Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial.

Importance: Depression is a common disorder that may go untreated or receive suboptimal care in primary care settings. Computer-assisted cognitive behavior therapy (CCBT) has been proposed as a method for improving access to effective psychotherapy, reducing cost, and increasing the convenience and efficiency of treatment for depression. Objectives: To evaluate whether clinician-supported CCBT is more effective than treatment as usual (TAU) in primary care patients with depression and to examine the feasibility and implementation of CCBT in a primary care population with substantial numbers of patients with low income, limited internet access, and low levels of educational attainment. Design, Setting, and Participants: This randomized clinical trial included adult primary care patients from clinical practices at the University of Louisville who scored 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) and were randomly assigned to CCBT or TAU for 12 weeks of active treatment. Follow-up assessments were conducted 3 and 6 months after treatment completion. Enrollment occurred from June 24, 2016, to May 13, 2019. The last follow-up assessment was conducted on January 30, 2020. Interventions: CCBT included use of the 9-lesson computer program Good Days Ahead, along with as many as 12 weekly telephonic support sessions of approximately 20 minutes with a master's level therapist, in addition to TAU, which consisted of the standard clinical management procedures at the primary care sites. TAU was uncontrolled, but use of antidepressants and psychotherapy other than CCBT was recorded. Main Outcomes and Measures: The primary outcome measure (PHQ-9) and secondary outcome measures (Automatic Thoughts Questionnaire for negative cognitions, Generalized Anxiety Disorder-7, and the Satisfaction with Life Scale for quality of life) were administered at baseline, 12 weeks, and 3 and 6 months after treatment completion. Satisfaction with treatment was assessed with the Client Satisfaction Questionnaire-8. Results: The sample of 175 patients was predominately female (147 of 174 [84.5%]) and had a high proportion of individuals who identified as racial and ethnic minority groups (African American, 44 of 162 patients who reported [27.2%]; American Indian or Alaska Native, 2 [1.2%]; Hispanic, 4 [2.5%]; multiracial, 14 [8.6%]). An annual income of less than $30 000 was reported by 88 of 143 patients (61.5%). Overall, 95 patients (54.3%) were randomly assigned to CCBT and 80 (45.7%) to TAU. Dropout rates were 22.1% for CCBT (21 patients) and 30.0% for TAU (24 patients). An intent-to-treat analysis found that CCBT led to significantly greater improvement in PHQ-9 scores than TAU at posttreatment (mean difference, -2.5; 95% CI, -4.5 to -0.8; P = .005) and 3 month (mean difference, -2.3; 95% CI, -4.5 to -0.8; P = .006) and 6 month (mean difference, -3.2; 95% CI, -4.5 to -0.8; P = .007) follow-up points. Posttreatment response and remission rates were also significantly higher for CCBT (response, 58.4% [95% CI, 46.4-70.4%]; remission, 27.3% [95% CI, 16.4%-38.2%]) than TAU (response, 33.1% [95% CI, 20.7%-45.5%]; remission, 12.0% [95% CI, 3.3%- 20.7%]). Conclusions and Relevance: In this randomized clinical trial, CCBT was found to have significantly greater effects on depressive symptoms than TAU in primary care patients with depression. Because the study population included people with lower income and lack of internet access who typically have been underrepresented or not included in earlier investigations of CCBT, results suggest that this form of treatment can be acceptable and useful in diverse primary care settings. Additional studies with larger samples are needed to address implementation procedures that could enhance the effectiveness of CCBT and to examine potential factors associated with treatment outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02700009.

Effects of Robotic Therapy Associated With Noninvasive Brain Stimulation on Upper-Limb Rehabilitation After Stroke: Systematic Review and Meta-analysis of Randomized Clinical Trials.

