Active Control Intervention Research Articles

Effectiveness of a mindfulness-based walking programme in reducing symptoms of stress–a randomised controlled trial

Summary: Background: Distress reduces quality of life and induces the development and negative progress of diseases. It is therefore a current topic of public interest. Mind-body medicine and physical exercise have shown to reduce symptoms of stress. The aim of this randomized, controlled study was to investigate the effectiveness of a mindfulness based walking program in patients with distress. Methods: Participants aged between 18-65 years with high distress levels (self-assessment on a 10 mm visual analogue scale > 4 mm) were included. Participants were randomized into an intervention group which received a mindfulness based walk taking place twice a week over a period of four weeks or a waiting-list control group which received no study intervention. Outcome parameters were assessed at baseline, after 4 and 12 weeks. The primary outcome parameter was Cohen’s Perceived Stress Scale (PSS) after 4 weeks. Secondary outcome parameter included the Perceived Stress Questionnaire (PSQ), the visual analogue scale (VAS) and SF-36 to measure health related quality of life after 4 and 12 weeks. The statistical comparison of groups was performed by analysis of covariance on the intention-to-treat population adjusted for baseline differences. Results: Seventy-four participants were randomized in the study, 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8years) to the control group. After 4 weeks the adjusted mean of the PSS was with 24.2 (95 % CI: 22.2 – 26.2) significantly (p < 0.001) lower in the intervention group compared to the control group (32.0; 30.1 – 33.9). After 12 weeks the PSS of the intervention group was with 25.8 (23.6 – 28.0) vs. 29.2 (27.0 -31.3) still significantly (p = 0.038) better. Also the PSQ in the intervention group was significantly better after 4 weeks (p < 0.001) and after 12 weeks (p = 0.018) compared with control. Significant group differences were also found after 4 weeks for the VAS (p = 0.008) and the SF-36 Mental Components Score (p = 0.020) in favor of the intervention group. Discussion: Participating in a mindfulness based walking program reduced subjective symptoms of distress compared to no study intervention. Further studies with more study participants should include an active treatment control group and aim to measure the effects of walking and mindfulness separately.

Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

BackgroundOver the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined.MethodsWe will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention) or control treatment (a leaflet on healthy living). Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period.DiscussionOpportunistic intervention for excessive alcohol use has been shown to be effective in a range of medical settings. The SHEAR study will examine whether delivering such interventions in sexual health clinics results in reductions in alcohol consumption and will explore whether this is associated with changes in sexual behavior.

A Potential Outcomes, and Typically More Powerful, Alternative to 'Cochran-Mantel-Haenszel'

In studies of public health, outcome measures such as the odds ratio, rate ratio, or efficacy are often estimated across strata to assess the overall effect of active treatment versus control treatment. Patients may be partitioned into such strata or blocks by experimental design, or, in non-randomized studies, patients may be partitioned into subclasses based on key covariates or estimated propensity scores to improve observed covariate balance across treatment groups. In finite samples, there exist tests and intervals for these estimands that can be more powerful than tests and intervals created with Cochran-Mantel-Haenszel (Cochran, 1954; Mantel and Haenszel, 1959) or analogous procedures (Tarone, 1981). The proposed methods multiply impute missing potential outcomes within the Rubin Causal Model (Holland, 1986; Rubin, 1974; Rubin, 1978) so that estimands can be directly estimated. The assumptions underlying these typically more powerful methods are appropriate in many circumstances, especially when the strata are based on covariates highly predictive of treatment decisions and outcomes. When used to draw inferences about a population from which the patients in the study are considered a random sample, and the sample is large, these methods are extremely similar to the classical methods. The proposed approach is particularly relevant when assessing the safety of a new treatment relative to a standard one because, under typical conditions, the tests are more powerful and the intervals are shorter, thereby detecting smaller differences.

Casebook of Interpersonal Psychotherapyedited by MarkowitzJohn C. and WeissmanMyrna M.. New York, Oxford University Press, 2012, 504 pp., $55.00 (paper).

Casebook of Interpersonal Psychotherapyedited by MarkowitzJohn C. and WeissmanMyrna M.. New York, Oxford University Press, 2012, 504 pp., $55.00 (paper).

