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

退伍军人事务部初级保健中短暂 CBT 治疗焦虑的实用试验

• 批准号: 10844344
• 负责人: Jeffrey Alexander Cully
• 金额: --
• 依托单位: MICHAEL E DEBAKEY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10844344
• 关键词: Address; Adoption; Anxiety; Anxiety Disorders; Attention; Brief Psychotherapy; Caring; Clinic; Clinical; Clinical Practice Guideline; Clinical effectiveness; Cognitive Therapy; Data; Diagnosis; Disease; E-learning; Effectiveness; Eligibility Determination; Evidence based intervention; Evidence based treatment; Future; Goals; Health Sciences; Health Services; Health Services Accessibility; Healthcare; Home; Homogeneously Staining Region; Improve Access; Individual; Intervention; Interview; Leadership; Learning; Measurement; Medical; Medical Records; Mental Depression; Mental Health; Mental Health Services; Methods; Outcome; Panic; Participant; Patient Education; Patient Preferences; Persons; Post-Traumatic Stress Disorders; Pragmatic clinical trial; Prediction of Response to Therapy; Primary Care; Provider; Psychotherapy; Quality of Care; Quality of life; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; SF-12; Services; Site; Social Phobia; Standardization; Suicide; Surveys; Technology; Therapeutic Intervention; Time; Training; Training Programs; Veterans; Veterans Health Administration; Work; anxiety reduction; anxiety symptoms; anxiety treatment; attentional control; care delivery; care preference; care seeking; care systems; design; effectiveness evaluation; evidence base; flexibility; formative assessment; functional disability; generalized anxiety; health related quality of life; health service use; implementation outcomes; implementation science; improved; innovation; integrated care; medical specialties; multi-site trial; practice setting; pragmatic randomized trial; pragmatic trial; primary care patient; primary care setting; programs; psychiatric comorbidity; recruit; reduce symptoms; service delivery; skills; success; telehealth; treatment as usual; treatment response; trial design

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.

对退伍军人医疗保健的预期影响退伍军人事务部已经制定了与“准入”相关的战略目标， “及时和全面的护理”。拟议的务实试验通过解决一个重大差距来实现这些目标 在VA精神卫生保健-即在初级保健环境中使用创新交付治疗焦虑 选项.该项目将采用伙伴关系的办法， 一个简短的心理治疗计划，为退伍军人与焦虑的初级保健。心理治疗服务将 可亲自或通过VA Video Connect-Home（VVC-H）提供。临床和实施结果 将为未来的传播工作提供信息，以改善VA中高质量焦虑护理的获取和提供 初级保健机构。 背景焦虑症在VA初级保健机构中很常见， 功能障碍、健康相关的生活质量差、自杀和精神和精神疾病共病率高， 医学疾病VA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 - 许多退伍军人寻求照顾。认知行为疗法（CBT）是治疗焦虑的一线疗法， 初级保健心理健康整合（PCMHI）提供者需要对焦虑症采取干预措施 简短，以问题为中心，适合他们的护理系统。 目的：这项4年多中心试验将采用一种实用的随机试验设计， 一个简短的CBT干预焦虑的有效性和实施潜力，无论是在人或 根据患者偏好，通过VVC-H。CBT将由现有的PCMHI供应商在三个大型 吸血鬼目标1将检查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个月随访时，目标2将确定与bCBT反应相关的因素， 探索与VVC-H参与相关的退伍军人人口统计学和临床因素。一个探索性的目标将 使用混合的定性和定量方法，以更好地了解实施的成功， 与PCMHI环境中bCBT焦虑和VVC-H使用的交付和影响相关的挑战。 方法拟议的项目旨在嵌入bCBT到PCMHI计划使用现有的VHA供应商。一 总共225名被诊断患有焦虑症的退伍军人将从三个VAMC中招募。合格退伍军人 受试者将被随机分配至bCBT或增强型糖尿病护理（EUC）条件。一个专业 将邀请不同的PCMHI供应商提供bCBT。提供者将接受bCBT培训， 支持将治疗嵌入其现有的实践环境。随机分配到bCBT的退伍军人将接受4 - 9 根据第4次治疗的治疗反应（GAD-7降低50%）进行治疗。退伍军人也将被提供 选择亲自或通过VVC-H接受bCBT。EUC参与者将收到4份简短的月度检查- 在研究工作人员的电话中，以及在其病历中的注释中，提醒其提供者存在以下情况： 严重的焦虑症状。BCBT治疗和EUC检查电话将在4个月时结束。 拟议项目利用各级VA利益相关者， 退伍军人和退伍军人倡议。临床结局将提供合理性解释或警告，以告知未来的证据- 心理治疗（EBP）如果是肯定的，数据将用于协助VA领导层扩大 PCMHI中的EBP和VVC-H。例如，如果项目产生了稳健的临床结果-下一步 将涉及一个非研究/示范项目，在一个或两个VISN中，项目团队将进行培训， 支持更广泛的供应商群体提供简短的CBT焦虑。项目团队将使用Web- 基于培训计划和临床干预材料，以及从拟议的 HSR&D IIR支持和加强非研究背景下的简短CBT交付。