BACKGROUND: Robot-assisted therapy and noninvasive brain stimulation (NIBS) are promising strategies for stroke rehabilitation. OBJECTIVE: This systematic review and meta-analysis aims to evaluate the evidence of NIBS as an add-on intervention to robotic therapy in order to improve outcomes of upper-limb motor impairment or activity in individuals with stroke. METHODS: This study was performed according to the PRISMA Protocol and was previously registered on the PROSPERO Platform (CRD42017054563). Seven databases and gray literature were systematically searched by 2 reviewers, and 1176 registers were accessed. Eight randomized clinical trials with upper-limb body structure/function or activity limitation outcome measures were included. Subgroup analyses were performed according to phase poststroke, device characteristics (ie, arm support, joints involved, unimanual or bimanual training), NIBS paradigm, timing of stimulation, and number of sessions. The Grade-Pro Software was used to assess quality of the evidence. RESULTS: A nonsignificant homogeneous summary effect size was found both for body structure function domain (mean difference [MD] = 0.15; 95% CI = -3.10 to 3.40; P = 0.93; I2 = 0%) and activity limitation domain (standard MD = 0.03; 95% CI = -0.28 to 0.33; P = 0.87; I2 = 0%). CONCLUSIONS: According to this systematic review and meta-analysis, at the moment, there are not enough data about the benefits of NIBS as an add-on intervention to robot-assisted therapy on upper-limb motor function or activity in individuals with stroke.

Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial.

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) has been shown to be effective for reducing symptoms of anxiety and depression in adolescents with emotional disorders. Internet-delivered psychological treatments have great potential to improve access to evidence-based psychological therapy since they are associated with reduced human and economic costs and less social stigma. Recently, our group developed an online version of the UP-A (the iUP-A) for the treatment of emotional disorders in adolescents. The aim of this pilot trial was to test the clinical utility of the iUP-A in a small sample (n = 12) of adolescents with elevated anxiety and/or depressive symptoms. Intention-to-treat and completer analyses revealed pre- to post-intervention self-reported decreases of anxiety and depressive symptoms, anxiety sensitivity, emotional avoidance, panic disorder symptoms, panic disorder severity, generalized anxiety disorder symptoms, pathological worry, and major depressive disorder symptoms. We found high feasibility and acceptability of the program with all participants and responsible parents reporting an improvement in the adolescents' ability to cope with emotions. Results suggest that the iUP-A may provide a new approach to improve access to treatment for anxious and depressive adolescents in Spain; however, further research must be conducted before firm conclusions can be drawn.

Effectiveness of Computerized Cognitive Training Programs (CCTP) with Game-like Features in Children with or without Neuropsychological Disorders: a Meta-Analytic Investigation.

Computerized cognitive training programs (CCTP) are based on the assumption that cognitive abilities may be boosted by repetitively performing challenging tasks. The integration of game-like features in these programs, associated with the goal of amusing or rewarding participants, may contribute to generate cognitive benefits. Indeed, reinforcement contingencies have been reported to produce positive effects on performance and motivation, especially in children. This meta-analysis was aimed at providing a quantitative summary of the effectiveness of CCTP with game-like features in school-aged children with typical and atypical development. A total of 24 studies, with the cognitive and behavioral outcome data of 1547 participants, were selected for inclusion in the meta-analysis. Subgroup analyses were performed to identify the sources of the observed methodological heterogeneity. A robust variance estimation model, after removal of study outliers, yielded a small-to-moderate significant effect size. Final results pointed out smaller but more precise estimate effect sizes according to methodological aspects related to cognitive domain of outcomes, standardization of measures and type of control applied. Alongside supporting the use of CCTP for rehabilitating cognitive functions, the present results shed light on how different methodological choices are able to shape research findings in the field of children's cognitive rehabilitation.

[Online therapy for depressive disorders : An acceptance-based analysis from the perspective of therapists]. / Onlinetherapie bei depressiven Störungen : Eine Akzeptanzanalyse aus der Perspektive der Behandelnden.

