Game-based meditation therapy to improve posttraumatic stress and neurobiological stress systems in traumatized adolescents:Protocol for a randomized controlled trial

Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents

Validity of the Empatica E4 wristband to measure heart rate variability (HRV) parameters:A comparison to electrocardiography (ECG)

Wearable monitoring devices are an innovative way to measure heart rate (HR) and heart rate variability (HRV), however, there is still debate about the validity of these wearables. This study aimed to validate the accuracy and predictive value of the Empatica E4 wristband against the VU University Ambulatory Monitoring System (VU-AMS) in a clinical population of traumatized adolescents in residential care. A sample of 345 recordings of both the Empatica E4 wristband and the VU-AMS was derived from a feasibility study that included fifteen participants. They wore both devices during two experimental testing and twelve intervention sessions. We used correlations, cross-correlations, Mann-Whitney tests, difference factors, Bland-Altman plots, and Limits of Agreement to evaluate differences in outcomes between devices. Significant correlations were found between Empatica E4 and VU-AMS recordings for HR, SDNN, RMSSD, and HF recordings. There was a significant difference between the devices for all parameters but HR, although effect sizes were small for SDNN, LF, and HF. For all parameters but RMSSD, testing outcomes of the two devices led to the same conclusions regarding significance. The Empatica E4 wristband provides a new opportunity to measure HRV in an unobtrusive way. Results of this study indicate the potential of the Empatica E4 as a practical and valid tool for research on HR and HRV under non-movement conditions. While more research needs to be conducted, this study could be considered as a first step to support the use of HRV recordings provided by wearables

Sequential intravascular ultrasound of the mechanisms of rotational atherectomy and adjunct balloon angioplasty

AbstractObjectives. The purpose of this study was to use sequential intravascular ultrasound imaging before intervention, after rotational atherectomy and after adjunct balloon angioplasty to characterize the mechanisms of lumen enlargement after each.Background. Rotational atherectomy uses a high speed, rotating, diamond-tipped elliptic burr to abrade atherosclerotic plaque to increase lumen size. In vitro studies have shown that high speed rotational atherectomy selectively abrades hard, especially calcified, plaque elements. However, rotational atherectomy procedures usually require adjunct balloon angioplasty.Methods. Forty-eight lesions in 46 patients were treated with rotational atherectomy followed by adjunct balloon angioplasty in 44. Quantitative coronary arteriographic and intravascular ultrasound measurements of the target lesion were made before intervention, after rotational atherectomy and after balloon angioplasty.Results. Before intervention, target lesion external elastic membrane area measured 17.3 ± 5.9 mm2, lumen area measured 1.8 ± 0.9 mm2and plaque plus media area measured 15.7 ± 4.1 mm2. After rotational atherectomy, lumen area increased, plaque plus media area decreased, arc of target lesion calcium decreased and 26% of the target lesions had dissection planes After adjunct balloon angioplasty, external elastic membrane area increased, lumen area increased, plaque plus media area did not change and 77% of the target lesions had dissection planes. Arterial expansion was seen in 80% of lesions. The pattern of dissection plane location, which was predominantly within calcified plaque after rotational atherectomy, became predominantly adjacent to calcified plaque after adjunct balloon angioplasty (p = 0.008).Conclusions. Sequential intravascular ultrasound imaging shows that high speed rotational atherectomy causes lumen enlargement by selective ablation of hard, especially calcific, atherosclerotic plaque with little tissue disruption and rare arterial expansion. Adjunct balloon angioplasty further increased lumen area by a combination of arterial dissection and arterial expansion, especially of compliant, noncalcified plaque elements

3-Year Follow-Up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) Trial

ObjectivesThe aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).BackgroundTreatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.MethodsWe evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.ResultsTarget vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).ConclusionsAt 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions

Small-scale, community-embedded youth justice facilities: lessons from Dutch reforms and recommendations for cross-jurisdictional implementation

Youth justice settings should provide safe, therapeutic environments, tailored to young people's needs. Current custodial models rarely meet these aims, mainly because a focus on security tends to outweigh an emphasis on care, diminishing rather than encouraging young people's positive development. This article reports on a three-year evaluation of youth justice reforms in the Netherlands, including small-scale, community-embedded facilities with an emphasis on relational security. We outline key operational elements and conditions for implementation of these facilities to provide guidance for youth justice professionals, and for managers and policymakers seeking to promote political and financial investments in effective youth justice strategies

Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement

ObjectivesTo assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR.BackgroundThe impact of CKD on mid‐term outcomes of patients undergoing TAVR versus SAVR is unclear.MethodsPatients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all‐cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis.ResultsModerate/severe CKD was present in 62.7% and 60.7% of high‐risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high‐risk patients with moderate/severe CKD, TAVR provided a lower 3‐year MACRE rate compared with SAVR: 42.1% vs. 51.0, P = .04. Of 3,733 extreme‐ and high‐risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3‐year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P = .001].ConclusionsTAVR results in lower 3‐year MACRE versus SAVR in high‐risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid‐term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate‐severe CKD would help elucidate the best treatment for these complex patients.Trial RegistrationCoreValve US Pivotal Trial: NCT01240902.CoreValve Continued Access Study: NCT01531374.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/1/ccd27928_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/2/ccd27928.pd