A resilient issue in research ethics is whether and when a placebo-controlled trial is justified if it deprives research subjects of a recognized treatment. The clinicians' moral duty to provide the best available care seems to require the use of ‘active’ controlled trials that use an established treatment as a control whenever such a therapy is available. In another regard, ACTs are supposedly methodologically inferior to PCTs. Hence, the moral duty of the clinical researcher to use (...) the best methods will favor PCTs. In this target article, I analyze the three reasons for believing that ACTs are inferior to PCTs namely: 1) ACTs lack ‘assay sensitivity’; 2) ACTs do not measure absolute effect size; and 3) ACTs require more participants; and I contend that none are acceptable. Consequently the tension between clinical and research ethics dissolves: the moral duty of the clinician to avoid PCTs is unopposed by methodological considerations. (shrink)

A resilient issue in research ethics is whether and when a placebo-controlled trial is justified if it deprives research subjects of a recognized treatment. The clinicians' moral duty to provide the best available care seems to require the use of ‘active’ controlled trials that use an established treatment as a control whenever such a therapy is available. In another regard, ACTs are supposedly methodologically inferior to PCTs. Hence, the moral duty of the clinical researcher to use (...) the best methods will favor PCTs. In this target article, I analyze the three reasons for believing that ACTs are inferior to PCTs namely: 1) ACTs lack ‘assay sensitivity’; 2) ACTs do not measure absolute effect size; and 3) ACTs require more participants; and I contend that none are acceptable. Consequently the tension between clinical and research ethics dissolves: the moral duty of the clinician to avoid PCTs is unopposed by methodological considerations. (shrink)

According to Howick (2009a), the three main reasons for believing that placebo-controlled trials (PCTs) are methodologically superior to active-controlled trials (ACTs)—sensitivity, absolute effect...

The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a superiority trial, (...) a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control — following the latest revision of Declaration of Helsinki — is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients’ rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless. (shrink)

The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a (...) modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure –Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities. (shrink)

The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of (...) an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the use of placebo may be the cause of the problem pointed to. Scientific, regulatory, ethical and legal advantages of the use of an active control are described. While the use of a placebo control may be acceptable in carefully defined circumstances, in most cases the use of an active control in schizophrenia research is ethically and scientifically preferable. (shrink)

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of (...) these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)

Despite ample evidence that speech production is associated with extensive trial-to-trial variability, it remains unclear whether this variability represents merely unwanted system noise or an actively regulated mechanism that is fundamental for maintaining and adapting accurate speech movements. Recent work on upper limb movements suggest that inter-trial variability may be not only actively regulated based on sensory feedback, but also provide a type of workspace exploration that facilitates sensorimotor learning. We therefore investigated whether experimentally reducing or magnifying inter-trial formant variability (...) in the real-time auditory feedback during speech production leads to adjustments in formant production variability that compensate for the manipulation, changes the temporal structure of formant adjustments across productions, and enhances learning in a subsequent adaptation task in which a predictable formant-shift perturbation is applied to the feedback signal. Results show that subjects gradually increased formant variability in their productions when hearing auditory feedback with reduced variability, but subsequent formant-shift adaptation was not affected by either reducing or magnifying the perceived variability. Thus, findings provide evidence for speakers’ active control of inter-trial formant variability based on auditory feedback from previous trials, but–at least for the current short-term experimental manipulation of feedback variability–not for a role of this variability regulation mechanism in subsequent auditory-motor learning. (shrink)

The purpose of the present two studies was to investigate whether in framing messages that target salient beliefs of youth, the type of goal framed matter to promote physical activity participation among low-active adolescents. More specifically, the main trial compared the effect of intrinsic and extrinsic-goal framing messages alongside planning to a control condition on low-active adolescents’ physical activity, intention, attitude, and exercise goals, and examined the potential meditational effect of these variables between condition and PA. Low-active (...) students from fifteen classes were assigned to one of these three conditions. PA was assessed using an accelerometer, and the socio-cognitive mediators were measured at baseline and post-test, and the intention was measured again at follow-up. Results showed that compared to adolescents in the CC group, those in the experimental conditions did not do more moderate PA, but carried out more light PA, and yielded an increase in attitude and intention. Mediational analysis revealed no significant effect of the potential mediators. (shrink)

Although the study of the affective components involved in predicting physical activity is spreading faster and faster, there is a lack of studies testing their role when promoting physical activity through message interventions. In the present study, we considered these components by focusing on how anticipated affective reactions and emotional processing of the messages influence receivers’ affective attitude toward physical activity, concurrent behavior, and future intention. A sample of 250 participants was involved in an intervention relying on prefactual messages promoting (...) physical activity. All messages were sent through a research app and were focused on the expected consequences of exercising. Four experimental conditions involving messages differing as to their outcome sensitivity framing were compared to a control condition. Results showed that reading gain and non-gain messages enhanced the positive affective attitude toward physical activity, compared to control. Enhanced affective attitude after the intervention increased, in turn, self-reported physical activity and future intention. Interestingly, gain messages were even more persuasive for people with a low level of positive anticipated affective reactions. Furthermore, their effectiveness was especially attributable to the elicitation of hope in receivers. Discussion focuses on the advantages of considering affective components and their implications when promoting physical activity. (shrink)

