Lessons Learned Conducting Dialectical Behavior Therapy via Telehealth in the Age of COVID-19.
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ABSTRACT:
SUBMITTER: Zalewski M
PROVIDER: S-EPMC8488181 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.
| S-EPMC3935288 | biostudies-literature
Project description:Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting. To convey these challenges to investigators planning future multi-center trials in military hospitals, we itemized various challenges that arose during the trial, interviewed clinic directors and coordinators to elicit their viewpoints, and then collated and organized their responses, together with those challenges presented while conducting the Tinnitus Retraining Therapy Trial. Results We encountered challenges in site selection, the approval process, administrative issues, study personnel training and retention, participant recruitment methods and issues, adherence to protocol, reimbursement issues, and military security. Site selection involved visiting 20 military hospitals to identify six sites that enrolled and followed study participants. We found that commitment for the trial must be obtained from the full military chain of command, but with ongoing changes in staff or military priorities, initial commitments were insufficient to sustain support throughout the entire trial. More time is required to obtain necessary administrative approvals by various military authorities and institutional review boards than is typically experienced in civilian settings. Recruitment strategies must be flexible due to changing military regulations regarding display of materials. Protracted periods of inactivity were due to sequestration and delays in institutional review board approval of required study personnel or protocol amendments. While mostly adherent to the protocol, study staff had difficulties in integrating study visits into the military clinical schedule. Unexpected study expenses revolved around hiring civilian study staff and obtaining associated security clearance while maintaining a consistent flow of funds to each site. The added expense negated cost savings realized by conducting the National Institutes of Health-funded trial at federal institutions, whose personnel could not be reimbursed for their efforts. Military security concerns impacted the use of web-based data systems and led to increased time and effort required for site visits. Conclusion Overall, US military hospitals provide a unique setting to conduct multi-center trials. Challenges arise mainly due to ever-changing authority personnel and military priorities. Pre-planning and flexibility are keys in overcoming these challenges. Multi-center trials conducted in the military will likely take longer to initiate and complete than those in the civilian sector due to multiple levels of command and administrative approvals.
| S-EPMC6133718 | biostudies-literature
Project description:BackgroundWhile the COVID-19 crisis has had numerous global negative impacts, it has also presented an imperative for mental health care systems to make digital mental health interventions a part of routine care. Accordingly, through necessity, many Dialectical Behaviour Therapy (DBT) programs transitioned to telehealth, despite little information on clinical outcomes compared with face-to-face treatment delivery. This study examined differences in client engagement (i.e. attendance) of DBT: delivered face-to-face prior to the first COVID-19 lockdown in Australia and New Zealand; delivered via telehealth during the lockdown; and delivered post-lockdown. Our primary outcomes were to compare: [1] client attendance rates of DBT individual therapy delivered face-to-face with delivery via telehealth, and [2] client attendance rates of DBT skills training delivered face-to-face compared with delivery via telehealth.MethodsDBT programs across Australia and New Zealand provided de-identified data for a total of 143 individuals who received DBT treatment provided via telehealth or face-to-face over a six-month period in 2020. Data included attendance rates of DBT individual therapy sessions; attendance rates of DBT skills training sessions as well as drop-out rates and First Nations status of clients.ResultsA mixed effects logistic regression model revealed no significant differences between attendance rates for clients attending face-to-face sessions or telehealth sessions for either group therapy or individual therapy. This result was found for clients who identified as First Nations persons and those who didn't identify as First Nations persons.ConclusionsClients were as likely to attend their DBT sessions over telehealth as they were face-to-face during the first year of the Covid-19 pandemic. These findings provide preliminary evidence that providing DBT over telehealth may be a viable option to increase access for clients, particularly in areas where face-to-face treatment is not available. Further, based on the data collected in this study, we can be less concerned that offering telehealth treatment will compromise attendance rates compared to face-to-face treatment. Further research is needed comparing clinical outcomes between treatments delivered face-to-face compared delivery via telehealth.
| S-EPMC10198751 | biostudies-literature
Project description: Not available
| S-EPMC7478104 | biostudies-literature
Project description:Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) Planning phase, to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) Project Development phase, when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) Study Execution phase, involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) Dissemination phase, where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter research with a focus on simulation-specific issues.