Statin Therapy and the Risk of Intracerebral Hemorrhage

Statin therapy decreases the risk of ischemic stroke. An increased risk of intracerebral hemorrhage (ICH) has been observed in some studies. To investigate this issue, we performed a meta-analysis of randomized controlled trials using statins that reported ICH. We performed a literature search of Medline, Web of Science, and The Cochrane Library through January 25, 2012, and identified additional randomized controlled trials by reviewing reference lists of retrieved studies and prior meta-analyses. All randomized controlled trials of statin therapy that reported ICH or hemorrhagic stroke were included. The primary outcome variable was ICH. Thirty-one randomized controlled trials were included. All analyses used random effects models and heterogeneity was not observed in any of the analyses. A total of 91,588 subjects were included in the active group and 91,215 in the control group. There was no significant difference in incidence of ICH observed in the active treatment group versus control (OR, 1.08; 95% CI, 0.88-1.32; P=0.47). ICH risk was not related to the degree of low-density lipoprotein reduction or achieved low-density lipoprotein cholesterol. Total stroke (OR, 0.84; 95% CI, 0.78-0.91; P<0.0001) and all-cause mortality (OR, 0.92; CI, 0.87-0.96; P=0.0007) were significantly reduced in the active therapy group. There was no evidence of publication bias. Active statin therapy was not associated with significant increase in ICH in this meta-analysis of 31 randomized controlled trials of statin therapy. A significant reduction in all stroke and all-cause mortality was observed with statin therapy.

Use of amiloride and multiple sclerosis: registry‐based cohort studies

Amiloride reduces functional neurological deficits and neuronal damage in animal models of multiple sclerosis (MS). We investigated whether amiloride use was associated with reduced risk of incident MS and of MS hospitalization and death in humans. We conducted two propensity score-matched cohort studies, linking nationwide registry data on filled drug prescriptions, diagnostic information, and covariates. First, we compared rates of incident MS in new users of amiloride and new users of an active control treatment, thiazide diuretics. Second, rates of hospitalizations for MS and of death were compared between users of amiloride and thiazides in a cohort of MS patients. Treatment groups were matched 1 : 4 on propensity scores that included a wide range of covariates, and Cox regression was used to estimate hazard ratios (HRs). Comparing 36 659 users of amiloride and 177 031 users of thiazides, there were 19 cases of incident MS during 92 548 person-years of follow-up among amiloride users and 81 cases during 567 599 person-years of follow-up among thiazide users. There was no significantly decreased risk of MS associated with amiloride use (HR 1.34, 95%CI 0.81-2.20). In the cohort of MS patients, amiloride use was not associated with significantly decreased risk of MS hospitalization (HR 1.11, 95%CI 0.79-1.59) or death (HR 1.38, 95%CI 0.83-2.28). Amiloride use was not associated with significantly decreased risk of incident MS or hospitalizations and death among patients with MS. Because amiloride users were represented by older patients, risks could not be evaluated in younger individuals.

Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial

Little is known about the clinical impact on cardiovascular stability during intermittent haemodialysis (IHD) for acute kidney injury (AKI) of online monitoring devices that control blood volume (BV) and blood temperature in the intensive care unit (ICU) setting. We compared different dialysis treatment modalities with or without these new systems among critically ill patients requiring IHD. In a prospective single-centre three-arm randomized controlled trial, 600 dialysis sessions in 74 consecutive AKI critically ill patients were involved to assess intradialytic hypotension. Standard dialysis therapy with constant ultrafiltration (UF) rate, cool dialysate and high sodium conductivity (Treatment A) was compared to regimens with adjunctive interventions including BV control (Treatment B) and the combination of BV and active blood temperature control (Treatment C). Each dialysis session was randomly assigned to one of the three treatment arms and served as statistical unit. Five hundred and seventy-two dialysis sessions were analysed (188, 190 and 194 in Treatments A, B and C, respectively). Hypotension occurred in 16.6% treatments, with similar rates among the arms. Haemodynamic parameters and dialysis-related complications did not differ between therapies. Based on generalized estimating equation adjusted to dialysate sodium conductivity, higher Sequential Organ Failure Assessment the day of dialysis session, the need for vasopressors and lower systolic blood pressure at the onset of the session were identified as independent predictors of hypotensive episodes, whereas regimens containing the new online monitors were not. These results suggest that both actively controlled body temperature and UF profiled by online monitoring systems have no significant impact on the incidence of intradialytic hypotension in the ICU setting. Further research is needed before the use of these new sophisticated automatic methods can be applied routinely to the ICU setting.