BACKGROUND: The supply of online therapy options for mild to moderate depressive disorders has substantially risen both nationally and internationally in the past years. While the efficacy and efficiency of specific online-based therapeutic services were indicated within the framework of scientific evaluations, little is known about the acceptance of these new therapy options. METHODS: In a nationwide online survey of online-based therapy options for mild to moderate depressive disorders, the attitude and stance as well as the use intention and the subjectively perceived knowledge of 657 medical practitioners and therapists, active in psychotherapeutic and psychiatric treatment were collated. The impact of the potential predictors on the use intention of online-based therapies, based on the unified theory of acceptance and use of technology, was analyzed by means of a binary logistic regression model. RESULTS: Besides the perceived performance and expense expectations, the supportive framework conditions, the influence of the cooperative environment, the individual technical affinity as well as the evaluation of the prospective significance of online-based therapy proved to be significantly influential predictors on the user intention. Special predictability for a positive user intention was shown related to the perceived potential of online therapy. CONCLUSION: The results underline the relevance of further evidence-basing of online therapy for mild to moderate depressive disorders. A user-oriented, participatory technology development proves to be just as relevant as a comprehensive sensitization, elucidation and education of potential users for a successful implementation.

Computer-based cognitive training for older adults: Determinants of adherence.

The possibilities of computer-based cognitive training (CCT) in postponing the onset of dementia are currently unclear, but promising. Our aim is to investigate older adults´ adherence to a long-term CCT program, and which participant characteristics are associated with adherence to the CCT. This study was part of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Participants were 60-77-year-old individuals with increased dementia risk, recruited from previous population-based studies. The participants included in this study (n = 631) had been randomized to receive a multi-domain lifestyle intervention, including CCT. The measure of adherence was the number of completed CCT sessions (max = 144) as continuous measure. Due to a substantial proportion of participants with 0 sessions, the zero inflated negative binomial regression analyses were used to enable assessment of both predictors of starting the training and predictors of completing a higher number of training sessions. Several cognitive, demographic, lifestyle, and health-related variables were examined as potential predictors of adherence to CCT. Altogether, 63% of the participants participated in the CCT at least once, 20% completed at least half of the training, and 12% completed all sessions. Previous experience with computers, being married or cohabiting, better memory performance, and positive expectations toward the study predicted greater odds for starting CCT. Previous computer use was the only factor associated with a greater number of training sessions completed. Our study shows that there is a large variation in adherence to a long-lasting CCT among older adults with an increased risk of dementia. The results indicate that encouraging computer use, and taking into account the level of cognitive functioning, may help boost adherence to CCT.

Observation and Imitation of Social Emotions Are Essential for Improving Cognitive and Affective Theory of Mind in Schizophrenia: A Meta-analysis.

People with schizophrenia often demonstrate deficits in theory of mind (ToM), which may be addressed via social cognition training that includes observation and imitation of social emotions. We examined the effect of observation and imitation on ToM and whether computerized cognitive training (CCT) can improve ToM. Among 14 controlled trials, 264 of 494 people with schizophrenia received treatment. Observation and imitation of social emotions improved cognitive (g = 0.53; 95% confidence interval [CI], 0.29-0.76) and affective ToM (g = 0.54; 95% CI, 0.34-0.73), versus treatment as usual or cognitive rehabilitation alone. CCT did not significantly enhance affective ToM (p = 0.42); however, cognitive ToM improvements without CCT (g = 1.20; 95% CI, 0.78-1.61) were superior to those with CCT (g = 0.33; 95% CI, 0.02-0.64; p < 0.01). Observation and imitation of social emotions are essential for improving ToM in schizophrenia, but CCT may not improve ToM.

Technology-based parenting interventions for children's physical and psychological health: a systematic review and meta-analysis.