Research over the past few decades has shown the positive influence that cognitive, social, and physical activities have on older adults’ cognitive and affective health. Especially interventions in health-related behaviors, such as cognitive activation, physical activity, social activity, nutrition, mindfulness, and creativity, have shown to be particularly beneficial. Whereas most intervention studies apply unimodal interventions, such as cognitive training, this study investigates the potential to foster cognitive and affective health factors of older adults by means of an autonomy-supportive multimodal intervention. (...) The intervention integrates everyday life recommendations for six evidence-based areas combined with psychoeducational information. This randomized controlled trial study compares the effects of a MMI and CT on those of a waiting control group on cognitive and affective factors, everyday life memory performance, and activity in everyday life. Three groups, including a total of 119 adults aged 65–86 years, attended a 5- or 10-week intervention. Specifically, one group completed a 10-week MMI, the second group completed 5-week of computer-based CT followed by a 5-week MMI, whereas the third group paused before completing the MMI for the last 5 weeks. All participants completed online surveys and cognitive tests at three test points. The findings showed an increase in the number and variability of activities in the everyday lives of all participants. Post hoc analysis on cognitive performance of MMI to CT indicate similar or better effects. Furthermore, results on far transfer variables showed interesting trends in favor of the MMI, such as increased well-being and attitude toward the aging brain. Also, the MMI group showed the biggest perceived improvements out of all groups for all self-reported personal variables. The results implicate a positive trend toward MMI on cognitive and affective factors of older adults. These tendencies show the potential of a multimodal approach compared to training a specific cognitive function. Moreover, the findings suggest that information about MMI motivates participants to increase activity variability and frequency in everyday life. Finally, the results could also have implications for the primary prevention of neurocognitive deficits and degenerative diseases. (shrink)

The aim of the present study is to examine the effect of group-play intervention on executive function in preschoolers. This group-play intervention was integrated as moderate to vigorous physical activity and cognitively loaded exercise to promote EF in preschoolers. An 8-week group-play MVPA intervention program, consisting of a series of outdoor physical and cognitively loaded games, was designed to improve preschoolers’ EF. This intervention program was implemented in group-play form, and conducted by teachers who received standardized training before the intervention. (...) Two classes of second grade preschoolers were randomly allocated to experimental and control groups. The intervention group received the intervention three times a week, while the control group exercised as usual in preschool. Before, in the middle of, and after the intervention, 10-m running, standing broad jump, throwing, body flexion, balance beam, and skip jump were assessed as tests of motor skills. In addition, three components of EF were measured separately before, in the middle of, and after the intervention: inhibitory control was assessed by using the silly sound Stroop task, working memory was tested using the empty house task, and shifting was assessed using the dimensional change card sorting task. Although both groups showed an increasing trend in terms of motor skills and EF during the intervention, the increasing amounts of the intervention group were significantly higher than the control group. The findings of the present study suggested that group-play intervention has positive effects on aspects of EF in addition to motor skills in preschoolers. (shrink)

The principle of clinical equipoise requires that, aside from certain exceptional cases, second generation treatments ought to be tested against standard therapy. In violation of this principle, placebo-controlled trials (PCTs) continue to be used extensively in the development and licensure of second-generation treatments. This practice is typically justified by appeal to methodological arguments that purport to demonstrate that active-controlled trials (ACTs) are methodologically flawed. Foremost among these arguments is the so called assay sensitivity argument. In (...) this paper, I take a closer look at this argument. Following Duhem, I argue that all trials, placebo-controlled or not, rely on external information for their meaningful interpretation. Pending non-circular empirical evidence that we can trust the findings of PCTs to a greater degree than the findings of ACTs, I conclude that the assay sensitivity argument fails to demonstrate that placebo-controlled trials are preferable, methodologically or otherwise, to active-controlled trials. Contrary to the intentions of its authors, the fundamental lesson taught by the assay sensitivity argument is Duhemian: the validity of all clinical trials depends on external information. (shrink)

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of (...) Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard. (shrink)