An efficacy trial of 'Steps to Your Health', a health promotion programme for adults with intellectual disability.

Although there are evaluation and effectiveness studies of health promotion interventions for adults with intellectual disabilities (ID), randomized efficacy trials of such interventions are lacking. A randomized active control intervention trial. The participants attended the health promotion classes in local disability agency service facilities. Method: We enrolled 443 individuals and randomly assigned them to one of two eight-week participatory classes. The 'Steps to Your Health' (STYH) classes emphasized moderate to vigorous physical activity (MVPA), healthy eating and body mass index (BMI) reduction. The control intervention focused on hygiene and safety. We did not find a statistically significant difference in mean MVPA or BMI change between completers of the STYH group compared to the control group one year after the intervention was completed. We did find that participation in STYH classes had a non-significant association with odds of reduction in BMI (odds ratio [OR] 2.87, 95% confidence interval [CI] 0.91-9.11) and completers who lived in group homes were more likely than their counterparts who lived with families or in apartments to decrease their BMI (OR 4.61; 95% CI 1.14-18.64). This trial did not demonstrate a significant effect of STYH participation on change in mean minutes of MVPA or mean BMI 12 months after classes ended, although there was a non-significant association with odds of reduction of BMI (p = 0.07). This study has implications for design of intervention studies in people with intellectual disability (ID).

Cross-training in hemispatial neglect: Auditory sustained attention training ameliorates visual attention deficits

Prominent deficits in spatial attention evident in patients with hemispatial neglect are often accompanied by equally prominent deficits in non-spatial attention (e.g., poor sustained and selective attention, pronounced vigilance decrement). A number of studies now show that deficits in non-spatial attention influence spatial attention. Treatment strategies focused on improving vigilance or sustained attention may effectively remediate neglect. For example, a recent study employing Tonic and Phasic Alertness Training (TAPAT), a task that requires monitoring a constant stream of hundreds of novel scenes, demonstrated group-level (n=12) improvements after training compared to a test–retest control group or active treatment control condition on measures of visual search, midpoint estimation and working memory (DeGutis and Van Vleet, 2010). To determine whether the modality of treatment or stimulus novelty are key factors to improving hemispatial neglect, we designed a similar continuous performance training task in which eight patients with chronic and moderate to severe neglect were challenged to rapidly and continuously discriminate a limited set of centrally presented auditory tones once a day for 9days (36-min/day). All patients demonstrated significant improvement in several, untrained measures of spatial and non-spatial visual attention, and as a group failed to demonstrate a lateralized attention deficit 24-h post-training compared to a control group of chronic neglect patients who simply waited during the training period. The results indicate that TAPAT-related improvements in hemispatial neglect are likely due to improvements in the intrinsic regulation of supramodal, non-spatial attentional resources.

日本語母語話者による「言いさし」表現の使用に影響を与える要因について

This paper presents a human factor considered risk management using vehicular communication for application to automated vehicle. A vehicle to vehicle (V2V) wireless communication have been implemented and fused with a radar sensor to obtain the prediction of remote vehicle’s motion. Based on the predicted behavior of remote vehicles, a collision risk and a human reaction time are determined for a human-centered active safety control intervention moment. The human-centered risk assessment algorithm has been incorporated into a collision avoidance algorithm to monitor threat vehicles ahead and to find the best intervention point. Effects of the vehicular communication on a host vehicle control performance is investigated. The performance of the proposed algorithm has been evaluated via computer simulations. It has been shown from both simulations that the proposed human-centered risk assessment algorithm with the V2V communication can be beneficial to active safety systems in decision of controller intervention moment and in control of automated drive for the guaranteed safety.