BACKGROUND: Parenting interventions have important consequences for the wellbeing and emotional competences of parents and their children. Technology provides an opportunity with advantages for psychological intervention. The aim of this systematic review and meta-analysis is to analyze the characteristics and effectiveness of technology-based interventions for parents to promote children's physical health or psychological issues. METHODS: We conducted a systematic review and meta-analysis for articles about parenting skills for prevention or treatment of children's physical or psychological concerns using technology. We explore the aim of the intervention with parents, kind of problem with children, intervention model, instruments, methodological quality, and risk of bias. A random-effects meta-analysis was conducted. RESULTS: Twenty-four studies were included in the systematic review and a meta-analysis of 22 studies was performed to find out the effects of intervention depending on the kind of problem, intervention model, follow-up, type of intervention, type of control condition, and type of outcome data. Results show the usefulness of technology-based therapy for parenting interventions with moderate effect sizes for intervention groups with statistically significant differences from control groups. CONCLUSIONS: Technology-based parenting programs have positive effects on parenting and emotional wellbeing of parents and children. Attendance and participation level in technology-based treatment increase compared with traditional parenting intervention.

Effect of an Asthma Question Prompt List and Video Intervention on Adolescents' Medication Adherence 12 Months Later.

BACKGROUND: Many adolescents do not obtain the maximum benefit from their asthma medications. Improving patient-provider communication may improve adolescents' asthma knowledge, adherence, and clinical outcomes. OBJECTIVE: To determine how a question prompt list and educational video intervention affect youth- and caregiver-reported medication adherence and self-reported medication problems. METHODS: Adolescents with persistent asthma (n = 359; 56.4% with moderate to severe asthma) and their caregivers were enrolled in a randomized controlled trial at 4 pediatric clinics. Intervention group families received a question prompt list and watched a short video before seeing the provider; control families received usual care. Youth- and caregiver-reported medication adherence was measured with a Visual Analog Scale, ranging from 0 to 100. Generalized estimating equations were used to determine how the intervention and covariates were associated with medication adherence and reported problems at 12 months. RESULTS: The intervention was not a significant predictor of medication adherence at 12 months. Higher caregiver education was associated with higher youth-reported adherence (ß = 1.1; 95% CI = 0.1, 2.1; P = 0.036) and caregiver-reported adherence (ß = 1.2; 95% CI = 0.3, 2.0; P = 0.006). The intervention was associated with fewer caregiver-reported problems at 12 months (ß = -0.32; 95% CI = -0.48, -0.16; P < 0.001). CONCLUSIONS AND RELEVANCE: A question prompt list and educational video decreased the number of caregiver-reported medication problems, but did not significantly affect medication adherence. Further research is needed to develop more effective interventions to improve medication adherence and outcomes.

Technology Delivered Interventions for Depression and Anxiety in Children and Adolescents: A Systematic Review and Meta-analysis.

Depression and anxiety are common during adolescence. Whilst effective interventions are available treatment services are limited resulting in many adolescents being unable to access effective help. Delivering mental health interventions via technology, such as computers or the internet, offers one potential way to increase access to psychological treatment. The aim of this systematic review and meta-analysis was to update previous work and investigate the current evidence for the effect of technology delivered interventions for children and adolescents (aged up to 18 years) with depression and anxiety. A systematic search of eight electronic databases identified 34 randomized controlled trials involving 3113 children and young people aged 6-18. The trials evaluated computerized and internet cognitive behavior therapy programs (CBT: n = 17), computer-delivered attention bias modification programs (ABM: n = 8) cognitive bias modification programs (CBM: n = 3) and other interventions (n = 6). Our results demonstrated a small effect in favor of technology delivered interventions compared to a waiting list control group: g = 0.45 [95% CI 0.29, 0.60] p < 0.001. CBT interventions yielded a medium effect size (n = 17, g = 0.66 [95% CI 0.42-0.90] p < 0.001). ABM interventions yielded a small effect size (n = 8, g = 0.41 [95%CI 0.08-0.73] p < 0.01). CBM and 'other' interventions failed to demonstrate a significant benefit over control groups. Type of control condition, problem severity, therapeutic support, parental support, and continuation of other ongoing treatment significantly influenced effect sizes. Our findings suggest there is a benefit in using CBT based technology delivered interventions where access to traditional psychotherapies is limited or delayed.

Are digital interventions for smoking cessation in pregnancy effective? A systematic review and meta-analysis.