Objective: Inhibitory control training has shown promise for improving health behaviours, however, less is known about its mediators of effectiveness. The current paper reports whether ICT reduces smoking-related outcomes such as craving and nicotine dependence, increases motivation to quit and whether reductions in smoking or craving are mediated by response inhibition or a devaluation of smoking stimuli.Method: Adult smokers were randomly allocated to receive 14 days of smoking-specific ICT or active control training. Participants were followed up to 3-months post-intervention. (...) This trial was preregistered.Results: There were no significant differences between ICT and active control training groups. Specifically, participants in both groups showed significant reductions in craving, nicotine dependence, motivation and a devaluation of smoking-stimuli up to 3-months follow-up compared to baseline. Inhibition and devaluation of smoking stimuli did not act as mediators. Devaluation of smoking stimuli was an independent predictor of smoking and craving at follow-up.Conclusion: Inhibitory control training was no more effective at reducing smoking-related outcomes compared to the active control group, however, significant improvements in craving, dependence indicators and evaluation of smoking stimuli were observed across both groups. A return to basic experimental research may be required to understand the most effective ICT approach to support smoking cessation. (shrink)

Introduction: Probationers, offenders with less serious and non-violent offences, and under statutory supervision, have low levels of self-esteem and physical health, and high level of family conflict, and poorer quality of family relationships. This study examined the effectiveness of the existing probation service and the additional use of a positive family holistic health intervention to enhance physical, psychological, and family well-being in probationers and relationships with probation officers.Methods: Probationers under the care of the Hong Kong Social Welfare Department were randomized (...) into a care-as-usual control group, a brief intervention group receiving two 1-h individual sessions [of a brief theory-based positive family holistic health intervention integrating Zero-time Exercise and positive psychology themes of “Praise and Gratitude” in the existing probation service], or a combined intervention group receiving BI and a 1-day group activity with family members. The outcomes were physical activity, fitness performance, self-esteem, happiness, anxiety and depression symptoms, life satisfaction, quality of life, family communication and well-being, and relationships with probation officers. Self-administered questionnaires and simple fitness tests were used at baseline, 1-month and 3-month follow-up. Linear mixed model analysis was used to compare difference in the changes of outcome variables among groups, adjusted of sex, age, and baseline values. Focus group interviews were conducted. Thematic content analysis was used.Results: 318 probationers were randomized into CAU, BI, or CI group. CAU showed enhanced physical activity, fitness performance and psychological health, and family communication with small effect sizes. BI and CI showed further improved physical activity, family communication and family well-being. Additionally, CI reported greater improvements in the relationships with probation officers than CAU with a small effect size. CI also reported greater increases in physical activity and family communication than BI with small to moderate effect sizes. Qualitative feedbacks corroborated the quantitative findings.Conclusion: Our trial provided the first evidence of the effectiveness of probation service and the additional use of an innovative, relatively low-cost, theory-based brief positive family holistic health intervention. This intervention may offer a new model for enhancing probation service.Trial Registration: The research protocol was registered at the National Institutes of Health. (shrink)

Schools have been the main context for physical activity and sedentary behavior interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health−related quality of life. The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at three (...) control and three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; environmental improvements ; and education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention using the KIDSCREEN−27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the Movimente intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively. The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control and intervention groups. Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.Clinical Trial RegistrationThe trial is registered at the Clinical Trial Registry. (shrink)

There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and (...) the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent. (shrink)

A capacity model of mindfulness is adopted to differentiate the cognitive faculty of mindfulness from the metacognitive processes required to cultivate this faculty in mindfulness training. The model provides an explanatory framework incorporating both the developmental progression from focussed attention to open monitoring styles of mindfulness practice, along with the development of equanimity and insight. A standardised technique for activating these processes without the addition of secondary components is then introduced. Mindfulness-based interventions currently available for use in randomised control (...) class='Hi'>trials introduce components ancillary to the cognitive processes of mindfulness, limiting their ability to draw clear causative inferences. The standardised technique presented here does not introduce such ancillary factors, rendering it a valuable tool with which to investigate the processes activated in mindfulness practice. (shrink)

Many women are initially unable to contract the pelvic floor muscles (PFMs) properly, activating other muscle groups before, or instead of, PFM. Numerous authors have proved that biofeedback can be an ideal tool supporting learning of the PFM contraction. However, there is currently a lack of scientific data on how many biofeedback sessions are necessary in this educational process. In this study we aimed at assessing the effects of one-time electromyography (EMG) biofeedback session on the order in which PFM are (...) activated (so called firing order) during conscious contractions in relation to selected synergistic muscles in pregnant, continent women. A randomized controlled trial was conducted in 90 healthy nulliparous women with uncomplicated pregnancies and without diagnosed urinary incontinence. We divided the participants into a biofeedback group (50) and a control group (40). They were, respectively: 30 ± 4 and 30 ± 4 years old, at their 23 ± 5 or 25 ± 7 week of gestation and presented 23 ± 5 or 24 ± 5 kg/m2 BMI value (M + SD). Surface EMG with vaginal probes has been used to assess the PFM firing order in selected tasks: in five 3-s maximal contractions (quick flicks), five 10-s contractions, and in a 60-s contraction (static hold). We used the 1–5 scale, where “1” meant the best score, awarded when PFM was activated first in order. The most important finding of our study is that a single EMG biofeedback substantially improved the PFM contractions in pregnant women. First, when applying one-time biofeedback session, more women maintained correct technique or improved it in the second assessment, compared to the control group (73 vs. 65%). Secondly, using the quantitative and qualitative analysis with the Chi-square McNamara B/C test, in the biofeedback group we observed a statistically significant improvement of PFM firing order in four tasks: in the first quick flicks (p = 0.016), third quick flicks (p = 0.027), fifth quick flicks (p = 0.008), and in the first 10-s contractions (p = 0.046). In the control group we observed better outcome only in one motor task: in the fourth 10-s contraction (p = 0.009). Given the positive effects of a single session of EMG biofeedback on the firing order in the PFM contractions, it should be recommended for pregnant women without urinary incontinence to teach them how to perform PFM exercises correctly. (shrink)

