compared with controls. Specifically, those children starting out with poor EF who went through the MAPs training showed gains in behavioral regulation, metacognition, and overall global executive control. These results indicate a stronger effect of MAPs on children with executive function difficulties. The finding that both teachers and parents reported changes suggests that improvements in children's behavioral regulation generalized across settings. Future work is warranted using neurocognitive tasks of executive functions, behavioral observation, and multiple classroom samples to replicate and extend these preliminary findings.</p>
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Up to 50% of breast cancer survivors on aromatase inhibitor therapy report musculoskeletal symptoms such as joint and muscle pain, significantly impacting treatment adherence and discontinuation rates. We conducted a secondary data analysis of a nationwide, multi-site, phase II/III randomized, controlled, clinical trial examining the efficacy of yoga for improving musculoskeletal symptoms among breast cancer survivors currently receiving hormone therapy (aromatase inhibitors [AI] or tamoxifen [TAM]). Breast cancer survivors currently receiving AI (N = 95) or TAM (N = 72) with no participation in yoga during the previous 3 months were randomized into 2 arms: (1) standard care monitoring and (2) standard care plus the 4-week yoga intervention (2x/week; 75 min/session) and included in this analysis. The yoga intervention utilized the UR Yoga for Cancer Survivors (YOCAS©(®)) program consisting of breathing exercises, 18 gentle Hatha and restorative yoga postures, and meditation. Musculoskeletal symptoms were assessed pre- and post-intervention. At baseline, AI users reported higher levels of general pain, muscle aches, and total physical discomfort than TAM users (all P ≤ 0.05). Among all breast cancer survivors on hormonal therapy, participants in the yoga group demonstrated greater reductions in musculoskeletal symptoms such as general pain, muscle aches and total physical discomfort from pre- to post-intervention than the control group (all P ≤ 0.05). The severity of musculoskeletal symptoms was higher for AI users compared to TAM users. Among breast cancer survivors on hormone therapy, the brief community-based YOCAS©® intervention significantly reduced general pain, muscle aches, and physical discomfort.
BackgroundWe examined the experiences of incarcerated adolescent males (N = 29) who participated in a one‐day meditation retreat and 10‐week meditation programme.
Method
Self‐report surveys assessing mindfulness, self‐regulation, impulsivity and stress; behavioural assessments; and focus group data were examined.
Results
We observed significantly higher scores in self‐regulation (p = .012) and psychometric markers demonstrated psychological enhancement. No behavioural change was observed. Six themes emerged: enhanced well‐being, increased self‐discipline, increased social cohesiveness, expanded self‐awareness, resistance to meditation and future meditation practice.
Conclusions
Early evidence suggests that meditation training for incarcerated youth is a feasible and promising intervention.
The study design for the different stages of fieldwork undertaken during this ethnobotanical investigation is described in this chapter. The knowledge base for this project was from interviews with traditional Thai healers in northern Thailand who are aware of plants they believe can nourish the brain and enhance memory. The selection of informants was paramount to gather high quality information on plants to treat cognitive impairment. A number of traditional healers were interviewed to determine which ones had deep knowledge regarding medicinal plants for the brain. These healers reported individual plants, as well as plant formulas, used to increase memory and formulas for diseases established as preconditions to a diagnosis of dementia. Establishing these participants required developing a comprehensive interview questionnaire, and properly identifying the plant specimen discussed by the healers. The ethics of a medical ethnobotany project can be quite complex. The protection of biocultural diversity in Thailand, and the traditional knowledge of the healers, is presented at the end of the chapter.