Smoking in pregnancy remains a global public health issue due to foetal health risks and potential maternal complications. The aims of this systematic review and meta-analysis were to explore: (1) whether digital interventions for pregnancy smoking cessation are effective, (2) the impact of intervention platform on smoking cessation, (3) the associations between specific Behaviour Change Techniques (BCTs) delivered within interventions and smoking cessation and (4) the association between the total number of BCTs delivered and smoking cessation. Systematic searches of 9 databases resulted in the inclusion of 12 published articles (n = 2970). The primary meta-analysis produced a sample-weighted odds ratio (OR) of 1.44 (95% CI 1.04-2.00, p = .03) in favour of digital interventions compared with comparison groups. Computer-based (OR = 3.06, 95% CI 1.28-7.33) and text-message interventions (OR = 1.59, 95% CI 1.07-2.38) were the most effective digital platform. Moderator analyses revealed seven BCTs associated with smoking cessation: information about antecedents; action planning; problem solving; goal setting (behaviour); review behaviour goals; social support (unspecified); and pros and cons. A meta-regression suggested that interventions using larger numbers of BCTs produced the greatest effects. This paper highlights the potential for digital interventions to improve rates of smoking cessation in pregnancy.

Tau-U: A Quantitative Approach for Analysis of Single-Case Experimental Data in Aphasia.

Purpose: Tau-U is a quantitative approach for analyzing single-case experimental design (SCED) data. It combines nonoverlap between phases with intervention phase trend and can correct for a baseline trend (Parker, Vannest, & Davis, 2011). We demonstrate the utility of Tau-U by comparing it with the standardized mean difference approach (Busk & Serlin, 1992) that is widely reported within the aphasia SCED literature. Method: Repeated writing measures from 3 participants with chronic aphasia who received computer-based writing treatment are analyzed visually and quantitatively using both Tau-U and the standardized mean difference approach. Results: Visual analysis alone was insufficient for determining an effect between the intervention and writing improvement. The standardized mean difference yielded effect sizes ranging from 4.18 to 26.72 for trained items and 1.25 to 3.20 for untrained items. Tau-U yielded significant (p < .05) effect sizes for 2 of 3 participants for trained probes and 1 of 3 participants for untrained probes. A baseline trend correction was applied to data from 2 of 3 participants. Conclusions: Tau-U has the unique advantage of allowing for the correction of an undesirable baseline trend. Although further study is needed, Tau-U shows promise as a quantitative approach to augment visual analysis of SCED data in aphasia.

Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial.

An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min-1 m-2, p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.

Control of Blood Glucose for Type-1 Diabetes by Using Reinforcement Learning with Feedforward Algorithm.

BACKGROUND: Type-1 diabetes is a condition caused by the lack of insulin hormone, which leads to an excessive increase in blood glucose level. The glucose kinetics process is difficult to control due to its complex and nonlinear nature and with state variables that are difficult to measure. METHODS: This paper proposes a method for automatically calculating the basal and bolus insulin doses for patients with type-1 diabetes using reinforcement learning with feedforward controller. The algorithm is designed to keep the blood glucose stable and directly compensate for the external events such as food intake. Its performance was assessed using simulation on a blood glucose model. The usage of the Kalman filter with the controller was demonstrated to estimate unmeasurable state variables. RESULTS: Comparison simulations between the proposed controller with the optimal reinforcement learning and the proportional-integral-derivative controller show that the proposed methodology has the best performance in regulating the fluctuation of the blood glucose. The proposed controller also improved the blood glucose responses and prevented hypoglycemia condition. Simulation of the control system in different uncertain conditions provided insights on how the inaccuracies of carbohydrate counting and meal-time reporting affect the performance of the control system. CONCLUSION: The proposed controller is an effective tool for reducing postmeal blood glucose rise and for countering the effects of external known events such as meal intake and maintaining blood glucose at a healthy level under uncertainties.

Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis.