Behavioral interventions have shown promising neuroprotective effects, but the cascade of molecular, brain and behavioral changes involved in these benefits remains poorly understood. Projecte Moviment is a 12-week multi-domain, single-blind, proof-of-concept randomized controlled trial examining the cognitive effect and underlying mechanisms of an aerobic exercise, computerized cognitive training and a combined groups compared to a waitlist control group. Adherence was > 80% for 82/109 participants recruited. In this study we report intervention-related changes in plasma biomarkers and structural-MRI and how (...) they related to changes in physical activity and individual variables and their potential role as mediators in the cognitive changes. Our results show that although there were no significant changes in molecular biomarker concentrations in any intervention group, changes in ICAM-1 and SDF1-α were negatively associated with changes in physical activity outcomes in AE and COMB groups. Brain volume changes were found in the CCT showing a significant increase in precuneus volume. Sex moderated the brain volume change in the AE and COMB groups, suggesting that men may benefit more than women. Changes in molecular biomarkers and brain volumes did not significantly mediate the cognitive-related benefits found previously for any group. This study shows crucial initial molecular and brain volume changes related to lifestyle interventions at early stages and highlights the value of examining activity parameters, individual difference characteristics and using a multi-level analysis approach to address these questions. (shrink)

BackgroundDepression is a prevalent condition that has a significant impact on psychosocial functioning and quality of life. The onset and persistence of depression have been linked to a variety of biological and psychosocial variables. Many of these variables are associated with specific lifestyle characteristics, such as physical activity, diet, and sleep patterns. Some psychosocial determinants have an impact on people’ health-related behavior change. These include personal factors such as sense of coherence, patient activation, health literacy, self-efficacy, and procrastination. This study (...) aims to analyze the association between the severity of depression, lifestyle patterns, and personal factors related to health behavior. It also aims to analyze whether personal factors moderate the relationship between lifestyles and depression.MethodsThis study is a secondary data analysis of baseline data collected at the start of a randomized controlled trial. A sample of 226 patients with subclinical, mild, or moderate depression from primary healthcare centers in two sites in Spain was used, and descriptive, bivariate, multivariate, and moderation analyses were performed. Depression was the primary outcome, measured by Beck II Self-Applied Depression Inventory. Lifestyle variables such as physical exercise, adherence to Mediterranean diet and sleep quality, social support, and personal factors such as self-efficacy, patient activation in their own health, sense of coherence, health literacy, and procrastination were considered secondary outcomes.ResultsLow sense of coherence, poor sleep quality, low patient activation, and sedentarism are predictors of having more depressive symptoms. Moderation analyses were not significant.DiscussionLifestyle and personal factors are related to depressive symptomatology. Our findings reveal that sense of coherence, patient’s activation level, sedentarism, and sleep quality are associated with depression. Further research is needed regarding adherence to Mediterranean diet, minutes walking per week and the interrelationship between lifestyles, personal factors, and depression. (shrink)

To investigate the effects of two different modes of physical activity on body composition, physical fitness, cardiometabolic risk, and psychological responses in female adolescents participating in a multi-disciplinary program. The 12-week randomized intervention included 25-adolescents with overweight divided into two groups: sports practice-SPG and functional training-FTG. The SPG intervention was divided into three sports: basketball, handball, and futsal. SPG participants performed one sport 3-times/week, over the course of 1 month. The FTG performed concurrent exercises 3-times/week. This study was registered in (...) Clinical Trials Registry Platform under number: RBR-45ywtg and registered in Local Ethics Committee number: 2,505.200/2018. The intensity of physical exercises-PE was matched between groups by the rating of perceived exertion. The primary outcome was body composition, and secondary outcomes were physical fitness, cardiometabolic risk, and psychological responses. There was a significant time-effect for body mass, body mass index, and low-density lipoprotein, all being reduced. There were increases over time for musculoskeletal mass, aerobic fitness, and high-density lipoprotein. There was a group time interaction with body fat percentage being lower post-intervention in the SPG. No significant differences were observed for the other variables. Both physical activity models were effective in improving a subset of obesity-related health parameters. The findings should be extended by further investigation using more sophisticated measures of energy expenditure.Clinical Trial Registration:https://ensaiosclinicos.gov.br/, identifier: RBR-45ywtg. (shrink)