Physical and Cognitive Stimulation in Alzheimer Disease. The GAIA Project

Several data suggest that physical activity and cognitive stimulation have a positive effect on the quality of life (QoL) of people with Alzheimer's disease (AD), slowing the decline due to the disease. A pilot project was undertaken to assess the effect of cognitive stimulation, physical activity, and socialization on patients with AD and their informal caregiver's QoL and mood. Fourteen patients with AD were randomly divided into active treatment group and control group. At the end of treatment, a significant improvement in apathy, anxiety, depression, and QoL in the active treatment group was found. Considering caregivers, those of the active treatment group exhibited a significant improvement in their mood and in their perception of patients' QoL. This study provides evidence that a combined approach based on cognitive stimulation, physical activity, and socialization is a feasible tool to improve mood and QoL in patients with AD and their caregivers.

Realignment treatment for medial tibiofemoral osteoarthritis: randomised trial

ObjectivesThe objective of this 30-week randomised crossover trial was to determine whether a multi-modal realignment treatmentwould be successful in relieving pain and improving function among persons with medial tibiofemoral osteoarthritis...

Effects of mindful-attention and compassion meditation training on amygdala response to emotional stimuli in an ordinary, non-meditative state

The amygdala has been repeatedly implicated in emotional processing of both positive and negative-valence stimuli. Previous studies suggest that the amygdala response to emotional stimuli is lower when the subject is in a meditative state of mindful-attention, both in beginner meditators after an 8-week meditation intervention and in expert meditators. However, the longitudinal effects of meditation training on amygdala responses have not been reported when participants are in an ordinary, non-meditative state. In this study, we investigated how 8 weeks of training in meditation affects amygdala responses to emotional stimuli in subjects when in a non-meditative state. Healthy adults with no prior meditation experience took part in 8 weeks of either Mindful Attention Training (MAT), Cognitively-Based Compassion Training (CBCT; a program based on Tibetan Buddhist compassion meditation practices), or an active control intervention. Before and after the intervention, participants underwent an fMRI experiment during which they were presented images with positive, negative, and neutral emotional valences from the IAPS database while remaining in an ordinary, non-meditative state. Using a region-of-interest analysis, we found a longitudinal decrease in right amygdala activation in the Mindful Attention group in response to positive images, and in response to images of all valences overall. In the CBCT group, we found a trend increase in right amygdala response to negative images, which was significantly correlated with a decrease in depression score. No effects or trends were observed in the control group. This finding suggests that the effects of meditation training on emotional processing might transfer to non-meditative states. This is consistent with the hypothesis that meditation training may induce learning that is not stimulus- or task-specific, but process-specific, and thereby may result in enduring changes in mental function.

AS19-04 - Impaired facial emotion recognition: behavioral and neurobiological treatment effects

Impairments in facial emotion recognition have proven to be a trait-like characteristic in schizophrenia mostly unaffected by traditional treatment. This raised the question whether cognitive remediation strategies may be a treatment option for these impairments. A special Training of Affect Recognition (TAR) was evaluated in three consecutive studies using pre-post-control group designs with either an active control treatment (studies 1 and 2), a „passivetreatment as usual group (study 1), or a waiting group (study 3). The active control treatment consisted of a Cognitive Remediation Training (CRT) aiming at improvement of basic neurocognitive functioning. Outcome measures comprised facial and prosodic affect recognition, basic cognitive functioning and social interaction. Analyses revealed specific training effects in the form of a double dissociation both in studies 1 and 2: the TAR improved facial and prosodic affect recognition as well as understanding of social scenes, but had no effects on memory, attention and executive functioning. Patients under CRT and those without training did not show improvements in affect recognition, though patients under CRT improved in some memory functions. Positive effects of the TAR on facial affect recognition could also be replicated in forensic schizophrenia patients (study 3) and proved to be stable for at least 4–6 weeks after the end of training (studies 2, 3). According to these results, improvements in disturbed facial affect recognition in schizophrenia patients are not obtainable with a traditional cognitive remediation program like CRT, but need a functional specific training like the newly developed TAR.

Understanding noninferiority trials

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

AS02-03 - Metacognitive training for schizophrenia

Although antipsychotic medication still represents the treatment of choice for schizophrenia, its objective impact on symptoms is only in the medium effect size range. Hence, clinical researchers are intensively looking for complementary therapeutic options. Cognitive research has elucidated a number of cognitive biases in schizophrenia that seem to play a crucial role in the formation and maintenance of the disorder: jumping to conclusions, attributional biases, a bias against disconfirmatory evidence, overconfidence in errors, and distorted theory of mind. Metacognitive training for schizophrenia patients (MCT) is a group intervention that seeks to sharpen the awareness of schizophrenia patients on these biases. The training is available in 25 languages at no cost via www.uke.de/mkt/ . The talk will also present a new treatment program called MCT+ which is a hybrid of MCT and individualized cognitive-behavioral therapy. Results assert that MCT and MCT+ are feasible interventions. According to randomized controlled trials, metacognitive intervention leads to an accelerated symptom improvement and alleviates some cognitive biases (particularly jumping to conclusions) in patients relative to active control interventions.

