Improving Anxiety Treatment Engagement and Effectiveness in Primary Care-Mental Health Integration: Multi-site Hybrid I RCT of a Brief Veteran-Centered Anxiety Intervention

背景：许多退伍军人经历了焦虑症的损害症状，并寻求初级保健治疗， 然而，在这种情况下，焦虑被严重低估了。初级保健-精神卫生一体化(PCMHI)，其中 嵌入初级保健的精神健康临床医生提供短暂的治疗，为解决 这一治疗差距。然而，与简短的PCMHI治疗相适应的行为干预 格式，并能够适应广泛的焦虑演示文稿是必需的。因此，退伍军人 焦虑技能培训(Vavast)旨在以证据为基础，跨诊断，适用于PCMHI，以及 以老兵为中心。Vavast由经验支持的认知行为疗法(CBT)技术组成 调整为专门为在PCMHI实施而设计的手动模块干预。如同浩瀚的生命 与研究治疗师在一个地点进行试验，下一个科学步骤是多个地点的随机对照试验 (RCT)评估其在常规护理中使用PCMHI提供者的有效性。意义/影响：这项研究 解决心理健康和预防自杀的退伍军人护理优先事项，使命法的优先事项增加 获得护理并提高患者对退伍军人健康管理局(VHA)护理和健康的满意度 服务研发(HSR&D)的重点领域是质量、效力和效率以及 实施科学的研究方法。改善PCMHI的焦虑症治疗将解决 VHA治疗方案，鉴于初级保健中焦虑症的高患病率，焦虑患者的倾向 在初级保健而不是专门的精神卫生环境中寻求治疗，并且缺乏循证证据 心理治疗(EBP)方案解决非创伤相关焦虑。创新：模块化(与标准) 干预设计在效率、患者和提供者满意度、疗效、有效性、 实施和可持续性。其他创新方面包括跨诊断方法和 检查保真度，以便为未来的实施提供信息。具体目标：具体目标是：(1)比较 在多个地点，在基线和16周(后)之间，VASSET与PCMHI常规护理的患者临床结果 PCMHI提供者提供大量的RCT，并检查治疗收益是否更有可能 在28周时维持大量护理与PCMHI常规护理(随访)；(2)分配给参与者接受 探索患者水平对(A)早期(8周)和(B)总体(16周)治疗反应的预测因子； 以及(3)进行大规模实施的混合方法过程评估，以检查 以及实现和维持高保真干预交付的促进者。方法：在这个多站点中， 混合型I型有效性-实施随机对照试验，178名焦虑症状升高的成年退伍军人将 从两个VHA地点的初级保健中心招募的。PCMHI提供商将随机提供大量或 常规护理(常规PCMHI护理，即提供者认为适当的任何护理)，参与者将 随机化，随机化。Vavar(最多六次，每周30分钟)包括标准的初始和 最后一堂课以及最多4个基于CBT技能的模块。主要结果(总体焦虑严重程度和 损害程度)和二次结果(焦虑和抑郁症状的严重程度、功能、质量 在基线、4周、8周、12周、16周(后)和28周(随访)进行评估。多层次建模 将用于评估患者临床结果将从基线提高到16%的假设 与PCMHI通常的护理相比，参与者接受的护理时间更长。多元Logistic回归将是 用于探索早期(8周)和总体(16周)巨大治疗反应的预测因素。一种混合的- 方法过程评估将检查PCMHI提供者实现并保持高 高保真广泛的交付以及高保真交付的障碍和促进者。实施/下一步 步骤：Vavast将向VHA PCMHI领导层和全国供应商传播，使用几个 战略和后续混合三期试验将有助于在VHA PCMHI中正式实施。

Background: Many Veterans experience impairing symptoms of anxiety and seek treatment in primary care, yet anxiety is highly undertreated in this setting. Primary Care-Mental Health Integration (PCMHI), in which mental health clinicians embedded in primary care provide brief treatment, affords an opportunity to address this treatment gap. However, behavioral interventions that are compatible with the brief PCMHI treatment format and able to accommodate a wide range of anxiety presentations are needed. Accordingly, Veterans Anxiety Skills Training (VAST) was designed to be evidence-based, transdiagnostic, feasible for PCMHI, and Veteran-centered. VAST comprises empirically-supported cognitive-behavioral therapy (CBT) techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI. As VAST is being piloted at a single site with study therapists, the next scientific step is a multi-site randomized controlled trial (RCT) to evaluate its effectiveness using PCMHI providers in routine care. Significance/Impact: This study addresses Veteran care priorities of mental health and suicide prevention, MISSION Act priorities of increasing access to care and improving patient satisfaction with Veterans Health Administration (VHA) care, and Health Services Research and Development (HSR&D) focus areas of quality, effectiveness, and efficiency as well as implementation science research methods. Improving anxiety treatment in PCMHI will address a major gap in VHA treatment options, given the high prevalence of anxiety in primary care, tendency for patients with anxiety to seek treatment in primary care rather than specialty mental health settings, and absence of Evidence-Based Psychotherapy (EBP) protocols addressing non-trauma related anxiety. Innovation: Modular (vs. standard) intervention designs offer advantages in efficiency, patient and provider satisfaction, efficacy, effectiveness, implementation, and sustainability. Other innovative aspects include the transdiagnostic approach and examination of fidelity to inform future implementation. Specific Aims: The specific aims are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post) in a multi-site RCT in which PCMHI providers deliver VAST, and examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants assigned to receive VAST, explore patient-level predictors of (a) early (8 weeks) and (b) overall (16 weeks) treatment response; and (3) Conduct a mixed-methods process evaluation of VAST implementation to examine rates of, barriers to, and facilitators of achieving and sustaining high-fidelity intervention delivery. Methodology: In this multi-site, hybrid type I effectiveness-implementation RCT, 178 adult Veterans with elevated anxiety symptoms will be recruited from primary care at two VHA sites. PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and participants will be randomized to condition. VAST (up to six biweekly 30-minute sessions) consists of a standard initial and final session as well as up to 4 CBT skills-based modules. The primary outcome (Overall Anxiety Severity and Impairment Scale) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 4, 8, 12, 16 (post) and 28 weeks (follow-up). Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to 16 weeks for participants receiving VAST compared to PCMHI usual care. Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response. A mixed- methods process evaluation will examine the proportion of PCMHI providers who achieve and sustain high- fidelity VAST delivery as well as barriers to and facilitators of high-fidelity delivery. Implementation/Next Steps: VAST will be disseminated to VHA PCMHI leadership and providers nationwide using several strategies, and a follow-up hybrid III trial will facilitate formal implementation in VHA PCMHI.