Physical activities are generally accepted as promoting important psychological benefits. However, studies examining martial arts as a form of physical activity and mental health have exhibited many methodological limitations in the past. Additionally, recent philosophical discussion has debated whether martial arts training promotes psychological wellbeing or illness. Self-efficacy has an important relationship with mental health and may be an important mechanism underpinning the potential of martial arts training to promote mental health. This study examined the effect of martial arts training (...) on the psychological construct of self-efficacy. A total of 283 secondary school students with a mean age of 12.76 (SD = 0.68) years were recruited to complete a time-limited (10-session) martial arts intervention, which was examined using a randomised controlled trial. Univariate ANOVAs found that the intervention improved the experimental group’s self-efficacy compared to the control group, which was sustained at follow-up. Regression analysis indicated that socio-educational status moderated this outcome. These findings support the martial arts-based intervention’s potential to improve self-efficacy and promote wellbeing through physical activity. Martial arts training may be an efficacious psychosocial treatment that can be used as a complementary approach to promote mental health. (shrink)

Objectives: This study aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to improve subjective well-being (SWB), including evaluative, hedonic, and eudemonic well-being, and the mental component of quality of life (QOL) of working population. Methods: A literature search was conducted, using PubMed, Embase, PsycINFO, and PsycARTICLES. Eligible studies included those that were RCTs of any intervention, conducted among healthy workers, measured SWB as a primary outcome, and original articles in English. Study characteristics, intervention, (...) outcomes, and results on SWB outcomes were extracted by the investigators independently. After a brief narrative summarizing and classifying the contents of the interventions, the included outcomes were categorized into each aspect of SWB (evaluative, hedonic, and eudemonic well-being, and the mental component of QOL). Finally, the characteristics of the effective interventions for increasing each aspect were summarized, and the pooled effect of interventions on SWB was investigated by a meta-analysis. Publication bias was investigated by drawing a funnel plot and conducting Egger's test. Results: From the 5,450 articles found, 39 met the inclusion criteria for the systematic review. The interventions included in this review were classified into six categories (physical activity, ergonomics, psychological, environmental, multicomponent intervention, and others). The meta-analysis from 31 studies showed that the pooled effect of included interventions on SWB was significantly positive (standardized mean difference (SMD) = 0.51; standard error (SE) = 0.10). A funnel plot showed there were extremely large or small SMDs, and Egger's test was significant. Thus, we conducted sensitivity analysis, excluding these extreme SMDs, and confirmed that the estimated pooled effect was also significantly positive. Subgroup analyses for separate types of interventions showed the effects of psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) were also significantly positive. Conclusion: The current study revealed the effectiveness of interventions for increasing SWB. Specifically, psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) may be useful for improving SWB. (shrink)

Depressive symptoms and disorders are major public health concerns, affecting many adolescents and young adults. Despite extensive research, depression prevention programs for youth show limited effectiveness. Moreover, the maximal potential of youth psychotherapy — on which depression prevention programs are based — may have been reached. Commercial video games may offer an engaging alternative vehicle for youth to practice emotional and social skills vital to mental health. The current study investigated the potential for the commercial video game Journey to prevent (...) the exacerbation of depressive symptoms. A pre-registered randomized controlled trial tested the effectiveness of Journey as an indicated depression prevention approach compared to a control game condition and a passive control condition. Additionally, potential action mechanisms for depression prevention using video games were examined. Participants aged 15 to 20 years old with elevated depressive symptoms were given 4 weeks to play Journey or the control game, Flower. Results showed no beneficial effects of playing the commercial video game, Journey, on youth’s change in depressive symptoms above and beyond the active and passive control conditions up to 12-months after the intervention. Additionally, no action mechanisms were found specifically for Journey. Nevertheless, over the whole study, participants decreased in depressive symptoms, became less sensitive to rejection, and experienced more hope and optimism. Moreover, participants who during the study decreased in rejection sensitivity or rumination or who increased in hope and optimism or in distraction and problem solving showed the strongest decrease in depressive symptoms. Although results do not support the use of the studied commercial game as an effective indicated depression prevention strategy, our results do suggest that rejection sensitivity, hope, optimism, rumination, distraction, and problem solving are promising targets for future depression prevention efforts. We conclude with important lessons for future research on games to promote mental health. Particularly, encouraging careful consideration of research designs to explore for whom and how potential action mechanisms and associated game mechanics may be effective. (shrink)