Background. The purpose of this article is to review the evidence for the efficacy of hatha yoga for depression and possible mechanisms by which yoga may have an impact on depression, and to outline directions for future research. Methods. Literature review and synthesis. Results and conclusions. A literature search for clinical trials examining yoga for depression uncovered eight trials: 5 including individuals with clinical depression, and 3 for individuals with elevated depression symptoms. Although results from these trials are encouraging, they should be viewed as very preliminary because the trials, as a group, suffered from substantial methodological limitations. We would argue, however, that there are several reasons to consider constructing careful research on yoga for depression. First, current strategies for treating depression are not sufficient for many individuals, and patients have several concerns about existing treatments. Yoga may be an attractive alternative to or a good way to augment current depression treatment strategies. Second, aspects of yoga-including mindfulness promotion and exercise-are thought to be "active ingredients" of other successful treatments for depression. Third, there are plausible biological, psychological, and behavioral mechanisms by which yoga may have an impact on depression. We provide suggestions for the next steps in the study of yoga as a treatment for depression. (Journal of Psychiatric Practice 2010;16:22-33)
Background. The purpose of this article is to review the evidence for the efficacy of hatha yoga for depression and possible mechanisms by which yoga may have an impact on depression, and to outline directionsfor future research. Methods. Literature review and synthesis. Results and conclusions. A literature search
for clinical trials examining yoga for depression uncovered eight trials: 5 including individuals with clinical depression, and 3 for individuals with elevated depression symptoms. Although results from these trials
are encouraging, they should be viewed as very preliminary because the trials, as a group, suffered from
substantial methodological limitations. We would argue, however, that there are several reasons to consider constructing careful research on yoga for depression. First, current strategies for treating depression are not sufficient for many individuals, and patients have several concerns about existing treatments. Yoga may
be an attractive alternative to or a good way to augment current depression treatment strategies. Second, aspects of yoga—including mindfulness promotion and exercise—are thought to be “active ingredients” of other successful treatments for depression. Third, there are plausible biological, psychological, and behavioral mechanisms by which yoga may have an impact on depression. We provide suggestions for the next steps in the study of yoga as a treatment for depression.
Provides exercises and meditations to help people diagnosed with cancer to rebuild strength, stamina, and flexibility during and following cancer treatments.
"When you feel anxious, angry, happy, or surprised, what's really going on inside you? Most scientists would agree that emotions come from specific parts of the brain, and that we feel them whenever they're triggered by the world around us. The thrill of seeing an old friend, the sadness of a tear-jerker movie, the fear of losing someone you love - each of these sensations arises automatically and uncontrollably within us, finding expression on our faces and in our behaviour, and carrying us away with the experience. This understanding of emotion has been around since Aristotle. But what if it's wrong? In How Your Emotions Are Made, pioneering psychologist Lisa Feldman Barrett draws on the latest scientific evidence to reveal that our ideas about emotion are dramatically, even dangerously, out of date - and that we have been paying the price. Emotions don't exist objectively in nature, Barrett explains, and they aren't pre-programmed in our brains and bodies; rather, they are psychological experiences that each of us constructs based on our unique personal history, physiology and environment. This new view of emotions has serious implications: when judges issue lesser sentences for crimes of passion, when police officers fire at threatening suspects, or when doctors choose between one diagnosis and another, they're all, in some way, relying on the ancient assumption that emotions are hardwired into our brains and bodies. Revising that conception of emotion isn't just good science, Barrett shows; it's vital to our wellbeing and the health of society itself"--Provided by publisher.
Introduction: Depression and anxiety disorders are highly prevalent among primary care patients. Group visits provide a way of delivering interventions to multiple patients at the same time. Group visits for depression and anxiety present an opportunity to expand the reach of behavioral health services for primary care patients. The goal of the current study was to evaluate the implementation of an acceptance and mindfulness-based group for primary care patients with depression and anxiety. Methods: Adult family medicine patients with Patient Health Questionnaire–9 (PHQ-9) and/or Generalized Anxiety Disorder Scale–7 (GAD-7) scores > 5 were eligible for the group. The group was held biweekly in the family medicine practice with rolling enrollment. The PHQ-9 and GAD-7 were administered at every visit, and changes in depression and anxiety symptoms were analyzed using multilevel modeling. We evaluated feasibility, acceptability/satisfaction, penetration, and sustainability. Results: Over the course of 19 months, 50 patients were referred to the group, and 29 enrolled. The median number of visits attended was four among those who attended more than one group visit. Results revealed that depression and anxiety symptoms decreased significantly over the first four visits attended (d = −.26 and −.19, respectively). Patients who attended more than one group reported high satisfaction. The group was sustainable after the research funding ended; however, penetration was low. Discussion: A rolling enrollment group for patients with depression and anxiety that utilized mindfulness- and acceptance-based treatment principles is feasible to implement in a primary care setting but is not without challenges. Recommendations for ways to enhance implementation and future research are provided.
