Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol.

Background: Long-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. Methods: Design: Two-arm individually randomized controlled trial. Setting: US Veterans Health Administration primary care clinics. Participants: Primary care patients taking benzodiazepines for three or more months and having access to a smartphone, tablet or desktop computer. Intervention and comparator: Participants 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). Measurements: The 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. Comments: This 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.

Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders.

BACKGROUND: Long-term dependence on prescribed benzodiazepines is a public health problem. Eliminating Medications Through Patient Ownership of End Results (EMPOWER) is a promising self-management intervention, delivered directly to patients as a printed booklet, that is effective in promoting benzodiazepine reduction and cessation in older adults. EMPOWER has high potential to benefit large health care systems such as the US Veterans Health Administration (VHA), which cares for many veterans who use benzodiazepines for extended periods. OBJECTIVE: We aimed to adapt the original EMPOWER booklet materials for electronic delivery and for use among US military veterans receiving VHA care who were long-term benzodiazepine users. METHODS: We used elements of Analysis, Design, Development, Implementation, and Evaluation, a framework commonly used in the field of instructional design, to guide a qualitative approach to iteratively adapting EMPOWER Electronic Delivery (EMPOWER-ED). We conducted 3 waves of focus groups with the same 2 groups of VHA stakeholders. Stakeholders were VHA-enrolled veterans (n=16) with medical chart evidence of long-term benzodiazepine use and national VHA leaders (n=7) with expertise in setting VHA policy for prescription benzodiazepine use and developing electronically delivered educational tools for veterans. Qualitative data collected from each wave of focus groups were analyzed using template analysis. RESULTS: Themes that emerged from the initial focus groups included veterans' anxiety about self-tapering from benzodiazepines and prior negative experiences attempting to self-taper without support. Participants also provided feedback on the protocol's look and feel, educational content, the tapering protocol, and website functionality; for example, feedback from policy leaders included listing, on the cover page, the most commonly prescribed benzodiazepines to ensure that veterans were aware of medications that qualify for self-taper using the EMPOWER-ED protocol. Both groups of stakeholders identified the importance of having access to supportive resources to help veterans manage sleep and anxiety in the absence of taking benzodiazepines. Both groups also emphasized the importance of ensuring that the self-taper could be personalized and that the taper instructions were clear. The policy leaders emphasized the importance of encouraging veterans to notify their provider of their decision to self-taper to help facilitate provider assistance, if needed, with the taper process and to help prevent medication stockpiling. CONCLUSIONS: EMPOWER-ED is the first direct-to-patient electronically delivered protocol designed to help US military veterans self-taper from long-term benzodiazepine use. We used the Analysis, Design, Development, Implementation, and Evaluation framework to guide the successful adaption of the original EMPOWER booklet for use with this population and for electronic delivery. The next step in this line of research is to evaluate EMPOWER-ED in a randomized controlled trial.

Study protocol: a hybrid effectiveness-implementation trial of Moral Reconation Therapy in the US Veterans Health Administration.

BACKGROUND: Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention aimed at reducing risk for criminal recidivism by restructuring antisocial attitudes and cognitions (i.e., "criminogenic thinking"). MRT has empirical support for reducing risk for criminal recidivism among civilian offenders. Recently, a version of MRT was developed for military veterans; however, no randomized controlled trials (RCT) have been conducted with the veteran-specific protocol, and the effectiveness and implementation potential of MRT outside of correctional settings has not been established. METHODS: Using a Hybrid Type 1 RCT design, this study will test the effectiveness of MRT to reduce risk for criminal recidivism and improve health-related outcomes among justice-involved veterans entering mental health residential treatment at three US Veterans Health Administration (VHA) Medical Centers. Upon admission to the treatment program, justice-involved veterans will complete a baseline assessment, be randomized to usual care (UC) or UC + MRT, and be followed 6 and 12 months post-baseline. A process evaluation will also be conducted to identify barriers and facilitators to implementation of MRT in residential treatment. DISCUSSION: The primary aim of this study is to evaluate the effectiveness of MRT with justice-involved veterans. If MRT proves effective in this trial, the findings can provide large healthcare systems that serve veterans with an evidence-based intervention for addressing criminogenic thinking among justice-involved adults, as well as guidance on how to facilitate future implementation of MRT in non-correctional settings. TRIAL REGISTRATION: This trial is funded by the VA Health Services Research & Development Program (IIR 14-081) and is registered with ClinicalTrials.gov (ID: NCT02524171 ).

Developing a Peer Support Protocol for Improving Veterans' Engagement to Computer-Delivered Cognitive Behavioural Therapy.

BACKGROUND: Computer-delivered cognitive behavioural therapy (cCBT) is an effective alternative to provider-delivered treatment for depression and anxiety, but high attrition poses a significant challenge to its use. Peer support is a feasible approach to improving cCBT engagement, but less is known about its acceptability among Veterans. AIMS: To obtain feedback from Veterans (n = 24) with depression and/or anxiety on their preferences for (a) activities of Veterans Administration Peer Support Specialists (VA PSS) in helping Veterans use Moving Forward, a cCBT-based protocol developed by VA, and (b) methods for delivering support to Veterans using this programme. METHOD: Four focus groups (5-7 Veterans per group) provided feedback to be used in the development of a peer-supported engagement intervention to help Veterans with depression and anxiety use Moving Forward. Content areas included roles that a VA PSS might play in supporting the use of and engagement in Moving Forward, as well as methods of delivering that support. RESULTS: Veteran preferences for PSS activity focused on practical aspects of using Moving Forward, including orientation to the programme, technical support, and monitoring progress. Feedback also suggested that Veterans preferred more personal roles for the PSS, including emotional support, as well as application of Moving Forward to 'real life' problems. CONCLUSIONS: The findings extend the literature on online, patient-facing mental health protocols by identifying emotional support and 'real life' skills application as Veteran-preferred components of a peer-support protocol designed to enhance use of and engagement in cCBT for depression and anxiety.