ObjectivePost-traumatic stress disorder may affect individuals exposed to adversity. Eye Movement Desensitization and Reprocessing is an evidence-based trauma-focused psychotherapy for PTSD. There is still some debate whether the eye movements are an effective component of EMDR. The primary aim of this study was to investigate the effectiveness of Eye Movement Desensitization treatment in reducing PTSD symptoms compared to a retrieval-only active control condition. We also investigated whether PTSD symptom reduction was associated with reductions in depression and anxiety, and improvements (...) in quality of life.MethodologyAdult PTSD patients were recruited at public psychological services in Jakarta, Bandung and Cimahi, Indonesia. PTSD was diagnosed with the Structured Clinical Interview for DSM-5 disorders. Participants were randomized into: EMD or retrieval-only. EMD consisted of clinical history and treatment planning, preparation, assessment, EMs, closure, whereas retrieval-only consisted of the same elements except EMs. Data were collected at baseline, 1-week post-treatment, 1-month follow-up, and 3-months follow-up. Outcome measures included the PTSD Checklist for DSM-5, Hopkins Symptoms Checklist-25, and the World Health Organization Quality of Life–BREF. Data were analyzed with linear mixed model analysis in R Statistics.ResultsAlthough there were main effects of time indicating reductions for both EMD and retrieval-only in PCL-5 and HSCL-25 scores, and improvements in WHOQoL-BREF scores at T1, T2, and T3, no significant differences in PCL-5, HSCL-25, and WHOQoL-BREF total scores between the EMD and retrieval-only groups at T1, T2, and T3 were found.ConclusionWithin a clinical sample of PTSD patients in Indonesia, both EMD and retrieval-only was associated with reductions in symptoms of PTSD, anxiety and depression, and improvements in quality of life, although EMs did not add to the efficacy of the treatments. Further research to examine the underlying mechanisms of EMDR’s effective treatment elements in clinical samples is needed.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [ISRCTN55239132]. (shrink)

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues. The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial -design and methods. The main hypothesis is that participants receiving PIPCI will increase (...) their psychological flexibility compared to participants in the active control group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group, an active control group or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers and health care costs. Assessments will be performed at pre- and post-intervention, as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924. (shrink)

The expert clinical community is split about whether the difference between antidepressant treatment and treatment with placebos stems from the efficacy of the drug or from subjects’ heightened expectancy enhanced by side effects—i.e., enhanced placebo effects. Proving whether pharmacological efficacy has been established reliably by randomized controlled trials of antidepressant drugs is difficult, primarily because substituting a placebo for an effective treatment in the control arm of a trial is ethically questionable. I argue that clinical equipoise permits the (...) use of active placebo controls in trials that test antidepressants. Placebo controls for drug trials are ethically defensible and scientifically justified when we have evidence that a standard treatment might only work because of enhanced placebo effects, and when a respectable minority of the expert clinical community endorses these concerns. (shrink)

ObjectivesThe present study explores the effect of visual art training on people with dementia, utilizing a randomized control trial design, in order to investigate the effects of an 8-week visual art training program on cognition. In particular, the study examines overall cognition, delayed recall, and working memory, which show deficits in people with dementia.MethodFifty-three individuals with dementia were randomly assigned into either an art training or usual-activity waitlist control group. Overall cognition and delayed recall were assessed with the Montreal Cognitive (...) Assessment, and working memory was assessed with the Backward Digit Span task.ResultsThere were no group differences in overall cognition, or working memory, while a difference in delayed recall was undetermined, based on post-test—pre-test difference scores. Groups were comparable at baseline on all measures.ConclusionThe measures of cognition, delayed recall, and working memory used in this study were not affected by an 8-week visual art training program.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NCT03175822. (shrink)

BackgroundThere is numerous literature on mechanisms underlying variability of practice advantages. Literature includes both behavioral and neuroimaging studies. Unfortunately, no studies are focusing on practice in constant conditions to the best of our knowledge. Hence it is essential to assess possible differences in mechanisms of neuroplasticity between constant vs. variable practice conditions. The primary objectives of the study described in this protocol will be: to determine the brain’s structural and functional changes following constant and variable practice conditions in motor learning (...) ; to determine the EEG activation and connectivity between cognitive, sensory, and motor cerebral cortex areas in constant and variable practice conditions and as a function of practice time.MethodsThe study will follow the interventional design with two arms. Fifty participants will be randomly assigned to two groups practicing in constant and variable conditions. CG will be practicing only one pattern of step isometric contractions during unimanual index finger abduction, i.e., 90 trials in all training sessions, whereas VG will practice three different patterns. Each will be practiced 30 times per session in variable conditions. Resting-state fMRI, EEG, and motor task proficiency will be examined before and after practice.DiscussionFindings will enhance our understanding of structural and functional neural changes following practice in constant and variable conditions. Therefore, the study can be considered pure research.Clinical Trial RegistrationStudy registered at clinicaltrials.gov on 9 June 2021. Last version update: 21 December 2021.The protocol has been prepared according to the complete SPIRIT checklist, although the item order has been modified in order to comply with the manuscript structure. (shrink)