During the last two decades, Internet-delivered cognitive behavior therapy (ICBT) has been tested in hundreds of randomized controlled trials, often with promising results. However, the control groups were often waitlisted, care-as-usual or attention control. Hence, little is known about the relative efficacy of ICBT as compared to face-to-face cognitive behavior therapy (CBT). In the present systematic review and meta-analysis, which included 1418 participants, guided ICBT for psychiatric and somatic conditions were directly compared to face-to-face CBT within the same trial. Out of the 2078 articles screened, a total of 20 studies met all inclusion criteria. Results showed a pooled effect size at post-treatment of Hedges g = .05 (95% CI, -.09 to .20), indicating that ICBT and face-to-face treatment produced equivalent overall effects. Study quality did not affect outcomes. While the overall results indicate equivalence, there have been few studies of the individual psychiatric and somatic conditions so far, and for the majority, guided ICBT has not been compared against face-to-face treatment. Thus, more research, preferably with larger sample sizes, is needed to establish the general equivalence of the two treatment formats.

Computer-based versus in-person interventions for preventing and reducing stress in workers.

BACKGROUND: Chronic exposure to stress has been linked to several negative physiological and psychological health outcomes. Among employees, stress and its associated effects can also result in productivity losses and higher healthcare costs. In-person (face-to-face) and computer-based (web- and mobile-based) stress management interventions have been shown to be effective in reducing stress in employees compared to no intervention. However, it is unclear if one form of intervention delivery is more effective than the other. It is conceivable that computer-based interventions are more accessible, convenient, and cost-effective. OBJECTIVES: To compare the effects of computer-based interventions versus in-person interventions for preventing and reducing stress in workers. SEARCH METHODS: We searched CENTRAL, MEDLINE, PubMed, Embase, PsycINFO, NIOSHTIC, NIOSHTIC-2, HSELINE, CISDOC, and two trials registers up to February 2017. SELECTION CRITERIA: We included randomised controlled studies that compared the effectiveness of a computer-based stress management intervention (using any technique) with a face-to-face intervention that had the same content. We included studies that measured stress or burnout as an outcome, and used workers from any occupation as participants. DATA COLLECTION AND ANALYSIS: Three authors independently screened and selected 75 unique studies for full-text review from 3431 unique reports identified from the search. We excluded 73 studies based on full-text assessment. We included two studies. Two review authors independently extracted stress outcome data from the two included studies. We contacted study authors to gather additional data. We used standardised mean differences (SMDs) with 95% confidence intervals (CIs) to report study results. We did not perform meta-analyses due to variability in the primary outcome and considerable statistical heterogeneity. We used the GRADE approach to rate the quality of the evidence. MAIN RESULTS: Two studies met the inclusion criteria, including a total of 159 participants in the included arms of the studies (67 participants completed computer-based interventions; 92 participants completed in-person interventions). Workers were primarily white, Caucasian, middle-aged, and college-educated. Both studies delivered education about stress, its causes, and strategies to reduce stress (e.g. relaxation or mindfulness) via a computer in the computer-based arm, and via small group sessions in the in-person arm. Both studies measured stress using different scales at short-term follow-up only (less than one month). Due to considerable heterogeneity in the results, we could not pool the data, and we analysed the results of the studies separately. The SMD of stress levels in the computer-based intervention group was 0.81 standard deviations higher (95% CI 0.21 to 1.41) than the in-person group in one study, and 0.35 standard deviations lower (95% CI -0.76 to 0.05) than the in-person group in another study. We judged both studies as having a high risk of bias. AUTHORS' CONCLUSIONS: We found very low-quality evidence with conflicting results, when comparing the effectiveness of computer-based stress management interventions with in-person stress management interventions in employees. We could include only two studies with small sample sizes. We have very little confidence in the effect estimates. It is very likely that future studies will change these conclusions.

Additional electrodes on the Quartet™ LV lead provide more programmable pacing options than bipolar and tripolar equivalents.