The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR)

Most of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. The current article specifies and validates an active control condition, the Health Enhancement Program (HEP), thus providing the foundation necessary for rigorous investigations of the relative efficacy of Mindfulness Based Stress Reduction (MBSR) and for testing mindfulness as an active ingredient. 63 participants were randomized to either MBSR ( n = 31) or HEP ( n = 32). Compared to HEP, MBSR led to reductions in thermal pain ratings in the mindfulness- but not the HEP-related instruction condition ( η 2 = .18). There were significant improvements over time for general distress ( η 2 = .09), anxiety ( η 2 = .08), hostility ( η 2 = .07), and medical symptoms ( η 2 = .14), but no effects of intervention. Practice was not related to change. HEP is an active control condition for MBSR while remaining inert to mindfulness. These claims are supported by results from a pain task. Participant-reported outcomes (PROs) replicate previous improvements to well-being in MBSR, but indicate that MBSR is no more effective than a rigorous active control in improving these indices. These results emphasize the importance of using an active control condition like HEP in studies evaluating the effectiveness of MBSR.

Issues in the assessment of non‐inferiority: perspectives drawn from case studies

Superiority claims for improved efficacy are the backbone of clinical development of new therapies. However, not every new therapy in development allows for such a claim. Some therapies per se do not try to improve efficacy further but concentrate on important aspects in safety or convenience. Such improvements can be equally important to patients, and development strategies should be available for such compounds. A three-arm design with placebo, active control and experimental treatment may be viewed as the golden standard for such compounds; however, it may be difficult if not impossible to add a placebo arm in certain diseases. In such situations, non-inferiority designs are the only development option left. This paper will highlight some of the key issues with such designs in practice and will report experience from two studies from different therapeutic areas intended for regulatory submission.

Nurse-Enhanced Memory Intervention in Heart Failure: The MEMOIR Study

Background Many patients with heart failure (HF) have cognitive deficits, including memory loss. Objectives The aim of this study was to evaluate the efficacy of a cognitive training intervention on memory (primary outcome), working memory, psychomotor speed, executive function, and performance of cognitive activities and instrumental activities of daily living (IADLs). Methods and Results Forty patients with HF were randomly assigned to the computerized plasticity-based cognitive training intervention called Brain Fitness or to the health education active control intervention. Advanced practice nurses made weekly home visits to assess symptoms and monitor intervention adherence. Patients completed demographic and clinical data (baseline), neuropsychologic tests (baseline and 8 and 12 weeks), and measures of cognitive and IADLs performance (baseline and 12 weeks) and satisfaction (12 weeks). Linear mixed models analyses indicated a significant group by time interaction for delayed recall memory ( P = .032) and a significant time effect for total (list learning) ( P < .001) and delayed ( P = .015) recall memory, psychomotor speed ( P = .029), and performance of IADLs ( P = .006). Intervention adherence and patient satisfaction were high. Conclusions To our knowledge, this was the first test of Brain Fitness in HF. Although it was a preliminary study with limitations, results support the need for a larger randomized controlled trial to determine whether the memory loss of HF is amenable to plasticity-based interventions.

Pilot Studies of Robotics Suggest Efficacy, but Randomized Clinical Trials Reveal Little: Why?

Robotic assistive devices to aid retraining an upper extremity or enable walking have led to gains in pilot studies of patients with spinal cord injury, as well as stroke, multiple sclerosis, and cerebral palsy. When tested scientifically in a randomized clinical trial with blinded assessments and an active control intervention, the results usually reveal equivalent efficacy at best. Confounders in pilot studies play a role in these disappointing results. The conceptual basis for robotic training-induced motor learning may also require examination, if the future of robotics is to produce better interventions for highly impaired patients.