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the (...) physician-patient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients. (shrink)

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the (...) physician-patient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients. (shrink)

The purpose of this study was to examine the effectiveness of a neuro-meditation program to support nurses during the COVID-19 pandemic. Forty-five nurses were classified into three groups based on their systolic blood pressure: normotensive, hypertensive and control. Using a parallel, randomly controlled design across a 4-week period, 10 × 30-min sessions using the Rebalance© Impulse were completed. Sleep was assessed by wrist actigraphy and subjective sleep questionnaires; perceived sleep quality, Ford Insomnia Response to Stress Test questionnaire and the (...) Spiegel Sleep Quality questionnaire. Blood pressure, resting heart rate, mean heart rate, heart rate variability index, cortisol, and alpha-amylase were also measured. Statistical analysis was completed using factorial ANOVA. Sleep improved in the G-hyp group; SSQ ; perceived sleep quality ; sleep efficiency and fragmentation index. In the G-nor group, sleep was improved to a lesser extent; perceived sleep quality. A significant time–group interaction was reported in resting heart rate, systolic blood pressure, and diastolic blood pressure with these measures being significantly reduced in the G-hyp group. RMSSD increased in the G-nor group. This initial evidence suggests that neuro-meditation reduces excessive sympathetic activity, promoting enhanced sleep quality and autonomic control during periods of increased work-related stress.Clinical Trial RegistrationThe study was conducted at Bioesterel, Sophia-Antipolis, France as a clinical trial: Neuro-meditation improves sleep quality, https://www.drks.de/ui_data_web/DrksUI.html?locale=en, DRKS00025731. (shrink)

BackgroundPost-stroke depression is one of the most common neuropsychiatric diseases in patients with stroke, and it can increase the disability rate, mortality, and recurrence rate of stroke. Currently, many clinical studies have indicated that traditional Chinese medicine, such as acupuncture and herbs, Western medicine, rehabilitation, repeated transcranial magnetic stimulation, and other treatment methods, are effective in treating PSD. However, no study has formulated a comprehensive treatment plan that integrates TCM, Western medicine, and rehabilitation for PSD. Thus, this trial aims to (...) assess the efficacy and safety of integrative medicine for treating PSD.MethodsThis multicenter, prospective, randomized, controlled study aims to form a set of effective clinical treatment schemes that integrate TCM, Western medicine, and rehabilitation for PSD. A total of 202 participants recruited from four centers will be randomized into either the integrative medicine or standard care group. Standard care—basic treatment, general nursing care, and exercise therapy—will be provided to all participants. The integrative medicine group will also receive acupuncture, Chinese herbs, and repeated transcranial magnetic stimulation. Participants will receive acupuncture and rTMS treatments five times per week for 4 weeks and will be administered Chinese herbs, basic treatment, general nursing care, and exercise therapy for 4 weeks. The primary outcomes include the Hamilton Depression Scale, Self-Rating Depression Scale, and Activity of Daily Living Scale. And the secondary outcomes include the Montreal Cognitive Assessment Scale, the Fugl-Meyer Assessment Scale, and the Pittsburgh Sleep Quality Index. All outcome measures will be evaluated at baseline, week 4, and week 8. Safety assessments will be performed throughout the study.DiscussionThis study is expected to verify the efficacy and safety of integrative medicine for treating PSD, providing an evidence-based clinical reference for the future development of a standardized scheme.Clinical trial registrationClinicalTrials.gov, identifier: NCT05187975. (shrink)

This study evaluated the biological dimension of meditation and self-transcendent states. A convenience sample of 513 participants was drawn from attendees at a 4-day guided meditation workshop. Half were randomly assigned to an active placebo control intervention. All were assessed on a variety of measures, both psychological [anxiety, pain, posttraumatic stress disorder, positive emotions, and transcendent states], and physiological. Additional biological assessments including salivary immunoglobulin-A, cortisol, and Quantitative Electroencephalography were obtained from subset of the Experimental group. No significant difference (...) in psychological symptoms or positive emotions was observed between Experimental and placebo groups at baseline. At post-test, significant improvements were noted in the Experimental group, including a 49.5% median increase in SIgA, though cortisol remained unchanged. qEEG z-score analysis identified sustained stress reduction, including delta frequency band amplitude increases, high beta decreases, and faster acquisition of sustained alpha states. Psychological symptoms also improved on all measures. At 6-month follow-up, PTSD and somatic symptoms significantly improved from baseline, and post-test versus 6-month follow-up results indicated significant increases in happiness and spiritual and physical oneness, along with decreases in depressive symptoms. These findings suggest that autonomic self-regulation and transcendent states may be measured in both biological and psychological dimensions and are associated with pervasive health benefits. (shrink)