This introduction to the second part of our Symposium on Teachers as Leaders examines the role of collaboration and writing as part of teacher leadership. The first part of the symposium described teacher leadership as a stance that values professionalism and the intellectual, political, and collaborative work of teaching. This introduction explores how a group of teacher leaders who have met regularly during the past several years have used writing to reflect on practice, to share ideas with one another, and to communicate their perspectives to others. [For the introduction to Part 1 of the symposium, see EJ1110798.]
Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective. This article summarizes the methodology of an ongoing NIH-funded randomized controlled trial aimed at investigating whether the placebo effect in irritable bowel syndrome (IBS) exists and whether the magnitude of such an effect can be manipulated to vary in a manner analogous to “dose dependence.” The trial also uses an innovative combination of quantitative and qualitative methods.
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Study Objective
To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis.
Design
Randomized, sham-controlled trial.
Settings
Tertiary-referral hospital.
Participants
Eighteen young women (13–22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain.
Interventions
A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks.
Main Outcome Measures
Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation.
Results
Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points (P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported.
Conclusion
Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.
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Self-conscious emotions such as embarrassment and shame are associated with 2 aspects of theory of mind (ToM): (a) the ability to understand that behavior has social consequences in the eyes of others and (b) an understanding of social norms violations. The present study aimed to link ToM with the recognition of self-conscious emotion. Children with and without autism identified facial expressions conscious of self-conscious and non-self-conscious emotions from photographs. ToM was also measured. Children with autism performed more poorly than comparison children at identifying self-conscious emotions, though they did not differ in the recognition of non-self-conscious emotions. When ToM ability was statistically controlled, group differences in the recognition of self-conscious emotion disappeared. Discussion focused on the links between ToM and self-conscious emotion.
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Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such “placebo effects” exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed “expectation” of improvement but spoke of “hope” instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo—e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment—provides an inadequate model to explain its salubrious benefits.
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Meditation in Higher Education: The Question of Change, a Current Problem, and Evidence Toward a Solution
The purpose of this study was to evaluate the feasibility, acceptability, and helpfulness of Mindfulness-Based Cognitive Therapy for Children (MBCT-C) for the treatment of internalizing and externalizing symptoms in a sample of nonreferred children. Twenty-five children, ages 9 to 12, participated in the 12-week intervention. Assessments were conducted at baseline and posttreatment. Open trial analyses found preliminary support for MBCT-C as helpful in reducing internalizing and externalizing symptoms within subjects on the parent report measure. The high attendance rate (Intent-to-Treat sample, 78%; Completer sample, 94%), high retention rate (68%), and positive ratings on program evaluations supported treatment feasibility and acceptability. Overall, this pilot study offers feasibility and acceptability data for MBCT-C as a potential treatment for internalizing and externalizing symptoms in children. Further research is needed to test the efficacy of the intervention with a larger sample of children who meet diagnostic criteria for clinical disorders.
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Despite the crucial role of teachers in fostering children's academic learning and social-emotional well-being, addressing teacher stress in the classroom remains a significant challenge in education. The present study reports results from a randomized controlled pilot trial of a modified Mindfulness-Based Stress Reduction course (mMBSR) adapted specifically for teachers. Results suggest the course may be a promising intervention, with participants showing significant reductions in psychological symptoms and burnout, improvements in observer-rated classroom organization and performance on a computer task of affective attentional bias, and increases in self-compassion. In contrast, control group participants showed declines in cortisol functioning over time and marginally significant increases in burnout. Furthermore, changes in mindfulness were correlated in the expected direction with changes across several outcomes (psychological symptoms, burnout, sustained attention) in the intervention group. Implications of these findings for the training and support of teachers are discussed.
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