A pragmatic trial of brief CBT for anxiety in VA primary care

对退伍军人医疗保健的预期影响退伍军人退伍军人管理局已制定了与“获取”和 “及时和综合护理”。拟议的务实试验旨在通过解决一个重大差距来实现这些目标 退伍军人精神卫生保健--即在初级保健环境中使用创新的交付方式治疗焦虑症 选择。利用伙伴关系办法，该项目将审查其有效性和实施潜力。 为初级保健中患有焦虑症的退伍军人提供简短的心理治疗计划。心理治疗服务将是 面对面交付或通过VA Video Connect-Home(VVC-H)交付。临床和实施结果 将为未来的传播努力提供信息，以改善退伍军人管理局获得和提供高质量焦虑护理的机会 初级保健设置。 背景焦虑症在退伍军人事务部初级保健机构中很常见，并与 功能障碍，与健康相关的生活质量差，自杀，以及高比例的精神疾病和 医学上的障碍。退伍军人事务部初级保健机构目前没有针对焦虑的简短心理治疗干预措施 -许多退伍军人在那里寻求护理。认知行为疗法(CBT)是治疗焦虑的一线疗法，但 初级保健精神卫生一体化(PCMHI)提供者需要一种焦虑障碍的干预方法 这是简短的，专注于问题，符合他们的护理体系。 目的拟议的为期4年的多点试验将使用务实的随机试验设计来检查 简明CBT干预焦虑症的有效性和实施潜力 通过VVC-H，根据患者的喜好。CBT将由现有的PCMHI提供商在三个大的 VAMCS。目标1将检验bcbt干预与euc在焦虑和质量方面的临床有效性。 在4个月、8个月和12个月的随访期内。目标2将确定与bCBT反应相关的因素和 探索与VVC-H参与度相关的退伍军人人口统计学和临床因素。探索性的目标将是 使用混合、定性和定量的方法，更好地了解实施成功和 在PCMHI环境中，与bCBT焦虑和VVC-H使用的交付和影响相关的挑战。 方法建议的项目寻求利用现有的VHA提供者将bCBT嵌入PCMHI计划。一个 总共225名被诊断患有焦虑症的退伍军人将从三个VAMC招募。符合条件的退伍军人 参与者将被随机分为bCBT组或增强型日常护理(EUC)组。一位专业的 不同的PCMHI供应商将被邀请提供bCBT。供应商将接受bCBT培训和 支持将治疗嵌入到他们现有的实践环境中。随机参加bCBT的退伍军人将获得4-9 根据治疗反应(GAD-7减少50%)到第四次治疗。退伍军人也将被提供 选择亲自或通过VVC-H接收bCBT。EUC参与者将收到每月4次的简短检查- 在研究人员的电话和他们的医疗记录中放置的便条中，提醒他们的提供者注意到 严重的焦虑症状。BCBT治疗和EUC登记电话将在4个月后结束。 下一步建议的项目利用各级退伍军人管理局利益相关者来改进工作与 退伍军人事务部和老牌计划。临床结果将提供理由或警告，以告知未来的证据- 以心理治疗为基础的(EBP)计划。如果是肯定的，数据将用于帮助退伍军人管理局领导层扩大 PCMHI中的EBPS和VVC-H。例如，该项目是否应产生稳健的临床结果--下一步 将涉及一个或两个VISN中的非研究/演示项目，项目团队将在那里进行培训和 支持更广泛的提供者提供针对焦虑症的简短CBT。项目团队将使用网络- 以培训计划和临床干预材料为基础，以及从拟议的 HSR&D IIR在非研究背景下支持和加强简短的CBT交付。

Anticipated Impacts on Veteran's Healthcare VA has established strategic goals related to “Access” and "Timely and Integrated Care". The proposed pragmatic trial targets these goals by addressing a significant gap in VA mental health care - namely the treatment of anxiety in the primary care setting using innovative delivery options. Using a partnership approach, the project will examine the effectiveness and implementation potential of a brief psychotherapy program for Veterans with anxiety in primary care. Psychotherapy services will be delivered either in-person or through VA Video Connect-Home (VVC-H). Clinical and implementation outcomes will inform future dissemination efforts to improve access and delivery of high quality anxiety care in VA primary care settings. Background Anxiety disorders are common in VA primary care settings and are associated with substantial functional impairment, poor health-related quality of life, suicide, and high rates of comorbid psychiatric and medical disorders. No brief psychotherapy interventions for anxiety currently exist for VA primary care settings - where many Veterans seek care. Cognitive Behavioral Therapy (CBT) is a first line treatment for anxiety but Primary Care Mental Health Integration (PCMHI) providers need an intervention approach for anxiety disorders that is brief, problem-focused, and fits into their system of care. Objectives The proposed 4-year, multisite trial will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief CBT intervention for anxiety delivered either in-person or via VVC-H, according to patient preference. CBT will be delivered by existing PCMHI providers at three large VAMCs. Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. EUC for anxiety and quality of life at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. Methods The proposed project seeks to embed bCBT into PCMHI programs using existing VHA providers. A total of 225 Veterans diagnosed with an anxiety disorder will be recruited from three VAMCs. Eligible Veteran participants will be randomized to a bCBT or to an Enhanced Usual Care (EUC) condition. A professionally diverse set of PCMHI providers will be invited to deliver bCBT. Providers will receive bCBT training and support to embed treatment into their existing practice setting. Veterans randomized to bCBT will receive 4 – 9 sessions based upon treatment response (50% reduction in GAD-7) by session 4. Veterans will also be offered the choice of receiving bCBT in-person or through VVC-H. EUC participants will receive 4 brief monthly check- in calls from study staff and a note placed in their medical record alerting their provider to the presence of significant anxiety symptoms. BCBT treatment and EUC check-in calls will end at 4 months. Next Steps The proposed project leverages VA stakeholders at all levels to improve alignment of the work with VA and Veteran initiatives. Clinical outcomes will provide justifications or cautions to inform future evidence- based psychotherapy (EBP) programs. If positive, data will be used to assist VA leadership in the expansion of EBPs and VVC-H in PCMHI. For example, should the project produce robust clinical outcomes - next steps would involve a non-research / demonstration project in one or two VISNs where the project team will train and support a wider group of providers in the delivery of brief CBT for anxiety. The project team will use the web- based training program and clinical intervention materials as well as lessons learned from the proposed HSR&D IIR to support and enhance brief CBT delivery in a non-research context.