AIMS: The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT). METHODS AND RESULTS: A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2.5 V and no phrenic nerve stimulation and maximal spatial coverage of viable vectors in CRT patients at pre-discharge (n = 370) and first follow-up (n = 355). Bipolar and tripolar lead configurations were modelled by systematic elimination of two and one electrode(s), respectively, from the Quartet lead. The Quartet lead with its four pacing electrodes exhibited the greatest number of pacing vectors per patient when compared with the best bipolar and the best tripolar modelled equivalents. Similarly, the Quartet lead provided the highest spatial coverage in terms of the distance between two furthest viable pacing cathodes when compared with the best bipolar and the best tripolar configurations (P < 0.05). Among the three modelled bipolar configurations, the lead configuration with the two most distal electrodes resulted in the highest number of viable pacing vectors. Among the four modelled tripolar configurations, elimination of the second proximal electrode (M3) resulted in the highest number of viable pacing options per patient. There were no significant differences observed between pre-discharge and first follow-up analyses. CONCLUSION: The Quartet lead with its four electrodes and the capability to pace from four anatomical locations provided the highest number of viable pacing vectors at pre-discharge and first follow-up visits, providing more flexibility in device programming and enabling continuation of CRT in more patients when compared with bipolar and tripolar equivalents.

Recruitment Strategies and Costs Associated With Enrolling People With Insomnia and High Blood Pressure Into an Online Behavioral Sleep Intervention: A Single-Site Pilot Study.

BACKGROUND: Recruitment in clinical research is a common challenge and source of study failure. The reporting of recruitment methods and costs in hypertension trials is limited especially for smaller, single-site trials, online intervention trials, and trials using newer online recruitment strategies. OBJECTIVE: The aims of this study are to describe and examine the feasibility of newer online-e-mail recruitment strategies and traditional recruitment strategies used to enroll participants with insomnia and high blood pressure into an online behavioral sleep intervention study (Sleeping for Heart Health). METHODS: The 16 online-e-mail-based and traditional recruitment strategies used are described. Recruitment strategy feasibility was examined by study interest and enrollee yields, conversion rates, and costs (direct, remuneration, labor, and cost per enrollee). RESULTS: From August 2014 to October 2015, 183 people were screened and 58 (31.7%) enrolled in the study (51.1 ± 12.9 years, 63.8% female, 72.4% African American, 136 ± 12/88 ± 7 mm Hg, 87.9% self-reported hypertension, 67.2% self-reported antihypertensive medication use). The recruitment strategies yielding the highest enrollees were the university hospital phone waiting message system (25.4%), Craigslist (22.4%), and flyers (20.3%) at a per enrollee cost of $42.84, $98.90, and $128.27, respectively. The university hospital phone waiting message system (55.6%) and flyers (54.5%) had the highest interested participant to enrolled participant conversion rate of all recruitment strategies. CONCLUSION: Approximately 70% of all enrolled participants were recruited from the university hospital phone waiting message system, Craigslist, or flyers. Given the recruitment challenges that most researchers face, we encourage the documenting, assessing, and reporting of detailed recruitment strategies and associated recruitment costs so that other researchers may benefit.

A Systematic Review and Meta-Analysis of Intervention for Pediatric Obesity Using Mobile Technology.

We reviewed the effect sizes of pediatric obesity intervention studies using mobile technology. Ten databases (Cochrane CENTRAL, CINAHL, EMBASE, PubMed/Medline, KoreaMED, KMBASE, KISS, NDSL, KSITI, and RISS) were reviewed, and four studies were included in a qualitative synthesis. To obtain significant change in obesity-related outcomes among elementary school students, including parents and utilizing text messages in interventions are recommended. Furthermore, devices such as accelerometers may aid obesity management. A meta-analysis of four studies indicated that the mobile intervention positively influenced dropout rates but was ineffective for outcomes of weight control, exercise, and sugar-sweetened beverage intake.

Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre.

PURPOSE: Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a "real-world" setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients. METHODS: We analysed 270 consecutive ICD recipients implanted in a single centre-135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death. RESULTS: At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group, n = 31 vs. standardised group, n = 16). There was a 47 % risk reduction in any device therapy (p = 0.04) and an 86 % risk reduction in inappropriate therapy (p = 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (p = 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death. CONCLUSIONS: In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.