| S-EPMC5806260 | biostudies-literature
Project description:An evidence-based triage plan for cellular therapy distribution is critical in the face of emerging constraints on healthcare resources. We evaluated the impact of treatment delays related to COVID-19 on patients scheduled to undergo hematopoietic cell transplantation (HCT) or chimeric antigen receptor T-cell (CAR-T) therapy at our center. Data were collected in real time between March 19 and May 11, 2020, for patients who were delayed to cellular therapy. We evaluated the proportion of delayed patients who ultimately received cellular therapy, reasons for not proceeding to cellular therapy, and changes in disease and health status during delay. A total of 85 patients were delayed, including 42 patients planned for autologous HCT, 36 patients planned for allogeneic HCT, and 7 patients planned for CAR-T therapy. Fifty-six of these patients (66%) since received planned therapy. Five patients died during the delay. The most common reason for not proceeding to autologous HCT was good disease control in patients with plasma cell dyscrasias (75%). The most common reason for not proceeding to allogeneic HCT was progression of disease (42%). All patients with acute leukemia who progressed had measurable residual disease (MRD) at the time of delay, whereas no patient without MRD at the time of delay progressed. Six patients (86%) ultimately received CAR-T therapy, including 3 patients who progressed during the delay. For patients with high-risk disease such as acute leukemia, and particularly those with MRD at the time of planned HCT, treatment delay can result in devastating outcomes and should be avoided if at all possible.
| S-EPMC7952254 | biostudies-literature
Project description:The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current "gold standard" clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation-focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions.
| S-EPMC4609529 | biostudies-literature
Project description:Proactive engagement and care with regular and timely information are required to manage the health and well-being of people in quarantine. At Australia's Howard Springs International Quarantine Facility, a telehealth model was rapidly established using trained non-clinical Customer Service Officers (CSO's) with the aim to provide comprehensive care to residents, maximize staff safety, and reduce clinical workforce capacity pressures. We describe this model, whereby CSO's provided residents with daily COVID-19 symptom and well-being screening, weekly psychological screening, and ongoing linkage to additional clinical and administrative services. In addition, CSO's went beyond these duties to deliver personalized care through delivery of care packages and attendance of the departure point to farewell residents. From October 2020 to May 2021, across 7105 residents, we estimated that CSO's prevented over 75 000 face-to-face resident visits, which reduced workforce requirements and preserved staff safety through minimizing potential COVID-19 transmission and time spent in personal protective equipment in the challenging ambient environment. We share key lessons learned which may inform future telehealth models and guide a positive experience for quarantine residents.
| S-EPMC10286160 | biostudies-literature
Project description:BackgroundEarly weak treatment response is one of the few trans-diagnostic, treatment-agnostic predictors of poor outcome following a full treatment course. We sought to improve the outcome of clients with weak initial response to guided self-help cognitive behavior therapy (GSH).MethodOne hundred and nine women with binge-eating disorder (BED) or bulimia nervosa (BN) (DSM-IV-TR) received 4 weeks of GSH. Based on their response, they were grouped into: (1) early strong responders who continued GSH (cGSH), and early weak responders randomized to (2) dialectical behavior therapy (DBT), or (3) individual and additional group cognitive behavior therapy (CBT+).ResultsBaseline objective binge-eating-day (OBD) frequency was similar between DBT, CBT+ and cGSH. During treatment, OBD frequency reduction was significantly slower in DBT and CBT+ relative to cGSH. Relative to cGSH, OBD frequency was significantly greater at the end of DBT (d = 0.27) and CBT+ (d = 0.31) although these effects were small and within-treatment effects from baseline were large (d = 1.41, 0.95, 1.11, respectively). OBD improvements significantly diminished in all groups during 12 months follow-up but were significantly better sustained in DBT relative to cGSH (d = -0.43). At 6- and 12-month follow-up assessments, DBT, CBT and cGSH did not differ in OBD.ConclusionsEarly weak response to GSH may be overcome by additional intensive treatment. Evidence was insufficient to support superiority of either DBT or CBT+ for early weak responders relative to early strong responders in cGSH; both were helpful. Future studies using adaptive designs are needed to assess the use of early response to efficiently deliver care to large heterogeneous client groups.
| S-EPMC7418949 | biostudies-literature
Project description:Male worm mating requires lov-1 and pkd-2 (homologs of the human polycystic kidney disease genes, PKD1 and PKD2), which are expressed in male-specific neurons. Transcriptomic analysis of these neurons now catalogs molecules involved in signaling and ectosome biogenesis, with implications for human PKD.
| S-EPMC6077978 | biostudies-literature