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BackgroundLong-term benzodiazepine dependence carries significant health risks which might be reduced with low-cost patient self-management interventions. A booklet version of one such intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) proved effective in a Canadian clinical trial with older adults. Digitizing such an intervention for electronic delivery and tailoring it to different populations could expand its reach. Accordingly, this article describes the protocol for a randomized controlled trial to test the effectiveness of an electronically-delivered, direct-to-patient benzodiazepine cessation intervention tailored to U.S. military veterans.MethodsDesign: Two-arm individually randomized controlled trial.SettingUS Veterans Health Administration primary care clinics.ParticipantsPrimary care patients taking benzodiazepines for three or more months and having access to a smartphone, tablet or desktop computer.Intervention and comparatorParticipants will be randomized to receive either the electronically-delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow provider recommendations regarding their benzodiazepine use (treatment-as-usual).MeasurementsThe primary outcomes are complete benzodiazepine cessation and 25% dose reduction, assessed using administrative and self-report data, between baseline and six-month follow-up. Secondary outcomes are self-reported anxiety symptoms, sleep quality, and overall health and quality of life, measured at baseline and 6-month follow-up, and benzodiazepine cessation at 12-month follow-up.CommentsThis randomized controlled trial will evaluate whether the accessibility and effectiveness of a promising intervention for benzodiazepine cessation can be improved through digitization and population tailoring.

BackgroundBroadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CBT. The objectives of this study are to modify the CALM tool to meet the needs of mental health clinicians in veterans affairs (VA) community-based outpatient clinics (CBOCs) and rural "veterans", use external facilitation to implement CBT and determine the effect of the CALM tool versus a manualized version of CALM to improve fidelity to the CBT treatment model, and conduct a needs assessment to understand how best to support future implementation of the CALM tool in routine care.Methods/designFocus groups will inform the redesign of the CALM tool. Mental health providers at regional VA CBOCs; CBT experts; VA experts in implementation of evidence-based mental health practices; and veterans with generalized anxiety disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, "with or without" depression will be recruited. A hybrid type III design will be used to examine the effect of receiving CBT training plus either the CALM tool or a manual version of CALM on treatment fidelity. External facilitation will be used as the overarching strategy to implement both CBT delivery methods. Data will also be collected on symptoms of the targeted disorders. To help prepare for the future implementation of the CALM tool in VA CBOCs, we will perform an implementation need assessment with mental health providers participating in the clinical trial and their CBOC directors.DiscussionThis project will help inform strategies for delivering CBT with high fidelity in VA CBOCs to veterans with anxiety disorders and PTSD with or without depression. If successful, results of this study could be used to inform a national rollout of the CALM tool in VA CBOCs including providing recommendations for optimizing the adoption and sustained use of the computerized CALM tool among mental health providers in this setting.Trial registrationClinicalTrials.gov, NCT02488551.

INTRODUCTION Between 1994 and 2017, the National Institutes of Health (NIH) issued mandates that biomedical researchers include female participants in clinical research, (1) analyze sex/gender differences in NIH Phase III [...]

BackgroundBroadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CBT. The objectives of this study are to modify the CALM tool to meet the needs of mental health clinicians in veterans affairs (VA) community-based outpatient clinics (CBOCs) and rural "veterans", use external facilitation to implement CBT and determine the effect of the CALM tool versus a manualized version of CALM to improve fidelity to the CBT treatment model, and conduct a needs assessment to understand how best to support future implementation of the CALM tool in routine care.Methods/designFocus groups will inform the redesign of the CALM tool. Mental health providers at regional VA CBOCs; CBT experts; VA experts in implementation of evidence-based mental health practices; and veterans with generalized anxiety disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, "with or without" depression will be recruited. A hybrid type III design will be used to examine the effect of receiving CBT training plus either the CALM tool or a manual version of CALM on treatment fidelity. External facilitation will be used as the overarching strategy to implement both CBT delivery methods. Data will also be collected on symptoms of the targeted disorders. To help prepare for the future implementation of the CALM tool in VA CBOCs, we will perform an implementation need assessment with mental health providers participating in the clinical trial and their CBOC directors.DiscussionThis project will help inform strategies for delivering CBT with high fidelity in VA CBOCs to veterans with anxiety disorders and PTSD with or without depression. If successful, results of this study could be used to inform a national rollout of the CALM tool in VA CBOCs including providing recommendations for optimizing the adoption and sustained use of the computerized CALM tool among mental health providers in this setting.Trial registrationClinicalTrials.gov, NCT02488551.

Information technology (IT) is increasingly being used to facilitate, complement, and support the implementation of evidence-based practices (EBP) in psychology. This article reviews recent randomised trials that evaluate the integration of IT applications into the process of delivering EBP. More specifically, we review 11 studies that illustrate how IT has been successfully integrated into traditional clinician-delivered psychotherapy to promote the adoption of EBP. Advantages and disadvantages of this approach are discussed. The paper concludes with practical recommendations for clinicians who are interested in integrating IT into their practice. (Contains 1 table.)