Study in the period of coronavirus disease 2019 lockdown and the effect of different exercise training programs on the quality of life dimension are limited. This randomized control study as a part of which the impact of an 8-week neuromuscular training program on the 90 healthy young individuals’ QoL after COVID-19 lockdown was assessed using a short form of the WHOQOL-BREF questionnaire comprising of four domains. The intervention group took part in a neuromuscular training program consisting of dynamic neuromuscular stabilization (...) and whole-body vibration training. In contrast, the control group did not participate in any programmed physical activity. From pre- to post-intervention test, the NT group significantly and substantially improved [mean change ] all the QoL domains, physical for 12.78 scores, psychological for 13.12 scores, social relationships for 20.57 scores, and environmental for 24.40 scores. These results suggest that the NT program could enhance QoL in young and healthy participants following COVID-19 lockdown. (shrink)

BACKGROUND: There is a need for interdisciplinary research to better understand how pedagogical approaches in primary physical education (PE) can support the linked development of physical, cognitive and affective aspects of physical literacy and physical activity behaviours in young children. The Skill Acquisition Methods fostering Physical Literacy in Early-Physical Education (SAMPLE-PE) study aims to examine the efficacy of two different pedagogies for PE, underpinned by theories of motor learning, to foster physical literacy, especially for children living in disadvantaged areas. METHODS: (...) SAMPLE-PE will be evaluated through a cluster-randomised controlled trial targeting 5-6 year old children from schools located in areas of high deprivation in Merseyside, North-West England. Schools will be randomly allocated to one of three conditions: Linear Pedagogy, Nonlinear Pedagogy or Control. Nonlinear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice. Data will be collected at baseline (T0), immediately post-intervention (T1) and six months after the intervention has finished (T2). Children’s movement competence is the primary outcome in this trial. Secondary outcomes include physical activity, perceived competence, motivation, executive functions, and self-regulation. An extensive process evaluation will also examine implementation factors such as intervention context, reach, dose, fidelity and acceptability. DISCUSSION: The SAMPLE-PE project will enable better understanding surrounding how to operationalise physical literacy through enrichment of PE practices in early PE. The study will provide robust scientific evidence regarding the efficacy of underpinning PE pedagogy with theories of motor learning to promote the development of physical literacy. (shrink)

Background: Privacy laws have recently created restrictions on how researchers can approach study participants.Method: In a randomised trial of 152 patients, 50–74 years old, in a family practice, 60 were randomly selected to opt-out and 92 to opt-in methods. Patients were sent an introductory letter by their doctor in two phases, opt-out before and opt-in after introduction of the new Privacy Legislation in December 2001. Opt-out patients were contacted by researchers. Opt-in patients were contacted if patients responded by email, free (...) telephone number or a reply-paid card.Results: Opt-in recruited fewer patients after invitation compared with opt-out ; . No proportional difference in recruitment was found between opt-in and opt-out groups varied by age, sex or socioeconomic status. The opt-in group had significantly more people in active decision-making roles . Non-significant trends were observed towards opt-in being less likely to include people with lower education and people who were not screened . Opt-in was more likely to recruit people with a family history of colorectal cancer .Conclusions: The number of participants required to be approached was markedly increased in opt-in recruitment. Existing participants with a vested interest such as increased risk, and those preferring an active role in health decision making and with less education were likely to be recruited in opt-in. Research costs and generalisability are affected by implementing privacy legislation. (shrink)

In its roughly 25 years of existence, the trial consulting profession has grown dramatically in membership, recognition, and breadth of practice. What began as a small activist group of social scientists volunteering their expertise to assist in the defense of Vietnam War protestors has evolved into a diverse set of professionals from a range of educational and professional backgrounds. In spite of such enormous growth, the work of trial consultants has gone largely unexamined. Trial Consulting takes an in-depth look at (...) the primary activities of trial consultants, including witness preparation, focus groups and mock trials, jury selection, change of venue surveys, and attorney presentation style. It also examines the profession's struggle to define itself, resisting certification and licensure requirements and settling instead for a set of practice standards. The authors draw upon empirical and other scholarly work in the social sciences, recommended "best practices" from trial lawyers, and the written and spoken recommendations and reflections of the trial consultants themselves. Addressing a broad spectrum of topics ranging from handwriting analysis to medical malpractice cases, they also suggest reforms for improving the profession and the efficacy of the trial consultant in the courtroom. The result is a critical analysis of what trial consulting truly adds to, and detracts from, the administration of justice. This book is an indispensable guide for practicing and aspiring trial consultants as well as the judges, attorneys, and psychologists who work with them. Trial Consulting provides a thought-provoking statement on the state of the profession, and students and professionals alike will benefit from the challenges it offers. (shrink)